MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'avastin'. Sat, 03 Sep 2011 02:01:41 +0100 http://www.medworm.com/index.php?rid=5107895&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc4MfEOrnUtY%2F In a bid to salvage the breast cancer indication for Avastin, Roche’s Genentech unit has pitched to the FDA what it is calling a “middle-ground proposal” that would allow the drug to retain its indication and only for use with paclitaxel. The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide. The move comes just a few weeks after the completion of an extraordinary, two-day FDA advisory committee hearing in which panelists voted 6-to-0 to pull the breast cancer indication for Avastin. The drugmaker had appealed a decision last December by the agency t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107895 Mon, 08 Aug 2011 17:24:37 +0100 5107895 http://www.medworm.com/index.php?rid=5069826&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F51VWUJEh5j8%2F Earlier this month, the National Comprehensive Cancer Network, a non-profit group of oncologists whose guidance is closely followed by leading treatment centers, voted overwhelmingly in favor of maintaining its recommendation that Avastin should be used to treat breast cancer. The vote came shortly after an FDA panel voted 6-to-0 to revoke the breast cancer indication for Avastin. The endorsement is important because oncologists will likely continue to use Avastin even if FDA commish Margaret Hamburg rescinds the breast cancer indication. Roche and its Genentech unit had appealed a decision last December by the agency to pull the indication for their best-selling med after new studies showed Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069826 Tue, 26 Jul 2011 13:24:27 +0100 5069826 http://www.medworm.com/index.php?rid=5050880&cid=t_111609_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Ffda-decide-fate-cancer-drug-holds-life-hands%2F Back and forth goes the FDA when it comes to a decision regarding Avastin, the breast cancer treatment drug. The drug itself has an interesting history and relationship with the FDA. Back in 2004, Avastin received approval by the FDA. In 2007, the FDA suddenly pulled the approval, by a 5-4 vote. But only several months later re-granted the drug accelerated approval. Over the next couple of years it became a staple for women fighting breast cancer. Until last month, when the FDA announced it was questioning some of the studies done by the company and pulled approval once again. But what about the women who have been on it all these years? The debate is heated and not anywhere close to over yet. A study says it adds five months to your life, but now evidence says it actually marginally help... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=5050880 Tue, 19 Jul 2011 17:27:55 +0100 5050880 http://www.medworm.com/index.php?rid=5008184&cid=t_111609_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2F2NrKe40onN8%2F By Archelle Georgiou. The use of Avastin for breast cancer was addressed by the U.S. Food and Drug Administration this week. The outcome was devastating for Roche and an emotional one for many women who believe the FDA is subjecting them to a death sentence.  As usual, there are a variety of perspectives to take into consideration. The history: In 2008, Avastin was given preliminary approval by the FDA for the treatment of breast cancer on the condition that the company would do more studies to demonstrate its effectiveness. Many women have been successfully treated with Avastin — a billion dollar drug for Roche. But when Roche submitted the required follow-up studies in 2010, the data showed that there was no benefit from the drug for treating breast cancer.  Studies did not show ... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=5008184 Tue, 05 Jul 2011 13:00:08 +0100 5008184 http://www.medworm.com/index.php?rid=4992990&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLVsy771S9hA%2F The FDA may want to yank the breast cancer indication for Avastin, but the Centers for Medicare & Medicaid Services will continue to provide coverage, even if treatment amounts to off-label usage. “As long as doctors continue to prescribe it, we will continue to pay, even for an off-label use, until and unless some time in the future we decide to change our coverage policy. We have no such thing underway at this time,” a CMS spokesman tells us. “We often pay for off-label use of drugs, but not always.” The move will, no doubt, cheer many breast cancer patients and their loved ones, who feared the FDA would soon put Avastin out of reach (look here), now that an agency advisory panel unanimously voted - once again - to rescind the indication. The vote came earlie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992990 Fri, 01 Jul 2011 16:36:13 +0100 4992990 http://www.medworm.com/index.php?rid=4992996&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIKpuqSGxcXI%2F Good morning, everyone. And how are you today? Another beautiful morning is rising over the Pharmalot corporate campus. However, we will be rolling in the sidewalks early as we prepare for a long weekend on this side of the pond. Our modest agenda includes a dip in the pool, hanging with the short people, catching up on some research (with thanks to our sources) and one of our favorite sports - hunting for mice. What about you? Anything special planned? Maybe a ride in the country, a barbecue in the backyard or how about a day at the beach? This will be Independence Day, after all, so perhaps this is a good time to think of suggestions for trimming the national debt. The symbolism is heavy, yes? Whatever you do, have a great time and be safe. See you soon… Glaxo Kicks Off Sale Of OTC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992996 Fri, 01 Jul 2011 11:50:16 +0100 4992996 http://www.medworm.com/index.php?rid=4984687&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8Pxx2sLGKGM%2F After months of controversy, an FDA advisory panel yesterday voted unanimously to uphold an earlier agency decision to yank the breast cancer indication for Avastin, a widely used sold by Roche and its Genentech unit (see this). The run-up to the two-day meeting was highly contentious as the drugmaker accused the FDA panel of bias, there were behind-the-scenes debates over potential conflicts of interest among expert speakers, and patients and their families organized protests - online and in person. Clearly, more was at stake than the fate of a best-selling med, which remains available for treating other cancers. The hearing was also a referendum of sorts on the veracity of the FDA accelerated approval program and, by extension, the agency itself. We asked Daniel Carpenter, the Allie S. F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984687 Thu, 30 Jun 2011 12:45:07 +0100 4984687 http://www.medworm.com/index.php?rid=4984690&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnPwCL76CH9s%2F Concluding a rare, two-day hearing, an FDA panel has voted 6-to-0 to revoke the breast cancer indication for Avastin, dealing a huge blow to Roche and its Genentech unit, which now stand to lose an estimated $1 billion in annual sales. The drugmaker had appealed a decision last December by the agency to yank the indication, prompting a heated debate over the veracity of the FDA accelerated approval program. A final decision, however, rests with FDA commish Margaret Hamburg. Meanwhile, the FDA and Roche’s Genentech unit will provide additional written submissions by July 28, and the docket will remain open for public comment until then (see this). At the conclusion of the meeting, some patients were particularly vocal. “What do you want us to take!? We have nothing else!” shouted ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984690 Wed, 29 Jun 2011 20:07:35 +0100 4984690 http://www.medworm.com/index.php?rid=4953359&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVV5N71KRqKg%2F The FDA hearing officer who is presiding over the upcoming Avastin review has rejected a request from her agency colleagues to require all outside scientific experts who speak at the meeting to disclose financial ties to Roche’s Genentech unit or rival manufacturers. The June 17 request had been made by FDA lawyers in the name of greater transparency. The two-day event, which begins June 28, stems from an unprecedented decision last year by the FDA to yank the breast cancer indication for the best-selling Avastin cancer med. That came after results of four clinical studies showed the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks (see here). In response, Roche appealed the d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953359 Tue, 21 Jun 2011 18:10:01 +0100 4953359 http://www.medworm.com/index.php?rid=4953363&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFwKeDNIjZs4%2F Top of the morning to you. A shiny day is unfolding here on the Pharmalot corporate campus, where we are hustling assorted short people off to their last moments at the local school houses. This is cause for celebration. So please join us for a cup or two of stimulation. And we hope you will check out our 2 pm EDT webinar today on Social Media. Meanwhile, here are some tidbits from around the big, old world. Have a great day… European Union Approves Lilly Bydureon Diabetes Drug (Associated Press) Dentsply In Talks To Buy AstraZeneca Unit (Reuters) EMA Proposes Waiving Inspections Of US Plants Sometimes (InPharma Technologist) Calpers Taps CVS/Caremark To Manage Benefits (San Francisco Business Times) Abbott Hit By $4M Diagnostic Theft In Kentucky (Securing Pharma) Roche And Curis Ski... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953363 Tue, 21 Jun 2011 12:04:52 +0100 4953363 http://www.medworm.com/index.php?rid=4945197&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6lF6tGbTdbE%2F And so, another working week is about to draw to a close. This is, of course, our signal to daydream about weekend plans. For now, we intend to do some reading, catch up with our short people and promenade with the official Pharmalot mascots. And you? Anything special? Perhaps a drive in the country? A chance to meet with friends? Or maybe balance your checkbook and show the indebted nations how it’s done? Whatever your fancy, have a great time. Oh, and say ‘hi’ to Dad… FDA Reviewers Say Novartis Gout Drug Data Is Complicated (Reuters) Roche Faces Significant Hurdles For Avastin Breast Cancer Indication (Financial Times) UK Officials Say Pfizer Doing ‘Too Little’ As Plant Closes (BBC) FDA Approves Expanded Use Of Celgene Lymphoma Drug (Reuters) AstraZene... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945197 Fri, 17 Jun 2011 12:15:14 +0100 4945197 http://www.medworm.com/index.php?rid=4902696&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbKhZl7DkcDs%2F Hello, everyone, and nice to see you again. We apologize for the delay this morning, but we were having technical difficulties. To cope, we are having downing several cups of stimulation. Now, though, the time has come to tackle those meetings and deadlines. Meanwhile, here are some tidbits, including news from the ASCO meeting. Hope your day goes well and stay in touch… A Contraceptive Pill For Men With No Side Effects? (The Daily Mail) Merck And Ariad Drug Delays Sarcoma In Trial (Reuters) UK Pharma Industry In Crisis (Press TV) Roche Says Avastin And Chemo Cut Ovarian Cancer Growth (Bloomberg News) Bristol Melanoma Drug And Chemo Extended Life In Study (Reuters) Pfizer Divestiture May Hurt Its Credit Rating (Bloomberg News) Chinese Drugmaker Cited For Significant Pollution (East D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4902696 Mon, 06 Jun 2011 12:47:10 +0100 4902696 http://www.medworm.com/index.php?rid=4795058&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7SCLQKXldE8%2F Good morning, everyone. Another working week is about to draw to a close, which is our signal to daydream about weekend plans. Our agenda includes watching one of the short people play lacrosse, taking a long walk or two with Mrs. Pharmalot and catching up on some reading. And you? Will you ever clean out the garage? Maybe this is a chance to enjoy the great outdoors? Or simply count your blessings? Whatever you do, have a swell time. And, of course, say hi to mom… CVS Discloses SEC Inquiry Into Caremark (Associated Press) Former Bristol-Myers Chemist Indicted For Killing Her Husband (Daily Record) CVS Will Keep Caremark (The Street) Pfizer Returns Ashtma Med To Rigel (Xconomy) Most New Drugs Marketed Without Comparative Data (Reuters) Novartis Wins Expanded Indication For Pancreatic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4795058 Fri, 06 May 2011 12:10:08 +0100 4795058 http://www.medworm.com/index.php?rid=4789637&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcIcZrWjZnAo%2F Good morning and nice to see you again. A busy morning here on the Pharmalot corporate campus, where we have been hustling various short people off to the local school house for some learning. To cope, we are, of course, sipping that needed cup of stimulation. Please feel free to join us. Meanwhile, we are gearing up for another busy day of phone calls and our own version of R&D. And so here are some tidbits as you gear up for your own challenges. Hope all goes well and be in touch… Allergan Licenses Drug For Retinal Disease (Reuters) Osteoporosis Drug Linked To Rare Thigh Fractures (Wall Street Journal) Ranbaxy May Pay $1B Fine For Manufacturing Problems (Economic Times) Glaxo Is Ready To Settle Another 1,000 Avandia Lawsuits (Bloomberg News) Merck And Astra Asthma Pills As Goo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789637 Thu, 05 May 2011 12:09:04 +0100 4789637 http://www.medworm.com/index.php?rid=4768246&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwCO2OFhmr2I%2F Earlier this week, the long-awaited results of a head-to-head trial comparing two different drugs marketed by Roche’s Genentech unit were leaked. The upshot? The older Avastin cancer med is about as effective as Lucentis in treating a form of age-related macular degeneration. The significance? Avastin is not approved to treat the eye afflication, but is widely used off-label and costs up to $50 injection. Lucentis is approved to treat AMD, but costs an eye-popping $2,000 for an injection. The results, which are now available in The New England Journal of Medicine (read the abstract), placed Roche in a tight spot. The drugmaker is in the unenviable position of having to justify the cost of one of its drug that generates a significant revenue, but is not proven to be any more effective... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768246 Fri, 29 Apr 2011 14:29:25 +0100 4768246 http://www.medworm.com/index.php?rid=4762934&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FohIUuwRLw4k%2F The results of an eagerly anticipated clinical trial are leaking out and early indications are that the Avastin cancer med is about as effective as Lucentis in treating a form of age-related macular degeneration, The New York Times writes. And while there are some caveats - full results will not be disclosed until Sunday - the message is that execs at Roche and its Genentech unit may find themselves in a quandary. Why? Avastin is an older med approved to treat various cancers, but not the eye afflication that is common among the elderly. However, many docs have successfully used the drug on an off-label basis, especially since the price tag is low - up to $50 for injection. By comparison, Lucentis is approved to treat AMD, but costs $2,000 for an injection. And Genentech sells both drugs. