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 'genentech'. Sat, 03 Sep 2011 02:01:41 +0100 http://www.medworm.com/index.php?rid=5107893&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXpncqmok5No%2F Rise and shine. Another day is on the way. And it looks to be a sunny one here on the Pharmalot corporate campus, where we are brewing a delicious cup of mandatory stimulation. Our flavor today is Southern Pecan. Please join us. After all, there is much to do as meetings and deadlines beckon. You know the score, so time to dig in. Meanwhile, here are some tidbits. Have a great day and let us know if you hear of something interesting… FDA Approval Of Roche Melanoma Drug May Come Early (Reuters) Pfizer Sends Israeli Sniffing Dogs To Finland (The Jerusalem Post) Revlimid Side Effects Linked To Protein In Study (Reuters) Valeant Pharma Eyes Medicis For Another Acquisition (Pharma Times) Merck And J&J Sit On Piles Of Cash (The Star-Ledger of New Jersey) Lexicon Tumor Drug Shows Posit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107893 Tue, 09 Aug 2011 12:06:27 +0100 5107893 http://www.medworm.com/index.php?rid=5107895&cid=t_111612_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_111612_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=5140264&cid=t_111612_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2Fvd2KCKbMzG4%2Fepharma-summit-west-emarketing.html Landscape Overview: What Tools are in Your Backpack? Shawn O'Hagen, Daiichi Sankyo Inc This morning we kicked of the eMarketing University by examining what tools we have an what we need for successful digital marketing. Healthcare professionals are at an increasing rate are finding healthcare online. Mobile technology is also a growing sector for doctors and patients. Sales forces are downsizing, but digital techniques allow companies to still reach doctors. What is really needed for digital marketing? By default, all companies should have a digital presence, but the companies should understand where their market ads are. The two key things needed: Web page and banner ads. Start today collecting your patients and physicians email. It is the quickest way to communicate with them. O’Ha... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5140264 Mon, 25 Jul 2011 17:36:00 +0100 5140264 http://www.medworm.com/index.php?rid=4992996&cid=t_111612_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_111612_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_111612_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_111612_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=4945197&cid=t_111612_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=4768246&cid=t_111612_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_111612_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_111612_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_111612_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=4653607&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVId4_w7jKkA%2F Yesterday, we wrote that California State Controller John Chiang sent a letter to Gilead Sciences to ask the drugmaker for a reduction in the price of Atripla, a key AIDS med. As it turns out, Chiang actually sent letters to a total of nine drugmakers, asking each of them to lower the prices on their AIDS meds and also extend supplemental agreements that were reached last year to relieve financial pressure on the AIDS Drug Assistance Programs around the country. The other drugmakers he wrote were Abbott Laboratories, Merck, Boehringer Ingelheim, Genentech, Bristol-Myers Squibb, Merck, Johnson & Johnson’s Tibotec unit and ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline. In each case, Chiang wrote that California’s ADAP program has experienced a 257 percent ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653607 Tue, 29 Mar 2011 11:51:03 +0100 4653607 http://www.medworm.com/index.php?rid=4642994&cid=t_111612_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=4592695&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQzD6otG0mCU%2F One of the big gripes among biotech investors is that Amgen has refused to pay a dividend. No matter how many times the issue has been raised, execs have refused to consider the prospect. Never mind that the stock has been battered amid a raft of struggles, notably FDA warnings over health risks associated with the Aranesp and Epogen anemia meds, concerns about reduced Medicare reimbursement and uncertainty about its pipeline and acquisition strategy (see this). At one point, the combination of setbacks and miscues resulted in Kevin Sharer being named one of the worst chief executives a few years ago (see this). Now, though, attention is focused on the possibility of a dividend since Wall Street anticipates the issue will be addressed at the upcoming annual shareholder meeting. Investors, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592695 Mon, 14 Mar 2011 13:59:30 +0100 4592695 http://www.medworm.com/index.php?rid=4549937&cid=t_111612_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_111612_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_111612_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_111612_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_111612_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=4455484&cid=t_111612_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=4446031&cid=t_111612_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_111612_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=4372249&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0MCrR9F3g5k%2F Hello, everyone. Gray skies are enveloping the Pharmalot corporate campus this morning, but our spirits remain sunny. Why? Every so often we like to remind you of what the Morning Mayor would say: Every brand new day should be unwrapped like a precious gift. While you tug on the ribbon, please join us for a cup of stimulation and a gander at the news of the world. Hope your day goes well and drop us a line if you spot something interesting. Cheers… Pfizer Strikes Antibody Deal With Theraclone (New York Times) The Pfizer Model For Hiring Law Firms, A Year Later (American Lawyer) Roche Responds To The FDA Over Avastin (San Francisco Business Times) UK’s NICE Changes Mind Over Alzheimer’s Drugs (The Telegraph) Roche Melanoma Drug Helps Patients Live Longer: Study (Reuters) D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372249 Wed, 19 Jan 2011 12:49:23 +0100 4372249 http://www.medworm.com/index.php?rid=4331237&cid=t_111612_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_111612_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=4331243&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWZ2gg18cax0%2F Welcome to another working week, everyone, and nice to see you again. We hope your weekend was refreshing and pleasant. Now, though, the time has come to resume the routine as those meetings and deadlines loom. To cope, we are brewing our mandatory cup of stimulation. As always, we invite you to join us. Meanwhile, here are some tidbits to help you get going. Have a great day and stay in touch… Gilead Extends Length Of HIV Drug Study (Associated Press) GlaxoSmithKline And Epizyme Sign Development Deal (The Boston Globe) Lilly Pancreas Drug Questioned By FDA Staff (Reuters) Sanofi-Aventis and Genzyme Still Have ‘Significant’ Differences (Bloomberg News) J&J Bid For Smith & Nephew Wasn’t Disclosed (Reuters) Genentech Sued Over Raptiva Links To Brain Disease... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331243 Mon, 10 Jan 2011 12:54:12 +0100 4331243 http://www.medworm.com/index.php?rid=4322692&cid=t_111612_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=4322694&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkXQ0zP99dZg%2F And so another week will soon draw to a close. And you know what that means - daydreaming about weekend plans. After clearing still more snow from the Pharmalot corporate campus, we hope to visit the town dump (an interesting place; ask us about the time we met former Schering-Plough ceo Dick Kogan disposing of boxes of who-knows-what) and spend time with the short people. What about you? A snowball fight, perhaps? A cozy moment with a special person? Whatever you do have a nice time. Meanwhile, here are a few tidbits of interest. See you soon… Dendreon To Bring Provenge Vaccine To Europe (TheStreet) Savient Has Manufacturing Problems With Gout Drug (Reuters) FDA Wants More To Review Astra Thyroid Cancer Drug (Associated Press) A Woman’s Tears Lower Male Testosterone: Study (B... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4322694 Fri, 07 Jan 2011 12:53:13 +0100 4322694 http://www.medworm.com/index.php?rid=4305105&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F---sJ6wFY7c%2F This is hardly surprising. Given the ongoing talk at the FDA about placing greater emphasis on safety, no one should be shocked that the pace of drug approvals remains modest. Last year, 21 new drugs were approved, down from 25 in 2009 and 24 in 2008. However, the latest tally is actually higher than the 18 approvals issued in 2007. As The Wall Street Journal notes, the latest approvals included a few biologics that are expected to become sizeable sellers: Amgen won approval for Prolia, which is used to treat osteoporosis in postmenopausal women; Roche’s Genentech scored with Actemra for rheumatoid arthritis; Boehringer Ingelheim received approval for Pradaxa, a new type of bloodthinner and Novartis garnered FDA endorsement for its Gilenya multiple sclerosis pill. And how can anyone ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305105 Mon, 03 Jan 2011 13:02:45 +0100 4305105 http://www.medworm.com/index.php?rid=4134257&cid=t_111612_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=4082330&cid=t_111612_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=3987236&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcB0AB5jloI4%2F Welcome back, everyone. We hope you had a pleasant weekend and feel refreshed. Now, of course, the routine resumes as meetings and deadlines approach. To steel ourselves, we are preparing the mandatory cup of simulation. So please join us as we indulge and scan the news of the world. Hope your day goes well and do stay in touch… Bristol-Myers And Astra Tout Diabetes Study Results (Dow Jones) Roche’s Avastin Fails In Late-State Colon Cancer Study (Bloomberg News) India May Separate Approvals From Patent Status (LiveMint) Drugmakers Protest New Prices In Greece (PharmaTimes) Some African Nations Side With India Over Generics Debate (Economic Times) Genentech Exec Looks Ahead To Rockefeller University (Nature) Novartis Pulls European Application For Blood Pressure Pill (PharmaTime... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987236 Mon, 20 Sep 2010 11:35:40 +0100 3987236 http://www.medworm.com/index.php?rid=3973111&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsNp0T-pISJQ%2F Since working dad best describes our place in the world, we do not pretend to know what all working moms want from their employers. So we dutifully glanced at Working Mother magazine to learn that several drugmakers - 11, in fact - made the latest list of the 100 best employers in the land. Which ones? Abbott Labs, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Genentech, Johnson & Johnson, Merck, Novo Nordisk, Pfizer and Sanofi-Aventis. A notable exception is Novartis, which made the 2009 list (see here), but has since gained some notoriety for agreeing to pay a combined $402 million to settle a pair of embarassing class-action lawsuits brought by female employees who claimed the drugmaker engaged in a pattern of discrimination involving pay, promotion and pregna... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973111 Wed, 15 Sep 2010 15:33:26 +0100 3973111 http://www.medworm.com/index.php?rid=3973113&cid=t_111612_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=3973117&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb2h0UB6N-As%2F Rise and shine, everyone. Another day is upon us. But this is a good thing. As one of our favorite sages, the Morning Mayor, used to say: Every brand new day should be unwrapped like a precious gift. While you tug on the ribbon, we will brew the mandatory cup of stimulation and poke around for interesting items. Here, in fact, are a few to help you get started. Have a good one and stay in touch… Roche Rules Out Merging R&D With Genentech (Reuters) Abbott To Close Canadian Baby Formula Plant (Brockville Recorder & Times) China’s BGI And Merck Form Alliance (Bio-IT World) Abbott Fights To Keep Meridia Diet Pill On The Market (Reuters) K-V Pharmaceutical Secures A $20M Loan (Fox Business) Genentech CEO Resigns From Dendreon Board (Xconomy) Cell Therapeutics Appeals FDA R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973117 Wed, 15 Sep 2010 11:51:18 +0100 3973117 http://www.medworm.com/index.php?rid=3969184&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7rGeUjUn5rM%2F Last month, an FDA advisory committee voted 12 to 1 to recommend the agency withdraw approval for the multi-billion-dollar Avastin cancer drug to be used to treat 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. And Avastin patients also suffered more serious side effects. Two years ago, an FDA panel voted against approval (see here), but the agency endorsed treatment for breast cancer anyway. And later this week, the FDA is expected to decide again what to do about the breast cancer indication for the drug, which is already approved to treat colon, lung and brain cancer. The impending decision is sparking heated debat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3969184 Tue, 14 Sep 2010 13:32:32 +0100 3969184 http://www.medworm.com/index.php?rid=3965704&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0BKEg-uDqt0%2F Hello, everyone. Nice to see you again. We hope you enjoyed the weekend, which amounted to an extended break, in our case. In any event, the routine has now returned and, of course, we are brewing the mandatory cup of stimulation to help us along. Please join us with a cup of your own, or a water bottle, perhaps, we scan the news of the world. Have a great day and stay in touch… IRB Delays Frustrate Investigators (OutsourcingPharma) India Becomes A Hub For Counterfeit Meds (The Washington Post) Genzyme Sells Genetics Unit For $925M To LabCorp (Associated Press) An Eli Lilly Scout Discusses Social Media (140conf) AstraZeneca And UCL Sign Stem Cell Deal (The Guardian) Hopes Fade For Roche And Ipsen Diabetes Drug (Reuters) Mcgarrybowen Wins Creative Duties On Pfizer Advil Account (AdWee... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965704 Mon, 13 Sep 2010 11:56:12 +0100 3965704 http://www.medworm.com/index.php?rid=3915285&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJhu1W0Nq_XU%2F In a surprising move, the FDA late last week issued a Refuse to File letter to Roche’s Genentech unit for its T-DM1 biologic, which is being developed to treat women who have advanced breast cancer, test positive for the HER2 protein and hadn’t responded - or stopped responding - to other meds, including Roche’s Herceptin. The decision is a blow after the drugmaker trumpeted T-DM1 as an important salve - not only for women - but also as a way to extend its breast cancer franchise. The agency action came as a surprise, because the FDA explained not all treatment choices had been included in the single-arm, Phase II trial that was used as the basis for the Genentech application (see here). It was only last month that Genentech filed its application, noting T-DM1 shrank tumo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915285 Mon, 30 Aug 2010 14:26:39 +0100 3915285 http://www.medworm.com/index.php?rid=3865460&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7iWjrPhmH5E%2F Earlier this week, a 23-year-old Omaha man filed a lawsuit claiming that Genentech and Biogen failed to warn of the risks involving the use of their Rituxan immunosupressant -and the subsequent damage has transformed him into a “flaccid” quadriplegic who is dependent on a ventilator and requires round-the-clock care. Beyond dramatic images, what makes this case potentially significant is it may be the first product-liability lawsuit to level such charges. The story begins in 1995, when Jesse Peetz was 11 and diagnosed with thrombotic thrombocytopenia purpura, or TTP. His doctor prescribed Rituxan, which was approved to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis, but not TTP, which is an autoimmune disorder. His lawsuit claims that ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865460 Fri, 13 Aug 2010 12:23:41 +0100 3865460 http://www.medworm.com/index.php?rid=3714129&cid=t_111612_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F06%2Fsmoke-detector-medical-center-leader.html Last year we posted about the seemingly incongruous choice of a wealthy biotechnology executive with little academic or practice experience to run the prestigious University of California - San Francisco, a health oriented university housing a respected medical school.  We wondered whether her corporate background would make it difficult to uphold the university's academic and patient care missions.In line with our concerns, Duff Wilson, writing in the New York Times, reported:When Dr. Susan Desmond-Hellmann was named chancellor of the University of California, San Francisco, last summer, she took over a medical institution focused on world health generally and tobacco control in particular. But she forgot one thing in adjusting to her new role: personal stock holdings listed las... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3714129 Wed, 30 Jun 2010 20:49:00 +0100 3714129 http://www.medworm.com/index.php?rid=3699703&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqmL_7AMPh1Q%2F This may be a bad break for drugmakers. Wellpoint is using comparative effectiveness to make it more difficult for its members to use the Boniva osteoporosis drug after its own research found greater fractures, lower compliance and higher costs than other meds, according to Dow Jones. The insurer studied 26,000 members on osteo meds, comparing Boniva, which is marketed by Roche and GlaxoSmithKline with Actonel, which is sold by Sanofi-Aventis and Warner Chilcott, and Merck’s Fosamax. Although randomized clinical trials suggest the drugs should be equivalent, WellPoint data found differences. Now, WellPoint other drugs must be tried before Boniva is approved. The drug remains where on Tier 3, or non-preferred level, on the formulary. WellPoint actually made the change last year, Dow J... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3699703 Fri, 25 Jun 2010 13:57:57 +0100 3699703 http://www.medworm.com/index.php?rid=3691115&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgQcbNg-vDTc%2F Hello, everyone. Nice to see you again. Another sunny day here on the Pharmalot corporate campus and this can mean just one thing - a celebration with a deserved cup of stimulation. We invite you to join us. And as you do, please enjoy the smattering of world news accumulated below. Have a great day and stay in touch… Connecticut Subpoenas CVS Over Drug Program (Reuters) Dr. Reddy’s Expects Orders From Merck And Abbott (Economic Times) Sanofi Fights Counterfeiting In Egypt (InPharma-Technologist) Genentech Wins Another Approval For Lucentis (San Francisco Business Times) A Closer Look At The Biovail-Valeant Merger (Seeking Alpha) Piramal To Share Abbott Payout With Employees (Economic Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3691115 Wed, 23 Jun 2010 12:01:01 +0100 3691115 http://www.medworm.com/index.php?rid=3672034&cid=t_111612_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=3556375&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBZl1v-9-WXg%2F For years, the Garden State has bragged about being the nation’s medicine chest. Global headquarters dotted the map. Fledgling biotechs toiled in their shadow. Tens of thousands of employees commuted from manicured suburbs to manicured corporate campuses. Crucial meetings were held at golf courses. And there was that close relationship with offiicals in Trenton, the state capital. But New Jersey’s dominance in the pharmaceutical world is lessening. Consider the tale of Steve Weissman. Like thousands of other highly skilled professionals, he became a victim early last year of the cutbacks and mergers that are sweeping the industry. After working 18 years as a chemist at Merck, he found himself looking for a job and spent months were spent crisscrossing the state, networking and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3556375 Wed, 12 May 2010 12:11:28 +0100 3556375 http://www.medworm.com/index.php?rid=3511780&cid=t_111612_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2F0M0CHYvQrGo%2Fsave-date-multi-channel-pharma.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3511780 Wed, 28 Apr 2010 14:40:00 +0100 3511780 http://www.medworm.com/index.php?rid=3331606&cid=t_111612_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=3311931&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiexxRp7b9fs%2F In its annual survey of postdoc preferences, The Scientist lists 40 institutions that are favored places to work. Not surprisingly, the institutions cited are predominantly universities and government entities. Among the winners - Fred Hutchinson Cancer Research Center, Children’s Hospital of Philadelphia, Mayo Clinic, Whitehead Institute for Biomedical Research and the National Cancer Institute. However, two drugmakers not only were listed, but were highly ranked. Placing fourth was the Novartis Institutes for Biomedical Research in Cambridge, Ma. Why? Postdocs cited equity and benefits, although they’re not crazy about the value of the postdoc experience or demands on family and personal life. At number five was Genentech, which was cited for research funding and benefits, but wa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3311931 Fri, 26 Feb 2010 13:12:41 +0100 3311931 http://www.medworm.com/index.php?rid=3290893&cid=t_111612_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2010%2F02%2Fneurodegenerative-disease-drug.html From Fierce Biotech:UCSF enters drug discovery agreement with GenentechPosted February 19, 2010"The University of California, San Francisco has signed a partnership agreement with Genentech, Inc., a wholly owned member of the Roche Group, to discover and develop drug candidates for neurodegenerative diseases."Through the agreement, Genentech will provide funding and its research acumen in neuroscience and will collaborate with UCSF to identify small molecules."Read the full article (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=3290893 Sat, 20 Feb 2010 09:24:00 +0100 3290893 http://www.medworm.com/index.php?rid=3040021&cid=t_111612_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_111612_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_111612_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=2996027&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0VIUtqWQZCw%2F If some Congressional statements about health care from Republicans and Democrats sounded similar, there was a good reason. Remarks by more than a dozen lawmakers were ghostwritten, in whole or in part, by Washington lobbyists working for Genentech, The New York Times reports. E-mail messages obtained by the paper show that lobbyists drafted one statement for Democrats and another for Republicans. And the lobbyists, which were employed by Genentech and two Washington law firms, succeeded in getting the statements printed in the Congressional Record under the names of different members of Congress. Genentech, which is now owned entirely by Roche, tells the paper that 42 House members picked up some of its verbiage — 22 Republicans and 20 Democrats, to be exact. Representative Bill Pascr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2996027 Mon, 16 Nov 2009 14:29:34 +0100 2996027 http://www.medworm.com/index.php?rid=2939562&cid=t_111612_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=2886742&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2fURiNc_FuA%2F In a bid to maintain the Genentech culture, Roche plans to reward the biotech’s employees with more long-term stock options than the folks who work for the big drug maker. Severin Schwan, Roche’s ceo, says that reviewing Genentech pay is a top priority and wants to keep things “entrepreneurial” at Genentech, according to The Financial Times. They must remain “attractive and relevant to the specific environment in California,” he told the paper, while dismissing talk that this year’s acquisition of Genentech, in which Roche held a majority stake, would result in a significant reduction in tax charges. Schwan also maintains that all opposition to the previously hostile bid by Genentech’s board had dissipated. The move to offer more options to Gene... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2886742 Tue, 13 Oct 2009 12:26:33 +0100 2886742 http://www.medworm.com/index.php?rid=2279377&cid=t_111612_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F03%2F18%2Fabt-869-2%2F Vegf, Etc - Boring & Healthy…Tons of Ph2s in HCC but is it better then Sorafenib? no news is good news? previously Posted in Abbott, Genentech, TIE2, VEGF (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2279377 Wed, 18 Mar 2009 12:26:59 +0100 2279377 http://www.medworm.com/index.php?rid=2513160&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fpharmalot%2F%7E3%2FuIjujuLtkTM%2F Nothing like a drying pipeline to spur an acquisition, or an alliance, or a licensing deal. And there were certainly enough in 2008, given the dire straits confronting many large drugmakers. But which deal was truly clever, captivating and, most of all, potentially lucrative? What about the tie-up between Pfizer and Ranbaxy? Pfizer walked away with extra 20 months of Lipitor patent exclusivity and Ranbaxy got the right to sell generic versions in November 2011 in the US, and sell generics in some other countries. How about Lilly scooping up ImClone Systems? Or the Novartis diversification move to pay $11 billion for 25 percent of Alcon? Well, the In Vivo blog, which tracks such things closely all year long, is running a poll. So you can decide for yourselves right here. And no, only cons... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2513160 Wed, 24 Dec 2008 12:55:59 +0100 2513160 http://www.medworm.com/index.php?rid=2056346&cid=t_111612_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=2006398&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F471254136%2F The likelihood that Roche can raise a $45 billion syndicated loan to finance its proposed buyout of Genentech is becoming increasingly remote, bankers tells Reuters. The sheer size of the jumbo deal would eclipse today’s shrinking loan market, which senior banking sources say is putting pressure on Roche to consider alternative funding options, such as a combo of loans, bonds, equity and cash. “The question is about size. In light of the current climate, a $45 billion loan looks large. It would have to be a combination of everything - Roche would have to print bonds to get the deal done,” a senior banker close to the deal tells Reuters. Just last week, Roche reiterated its committment to its $43.7 billion bid to acquire the 44 percent of Genentech it doesn’t already... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2006398 Mon, 01 Dec 2008 12:30:15 +0100 2006398 http://www.medworm.com/index.php?rid=2006400&cid=t_111612_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=1985165&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F463970926%2F Roche says it will not go ahead with plans to redevelop its Basel headquarters site and construct Switzerland’s highest office tower block, SwissInfo reports. The $450 million project had been scheduled for completion by 2011 and would have included two buildings designed by Swiss star architects Herzog & de Meuron. Now, the drugmaker says the planned 40-story building, which would have resembled a giant helix, could not fulfill its “significant functional requirements.” (The picture is actually an artist’s rendering). The structure was originally intended to accommodate about 2,400 workplaces together with a new R&D center, which is to replace an old lab building. Instead, Roche is now looking at an alternative project that would bring around 1,700 employ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1985165 Mon, 24 Nov 2008 15:18:41 +0100 1985165 http://www.medworm.com/index.php?rid=1947490&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F448376933%2F Welcome back. We hope your weekend was pleasant. Big news, of course, emerged from the American Heart Association about AstraZeneca’s Crestor, which you can see below. Meanwhile, meetings, deadlines and projects beckon. So here are a few items to help you get acclimated. Enjoy the day, everyone… Roche Sticks By Its Genentech Bid (Yahoo/Reuters) High-Dose Zocor Study Has Mixed Results (Yahoo/Reuters) Roche Says Tarceva Data Is Promising (The Wall Street Journal) Shionogi Stock Soars On Crestor Study (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1947490 Mon, 10 Nov 2008 13:00:08 +0100 1947490 http://www.medworm.com/index.php?rid=1926686&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F437932856%2F Decisions, decisions. What will you be this Halloween? A sales rep? A cardiologist? A brand manager? Maybe a cost-cutting consultant? How about a compliance officer? Whatever your fancy, here are a few items to peruse while you mull this over… Erbitux Gets Priority FDA Review For Broader Use (The Wall Street Journal) AstraZeneca Posts Strong Sales Gain (The Financial Times) Sanofi Raises Guidance While Profits Rise Slightly (Yahoo/Reuters) Novo Nordisk May Spend $2 Billion On Acquisitions (Bloomberg News) Biogen & Genentech Develop Blood Cancer Drug (Reuters) Mylan Profit Jumps On Blood Pressure Drug (Bloomberg News) Vanda Pharmaceuticals Halts Development (Washington Business Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1926686 Fri, 31 Oct 2008 11:10:52 +0100 1926686 http://www.medworm.com/index.php?rid=1895597&cid=t_111612_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=1886682&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F423054673%2F The agency is adding labeling changes, including a boxed warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy, or PML, that may develop when using the drug, which is approved to treat moderate to severe plaque psoriasis. The FDA is also requiring Genentech to formulate a risk mitigation strategy and med guide for patients. The moves comes two weeks after Genentech sent a letter to healthcare professionals about the case of a 70-year-old man who was being treated for psoriasis for more than four years with its med, and developed PML. The FDA’s Office of Surveillance and Epidemiology has received reports of serious infections leading to hospitalizations and, in some cases, deaths (read here). The Boxed Warning will highlight t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1886682 Thu, 16 Oct 2008 21:12:10 +0100 1886682 http://www.medworm.com/index.php?rid=1883566&cid=t_111612_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_111612_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_111612_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=1852741&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F410197253%2F The biotech is sending a letter to healthcare