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762934 Thu, 28 Apr 2011 17:04:56 +0100 4762934 http://www.medworm.com/index.php?rid=4704954&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNe6vaqZAGEo%2F Despite weeks of haggling, Roche and the FDA remain unable to agree on the questions that must be addressed during the upcoming June hearing that will be held to decide whether the agency will proceed with plans to remove the metastatic breast cancer indication for the Avastin. The two sides are so far apart, in fact, that each one has submitted separate documents summarizing their differing views of the key questions to be addressed. Some quick background: The FDA decided to yank the breast cancer indication after results of four clinical studies showed that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; devel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704954 Tue, 12 Apr 2011 16:31:32 +0100 4704954 http://www.medworm.com/index.php?rid=4693505&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1ht08wD4WlQ%2F The run-up to what will be a closely watched FDA meeting this coming June to review the Avastin cancer med is prompting some interesting behind-the-scenes sparring between the agency and Roche. To wit, in a recent letter to different FDA officials, Covington & Burling attorney Michael Labson, who represents Roche’s Genentech unit, accused the FDA Oncologic Drugs Advisory Committee of bias. Why? In his view - and obviously, the view of the drugmaker - there are concerns about “objectivity and fairness.” To underscore this contention, Labson writes in his March 10 missive that nearly all members of the committee last July voted to withdraw FDA approval for the metastatic breast cancer indication for Avastin (back story). And since then, various committee members were q... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693505 Fri, 08 Apr 2011 13:26:24 +0100 4693505 http://www.medworm.com/index.php?rid=4642994&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCNw4FaSlyn0%2F To prompt drugmakers to follow through more quickly on post-marketing studies required as part of the controversial acceleted approval program, several FDA officials suggest the agency make use of an existing provision of a 2007 law - issuing fines of up to $10 million. And the FDA may also require post-marketing studies get under way before expedited approval is granted, according to agency officials who floated the possibilities in a new article in the Journal of the National Cancer Institute. The tougher approach for oncology meds is being considered in the wake of considerable handwringing after two episodes last year that questioned the veracity of the FDA accelerated approval program. Last June, Pfizer withdrew a drug used to treat acute myeloid leukemia, or AML, after a study found... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642994 Mon, 28 Mar 2011 15:46:53 +0100 4642994 http://www.medworm.com/index.php?rid=4592642&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F03%2F15%2F2011-nccn-conference-new-treatment-options-lead-to-steady-progress-against-ovarian-cancer%2F Recommendations stemming from recent clinical trials highlight notable updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Ovarian Cancer at the National Comprehensive Cancer Network® (NCCN®) 16th Annual Conference. Although finding effective screening tools remains a priority, new treatment options for women with ovarian cancer, such as the ones outlined in the [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4592642 Wed, 16 Mar 2011 01:20:30 +0100 4592642 http://www.medworm.com/index.php?rid=4566304&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F03%2F08%2Fohio-state-university-reports-that-ovarian-cancer-drug-bevacizumab-is-not-cost-effective%2F An analysis conducted by Ohio State University cancer researchers found that adding the targeted therapy bevacizumab to the first-line treatment of patients with advanced ovarian cancer is not cost effective. An analysis conducted by Ohio State University cancer researchers found that adding the targeted therapy bevacizumab [Avastin®] to the first-line treatment of patients with advanced [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4566304 Wed, 09 Mar 2011 00:51:51 +0100 4566304 http://www.medworm.com/index.php?rid=4549937&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fakf6ENsJfZk%2F How is this for timing? The UK’s NICE has rejected Roche’s Lucentis med for treating diabetic macular oedema because of insufficient value for the price. And the decision comes shortly before the US National Eye Institute releases results of a trial of 1,200 patients with age-related macular degeneration given Lucentis or Avastin, another Roche drug that costs less to treat eye problems. The rejection by the UK agency underscores the difficulties Roche has encountered with Lucentis, a newer medication the drugmaker has marketed for different eye ailments. And price has been a big issue. There are “reservations about the cost effectiveness estimates provided in the manufacturer‟s submission,” stated the UK’s National Institute for Health and Clinical Excellen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4549937 Fri, 04 Mar 2011 15:44:41 +0100 4549937 http://www.medworm.com/index.php?rid=4549940&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb1ZPBPi-rZM%2F And so another work week will soon draw to a close. This means, of course, that the time has come to daydream about weekend plans. Our agenda includes watching our shortest person in a martial arts tournament, dancing with Mrs. Pharmalot to cajun music, promenading with the official Pharmalot mascots and, as usual, catching up on sundry chores. What about you? Perhaps there will be time to see a picture show? Update your Facebook page? Get a jump on spring cleaning? Whatever you do, have fun. Meanwhile, here is the news of the world. See you soon… FDA Strengthens Birth Defect Warning For Topamax (Associated Press) Organon Workers Protest Merck Plan To Shut Plant (DutchNews) High-Profile Lawyer Sentenced For Running Internet Pharmacy (Miami Herald) Pfizer To Help Aurobindo With FDA Pr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4549940 Fri, 04 Mar 2011 13:07:31 +0100 4549940 http://www.medworm.com/index.php?rid=4517347&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEDGy36SFjlE%2F Two months after the FDA began the process of removing the breast cancer indication for Roche’s Avastin med, the agency has granted an appeal filed by the drugmaker and scheduled a two-day hearing on June 28 and 29 to review its decision. In the interim, Avastin will continue to be approved to treat breast cancer, along with indications for treating bowel, lung, brain and kidney cancers. The agency decided to yank the breast cancer indication after results of four clinical studies showed that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; development of perforations in the body, including in the nose, stomach... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4517347 Thu, 24 Feb 2011 22:57:50 +0100 4517347 http://www.medworm.com/index.php?rid=4517354&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcpY5QOLJzcA%2F Top of the morning, everyone. Another shiny day is unfolding here on the Pharmalot corporate campus, where the short people are lollygagging because the local schoolhouse is closed for winter break. This requires an additional cup of stimulation - our flavor today is Rain Forest Nut. Please join us, or grab a bottle of water, if you prefer. Meanwhile, here are some assorted items from around the world, such as it is. Hope your day is rewarding and do stay in touch… Can Sanofi Retain The Genzyme Culture? (Nature) Germany Probes Wholesalers Over HIV Med Fraud (Associated Press) Pfizer Taps Brewer To Enter Insulin Market (Bloomberg News) Feds Raid Florida Pill Mills (Associated Press) NicOx Will Appeal FDA Rejection Of Its Painkiller (Reuters) Elan Inks Strategic Clinical Deal With PPD ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4517354 Thu, 24 Feb 2011 13:04:44 +0100 4517354 http://www.medworm.com/index.php?rid=4507581&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNvoAwJK_fUk%2F Oncology is a big market and getting bigger, of course, but which drugmaker ranks highest is most effective in reaching oncologists? A recent poll of 475 medical and hematological oncologists found that Novartis commands a leading 12.5 share of details, although its position slipped slightly from the previous year, while Roche jumped from 10 percent to 12 percent thanks to combining sales teams with Genentech. Meanwhile, Sanofi-Aventis slid from 8 percent to about 6.5 percent thanks to looming patent expirations for Taxotere and Eloxatin, according to ImpactRx, a market research firm. In line with the results, Genentech tied with OSI Pharmaceuticals as the drugmaker with a top tier sales force, followed by Biogen Idec, Amgen, Eli Lilly and Celgene (here is the report). For the second year ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507581 Tue, 22 Feb 2011 14:08:29 +0100 4507581 http://www.medworm.com/index.php?rid=4489977&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTtqj3J1HvPI%2F Hello and nice to see you again. Having successfully deposited one of the short people at the local schoolhouse, we are celebrating with yet another cup of stimulation. Please join us or grab a bottle of water, if you prefer, and get ready for another day of meetings and deadlines and who-knows-what-else. Meanwhile, here are some fresh tidbits. Have a good one and stay in touch… China To Help Domestic Drugmakers Expand Overseas (Global Times) AstraZeneca Pays $150M To Settle More Seroquel Lawsuits (Bloomberg News) Amgen Haunted By Medicare Worries (Forbes) Glaxo Cuts Neuroscience Jobs In North Carolina (MedCity News) UK’s NICE Endorses Celgene Blood Cancer Med (Reuters) Allergan Wins Wider Use For Lap-Band Device (Wall Street Journal) EU Parliament Approves Tougher Counterfeit ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4489977 Thu, 17 Feb 2011 13:03:30 +0100 4489977 http://www.medworm.com/index.php?rid=4455484&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmsXo3RF7Rpo%2F For much of the past year, the FDA accelerated approval program has come under withering scrutiny. Last June, Pfizer withdrew a drug used to treat acute myeloid leukemia, or AML, after a study found a lack of clinical benefit and an unexpected number of deaths. But the study didn’t get under way until four years after approval was granted in 2000 (back story). More recently, the FDA decided the breast-cancer indication for Roche’s Avastin should be withdrawn after studies found patients on the med and chemotherpay didn’t survive longer than those given chemo alone. And Avastin patients suffered more serious side effects. The decision amounted to an about-face, having endorsed the indication in 2008 under accelerated approval (look here). And so the FDA’s Oncologic Drugs... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455484 Wed, 09 Feb 2011 14:06:27 +0100 4455484 http://www.medworm.com/index.php?rid=4450523&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FujKHiAQXNLE%2F Hello, everyone, and welcome to a brand new day. Here on the Pharmalot corporate campus we are getting our start by hustling our short people off to the local school houses. And you? No doubt, you are readying for another round of meetings and deadlines. To help you along, we have gathered some tidbits. Meanwhile, please join us for a cup of stimulation. Hope your day goes well and stay in touch… Merck-Serono Opens R&D Site, Adding 100 Jobs (Boston Business Journal) Roche’s Avastin Works In Late-Stage Trial For Ovarian Cancer (Reuters) Teva Earnings Miss Analyst Estimates (Bloomberg News) Has RNAi Fever Cooled? (The New York Times) Black Box Warnings Are Applied Inconsistently (Health Day) Glaxo To Move Philadelphia Offices, Denies Job Cuts (Philadelphia Inquirer) Schizoph... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450523 Tue, 08 Feb 2011 13:06:18 +0100 4450523 http://www.medworm.com/index.php?rid=4446031&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkOSamOvJCZE%2F In a brief interview late last week, Roche ceo Severin Schwan complained that his best-selling Avastin cancer treatment is not viewed appropriately by investors. “People talk as if Avastin is a problem, but it is a product with over six billion Swiss francs (in sales) and it still has growth potential,” he told Dow Jones. “Other companies would long for a problem like this.” Well, sort of. It is certainly true that Avastin rings registers; worldwide sales last year totaled about $6.8 billion and rose 9 percent, which meant this one drug accounted for 14 percent of total Roche sales. But you may recall the FDA recently decided it wants to rescind the breast cancer indication for the drug, which is approved to treat bowel, lung, brain and kidney cancers. This means t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4446031 Mon, 07 Feb 2011 20:14:55 +0100 4446031 http://www.medworm.com/index.php?rid=4429227&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6enU1acrRKw%2F File this under ‘going from bad to worse.’ Just a few weeks after the FDA decided to rescind the breast cancer indication for Avastin, the med sold by Roche’s Genentech unit is now linked to an increased risk of causing a fatal reaction when combined with chemotherapy, according to a study in the Journal of the American Medical Association (here is the abstract). The side effects occurred in 2.5 percent of patients given Avastin and other meds, compared to 1.7 percent for patients treated with just chemo. The study examined 16 clinical trials of Avastin for breast, lung and other cancers involving 10,217 patients. The most common side effects leading to death were hemorrhage, gastrointestinal tract perforation and infections in patients with weakened immune systems. And t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4429227 Wed, 02 Feb 2011 13:34:26 +0100 4429227 http://www.medworm.com/index.php?rid=4424450&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbxEIYiZB3gI%2F Hello, everyone, and nice to see you again. Another wintry day here on the Pharmalot corporate campus where, as usual, we are doing our best to hustle the short people off to the school houses. And of course, we armed with a shovel and a cup of stimulation - our flavor today is Gingerbread - as we prepare for the next round of deadlines and meetings. We trust you are doing the same, yes? So here are some tidbits to help you get started. May your day be fruitful… Roche Returns Diabetes Drug To Ipsen Over Side Effects (Bloomberg News) Sanofi’s Multaq On Latest FDA Safety Probe List (Reuters) China Arrests 18 People For Making Fake Avastin (Shanghai Daily) Biogen Profit Falls But Tysabri Sales Were Up (Reuters) Former Pfizer Chemist Gambles On Biofuel (Biodiesel Magazine) Valeant ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424450 Tue, 01 Feb 2011 13:08:26 +0100 4424450 http://www.medworm.com/index.php?rid=4331237&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FibJkV92R2cc%2F In a move that will hearten breast-cancer patients, several large insurers will continue to cover the Avastin medication, even though the FDA is taking steps to remove that indication for the Roche drug. The agency is doing so after analyzing clinical studies that found Avastin does not prolong overall survival or provide a sufficient benefit in slowing disease progression to outweigh serious side effects (back story). Among the insurers are UnitedHealth and WellPoint, which have cited a recommendation by the National Comprehensive Cancer Network, a non-profit group of oncologists whose guidance is closely followed. However, eight of the 33 members on its breast cancer panel have various ties to Roche and its Genentech unit as advisory board members, speakers, consultants, expert witnesses... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331237 Tue, 11 Jan 2011 13:26:25 +0100 4331237 http://www.medworm.com/index.php?rid=4331242&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0hEzGdmPUxo%2F Late last week, the Medicare contractor that provides coverage for several states unexpectedly posted a notice on its web site that it would no longer pay for Roche’s Avastin medication for treating breast cancer after January 29. But late Friday, Palmetto, which is a subsidiary of BlueCross BlueShield of South Carolina, did an embarassing about face and rescinded its decision (read this). The move came after the FDA last month began the process of removing the breast cancer indication for the medication following a review that found clinical studies indicated Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. At the same time, there were serious side effects (see here). The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331242 Mon, 10 Jan 2011 13:22:01 +0100 4331242 http://www.medworm.com/index.php?rid=4322692&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZwTtD0ctKmk%2F The debate over the breast cancer indication for Avastin was one of the more highly charged issues last year. After clinical studies revealed the Roche med did not prolong overall survival and caused serious side effects, an FDA panel recommended withdrawing approval. To the applause of some consumer advocates (see here), the agency last month took that step, even though many breast cancer patients urged the FDA to preserve an option they say worked for some people (look at this). After deciding to unravel the indication, however, the FDA was criticized by Republicans for using cost as a reason - the treatment carries a price tag of about $80,000 a year - amid growing concern that healthcare rationing is becoming an issue for regulators. Now, however, Richard Pazdur, who heads the FDA&#821... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4322692 Fri, 07 Jan 2011 14:37:39 +0100 4322692 http://www.medworm.com/index.php?rid=4314221&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6v6OHNUJQ_Y%2F Greetings, everyone. How are you this morning? We trust you feel invigorated as another day gets under way. As usual, we are brewing a delicious cup of stimulation and poking around for interesting items. Heard something fascinating? Send us a note. Meanwhile, we hope your workload is manageable and much gets accomplished. Catch you soon… Pfizer Faces 1,200 Chantix Lawsuits (Birmingham News) Spectrum To Make Biosimilar Of Roche’s Rituximab (Reuters) Roche Wins Wider Approval For Actemra (Bloomberg News) Evidence Links Avastin To Heart Failure In Breast Cancer Patients (HealthDay) EMA Worries Over Foreign APIs (InPharma-Technologist) J&J Files For FDA Approval Of Bloodthinner (Associated Press) Celgene Submits New Applications For Cancer Meds (Reuters) Xoma Inks $505M Diabe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4314221 Wed, 05 Jan 2011 12:48:44 +0100 4314221 http://www.medworm.com/index.php?rid=4277834&cid=t_111609_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Favastin-the-fdas-disappointing-decision%2F2010.12.21 “With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. . . We can’t allow this government takeover of health care to continue any longer.” That quote, courtesy of this morning’s [Dec 17th] Washington Post, incensed me to such a degree that I am writing this blog despite the two deadlines I have today. The speaker is Sen. David Vitter (R-La). The “disappointing decision” he refers to: The FDA’s decision to remove the breast cancer indication for Avastin (bevacizumab). I wrote about this earlier, and you can read the post here, but that was before yesterday’s [Dec 16th] decision. I’m not going to comment here on the benefits or risks of Avasti... Better Health blogs http://www.medworm.com/rss/comments.php?id=4277834 Tue, 21 Dec 2010 16:00:00 +0100 4277834 http://www.medworm.com/index.php?rid=4265576&cid=t_111609_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F12%2Ffda-recommends-suspending-avastin-breast-cancer%2F The United States Food and Drug Administration is recommending that use of Avastin (bevacizumab) be suspended in the treatment of breast cancer because of too severe side effects with too little efficacy. FDA officer Dr. Janet Woodcock comments. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=4265576 Thu, 16 Dec 2010 21:00:51 +0100 4265576 http://www.medworm.com/index.php?rid=4266266&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBvkC4XWP9nc%2F After months of anticipation, the FDA has started the process of removing the breast cancer indication for Roche’s Avastin med, dealing a huge setback to the drugmaker. The decision comes after months of intense debate over the merits of such a move and is estimated to cost Roche about $1 billion in annual sales. Roche plans to appeal in hopes of being granted a hearing. The European Medicines Agency, meanwhile, is not taking the same step. In explaining their decision, FDA officials cited the results of four clinical studies and determined the data indicate Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266266 Thu, 16 Dec 2010 16:48:27 +0100 4266266 http://www.medworm.com/index.php?rid=4245600&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYYaNnxW-kJ0%2F Two weeks ago, Roche sent docs in the UK a letter warning them of the risk of osteonecrosis, or jaw bone damage, in patients who are being treated with its Avastin medication and concurrent or previous use of chemotherapy or bisphosphonates. This group of meds are taken to inhibit the loss of bone mass in people with osteoporosis and have been linked to jaw bone damage and thigh fractures (see here). Avastin is used to treat colorectal, kidney and lung cancer, as well as glioblastoma, but may work to exacerbate soft-tissue damage that plays a role in causing osteonecrosis. So far, there have been 55 cases reported of osteonecrosis, or a rate of less than one in 10,000 patients. Overall, Avastin has been given to about 800,000 cancer patients. However, the letter was distributed only to doc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4245600 Thu, 09 Dec 2010 18:40:31 +0100 4245600 http://www.medworm.com/index.php?rid=4241950&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhR2DaFik_1g%2F The UK’s National Institute for Health and Clinical Excellence has rejected the use of Roche’s Avastin for treating breast cancer on the grounds that the med offers “limited and uncertain benefit” for patients compared with existing treatments. Roche had calcuated the total average cost of treating a patient with Avastin plus chemotherapy is more than $52,000. “Unfortunately, we did not receive any evidence from the manufacturer to show that (Avastin) can significantly lengthen a patient’s life or, importantly, offer a better quality of life than existing treatments. Although the data seemed to show that the drug may slow the growth and spread of the cancer, the size of this effect varied between studies. Furthermore, it was extremely unclear that the be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4241950 Wed, 08 Dec 2010 15:41:47 +0100 4241950 http://www.medworm.com/index.php?rid=4241952&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FM-_2VCTpo0I%2F Good morning, everyone. Our apologies for the late start but we are having technical difficulties and attempting to resolve them. Nonetheless, we are endeavoring to provide you with the usual flow of interesting items. Here are a few to get us all started. We hope your day goes well. As for us, we are going to down a much-needed cup of stimulation. Stay in touch… Merck Drops Fast-Acting Claim For Allergy Pill (Dow Jones) US Moves Toward Drug Development Center (Reuters) Orphan Drug Discounts Ended For Kids Hospitals (New York Times) Cephalon Buys Rights To Stem Cell Therapies (Bloomberg News) Caraco Pharma Considers Going Private (Detroit News) China To Prices On Some Drugs By 19 Percent (PharmaTimes) Sanofi-Aventis Signs Licensing Deal For HIV Drug (Montreal Gazette) (Source: Pharma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4241952 Wed, 08 Dec 2010 13:54:02 +0100 4241952 http://www.medworm.com/index.php?rid=4134257&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3vRiI0mzjQc%2F In an effort to promote Lucentis for treating age-related macular degeneration, Roche’s Genentech is offering a confidential rebate to retinal specialists who may otherwise use Avastin, which is another med sold by the same biotech. Why bother? Avastin is not approved to treat AMD, but many docs believe it is equally effective. Then there’s price - $20 to $30 an injection versus $2,000 for Lucentis. What kind of rebates? These are offered based on volume and increased use. For volume, they range from 0.25 percent to 1.5 percent of wholesale cost, according to The New York Times. One example in a document obtained by the paper: using 600 vials a quarter yields a $8,775 rebate. Added use offers rebates from 1 percent to 1.5 percent - another 0.01 percent usage qualifies for a 1 p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4134257 Thu, 04 Nov 2010 11:35:03 +0100 4134257 http://www.medworm.com/index.php?rid=4106064&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjEVliExIRuE%2F Hello, everyone. Nice to see you again. Hope your weekend was refreshing and relaxing. Now, of course, the routine returns as we gear up for those meetings and deadlines. To cope, we are brewing our favorite cup of stimulation. Please join us as we peruse the news of the world and continue our quest for interesting items. Tidbits are always welcome. Hope your day goes well and see you soon… Novartis Menveo Vaccine Protects Infants In Study (Bloomberg News) Glaxo Cuts Cervarix Price By 30 Percent In Canada (Reuters) Chinese SFDA Steps Up Fake Avastin Investigation (Shanghai Daily) Alcon Names Dan Vasella As Chairman (MarketWatch) FDA Finds High Levels Of Peroxide In Batch of Crospovidone (InPharma-Technologist) J&J Faces UK Class-Action Suit Over Hip Devices (The Daily Mail) Penn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106064 Mon, 25 Oct 2010 11:40:04 +0100 4106064 http://www.medworm.com/index.php?rid=4082330&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJycNCO0uTsg%2F Nobody likes a conundrum, but that’s what Roche may face now that a new paper found that both Lucentis and Avastin were no riskier for treating age-related macular degeneration, or AMD, than two other therapies, including Pfizer’s Macugen. The paper, which was published in the Archives of Ophthalmology, reviewed nearly 147,000 Medicare beneficiaries who received treatment for AMD in 2005 and 2006, and who were tracked through 2007 for heart attacks, strokes and bleeding (see the abstract). Here is the issue: Roche owns Genentech, which sells both Lucentis and Avastin, although only Lucentis is approved by the FDA to treat AMD. Nonetheless, the Avastin cancer med is used off-label by many ophthalmologists because it is much cheaper - about $1,950 versus $30 per dose. Genentech h... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4082330 Tue, 19 Oct 2010 12:15:30 +0100 4082330 http://www.medworm.com/index.php?rid=3994343&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJSN3QSy3_u0%2F Good morning, folks. Another shiny day is emerging as we hustle the short people off to the local schoolhouse and busy ourselves with the news of the world. Speaking of which, the House passed a bill that would ban corporate execs from doing business with Medicare and Medicaid if their companies were convicted of fraud (take a peek). Now, though, the time has come for a cup of stimulation. Please join us, and have a great day… Merck Will Review Planned Facility Closing (Radio Netherlands) Perils For Pill Pushers (The Financial Times) FDA Finds Risk In Glaxo Rotarix Vaccine Data (Reuters) European Parliament Endorses Drug Monitoring Rules (PharmaTimes) Clinical Trials In Russia & Eastern Europe Fell In 2009 (OutsourcingPharma) Fake Avastin Hurts 61 People (Shanghai Daily) Abbott ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994343 Thu, 23 Sep 2010 12:03:27 +0100 3994343 http://www.medworm.com/index.php?rid=3973113&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvMsYZlmD0us%2F As the FDA nears a decision on what to do about a metastatic breast cancer indication for Roche and Genentech’s Avastin medication, a growing number of people are petitioning the agency to maintain the status quo. Last month, you may recall, an FDA advisory panel recommended approval be withdrawn for treating breast cancer. The move came after two recently released studies - which were undertaken as a condition of approval - found that patients given Avastin and chemotherapy didn’t survive longer than those given chemo alone. Patients also suffered serious side effects. Agency critics argue the indication should be yanked because the FDA based its decision on what they say is an inadequate endpoint - progression-free survival - and the FDA should have required more trials instead o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973113 Wed, 15 Sep 2010 13:28:47 +0100 3973113 http://www.medworm.com/index.php?rid=3933263&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKEsJWhUkM-w%2F The speculation earlier this week that Roche was planning a round of cutbacks is, in fact, on the money. After a scheduled managerial meeting, the drugmaker issued a statement using the usual euphemisms to signal job losses - Roche will “adapt cost structures and accelerate productivity improvements.” There were scant details provided, other than that the entire organization will be reviewed in coming months and an announcement will be made by year’s end. One analyst tells Reuters the cuts could involve up to $1.9 billion in cost savings and will likely target salespeople, particularly in the US, and R&D. Of course, Roche has already rejiggered R&D in the wake of the Genentech acquisition. The move is hardly surprising, though, given recent setbacks Roche has en... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3933263 Fri, 03 Sep 2010 12:06:21 +0100 3933263 http://www.medworm.com/index.php?rid=3915289&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fhuv0ECHQp-M%2F The drugmaker recently discussed cutbacks at a management meeting and the number of jobs being considered for elimination are expected to be in the thousands, and come not only from sales and marketing, but also research and development and pharma administration, according to the Swiss newspaper, Sonntag. “This will not only concern a few hundred people but many more. And the job cuts will not be made in one single country but on a worldwide scale,” the paper quoted one source, who also indicated the announcement will be made this week, although a Roche spokesperson tells Reuters that no decision will be made that soon. “We are always working to improve productivity and will continue to do so. But it is too early to speculate on potential job cuts,” Reuters reports... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915289 Mon, 30 Aug 2010 12:15:24 +0100 3915289 http://www.medworm.com/index.php?rid=3907785&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnOh-g8JZPUg%2F A sunny day is unfolding here on the Pharmalot corporate campus, where the mascots are happily frollicking among the weeds. As for us, we are brewing the mandatory cup of stimulation. What about you? Heading off toward your own campus? Prepping for those meetings and deadlines? Whatever you encounter, we hope your day goes well. One housekeeping note: we will break early today to shuffle one of the short people off to an institution of higher learning. See you soon… Advanced Melanoma Treatment Shrinks Tumors: Study (Reuters) Cephalon CEO Takes A Medical Leave Of Absence (Bloomberg News) Drugmakers Experiment With Design (The Financial Times) Celgene Has Been Plotting Revlimid Challenge (The Wall Street Journal) CVS/Caremark Closes Mail-Order Facility And Cuts 400 Jobs (The Birmingham... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3907785 Thu, 26 Aug 2010 11:32:58 +0100 3907785 http://www.medworm.com/index.php?rid=3885343&cid=t_111609_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Favastin-for-breast-cancer-will-the-fda-revoke-it%2F2010.08.19 Time to get back up on my soap box. Next month the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month. The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing. Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other c... Better Health blogs http://www.medworm.com/rss/comments.php?id=3885343 Thu, 19 Aug 2010 20:00:00 +0100 3885343 http://www.medworm.com/index.php?rid=3845286&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPw1WMPduq3k%2F Hello, everyone, and welcome to another working week - unless you happen to be on vacation. For those of us who remain very much grounded in the routine, however, today ushers in yet another series of meetings and deadlines. So please join us for the mandatory cup of stimulation as we scan the news of the world. We hope your weekend was refreshing and today is a good one. Stay in touch… Avastin Gives Best Lung Cancer Survival Rate: Study (Reuters) FDA Cites Dendreon For Misleading Provenge Material (Dow Jones) Gastroenterologists Prescribing Humira Off Label For Ulcerative Colitis (PharmaTimes) India’s Lambda Buys Biovail’s CRO (Outsourcing Pharma) SSRIs Are Not Effective For Autism: Study (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3845286 Mon, 09 Aug 2010 11:43:19 +0100 3845286 http://www.medworm.com/index.php?rid=3784498&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtlfhLDQCC1Y%2F Being rejected by an FDA advisory committee is never fun. All sorts of things hang in the balance, so it is perfectly understandable when executives from the drugmaker appearing before a panel get upset and frustrated. But given that professional relations with the FDA are important, some of them may need to bite their tongues before saying too much. Take Stefan Frings. He is the Avastin director at Roche, which two days ago suffered a serious blow when an FDA committee voted to recommend the agency withdrawal approval for Avastin as a breast-cancer treatment (back story). Avastin is already a big seller at $6 billion or so annually, but Roche stands to lose an estimated $1 billion in sales if the FDA does withdraw the approval. And so during a conference call yesterday with analysts, Frin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3784498 Fri, 23 Jul 2010 14:37:37 +0100 3784498 http://www.medworm.com/index.php?rid=3780355&cid=t_111609_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fbreast-cancer-diagnosis-and-treatment-can-women-trust-it%2F2010.07.22 The news wasn’t good this week for women concerned about breast cancer. First came the story that some women were diagnosed with breast cancer, very early stage, had treatment –- including disfiguring surgery -– and then found out they never had cancer in the first place. The pathologist goofed, maybe even a second pathologist also misread the biopsies. How does this happen? Not surprisingly it comes back to the clinical experience of the doctor. Properly diagnosing breast cancer, whether through radiology scans or pathology biopsies is not always easy. And in many communities the general radiologists and pathologists just don’t have enough specialized experience. This leads to mistakes, especially when the suggestions of possible cancer are subtle and minute. (more…) ... Better Health blogs http://www.medworm.com/rss/comments.php?id=3780355 Thu, 22 Jul 2010 21:00:33 +0100 3780355 http://www.medworm.com/index.php?rid=3772462&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLzIE6gpetxY%2F An FDA advisory committee dealt a huge setback to Roche by voting 12 to 1 to recommend the agency withdraw approval for the multibillion-dollar Avastin cancer drug to be used to treat breast cancer. Avastin should generate $6.5 billion in sales this year, with about $1.2 billion coming breast cancer usage, according to Sanford Bernstein analyst Tim Anderson. Unless, of course, the agency revokes the breast cancer indication. Avastin, by the way, is the first med to fight cancer by blocking the growth of blood vessels that feed tumors, a process called angiogenesis. It targets a chemical signal known as vascular endothelial growth factor, or VEGF. The med is also approved for brain, lung and colon tumors, and costs about $50,000 a year. The panel vote may raise further questions about the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772462 Tue, 20 Jul 2010 22:08:48 +0100 3772462 http://www.medworm.com/index.php?rid=3772467&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcFuL0NnhnWQ%2F Two years ago, the FDA approved Avastin to combat breast cancer, even though an advisory panel determined that risks such as high blood pressure and death outweighed the benefit of slowing the spread of tumors. The agency, however, acted under its accelerated approval program and the move pumped up sales of a Roche drug that is also used to treat brain, lung and colon tumors. Now, though, Avastin is on trial again. Another FDA panel today will decide whether use of the $50,000-a-year med should be continued, expanded, or halted after two studies - which were undertaken as a condition of approval - found patients given Avastin and chemotherpay didn’t survive longer than those given chemo alone. And Avastin patients also suffered more serious side effects. This is the second time in re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772467 Tue, 20 Jul 2010 14:02:57 +0100 3772467 http://www.medworm.com/index.php?rid=3740828&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FO-Um2l3abYw%2F And so another work week will soon draw to a close. And not a moment too soon, yes? After the heat of the past few days, a cooling off is a good thing. Our plans are rather modest - a dip in the pool and a bit of exercise which, as always, includes promenading with the official Pharmalot mascots. Of course, some Avandia reading is de rigeur these days, too. Whatever is on your agenda, we hope your weekend is pleasant. Meanwhile, here are some headlines to help you along. Take care… UK’s NICE Rejects Roche’s Avastin For Metastatic Breast Cancer (Bloomberg News) J&J Recalls More Tylenol And OTC Products (Reuters) Alcon Directors Create Legal Fund For Novartis Battle (PharmaTimes) European Regulator Starts Avandia Safety Review (EMA statement) An AIDS Vaccine Appears On... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3740828 Fri, 09 Jul 2010 11:20:32 +0100 3740828 http://www.medworm.com/index.php?rid=3676897&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqLtn3zuuNJc%2F In a blow to its plans to grow beyond oncology, Roche has delayed development of its taspoglutide by at least 12 to 18 months after studies showed a higher-than-expected rate of side effects, including skin reactions, digestive symptoms, cardiovascular and respiratory probelms. (here is the statement from Ipsen, which licensed the drug to Roche). More time is needed to identify patients who may be sensitive to the drug and and remove them from the trials. Roche’s oncology franchise, which includes Herceptin, Avastin and Tarceva, accounts about 50 percent of its pharma sales. The drugmaker planned to seek FDA approval next year for its med, a once-weekly injectable that would compete with Byetta, a twice-a-day injectable from Lilly and Amylin, which hope to transform their own diabete... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3676897 Fri, 18 Jun 2010 12:53:36 +0100 3676897 http://www.medworm.com/index.php?rid=3671692&cid=t_111609_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fa-tv-physician-is-not-your-doctor-or-coach%2F2010.06.17 A German physician wrote me about this, so while CNN may have an international reach, it’s not always with an adoring audience. The physician was reacting to the weekend “Paging Dr. Gupta” program, which Dr. Gupta referred to once as “SG, MD.” The first thing that struck me was his introduction, in which he said: “I’m your doctor. I’m also your coach.” Later in the program he said: “Think of this as your appointment. No waiting. No insurance necessary.” I find this very troubling. He’s not my doctor. He’s not my coach. When I watch a “news” program, it’s NOT my medical appointment. It’s supposed to be news, not medical advice. But that’s not what the German physician wrote to me abo... Better Health blogs http://www.medworm.com/rss/comments.php?id=3671692 Thu, 17 Jun 2010 22:00:00 +0100 3671692 http://www.medworm.com/index.php?rid=3672034&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7CpBD1Qpr10%2F Once again, a battle looms over the cost of treating wet age-related macular degeneration. An unpublished study shows Medicare can save more than $500 million annually by using Avastin, instead of Lucentis to treat the illness, The Wall Street Journal reports. The disclosure underscores a heated debate that has embroiled federal officials and Genentech, which sells both drugs, for years. Why? Avastin is not approved to treat the eye disease, which is a leading cause of blindness among the elderly. Lucentis is approved, but Avastin is much cheaper. For instance, the study found Avastin, which is used in 65 percent of Medicare patients but only 40 percent are treated with Lucentis. But Medicare paid $537 million for Lucentis in 2008 and only $20 million for Avastin, the Journal writes. Put a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3672034 Thu, 17 Jun 2010 13:13:18 +0100 3672034 http://www.medworm.com/index.php?rid=3652691&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtbeaniQzUXk%2F And so another working week is about to draw to a close. What are your plans for the weekend? Ours include promenading with the official Pharmalot mascots, a round of (miniature) golf with the shortest of short people and pulling weeds that are springing up around the corporate campus. Whatever you choose to do, we hope your plans are exciting. Meanwhile, another day beckons. Here are a few items to help you along. Enjoy… Why Patients Don’t Get The Shingles Vaccine (The New York Times) Lilly’s Lechleiter Says US Loses Innovation Edge (Crain’s Detroit Business) Drugmakers To Form Alzheimer’s Data Coalition (The Wall Street Journal) Bristol-Myers To Price Drugs Lower In India (The Hindu Business Line) European Drugmakers Concerned About Market Access (PharmaTime... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3652691 Fri, 11 Jun 2010 11:56:17 +0100 3652691 http://www.medworm.com/index.php?rid=3652609&cid=t_111609_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F06%2Friding-the-roller-coaster-again.html Yesterday turned out to be one of those days, so I guess it's no wonder that I slept until 10:30 this morning!Actually, the day was more like playing on a teeter-totter than riding a roller coaster--remember standing on the seat of a teeter-totter (or see-saw) and then someone would jump off the other end and you'd go flying? Well, that was how my day went: Up and down with lots of bumps. I did manage to keep my balance, though, and I feel fine today. First was my phone conversation with Dr. Eulau about the results of my X-ray: He said there is erosion in the bone in my right femur because of a tumor. Treatment? Four weeks of daily radiation. Argh--there goes my summer!Then I went off to see Dr. Lee, my lovely medical oncologist, and to get treatment, which these days i... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3652609 Thu, 10 Jun 2010 18:41:15 +0100 3652609 http://www.medworm.com/index.php?rid=3636023&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9hbKmLSytOc%2F Welcome back, everyone. We hope the weekend was pleasant and refreshing. Now, of course, the routine returns as meetings and deadlines beckon. As we ease in with a mandatory cup of stimulation, here are a few items to help you along. Have a good day and stay in touch… Grifols To Pay $3.4B For Talecris (Bloomberg News) Roche’s Avastin Improved Survival In Ovarian Cancer (Reuters) Merck Strikes Wastewater Deal With Pa. Town (The Reporter) Bristol-Myers’ Melanoma Drug Improves Survival (Bloomberg News) A Look At AstraZeneca’s Plant In China (The Telegraph) Former Wyeth Employees Mourn Plant Closing (The Rockland Journal News) Novartis MS Pill Faces Safety Concerns (Reuters) Erbitux Fails To Stop Early-Stage Colon Cancer (Bloomberg News) Drugmakers Spend Billions On Fre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3636023 Mon, 07 Jun 2010 11:44:08 +0100 3636023 http://www.medworm.com/index.php?rid=3589016&cid=t_111609_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F05%2Fopen-wide-.html Well, I had delayed for as long as possible, like two years or more, but I finally had to go and see my dentist a couple of weeks ago. I knew something was wrong, and I had that "putting it off will only make it worse" feeling, so off I went. I should point out that I go to a very good dentist, and I like him and trust him, but I HATE having work done in my mouth and with all my cancer-related medical appointments it was easy to make excuses not to go. Very easy. But I was having some pain way back on the upper left, and also a lymph node under my left ear was swollen and sore, which I thought might mean an abscess, but that proved not to be the case. Just two new cavities in very bad places, one of them under an old filling that had cracked. Here are the proble... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3589016 Fri, 21 May 2010 20:23:37 +0100 3589016 http://www.medworm.com/index.php?rid=3534059&cid=t_111609_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F05%2Fa-trip-to-the-dentist.html Well, I finally bit the bullet, so to speak, and made a long-overdue trip to see my dentist. It's not that I don't like my dentist, because he's great, but with all the medical appointments I already have, squeezing in one more just seemed impossible. So I hadn't been for two years or more. Until I got a tooth ache. And the lymph nodes under my ear on that side were swollen and tender, which could have been from my snotty nose, but also could have been from an infected tooth. So, after delaying and procrastinating for more days that I care to admit, I made the appointment. I also told Dr. Lee, my oncologist, that I was going, and agreed to have my dentist call him to discuss any treatment before we started work on my mouth. The biggest issue is the A... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3534059 Tue, 04 May 2010 17:31:08 +0100 3534059 http://www.medworm.com/index.php?rid=3526947&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGcH7rZ8YJbU%2F Another month, another list. Once again, there is speculation about which medications will generate the most revenue over the next few years. Interestingly, the latest conclusion mirrors another recent list that suggests conventional pills will easily be eclipsed. Only two small molecules make this newest ranking, which was compiled by EvaluatePharma. Not surprisingly, one of them is AstraZeneca’s Crestor cholesterol fighter, although the newest list differs slightly from this list. And so once again, there are myriad implications raised, including the strategic direction pursued by the biggest drugmakers and the costs for patients. The percentage figure refers to sales growth from 2009 to 2016… 1. Humira (arthritis) Abbott Labs/Eisai - $10.1b; 9 percent 2. Avastin (cancer) Roc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526947 Mon, 03 May 2010 12:47:00 +0100 3526947 http://www.medworm.com/index.php?rid=3526950&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKDwZ00YYxY0%2F Welcome back. We hope your weekend was pleasant and you feel refreshed. A rainy day here on the Pharmalot corporate campus as the routine returns. And that means meetings and deadlines are looming. To help you along, we have assembled another collection of interesting items. So grab a cup or two of stimulation and dig in. Have a good day, everyone, and stay in touch… German Report Casts Doubt About Roche’s Avastin (Reuters) Takeda Drugs Tops Rivals In Blood Pressure Studies (Reuters) Sanofi-Aventis & Glenmark Strike Deal For Pain Drugs (The Wall Street Journal) Pfizer Sues Ranbaxy Over Rapamune Patent (The Business Standard) Oslo Court Backs Schering-Plough In Animal Vaccine Dispute (FishNewsEU) Serbia Halts Privatization Of Galenika Pharma (FocusFen) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526950 Mon, 03 May 2010 11:44:06 +0100 3526950 http://www.medworm.com/index.php?rid=3515577&cid=t_111609_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F04%2Fsome-good-news-for-a-change-.html I went in to see Dr. Lee today, and also to get treatment (we're calling it targeted therapies light: reduced doses of Herceptin, Avastin, and Tykerb--the only one that bothers me is the Tykerb), and of course I had my list of questions for Dr. Lee. But he had a surprise for me: My CEA (tumor marker) has dropped substantially in just a couple of months! That means less cancer in my body. Now, I had asked to have this test a few weeks back, but with everything else that was going on, I kinda forgot about it. It was great to get some good news for a change. Dr. Lee said he wasn't sure why my marker had dropped so far, but we agreed that the radiation I had in January had probably reduced the total volume of cancer, or my tumor load, so the marker dropped. And ... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3515577 Thu, 29 Apr 2010 05:23:18 +0100 3515577 http://www.medworm.com/index.php?rid=3468018&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbwVlkKVymw%2F And the winner is…. Roche’s Avastin, which is used to treat various cancers. Everyone loves a list, of course, so Reuters compiled this ranking and the most interesting finding is there seems to be just one pill that will be among the biggest sellers in 2014. In other words, injectables will dominate. Assuming this is reasonably accurate, what might it say about big drugmakers? Will they spend more in the lab or strike still more deals with smaller prey developing the next big thing? Will pills become passe? And what will it mean for patient costs? Consensus sales forecasts for world’s top 10 drugs in 2014: 1. Avastin (cancer) Roche - $8.9b 2. Humira (arthritis) Abbott - $8.5b 3. Enbrel (arthritis) Pfizer - $8b 4. Crestor (cholestero... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468018 Wed, 14 Apr 2010 15:58:25 +0100 3468018 http://www.medworm.com/index.php?rid=3429448&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrsVT21QODtA%2F US prescription sales rose 5.1 percent last year, to $300.3 billion, a big increase from the 1.8 percent rate in 2008, thanks to manufacturer coupons, rebates, price hikes of 3 percent to 4 percent, and low-cost generics, which accounted for 75 percent of all prescriptions. Nonetheless, demand remained at “historically low levels,” according to IMS Health, which released the data. Overall, the rate at which prescriptions were filled rose 2.1 percent in 2009, to 3.9 billion dispensed, up from 1 percent the previous year. However, another recent report noted that the rate at which scrips were submitted to a pharmacy but never picked up was 6.3 percent, a 24 percent increase over 2008 (see here). Other contributing factors included inventory management by retail pharmacies; greate... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3429448 Thu, 01 Apr 2010 12:08:20 +0100 3429448 http://www.medworm.com/index.php?rid=3378684&cid=t_111609_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F03%2Ftravel-advice.html Yesterday was a crazy day. Younger Son needed me to go with him to get his state ID card, and we drove all over town searching for a driver's licensing office, because the one in the north end of Seattle, our part of town, had closed while I wasn't paying attention. Of course, we didn't find out that it was closed until we drove up there. Then, after calling information, we drove to the south end, only to find that that office had also closed--why directory assistance gave us the phone number and address, I have no idea. So we ended up downtown, which is always difficult because of traffic and parking, plus that office is really busy. Anyway, he got the ID card, and I renewed my driver's license as well. Turns out I was driving on an expired license.... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3378684 Wed, 17 Mar 2010 22:35:32 +0100 3378684 http://www.medworm.com/index.php?rid=3359216&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzEiv7-Y0wkk%2F There are gray skies hovering over the Pharmalot corporate campus this morning, but our spirits are sunny. And why not? If nothing else, the weekend is just around the corner. Yes, there are deadlines and meetings between now and then, but still, we look ahead to spending time with the short people and catching up on our to-do list. What will you do? While you ponder, here are a few items to help you along. Whatever your choice, have a nice weekend… Birth Control Pills May Help Women Live Longer (Bloomberg News) Nigerian Start-Up Fights Counterfeit Drugs (The Wall Street Journal) Arena Will Launch Diet Drug With Or Without A Partner (Reuters) Roche’s Avastin Fails Prostate Cancer Study Goal (Bloomberg News) Merck’s Vytorin Effectiveness Study To Continue (Associated Press... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3359216 Fri, 12 Mar 2010 12:35:59 +0100 3359216 http://www.medworm.com/index.php?rid=3338404&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2010%2F03%2F05%2Fgog-says-continuation-of-pivotal-opaxio-maintenance-therapy-trial-gog-212-remains-high-priority%2F Gynecologic Oncology Group (GOG) Notifies CTI That Continuation of GOG-212 Pivotal Trial of OPAXIO Maintenance Therapy in Front Line Ovarian Cancer Remains High Priority.  GOG-218 Bevacizumab Results Do Not Influence Importance of GOG-212 Cell Therapeutics, Inc. (“CTI”) announced today that the company received a statement on March 1, 2010 from the Gynecologic Oncology Group (GOG) leadership [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=3338404 Sat, 06 Mar 2010 02:48:42 +0100 3338404 http://www.medworm.com/index.php?rid=3331606&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2p96dNLfh5Q%2F Hello, everyone. How are you today? Bracing for deadlines and meetings, no doubt. We understand. Our immediate challenge is rousting one of the short people from a deep slumber. To cope, we are brewing the ritual cup of stimulation and searching for interesting items. Here are a few, in fact, to help you along. Have a good day and stay in touch… Dendreon’s Provenge Boosts Survival 40 Percent (Reuters) Sanofi Prostate Cancer Drug May Set New Standard (TheStreet) Child Seizure Study Finds Older Drugs Work Best (Reuters) Hospital Takes Huge Mark-Up On Roche’s Avastin (Bloomberg) UK’s NICE Spurns Celgene Rare Blood Cancer Drug (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3331606 Thu, 04 Mar 2010 12:08:47 +0100 3331606 http://www.medworm.com/index.php?rid=3311889&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2010%2F02%2F25%2Fgenentech-announces-positive-results-of-avastin-phase-iii-study-in-women-with-advanced-ovarian-cancer%2F Genentech announces positive results of Avastin Phase III study (GOG 218) in women with advanced ovarian cancer. The study showed that women who continued maintenance use of Avastin alone, after receiving Avastin in combination with chemotherapy, lived longer without the disease worsening compared to those who received chemotherapy alone. This is the first Phase [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=3311889 Thu, 25 Feb 2010 18:40:30 +0100 3311889 http://www.medworm.com/index.php?rid=3302589&cid=t_111609_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F02%2Fpushing-back-my-second-walk-in-a-week.html I had another long (make that looooonng) day today, starting when I left the house at 10 to head for my cancer center. All I had before I left the house was coffee, because I wake up slowly and can't eat for an hour or two, but I threw a banana in my bag for later. Good thing I did, because Dr. Lee decided to give me treatment, so I was there until something like 3:30, which is five hours. I started with the blood draw, and then I waited more than an hour to see Dr. Lee. The waiting room was crowded, and some people were getting frustrated, and rude, in my book, but I didn't let it disturb my wa. (One woman was using her cell phone in the middle of the waiting room to loudly announce her appointment time, and then of course the time at that moment. She did this th... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3302589 Wed, 24 Feb 2010 01:47:23 +0100 3302589 http://www.medworm.com/index.php?rid=3067313&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnCqCy9SeLUc%2F The price for Folotyn, which was was approved to treat relapsed or refractory peripheral T-cell lymphoma, a rare blood cancer that hits about 5,600 people in the US each year, seems certain to cause controversy as health care reform legislation is debated. As The New York Times notes, the drug shrink tumors, but has not been shown to prolong lives. Allos defends the price, saying it made a significant investment to develop the first approved drug for this type of cancer. “It’s a very aggressive disease, and patients right now have no options,” Jim Caruso, chief commercial officer for Allos Therapeutics, which expects to begin selling the drug next month, tells the paper. “We believe we are fairly priced and we’re benchmarked” against other drugs. However, the paper points o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3067313 Mon, 07 Dec 2009 17:57:54 +0100 3067313 http://www.medworm.com/index.php?rid=3040021&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbRCJLCSatBw%2F Welcome to the working week. Hope your long weekend - those of you who are stateside, at least - was a good one. Ours was quiet, thanks. So, no complaints. Now, though, the routine returns. And that means deadlines, projects and meetings. To help you along, here are a few interesting items to help you ease back in. So grab a cup of stimulation and get started… Serge Weinberg May Be Next Sanofi Chairman (Reuters) Canada Extends Patient Access To Avastin (The Star) Glaxo To Provide Anti-Doping Gear To The Olympics (USA Today) Daewoong Threatens Pfizer Over Scrapped Deal (AsiaPulse) $50M Of Meds Overseas Diverted From UK Each Month (Daily Telegraph) Celgene Revlimid Sales May Trounce J&J’s Velcade (Bloomberg News) Ranbaxy Launches Herpes Drug In US (Reuters) Coffee courtesy o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3040021 Mon, 30 Nov 2009 13:49:25 +0100 3040021 http://www.medworm.com/index.php?rid=3019232&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA9XD-pE-Prg%2F After pressure from Congress, the Centers for Medicare and Medicaid has accelerated its recently announced changes to reimbursement coding for Avastin, which is used to treat wet macular degeneration, a leading cause of blindness among seniors. The drug, however, is controversial because it’s often used off-label in small amounts to treat the eye disease. Why? Avastin is made by Genentech, which also sells Lucentis, a more expensive drug approved by the FDA to combat the same problem. But anywhere from 50 percent to 60 percent of docs use Avastin instead of Lucentis, because it costs $2,000 a dose versus about $50 for Avastin. Last month, the CMS agreed to reinstate its original billing rate for Avastin. However, the agency was going to wait until Jan. 1 to make the change. However,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3019232 Mon, 23 Nov 2009 13:21:21 +0100 3019232 http://www.medworm.com/index.php?rid=2999852&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFMA0kA3DKWw%2F Good morning, everyone. Nice to see you again. Another pleasant day looks to be shaping up on the Pharmalot corporate campus. But so much to do and we know you can relate. So while we shuttle to and from the schoolhouse, here are a few items to help you on your own way…. Roche Applies for Avastin Breast Cancer Use (Reuters) FDA Delays Genzyme Pompe Disease Drug Again (MassHighTech) Icahn Buys Shares in Genzyme And Forest Labs (Wall Street Journal) Novartis Teams With Malaysia For Compound Research (Bernama) Iowa Gets $4.3M From Medicaid Settlement (WCFCourier) Heartburn Pills Linked To Higher Death Rate In Artery Cleanings (Bloomberg) Talecris To Add 259 Jobs (Triangle Business Journal) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2999852 Tue, 17 Nov 2009 12:05:01 +0100 2999852 http://www.medworm.com/index.php?rid=2939562&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7uuRROWNdjM%2F After pressure from Congress and concern from doctors, the Centers for Medicare and Medicaid now plans to reverse recently enacted reimbursement coding for Avastin, which is used to treat wet macular degeneration, a leading cause of blindness among seniors and the elderly. The drug, you may recall, is often used off-label in small amounts to treat the eye disease. Here’s the rub: Avastin is made by Genentech, which also sells Lucentis, a much more expensive drug approved by the FDA to combat the same problem. But, as noted by Herb Kohl, a Wisconsin Democrat on the Senate Special Committee on Aging, anywhere from 50 percent to 60 percent of docs use Avastin instead of Lucentis. Why? Lucentis cost $2,000 a dose versus about $50 for Avastin. Medicare recently introduced a new payment c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2939562 Wed, 28 Oct 2009 20:57:06 +0100 2939562 http://www.medworm.com/index.php?rid=2832371&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F09%2F24%2Fmodified-chemo-regime-increases-survival-in-advanced-ovarian-cancer-patients-but-adds-toxicity%2F Women with advanced ovarian cancer lived longer and without their tumors growing after receiving a modified regimen of a standard chemotherapy drug combination, Japanese researchers reported last week. In a large phase III clinical trial, women who received carboplatin every 3 weeks and a reduced dose of paclitaxel (Taxol®) once a week for 3 weeks [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2832371 Thu, 24 Sep 2009 20:44:57 +0100 2832371 http://www.medworm.com/index.php?rid=2719937&cid=t_111609_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F08%2Fvegf-inhibitors-and-prostate-cancer-therapy%2F In people with cancer angiogenesis involves the growth of tiny new blood vessels to generate a blood supply for tumors. This process has been shown to play an important role in the growth, proliferation and spread of prostate cancer tumors. Vascular endothelial growth factor (VEGF) is a chemical signal produced by cells that stimulates the [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2719937 Thu, 20 Aug 2009 14:43:53 +0100 2719937 http://www.medworm.com/index.php?rid=2512799&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F06%2F18%2F2009-asco-annual-meeting-highlights-ovarian-cancer-select-general-issues%2F The 2009 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Orlando, Florida from May 29 through June 2, 2009.  We provide below select highlights from the 2009 ASCO Annual Meeting that relate to ovarian cancer and other general issues. The 2009 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Orlando, [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2512799 Thu, 18 Jun 2009 22:11:35 +0100 2512799 http://www.medworm.com/index.php?rid=2398855&cid=t_111609_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FtSlALmqbICA%2F A cancer medication already available for other cancers, such as breast cancer, has now been given the FDA-go ahead to be used for a type of brain cancer, called glioblastoma multiforme (GBM). Senator Edward Kennedy was diagnosed last year with brain cancer called glioma. GBM is the most advanced of this type of brain cancer. The FDA reported yesterday: The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. GBM is a rapidly progressing cancer that invades brain tissue and can impact physical activities and mental abilities. It affects about 6,700 persons in the United States every year. Following initial treatment with surgery, radiati... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2398855 Sun, 10 May 2009 11:00:41 +0100 2398855 http://www.medworm.com/index.php?rid=2205989&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F02%2F21%2F2009-society-of-gynecologic-oncologists-annual-meeting-ovarian-cancer-highlights%2F From February 5th through 8th, 2009, the Society of Gynecologic Oncologists’ (SGO) held its 40th Annual Meeting on Women’s Cancer in San Antonio, Texas. The meeting, viewed as the preeminent scientific and educational conference for women’s cancer care specialists, featured more than 350 scientific oral and poster presentations as well as educational sessions [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2205989 Sun, 22 Feb 2009 01:22:59 +0100 2205989 http://www.medworm.com/index.php?rid=3808793&cid=t_111609_136_f&fid=35300&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmetastatic-liver-cancer%2F%7E3%2FXRxL3g6C9lU%2F   Or trail and error… Vicky shares her father’s colon cancer chemotherapy and the scary chemotherapy side effects. Vicky’s father was diagnosed with stage iv colon cancer that has spread into his lungs and liver.   Her father started his chemotherapy for colon cancer with Avastin cancer drug. This colon cancer chemotherapy worked well that it broke down [...] (Source: Metastatic liver cancer) Metastatic liver cancer blogs http://www.medworm.com/rss/comments.php?id=3808793 Thu, 22 Jan 2009 07:53:59 +0100 3808793 http://www.medworm.com/index.php?rid=2056346&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F490063416%2F The biotech gets a chance to say ‘I told you so.’ A letter posted on its web site and addressed to healthcare professionals says there 36 reports of off-label use in Canada last month that resulted in adverse events, 32 of which were serious. Genentech goes on to make the point that its Avastin cancer med, which was being used to treat wet maculer degeneration, was not approved for “use…in the ophthalmology setting.” The disclosure comes a year after controversy erupted when Genentech yanked distribution of Avastin to compounding pharmacies, which were repackaging and selling the drug to opthalmologists for treating wet macular degeneration. Unlike Avastin, Genentech’s similar, but newer Lucentis drug was approved two years ago to treat the malady, but at $2... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2056346 Fri, 19 Dec 2008 22:30:42 +0100 2056346 http://www.medworm.com/index.php?rid=2006400&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F471227544%2F A ban on drugs that can give kidney cancer patients many months of extra life is going to be lifted, The Guardian reports. At least two, and possibly all four, of the medicines that had previously been deemed too expensive to prescribe will be approved by the National Institute for Health and Clinical Excellence (Nice) early next year. The move is a major victory for campaigners, patients and cancer specialists, who described Nice’s refusal to approve the drugs - which cost up to $100,000 a year per patient - as unfair, inhumane and condemning patients to an unnecessarily early death, the paper writes. Oncologists believe Pfizer’s Sutent, Bayer’s Nexavar, Wyeth’s Torisel and Avastin, sold by Roche and Genentech, could benefit about half of the 7,000 people a year w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2006400 Mon, 01 Dec 2008 11:58:02 +0100 2006400 http://www.medworm.com/index.php?rid=3808810&cid=t_111609_136_f&fid=35300&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmetastatic-liver-cancer%2F%7E3%2FVUdonEfalp8%2F Ray from UK hasn’t an individual health coverage and therefore stopped his successful Avastin chemotherapy to stabilise his metastatic liver cancer. Read more about our other 2 metastatic liver cancer survivors Trish and Dan:   Dan Metastatic liver cancer survivor  Trish Metastatic Liver Cancer Survivor   On one hand I am surprised how seemingly easy Ray talks about major medical [...] (Source: Metastatic liver cancer) Metastatic liver cancer blogs http://www.medworm.com/rss/comments.php?id=3808810 Sun, 30 Nov 2008 16:00:43 +0100 3808810 http://www.medworm.com/index.php?rid=1969000&cid=t_111609_136_f&fid=35300&url=http%3A%2F%2Fwww.metastaticlivercancer.org%2F2008-11-18-cancer-treatment%2Favastin-chemotherapy-drug%2F 6 years old and needing chemotherapy… We got more reader’s input about Amanda’s question about the Avastin chemotherapy drug.   This time we see that a combination of the following 3 chemotherapy drugs : Avastin, Dosataxol and Gemcitabine is working for 7 year old boy having Angiosarcoma of the liver. The side effects of his chemotherapy are mild says his father Jon.   Anybody who has been in contact with Angiosarcoma of the liver, please leave a comment, your hugs and prayers: Jon’s son is only 7 years old and already one year undergoing different types of chemotherapy.   Jon’s Angiosarcoma of the liver cancer story Jon commented his son’s cancer story at Avastin cancer drug and Metastatic liver cancer facts : secondary liver cancer &nbsp... Metastatic liver cancer blogs http://www.medworm.com/rss/comments.php?id=1969000 Tue, 18 Nov 2008 07:54:34 +0100 1969000 http://www.medworm.com/index.php?rid=1960662&cid=t_111609_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F11%2Ffour-months.html What's that worth? (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1960662 Fri, 14 Nov 2008 20:42:00 +0100 1960662 http://www.medworm.com/index.php?rid=1961224&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F452971264%2F Somehow, we forgot to hit the send button earlier. So our usual morning greeting is appearing a bit out of sync. Apologies, everyone. As we wrote… And so the end of the week is upon us. What will you be doing this weekend? Taking in a movie? Throwing a football around? Puttering around the mansion? Our choice - raking leaves, which is good exercise, after all. Whatever your pleasure, we hope you enjoy. Meanwhile, here are a few items to digest as you prepare… Lupin Plant Slammed By FDA Inspectors (The Economic Times) Four Drug Combo Helps With Lung Cancer (Reuters) Actavis Unit Sued By FDA (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1961224 Fri, 14 Nov 2008 12:20:12 +0100 1961224 http://www.medworm.com/index.php?rid=1918075&cid=t_111609_136_f&fid=35300&url=http%3A%2F%2Fwww.metastaticlivercancer.org%2F2008-10-30-cancer-treatment%2Favastin-cancer-drug%2F Is Avastin as effective as people are told this cancer drug will be?   Please leave a comment if you or your loved one has used the Avastin cancer drug.   We would love to hear answers on the following Avastin questions   how effective is Avastin?  for which cancer did you use the Avastin cancer drug?  was Avastin given by itself or mixed with other chemotherapy?  in case of Taxol and Avastin chemotherapy: what-how is the survival after Taxol and Avastin?  in case of Avastin and Zeloda - Xeloda chemotherapy: what - how - how long is the survival after Avastin and Zeloda - Xeloda?  what were the Avastin side effects?  what was the Avastin cost and how did your health insurance intervene?  are you an Avastin cancer survivor?   T... Metastatic liver cancer blogs http://www.medworm.com/rss/comments.php?id=1918075 Thu, 30 Oct 2008 10:15:23 +0100 1918075 http://www.medworm.com/index.php?rid=1895597&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F427427604%2F If numbers tell the story… Pfizer reported that profits tripled thanks to higher sales of the Lyrica pain pill Lyrica and lower costs from 11,000 jobs that were cut last year. Net income rose to $2.28 billion, or 34 cents a share, from $761 million, or 11 cents, a year earlier, when Pfizer took a $2.8 billion charge for the Exubera inhaled insulin device. Revenue was roughly flat at $12 billion. The drugmaker raised the lower end of its forecast for 2008 sales by $1 billion to between $48 billion and $49 billion, and plans to save at least $2 billion as part of cost cutting announced last year (here is the Pfizer statement). Schering-Plough third-quarter earnings fell sharply, hurt by special charges and falling demand for its cholesterol drugs, but results beat expectations. Earning... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1895597 Tue, 21 Oct 2008 12:35:11 +0100 1895597 http://www.medworm.com/index.php?rid=1883566&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F421681523%2F What? No deal between Roche and Genentech? Unlikely, despite the veil of silence surrounding the transaction, according to Wall Street analysts, who are pontificating today after seeing Genentech’s robust earnings report. Consider this: Avastin sales were up 18 percent to $704 million; Rituxan sales rose 15 percent to $655 million and Herceptin sales increased 15 percent to $368 million. “While management refused to discuss the Roche situation, we believe a deal is inevitable, and that an agreement would be facilitated by a recovery in the credit markets,” writes Cowen biotech analyst Eric Schmidt in an investor note this morning. “Although we are frustrated by the lack of communication from Roche/Genentech regarding a full business combination, we believe there is... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1883566 Wed, 15 Oct 2008 15:31:45 +0100 1883566 http://www.medworm.com/index.php?rid=1856027&cid=t_111609_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F10%2Fgenentech-osi-avastin-tarceva-clinical.html Genentech and OSI Pharmaceuticals have announced top line results from a phase III study evaluating the combination of Avastin and Tarceva as second-line treatment for advanced non-small cell lung cancer.The trial did not meet its primary endpoint. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1856027 Mon, 06 Oct 2008 12:48:00 +0100 1856027 http://www.medworm.com/index.php?rid=1859777&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F412698859%2F Welcome back. We hope your weekend was enjoyable. We used our to catch up on sundry errands and tidy up around the Pharmalot corporate campus. Now, though, the time has come to settle back into the routine. To help you along, here are a few items to get you started. Hope your days goes well… Genetic Tests May Determine Who Gets Avastin (Yahoo) Spiriva Offers No Advantage Over Placebo (Reuters) Roche, Genentech Drugs Don’t Boost Lung Cancer Survival (Yahoo/Reuters) Dr. Reddy’s Stock Sinks On Diabetes Drug Delay (Bloomberg News) Bayer To Start Phase III Lung Drug Study (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1859777 Mon, 06 Oct 2008 11:03:22 +0100 1859777 http://www.medworm.com/index.php?rid=1739299&cid=t_111609_136_f&fid=35300&url=http%3A%2F%2Fwww.metastaticlivercancer.org%2F2008-08-29-cancer-treatment%2Fcan-chemotherapy-cure-metastatic-liver-cancer%2F   In all the metastatic liver cancer stories we gathered, none of them is told by a cancer survivor.   Some do get chemotherapy, but this cancer treatment is only to:   reduce pain (in case it can temporarily reduce or slow down the growth of a cancer)  prolong life.   But we get puzzled when reading Kistan2’s comment on Avastin for metastatic liver cancer where she says :   they tried another infusion of Avastin but we all knew that this next infusion of Avastin wouldn’t do anything to help my husband   What worries me is where Kistan2 says : we all knew that this next infusion of Avastin wouldn’t do anything.   3 worried questions come in mind…   when you know Avastin is not going to help, then why is it still given?... Metastatic liver cancer blogs http://www.medworm.com/rss/comments.php?id=1739299 Fri, 29 Aug 2008 02:54:28 +0100 1739299 http://www.medworm.com/index.php?rid=1730740&cid=t_111609_136_f&fid=35300&url=http%3A%2F%2Fwww.metastaticlivercancer.org%2F2008-08-25-cancer-treatment%2Favastin-for-metastatic-liver-cancer%2F What can Avastin do in the treatment of metastatic liver cancer? Reading the avastin.com website says that Avastin in combination with intravenous 5FU based chemotherapy is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.   In other words: it’s added to the 5FU chemotherapy cocktail, 5FU that father’s oncologist wanted to give father to treat his metastatic liver cancer. But the oncologist advised father to consider not to undergo 5FU (see Fu like in F… you!) treatment because:   at the age of 75 and in a weak condition due to the cancer, father could not survive the treatment  the chemotherapy side-effects could really spoil father’s quality of life in the few extra months the chemotherapy... Metastatic liver cancer blogs http://www.medworm.com/rss/comments.php?id=1730740 Mon, 25 Aug 2008 08:22:59 +0100 1730740 http://www.medworm.com/index.php?rid=1689198&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F358595604%2F The National Institute for Health and Clinical Excellence, or NICE, issued a preliminary decision that Pfizer’s Sutent, Wyeth’s Torisel, Bayer’s Nexavar and Avastin, sold by Roche and Genentech, are not cost effective for treating advanced or metastatic kidney cancer. And the move is causing outrage among patient groups, PharmaTimes reports. “Although these treatments are clinically effective, regrettably, the cost to the National Health Service is such that they are not a cost-effective use of resources,” says Peter Littlejohns, NICE’s clinical and public health director, adding that two of the drugmakers have developed proposals which may have the effect of reducing the cost of the drugs and “we will be happy to consider these proposals.” He explai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1689198 Thu, 07 Aug 2008 12:18:42 +0100 1689198 http://www.medworm.com/index.php?rid=1727802&cid=t_111609_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2008%2F08%2F03%2Fcombination-targeted-therapy-with-sorafenib-bevacizumab-shows-antitumor-activity%2F The results from a recent Phase I solid tumor clinical trial indicate that combination targeted therapy with sorafenib and bevacizumab produces anti-tumor activity (and enhanced toxicity) with respect to 43% of the ovarian cancer patients enrolled in that trial. Sorafenib (Nexavar®) inhibits the Raf kinase and vascular endothelial growth factor (VEGF) receptor. Bevacizumab (Avastin®) is [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=1727802 Mon, 04 Aug 2008 02:36:13 +0100 1727802 http://www.medworm.com/index.php?rid=1625800&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F336004509%2F Greetings. We apologize for the delay, but we had to pack off one of the short people on a long journey at a particularly early hour. Now, though, we are back to business. And today looks to be a pleasant one here in the nation’s medicine chest. Wherever you are, we hope your day is pleasant, too. Here are a few things to get you started… McCain Adviser Sees Drug Import Challenges (The Guardian) Genentech Sales Beat Expectations (Yahoo/Reuters) Sun Pharmaceutical Extends Offer For Tara Pharmaceuticals (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1625800 Tue, 15 Jul 2008 11:35:50 +0100 1625800 http://www.medworm.com/index.php?rid=1622995&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F335611506%2F A busy day here on the Pharmalot corporate campus where repairs were being made to the cafeteria. Nonetheless, we managed to get some work done. We hope you did as well. Meanwhile, here a few items that cropped up more recently. Have a good night and see you tomorrow… Judge Allows Abbott Class Action To Proceed (Yahoo/Reuters) Genentech Ends Studies On Drug-Combo Safety Issue (Associated Press) Amgen Drug Prevents Bone Loss In Prostate Cancer (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1622995 Tue, 15 Jul 2008 01:27:24 +0100 1622995 http://www.medworm.com/index.php?rid=1582221&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F327684670%2F That’s one of a series of questions asked - yet again - about Genentech’s Avastin, which is approved for treating advanced lung, colon or breast cancer by cutting a tumor’s blood supply. The med is widely used, despite a price tag of up to $100,000 a year. Studies, however, show Avastin prolongs life by only a few months and may not be as effective as once thought. Nonetheless, many patients and docs say the drug can improve the quality of life, The New York Times writes in revisting the issue, while adding such effects can be hard to document. Meanwhile, many patients with other cancers are taking the drug, even in cases where there is no compelling evidence that it can help, the paper adds. This, of course, generates more sales. Avastin also has serious, if infrequent, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1582221 Sun, 06 Jul 2008 05:39:53 +0100 1582221 http://www.medworm.com/index.php?rid=1546987&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F320478251%2F Take Roche. The drugmaker balked at providing the National Institute for Clinical Health and Excellence, or NICE, with cost-effectiveness data for its Avastin cancer med. NICE chairman Michael Rawlins claims Roche “would rather not supply the drug in the UK than risk a negative opinion,” according to The Financial Times. And so NICE has advised the UK National Health Service not to underwrite the med, which is used for first-line lung and breast cancer treatment. But the stand-off is the most high profile instance of growing tensions over the sharply escalating cost of cancer treatments between UK and pharma, which are cutting back on clinical trials in the UK, the FT writes. And Pfizer, Roche and Merck-Serono have all told the paper they have or will reduce the number of patie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1546987 Thu, 26 Jun 2008 12:10:59 +0100 1546987 http://www.medworm.com/index.php?rid=1526781&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F314122105%2F Last year, Genentech caused a ruckus by restricting distribution of its Avastin med to compounding pharmacies, which were repackaging and selling the drug to opthalmologists for treating wet macular degeneration. Unlike Avastin, Genentech’s similar, but newer Lucentis was approved to treat the malady, but at $2,000 a dose will cost about 40 times as much. The drugmaker subsequently struck a deal with opthalmologists to loosen the restrictions. But in explaining its original rationale, Genentech cited an FDA inspection that found 350,000 vials worth about $200 million were “unsuitable for use in the eye,” but the drugmaker insisted the lots “would have been entirely suitable for its approved use as an intravenous cancer medication.” As a result, Herb Kohl, the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1526781 Tue, 17 Jun 2008 22:12:34 +0100 1526781 http://www.medworm.com/index.php?rid=1482289&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F302184559%2F A clinical trial of 1,125 lung cancer patients who were treated with ImClone Systems’s Erbitux and chemo lived about five weeks longer than patients treated with chemo alone, according to a study released at the American Society of Clinical Oncology meeting. Here is the abstract. The results could make Erbitux, which is currently approved for colon tumors and head and neck cancer, the preferred therapy for half of non-small cell lung cancer patients who can’t take Genentech’s Avastin due to side effects. Patients getting Erbitux plus standard chemo had a median survival of 11.3 months, compared with 10.1 months for those given only chemo. In all, 36.3 percent responded to the combo, compared with 29.2 percent who improved after getting only chemo. Erbitux increased survi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1482289 Sat, 31 May 2008 15:58:57 +0100 1482289 http://www.medworm.com/index.php?rid=1478213&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F300816851%2F In an impassioned editorial in The Wall Street Journal this morning, former FDA medical officer Mark Thornton lashed out at Chuck Grassley, the ranking Republican on the Senate Finance Committee, for asking the General Accountability Office to launch an inquiry into whether the FDA was correct to grant accelerated approval for Genetech’s Avastin cancer med. The move, he wrote, “will have a catastrophic effect on America’s ability to develop new drugs.” At issue is whether the FDA should use surrogate endpoints as the basis for approval. That’s what the agency did three months ago by rejecting an advisory panel recommendation and approving Avastin for metastatic breast cancer. Tests found the drug slowed tumor growth, even though Avastin wasn’t shown to exten... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1478213 Thu, 29 May 2008 22:49:08 +0100 1478213 http://www.medworm.com/index.php?rid=1478214&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F300773805%2F Potential advances in the treatment of lung cancer will be a major focus as the American Society of Clinical Oncology gets under way in Chicago on Friday. In particular, ImClone Systems will unveil long-awaited results from a pivotal trial of its Erbitux drug, in combination with chemotherapy, in patients with advanced nonsmall cell lung cancer, Reuters writes. The drugmaker has already said its Flex study met its main goal of boosting survival, but what is not clear is how much longer patients were shown to live. “The Flex study will be one of the most important presentations at ASCO,” Roy Herbst, chief of thoracic oncology at Houston’s MD Anderson Cancer Center, tells Reuters. “Lung cancer doctors and patients would like to know more details.” The Chicago m... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1478214 Thu, 29 May 2008 20:28:10 +0100 1478214 http://www.medworm.com/index.php?rid=1464203&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F296007432%2F Mention the name Richard Pazdur to anyone with an interest in cancer and watch their reaction. As the head of the FDA’s Office of Oncologic Drugs, Pazdur is at the heart of every important or controversial agency decision. Take the approval of Avastin for breast cancer, which some saw as a major shift in standards for assessing the effectiveness of cancer meds, or the flap over the Provenge prostate cancer vaccine. He held an interesting chat with BusinessWeek and here is an excerpt… BW: What should the pharmaceutical industry do to improve its track record of getting drugs through the clinical trial process? Pazdur: The real progress in cancer will be a better understanding of the molecular basis of the disease. Drug companies are very good at developing drugs. We’re a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1464203 Thu, 22 May 2008 18:01:54 +0100 1464203 http://www.medworm.com/index.php?rid=1446424&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F291382043%2F Some folks will be pulling all-nighters reading the abstracts released by the American Society of Clinical Oncology this evening. (Please look here). But if you simply want to glean a few highlights, here are the latest news summaries moving over our transom… Lilly Drug Slows Lung Cancer (The Wall Street Journal) Rash Most Common Side Effect In Vectibix Trials (Yahoo/Reuters) Avastin Improves Brain Cancer Survival (Yahoo/Reuters) Herceptin Enhances Tykerb For Breast Cancer (Yahoo/Reuters) Amgen Says Denosumab Combats Rare Bone Tumors (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1446424 Fri, 16 May 2008 03:42:00 +0100 1446424 http://www.medworm.com/index.php?rid=1443176&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F290112005%2F A pioneering clinical trial recently launched by the National Institutes of Health may fundamentally reshape relations between payers and drugmakers, IMS Health is warning, The Financial Times reports. The National Eye Institute’s head-to-head trial will compare the effectiveness of two drugs made by Roche’s Genentech, and could lead to a much cheaper way to treat age-related macular degeneration, which causes blindness. Medicare, for instance, may save $1 billion or more annually (look here). But IMS says the $16 million study, called CATT, opens “a Pandora’s box” by taking testing out of industry hands, changing the rules of development and potentially undermining a blockbuster long before it comes off patent. CATT is listed as one of the top seven ”harbingers of ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1443176 Wed, 14 May 2008 11:31:46 +0100 1443176 http://www.medworm.com/index.php?rid=1303457&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F251369259%2F In a surprise move, the Ontario government announced yesterday it will begin covering the cost of an expensive drug to treat macular degeneration, a leading cause of blindness, even though an alternative is widely available at a fraction of the cost, The Globe and Mail reports. It will cost the province’s drug benefit plan roughly $100 million over the next three years to pay for Lucentis, a breakthrough drug that has been on the Canadian market since last September. The decision will give eligible Ontarians - primarily seniors - suffering from wet macular degeneration access to this new drug for the first time, the province’s Ministry of Health and Long-Term Care said in a statement. But the paper reports thousands of Canadians already have access to a similar drug that is mu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1303457 Fri, 14 Mar 2008 12:25:22 +0100 1303457 http://www.medworm.com/index.php?rid=1297940&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250085312%2F How’s this for imagery? For more than two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. But the doc says he declined, because he believed further treatment wouldn’t help. The patient died less than an hour later. This sets the tone for a profile in The Wall Street Journal, which writes that Pazdur, 55, still makes life-or-death judgments - and gets a lot of criticism as a result. That’s because each decision affects millions of Americans. Pazdur heads the FDA’s Office of Oncologic Drugs, which makes him the gatekeeper for any new cancer med that goes on the US market - and an estimated 30 percent of all drugs that are in an advanced stage of develop... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1297940 Wed, 12 Mar 2008 11:55:19 +0100 1297940 http://www.medworm.com/index.php?rid=1278310&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F245648954%2F The government’s watchdog agency is investigating whether the FDA’s review process cleared two blockbuster meds - Avandia and Vytorin - without sufficient proof of their safety or effectiveness, the Associated Press reports. Specifically, the GAO has agreed to study whether the FDA should approve drugs based on biological measures, like cholesterol and blood sugar, without evidence they improve more meaningful measures like survival. “There’s enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it’s approved,” says Chuck Grassley, the Iowa Republican on the Senate Finance Committee who requested the investigation, in a statement. (more…) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1278310 Tue, 04 Mar 2008 18:56:34 +0100 1278310 http://www.medworm.com/index.php?rid=1261808&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F242314452%2F Despite some tough talk from Herb Kohl last fall, the Senate Special Committee on Aging will not hold a hearing into the controversy surrounding Genentech’s pricing for its Lucentis drug for age-related macular degeneration. “I don’t think that we’re going to schedule a hearing at this time,” a Senate investigator tells the In Vivo blog. “However, we may have some staff findings on this matter which we may make public in the near future.” Genentech caused a furor a few months agoy by restricting distribution of its Avastin cancer med, which is widely used to treat wet macular degeneration, even though the drug was never approved for that purpose. The biotech wanted to halt sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is spl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1261808 Wed, 27 Feb 2008 20:51:29 +0100 1261808 http://www.medworm.com/index.php?rid=1258588&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F241643372%2F Last week, the FDA made a surprising decision by approving Genentech’s Avastin to treat metastatic breast cancer. And the decision is seen as a possible shift in standards for assessing the effectiveness of cancer meds, because the agency granted approval based on progression-free survival - which is another way of saying the drug slowed tumor growth - rather than whether the drug extended life. The issue resonates beyond any one medication, of course, as the agency grapples with increasingly vocal cancer patients and their doctors, some of whom insist any possible benefit is worth considering. The decision may also send an important signal to drugmakers, because it can be expensive to conduct the lengthy trials needed to prove a drug can extend life. Not everyone, however, was plea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1258588 Tue, 26 Feb 2008 18:46:42 +0100 1258588 http://www.medworm.com/index.php?rid=1251173&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F239627229%2F This decision could represent a major shift in standards for assessing the effectiveness of cancer meds. In granting approval, the FDA rejected the recommendation of its advisory panel, which last December voted 5-4 against the drug, because the benefit in slowing tumor growth wasn’t believed to be worth the added risk of serious side effects, including high blood pressure and death. At issue was whether slowing tumor growth - known as profession-free survival - for an additional 5-1/2 months in metastatic breast cancer merits approval, even though Avastin wasn’t shown to extend life. The question, of course, resonates far beyond any one drug as the agency grapples with increasingly vocal cancer patients and their advocates, who insist any benefit is important. For drugmakers, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1251173 Sat, 23 Feb 2008 04:32:09 +0100 1251173 http://www.medworm.com/index.php?rid=1229433&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234350130%2F The results were from a study called Avado, which included patients who took Avastin with Taxotere, but the data is too new to be included in the biotech’s application to market Avastin for this use. The benefit was seen among patients on both low and high doses, compared with patients given a placebo along with chemo, according to Genentech. The study also measured whether patients lived longer than those on placebo. The FDA is expected to decide later this month on whether to approve Avastin - which is already cleared to treat colon and lung tumors - based on a different study. The earlier trial, called ECOG 2100, showed Avastin was able to slow the spread of breast cancer by an additional 5.5 months when used with Taxotere, compared with just chemo. Genentech hopes the latest resu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1229433 Wed, 13 Feb 2008 13:18:58 +0100 1229433 http://www.medworm.com/index.php?rid=1182993&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F224529356%2F Welcome to the working week. We hope you enjoyed the weekend. As always, there is much to do. No doubt, the next few days will be busy ones. And so as you prepare for meetings and projects, we hope these will help you get oriented. So grab a cup of something hot and dig in… Mylan To Appeal $69M Anti-Trust Court Ruling (MarketWatch) Genmab Stock Jumps On Speculation Of Biogen Offer (Bloomberg News) World Wrestling Sues OTC Drugmaker Over Unpaid Sponsorship (The Augusta Chronicle) Roche Gets EU Approval For Wider Avastin Use (Yahoo/Reuters) Some Flu Viruses Resistant To Tamiflu (The Guardian) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1182993 Mon, 28 Jan 2008 12:14:09 +0100 1182993 http://www.medworm.com/index.php?rid=1170215&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F221173201%2F The controversy that has engrossed patients and docs in the US over two versions of the same Genentech drug - the older Avastin, which is used off-label to treat wet macular degeneration, and the newer Lucentis, which is approved by regulators but much more expensive - is now playing out north of the border. Canada’s Common Drug Review, a federal body responsible for determining whether drugs merit coverage on provincial health plans, rejected Lucentis for coverage late last year. But the application is being reconsidered and a final decision is expected tomorrow, according to The Globe & Mail. [UPDATE: We should have noted earlier that, while the Common Drug Review makes recommendations about which drugs should qualify for coverage, provinces still make their own decisions.] In... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1170215 Tue, 22 Jan 2008 19:15:03 +0100 1170215 http://www.medworm.com/index.php?rid=1156744&cid=t_111609_117_f&fid=34612&url=http%3A%2F%2Fwww.thedoctorweighsin.com%2Fjournal%2F2008%2F1%2F17%2Fjudah-folkman-a-giant-of-cancer-therapy-is-dead.html By Dov Michaeli MD, Ph.D The field of cancer therapy is orphaned ; Judah Folkman, “the father of angiogenesis”, died two days ago at age 74, of a heart attack.Judah, the son of a rabbi, was a visionary scientist with an uncommon compassion for his patients. I remember a presentation he gave at the American Society of Clinical Oncologists several years ago, where he was honored for his lifetime achievements. He was an absolutely mesmerizing speaker, describing his struggles in demonstrating experimentally his theories about tumor angiogenesis (don’t despair; I’ll explain in a minute). It was a triumphant speech. Judah had an unshakable conviction in his theory. He had no second thoughts about demolishing long entrenched opinions and received wisdo... The Doctor Weighs In blogs http://www.medworm.com/rss/comments.php?id=1156744 Thu, 17 Jan 2008 02:24:07 +0100 1156744 http://www.medworm.com/index.php?rid=1108782&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F203672507%2F After two months of anger and controversy, Genentech has struck a deal with opthamologists over distribution of the cancer med, which many docs use to treat wet macular degeneration, even though it was never approved for that use. The agreement comes shortly after US Sen. Herb Kohl, a Democrat from Wisconsin, called for an investigation into Genentech’s decision to halt supplies to compound pharmacies over concerns Medicare costs could rise by $3 billion annually. (Here’s the Genentech statement). The backdrop: Genentech planned to restrict sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into smaller doses and repackaged for docs. Opthalmologists complained that would hurt patients, because the alternative treatment is Gene... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1108782 Thu, 20 Dec 2007 22:58:05 +0100 1108782 http://www.medworm.com/index.php?rid=1072489&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F195735370%2F A slim majority - 5 to 4 - believe the Genentech med shouldn’t be approved for patients with breast cancer that has spread to other parts of the body, because the drug’s benefit in slowing tumor growth isn’t worth the added risk of serious side effects, including high blood pressure and death. The move rattled investors, who sent Genentech shares plunging. “Everybody wants to offer metastatic breast cancer patients hope, but we shouldn’t offer them false hope,” says Natalie Compagni-Portis, a panel member and a patient representative with Breast Cancer Action, an advocacy group, Bloomberg News reports. “We have to raise the bar in terms of safety.” Prior to the meeting, FDA medical reviewers noted that Avastin slowed the progression of cance... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1072489 Wed, 05 Dec 2007 21:36:56 +0100 1072489 http://www.medworm.com/index.php?rid=1067904&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F194512457%2F The biotech is hoping to win recommendation from an FDA panel on Wednesday to peddle Avastin as a treatment for breast cancer. But data posted on the FDA web site today suggests this may be a hard sell. The med failed to help breast cancer patients live longer and had serious side effects, including deaths, according to the FDA. Wall Street reacted by beating up Genentech stock on very heavy volume. The drug, which is currently approved as a part of a regimen for treating colon and non-small cell lung cancer, did slow the spread of metastatic breast cancer by an extra 5.5 months when used chemo, compared with patients who received only chemo. But Avastin patients had a 20 percent increase in serious side effects, and the med didn’t show a statistically significant ability to extend l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1067904 Mon, 03 Dec 2007 18:59:19 +0100 1067904 http://www.medworm.com/index.php?rid=1063014&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F193101030%2F We apologize for the long break. We had a task involving one of the short people and then a trip to the friendly dentist, who declared that our fangs are as sharp as ever (please see the photo). Now, though, we have returned and your service disruption is officially over. In our absence, much has happened and so let us now try to catch up together… FDA Needs More Money And Staff (Bloomberg News) Wyeth Promotes Joe Mahady to Pharma President (Yahoo/Reuters) Genentech Seeks Approval To Sell Avastin For Breast Cancer (Bloomberg News) Novartis Completes Its Latest Share Buyback (Yahoo/Reuters) Sanofi-Aventis Restructures Japan Joint Venture (Yahoo/AP) Caraco Gets FDA OK For Generic Lexapro (Yahoo/Reuters) Massachusetts Biotech Council Begins Lobbying Campaign (Boston Herald) Share / E-ma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1063014 Fri, 30 Nov 2007 19:07:08 +0100 1063014 http://www.medworm.com/index.php?rid=1057468&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F192078280%2F Herb Kohl is riled up. But first some background: You may recall that Genentech caused a furor recently by restricting distribution of its Avastin cancer med, which is widely used to treat wet macular degeneration, even though the drug was never approved for that purpose. The biotech wants to halt sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into different doses. Opthalmologists complain the move will hurt patients, because the alternative treatment is Genentech’s newer Lucentis, which is approved for the eye disease, but costs 40 times as much, or about $2,000. The decision renewed criticism that Genentech is trying to steer business toward Lucentis at the expense of patients, especially since the biotech won’t study Avastin fo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1057468 Wed, 28 Nov 2007 22:28:26 +0100 1057468 http://www.medworm.com/index.php?rid=1037066&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F187227743%2F Snow is fluttering over the nation’s medicine chest this morning. And so with the chilly wind passing by the Pharmalot corporate campus, what better to brace ourselves for the day than with a cup of coffee and a few interesting items? And if you want to catch up on weekend news, just scroll further down. Genentech’s Avastin Shows Positive Results For Treating Brain Cancer (CNNMoney.com) Boston Scientific Hikes Settlement Fund (Yahoo/AP) Sciele Signs Deal With Novo Nordisk (Yahoo/AP) Europe Backs AstraZeneca Nexium Patent (Yahoo/Reuters) Zentiva Could Turnaround With Restructuring (Czech Business Weekly) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1037066 Mon, 19 Nov 2007 16:14:22 +0100 1037066 http://www.medworm.com/index.php?rid=1022534&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F184096032%2F Finally, the kids are off to school. The dog has pooped. And the coffee in the Pharmalot conference room is piping hot. What better way to enjoy the morning than with a clear head and a screen full of interesting items? And so here they are…. Pharmaceutical Underwriters Are Migrating North (Canadian Underwriter) Drug Costs Hurt Retiree Savings: Medco Survey (Yahoo/AP) Roche, Novartis And J&J’s Ortho Settle Patent Dispute (Bloomberg News) VaxGen And Raven Biotechnologies Agree To Merger (PharmaTimes) Roche Says Avastin Study Misses Endpoint (Yahoo/Reuters) Sanofi To Market & Develop Acambis West Nile Vaccine (MarketWatch) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1022534 Tue, 13 Nov 2007 12:40:03 +0100 1022534 http://www.medworm.com/index.php?rid=1021388&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Fwww.aao.org%2Fnewsroom%2FGenentech.mp3 The American Academy of Opthalmology held its annual meeting this past weekend and the docs were served Genentech’s Susan Desmond-Hellman, the biotech’s president of product development, as the main course. In a speech and Q&A session, she struggled to defuse outrage over Genentech’s decision last month to restrict distribution of its Avastin cancer med, which is widely used to treat wet macular degeneration, even though the drug was never approved for that purpose. The biotech wants to halt sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into different doses. Opthalmologists complain the move will hurt patients, because the alternative treatment is Genentech’s newer Lucentis, which is approved for the eye dise... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1021388 Tue, 13 Nov 2007 00:04:22 +0100 1021388 http://www.medworm.com/index.php?rid=1003724&cid=t_111609_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F179836555%2F Bevacizumab is a biologic anti-cancer agent that prevents tumor growth by interfering with the formation of new blood vessels. Now, a new study found that bevacizumab may have the potential to improve the efficacy of standard combination chemotherapy in ovarian cancer. Ovarian cancer or cancer of the ovary is the fifth most common cancer in women and I reckon one of the deadliest. Almost 70% of ovarian cancer patients fail to win against the disease despite chemotherapy. According to Dr. Bram Goldstein, co-author of the study, whose findings are published in Vol. 17 Issue 4 of International Journal of Gynecological Cancer: “The results from our research suggest that the combination of Bevacizumab and standard therapy for the treatment of ovarian cancer may be promising, particularly with... Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=1003724 Mon, 05 Nov 2007 02:47:01 +0100 1003724 http://www.medworm.com/index.php?rid=992036&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F177222295%2F The biotech caused a stir this month after restricting distribution of its Avastin cancer med, which is widely used to treat wet macular degeneration, even though the drug was never approved for that purpose. At the time, Genentech planned to halt sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into different doses. Opthalmologists, however, complained the move will hurt patients - the alternative is Genentech’s newer Lucentis, which is approved for the eye disease, but costs 40 times as much, or about $2,000. The decision renewed criticism that Genentech is trying to steer business toward Lucentis at the expense of patients, especially since the biotech won’t study Avastin for the eye disease (but the NIH is doing so). For... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=992036 Tue, 30 Oct 2007 14:54:13 +0100 992036 http://www.medworm.com/index.php?rid=970222&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173472547%2F Herb Kohl, the Democrat from Wisconsin who chairs the Senate’s Special Committee on Aging, is suspicious about Genentech’s reasons for ending sales of its Avastin cancer drug to compounding pharmacies. And he’s worried that the biotech’s decision, which was announced two weeks ago, will wind up costing Medicare a great deal of money. You may recall Avastin is widely used to treat wet macular degeneration, but the biotech never sought FDA approval for that purpose. Why? Well, its much newer Lucentis drug, which happens to cost about 40 times more, was approved for that use. In explaining its move, Genentech cited FDA concerns about contamination when an Avastin vial is split into different doses; the agency issued a warning letter to a compounder recently. But optha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=970222 Mon, 22 Oct 2007 20:30:36 +0100 970222 http://www.medworm.com/index.php?rid=956306&cid=t_111609_117_f&fid=36026&url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Fmacular-degeneration-genentech-to-limit-avastin-in-favor-of-lucentis%2F In a move that has already angered many ophthalmologists, and that will surely anger many more macular degeneration patients, Genentech has announced its decision no longer to distribute Avastin (bevacizumab) to compounding pharmacies, effective November 30, 2007. While entirely appropriate, both medically and legally, and with the full blessing of the FDA, this decision is likely to be seen as price gouging by the patients who have to pay for it. That’s because Avastin costs only about $50 a dose while the company’s other macular degeneration product Lucentis (ranibizumab) costs more like $2000 per dose. So what’s going on here? Avastin and Lucentis are both products developed, manufactured and marketed by Genentech. Both products do the same thing in the body, which is to inhibit t... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=956306 Tue, 16 Oct 2007 23:22:14 +0100 956306 http://www.medworm.com/index.php?rid=954387&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170606829%2F The drugmaker missed analyst estimates as demand for Tamiflu fell and growth of the Herceptin breast cancer drug slowed. Revenue climbed 5.7 percent to $9.4 billion, as sales of Herceptin increased only 18 percent, the slowest rate in at least five quarters, Bloomberg News notes. And Roche expects core earnings to grow faster than sales in 2007, while revenue from pharmaceuticals is forecast to grow more than 10 percent. Here’s the statement. Sales of Avastin, the first treatment to choke off blood to tumors, jumped 45 percent, above analyst expectations. The med is approved for colon and lung cancer in the US as well as breast cancer in Europe. It faces competition, though, from ImClone’s Erbitux, which is also approved as a colon cancer treatment, Bloomberg reminds us. Sales... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=954387 Tue, 16 Oct 2007 11:43:19 +0100 954387 http://www.medworm.com/index.php?rid=944707&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F168629908%2F For the past year, Genentech has pushed its new Lucentis drug to treat wet macular degeneration and, in the process, caused some controversy. Its older Avastin cancer med is widely used to treat the degenerative eye disease, but never approved for that purpose. And the biotech never sought FDA approval, either. Why? Well, Lucentis costs about 40 times more - a higher profit margin. Now, though, Genentech is taking yet another step to restrict Avastin use. This time, the biotech is telling opthamologists it will soon be harder to get obtain the drug because sales won’t be made to compounders, citing FDA concerns about contamination when an Avastin vial is split into different doses; the agency issued a warning letter to a compounder recently. Moreover, Lucentis is now widely available... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=944707 Thu, 11 Oct 2007 21:39:52 +0100 944707 http://www.medworm.com/index.php?rid=864406&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155183897%2F ImClose stock rocketed skyward today on the news that Erbitux, which is currently approved to treat cancer in the colon, head and neck, extended survival in patients with small-cell lung cancer. The stock moved because the results were unexpected. At the same time, though, the full story isn’t really known, because full details weren’t released, so it’s not completely clear how much longer patients lived. Here are a couple of interpretations…. “The purpose of the trial was to investigate the efficacy of Erbitux in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who had not received prior chemotherapy. In our opinion, this news is clearly positive; however we will reserve judgment until we s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=864406 Tue, 11 Sep 2007 20:25:32 +0100 864406 http://www.medworm.com/index.php?rid=819668&cid=t_111609_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F147703947%2F And so for the first time since Pharmalot began earlier this year, we are taking an official vacation break. What does this mean? The usual flow of news, views and chattiness will be suspended until after Labor Day. Generally, this is a slow time of year, and we all need a respite now and then. You understand. However, we will be checking e-mail, of course, and prepare items of interest for our return. Have something interesting for us to see? Send it along. On that note, we look forward to seeing you again and resuming our correspondence. Until then, we leave you with these. Catch a wave, everyone…. Europe Places New Restrictions On Novartis’ Prexige (PharmaTimes) Roche’s Avastin Approved For NSCLC In European Union (PharmaTimes) Merck Lawyer Objects To Petition For New ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=819668 Fri, 24 Aug 2007 12:59:27 +0100 819668 http://www.medworm.com/index.php?rid=716526&cid=t_111609_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F07%2F05%2Favastin-te-fistula-warning-released%2F Filed under: Drug, Chemotherapy, Lung Cancer, Colon and Rectal Cancer, Esophageal Cancer, Clinical Trials, Daily newsRecently, a report came out from Health Canada possibly linking Avastin, a drug for colorectal cancer, with tracheo-esophageal fistula (an abnormal connection between the esophagus and the trachea).This week, the manufacturer of Avastin, Roche's Genentech, has warned healthcare providers that Avastin has caused at least one fatality in a recent clinical study in patients with small cell lung cancer, according to the FDA. Genentech stopped the trial after the individual's death.There are no plan to "re-engineer" the drug for the treatment of SCLC although other programs will go forward including those for non small cell lung cancer and kidney cancer, according to a Roche spok... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=716526 Thu, 05 Jul 2007 04:00:00 +0100 716526 http://www.medworm.com/index.php?rid=539095&cid=t_111609_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F04%2F12%2Ferbitux-fails-in-pancreatic-cancer-trials%2F Filed under: Drug, Pancreatic Cancer, Research, Daily newsImClone Systems Inc.'s drug Erbitux has failed to help pancreatic cancer patients live longer. It's also failed to grow ImClone's market -- not surprising since it's the company's only drug.Imclone, partnering with Bristol-Myers Squibb Co., wanted to see Erbitux -- already cleared for use with colon, head, and neck cancers -- extend the lives of patients with cancer marked by a spread to the pancreas.No one is giving up just yet, and Imclone plans additional tests on Erbitux's use in pancreatic cancer. A study using a combination of Erbitux and Avastin and chemotherapy is up next. "There are reasons to think Erbitux works in pancreatic cancer, but the current results are not as dramatic as we hoped," said Alex Denner, lead for an ex... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=539095 Thu, 12 Apr 2007 04:00:00 +0100 539095