professionals about the case of a 70-year-old man who was being treated for psoriasis for more than four years with its med, and developed a rare brain infection known as progressive multifocal leukoencephalopathy, or PML. Genentech says there are no other cases of confirmed PML in patients treated with Raptiva, but there has been a report of a 62-year old patient treated with Raptiva who developed progressive neurologic symptoms and died of an unknown cause. The risk of brain infection had already been noted on Rituxan’s label. Coincidentially, Genentech last month revised a warning on its Rituxan drug Rituxan to note a rheumatoid arthritis patient who was treated with the medicine and died from PML (back story). (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1852741 Fri, 03 Oct 2008 11:48:07 +0100 1852741 http://www.medworm.com/index.php?rid=1841250&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F406527891%2F The stock market plunge reminds Pharmalot of the following true story: As Chicken Little walks down Wall Street, he’s heard shouting ‘The Sky Is Falling!’ Right on cue, a wiseguy broker from Brooklyn opens his window and shouts, ‘Sell Sky!’ …Hang on, everyone. And try not to panic. Covance Abandons Plan For Research Venture In China (NJ.com) Cardinal Health To Spin Off Medical Products Unit (Yahoo/Reuters) Will Lending Woes Hurt Roche Bid For Genentech? (The Financial Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1841250 Mon, 29 Sep 2008 19:22:44 +0100 1841250 http://www.medworm.com/index.php?rid=1829478&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F402207457%2F Stroke sufferers can still benefit from the TPA clot buster even if they receive it up to 90 minutes beyond the current three-hour window following the start of symptoms, according to a study in The New England Journal of Medicine. The finding could potentially extend treatment to thousands more people each year and prevent many from being left disabled, the Associated Press notes. However, the results do not change long-standing advice that stroke victims seek immediate help. The study found the drug could safely be given up to 4½ hours after the start of symptoms. TPA is marketed by Boehringer Ingelheim, which funded the study, as Actilyse overseas and the med is sold in the US and Canada by Genentech as Activase. Here is the abstract. The best treatment is giving patients TPA to break... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1829478 Wed, 24 Sep 2008 22:28:44 +0100 1829478 http://www.medworm.com/index.php?rid=1794391&cid=t_111612_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Ftale-of-two-medicines-vytorin-and.html The world's pharmaceutical giants invent and market medicines that save, prolong and vastly improve the quality of our lives. In return, we give them more money than most people can imagine.That's not entirely a bad trade, except that the highly complex nature of evaluating drugs, the ever-improving marketing savvy of the drug companies and the weakness of the Food and Drug Administration are clearly combining to tilt the deal too far on the side of profits and too little on the side of human health.A small outburst of reports in recent days provides enough of a sample to build a scary theory about how drug makers are getting the better of the FDA, doctors and patients.One case involves two different medicines made by the same company, Genentech Inc.One drug, Avastin, is approved, marketed... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1794391 Tue, 16 Sep 2008 05:55:00 +0100 1794391 http://www.medworm.com/index.php?rid=1790489&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F390582868%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? Zafgen hired Tom Hughes as ceo; Genesis Pharma named John Yang Wang to its board; Glaxo hired Ellen Strahlman from Pfizer as chief medical officer; Encorium Group hired David Ginsberg as ceo; AstraZeneca added Rudy Markham to its board; Pfizer says Andy McCormick, vp of worldwide communications, is leaving; Genentech hired Morgan Sheng from MIT to oversee neurobiology drug ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1790489 Fri, 12 Sep 2008 11:14:40 +0100 1790489 http://www.medworm.com/index.php?rid=1788915&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F390073267%2F The agency says a woman died of the rare viral infection more than a year and a half after discontinuing the drug, which is used to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, and is marketed in the US by Genentech and Biogen Idec. Although cases of the infection have previously been reported in patients taking Rituxan for unapproved uses, including lupus, the FDA says the latest instance is the first reported in a patient taking the drug for arthritis. “The patient had a number of confounding factors that make it difficult to assess the potential role, if any, that Rituxan exposure may have played,” a Genentech spokeswoman tells the Associated Press, adding that the biotech disclosed the death during its July earnings call and the labeling mentions the infect... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1788915 Thu, 11 Sep 2008 22:22:38 +0100 1788915 http://www.medworm.com/index.php?rid=1763897&cid=t_111612_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Froche-to-cut-loose-its-old-syntex.html Swiss drug maker Roche is planning to shutter its 1,000-worker Palo Alto research lab as it pursues its takeover bid for Genentech.A Roche Palo Alto spokeswoman said the 1-million-square-foot facility's inflammation research unit will move to Nutley, N.J., Roche's current U.S. headquarters.The company expects to move its Palo Alto virology operations to Genentech's nearby South San Francisco campus, though the unit would remain separate from the biotechnology giant.Spokeswoman Jacqueline Wallach said the timing of the closure, which would force some job losses, depends on a deal with Genentech.Source (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1763897 Fri, 05 Sep 2008 00:46:00 +0100 1763897 http://www.medworm.com/index.php?rid=1723648&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F371781015%2F Just so Roche execs will know how much it will cost them to hold on to all those Genentech staffers, the biotech filed a document with the Securities and Exchange Commission yesterday showing retention bonuses are going to add up quickly. And the retention plan would extend to virtually all of its 10,700 employees, including, of course, ceo Arthur. Levinson, who would be entitled to a bonus of $8.7 million. Roche, which owns 56 percent of Genentech, offered last month to buy the rest of the company for $89 a share, or $43.7 billion. A committee of independent Genentech directors rejected that offer last week but said it would consider a higher price. Meanwhile, as we noted yesterday, headhunters are actively recruiting Genentech employees, potentially robbing Roche of valuable assets. (So... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1723648 Fri, 22 Aug 2008 11:02:24 +0100 1723648 http://www.medworm.com/index.php?rid=1723652&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F371124988%2F Never mind that Roche plans to move much of its US pharma operations from Nutley, New Jersey, to South San Francisco, if it succeeds in winning Genentech. Roche execs were happy this week to host New Jersey Governor Jon Corzine, who faces a shrinking pharma industry in the Garden State, and use the visit as an opportunity to boast that R&D will remain and may even expand there. “Our decision to move Roche’s commercial operations to California was a strategic business decision and not about the business climate in New Jersey. The Roche-Nutley campus remains a very important hub for the company and will focus on discovering and developing medicines for cancer, metabolic and inflammatory diseases,” George Abercrombie, who heads Roche’s US pharma biz, says in a statement. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1723652 Thu, 21 Aug 2008 17:47:49 +0100 1723652 http://www.medworm.com/index.php?rid=1714165&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F368462549%2F Layoffs and restructurings are taking a toll on drug and device makers in New Jersey, which for decades has prided itself on being home to many of the world’s biggest such companies. However, a survey released today shows employment fell 1 percent in 2007 from a year earlier among the 22 members of the HealthCare Institute of New Jersey. The total state payroll, however, rose 1.3 percent to $7.7 billion, and the statewide economic impact rose 3.8 percent to $27 billion last year. The survey found that members of the group increased R&D spending by 5.3 percent, to $7.9 billion. Of course, the picture is likely to look very different if Roche succeeds in buying the rest of Genentech and transfers most of its New Jersey operations - including US headquarters and manufacturing - to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1714165 Mon, 18 Aug 2008 22:03:21 +0100 1714165 http://www.medworm.com/index.php?rid=1689198&cid=t_111612_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=1686523&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F357707993%2F Hard to believe? Well, a new ranking suggests the Swiss drugmaker will become the biggest of the big by 2014 thanks to “surging” demand for various its cancer meds, such Avastin, Mircera and Herceptin, according to EvaluatePharma, adding that buying up all of Genentech would only solidify its position. The big loser? Pfizer, not surprisingly, since it faces patent expirations on so many big drugs, namely Lipitor, Norvasc and Viagra. We realize, by the way, that this list has been circulating for a couple of days, but we enjoy speculation as much as anyone. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1686523 Wed, 06 Aug 2008 19:56:20 +0100 1686523 http://www.medworm.com/index.php?rid=1679620&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F356263689%2F Rise and shine. ‘Tis a sunny day here in the nation’s medicine chest. And what better way to get going than to grab a cup of something stimulating and catch up on events? So we have gathered a few on your behalf. Dig in and have a great day… Wyeth Claims Retiree Lied To Get Benefits Package (LoHud.com) Daiichi Gets Regulatory OK To Buy Ranbaxy (Business Standard) Former Genentech Director Sues City Over Royalties (East Bay Business Times) Bayer Sues Sandoz Over Yaz Birth Control Pill (Bloomberg News) AstraZeneca HQ Gets Road Improvements (CommunityPub.com) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1679620 Tue, 05 Aug 2008 11:29:21 +0100 1679620 http://www.medworm.com/index.php?rid=1675139&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F352692430%2F That’s the speculation now that Roche has made an offer for the chunk of Genentech not under its control and Bristol-Myers Squibb is trying the same thing with ImClone Systems. So now the betting is that Lilly would bid for Amylin, its partner for the Byetta diabetes drug and a long-acting release version that is being developd. “While two large pharma companies have now moved to acquire their commercial partners (in which they already held shares), it is now reasonable to wonder whether there will be a rash of such deals, and who will be next,” Deutsche Bank analyst Barbara Ryan writes in an investor note. “While it is certainly possible and plausible that Lilly would buy Amylin…our assessment is that it is unlikely to be a near-term event, if it were to happ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1675139 Fri, 01 Aug 2008 15:04:42 +0100 1675139 http://www.medworm.com/index.php?rid=1655677&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F345585820%2F We are about to get a head start on the weekend in order to spruce up the Pharmalot corporate campus. We take great pride in our public image, after all. So while we keep busy, please enjoy a few of the items we have found floating about… Bayer Anticoagulant Wins Green Light From EU (Yahoo/Reuters) Genentech Forms Panel To Review Roche Bid (Bloomberg News) FDA Extends Exclusivity For J&J’s Topamax (Associated Press) Glaxo Strikes Stem Cell Deal With Harvard (The Boston Globe) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1655677 Fri, 25 Jul 2008 11:45:43 +0100 1655677 http://www.medworm.com/index.php?rid=1652566&cid=t_111612_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2371 The past few weeks have seen a dramatic increase in mergers and acquisitions, with the generic drug manufacturer Teva buying Barr and Roche bidding for Genentech.  Frost & Sullivan analyst Rhenu Bhuller, pharma industry VP, shared these perspectives. Click here to watch brief video. (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1652566 Thu, 24 Jul 2008 16:36:18 +0100 1652566 http://www.medworm.com/index.php?rid=1649306&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F343830430%2F Depends who you ask. But Contract Pharma magazine decided that a biopharma company is one that makes more than 40 percent of its drug revenues by selling biologic products, including biotherapeutics, vaccines and other proteins. As the mag’s editor, Gil Roth, says: No royalty-based companies allowed! (That means you, ImClone). This can be limiting, though. Gil could only find nine companies that would qualify for his Top 10 list. So to round it off, he threw in Elan, since it co-markets Tysabri with Biogen Idec. Good editors think creatively. 1 - Amgen - $14.3 billion 2 - Genentech - $9.4 billion 3 - Novo Nordisk - $7.7 billion 4 - Merck Serono - $6.1 billion 5 - Baxter BioScience - $4.6 billion 6 - Biogen Idec - $3.1 billion 7 - Genzyme - $2.8 billion 8 - CSL - $2.3 billion 9 - Alle... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1649306 Wed, 23 Jul 2008 19:06:15 +0100 1649306 http://www.medworm.com/index.php?rid=1646373&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F342701960%2F The surprise bid by the big drugmaker caught a good many people off guard, including Genentech ceo Art Levinson, who is expected to meet with Roche chairman Franz Humer this evening to talk about integrating the two companies and who will play what role in making that happen. Roche, you may recall, already owns 56 percent of Genentech and plans to shift many operations to California. Genentech, of course, has a different culture than Roche. One is a biotech, albeit a large one, that works to preserve an entrepreneurial mindset. The other is a lumbering drugmaker that favors traditional top-down edicts. So imagine Levinson’s surprise when he received a phone call Sunday night from Humer about the offer, as The Wall Street Journal reports. There is always fallout from a deal, but retai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1646373 Tue, 22 Jul 2008 16:38:08 +0100 1646373 http://www.medworm.com/index.php?rid=1640368&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F341448388%2F The bid would allow the drugmaker, which already controls 56 percent of the biotech, to gain control of all the revenues generated by such big-selling meds as the Avastin and Herceptin treatments, as well as access to Genentech’s developing portfolio. “The pharmaceutical industry has changed fundamentally in the last 20 years, and the trend to consolidation continues unabated,” Roche Chairman Franz Humer told a briefing earlier today, Reuters reports. “It is, therefore, essential for the company as a whole to have a stronger and more effective market presence, if we are to not only maintain but extend out position in the face of growing challenges and pressure on prices.” However, some analysts believe the $89-a-share offer, which works out to nearly $44 billi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1640368 Mon, 21 Jul 2008 11:14:09 +0100 1640368 http://www.medworm.com/index.php?rid=1625800&cid=t_111612_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_111612_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_111612_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=1531700&cid=t_111612_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2141 Once again, had to miss the best part of this presentation, but did hear Robert Bottone of Genentech discuss the problem that some managers in biopharm and pharma have with Operational Excellence. Many of them still expect “silver bullet’ solutions. This was also a conclusion reached by those who took our recent survey. Silver bullets simply [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1531700 Fri, 20 Jun 2008 15:02:44 +0100 1531700 http://www.medworm.com/index.php?rid=1526781&cid=t_111612_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=1512332&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F310353436%2F Every brand new day should be unwrapped like a precious gift. The morning mayor used to say that and it remains true. So no matter what hurdles you may face today, take heart. Those deadlines and meetings will come and go. They always do, yes? Meanwhile, here are a few items to help you move along… Genentech & MedImmune Settle Patent Fight (TheStreet.com) Jazz Pharmaceuticals Cuts 8 Percent Of Staff (San Francisco Business Times) Elan Alzheimer’s Vaccine Trial To Begin Anew (Yahoo/Reuters) Novo Nordisk Ends Trial Of Blood-Clotting Drug (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1512332 Thu, 12 Jun 2008 11:55:42 +0100 1512332 http://www.medworm.com/index.php?rid=1497753&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F305277536%2F Each year, Fortune magazine trots out a list that means something to top execs in corporate America - its annual ranking of the best companies to work. Making the list offers bragging rights, particularly if the ranking is high. Genentech, for instance, made it to the top ten for the past three years in a row. Conspicuously absent, however, is big pharma. Except for AstraZeneca, which finished No. 83 on the latest list, drugmakers don’t show up. (Here are the lists for 2008, 2007 and 2006). During the past three rankings, the only other big drugmaker to make an appearance at all was Lilly - just once. Given the pressures to develop new meds and the ongoing layoffs, one would be hard-pressed to say this is surprising. Of course, these are big companies and many employees are likely to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1497753 Thu, 05 Jun 2008 11:48:16 +0100 1497753 http://www.medworm.com/index.php?rid=1482289&cid=t_111612_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_111612_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_111612_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_111612_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=1443176&cid=t_111612_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=1407328&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F280165830%2F Investors are upset. Rituxan, which is already approved to treat non-Hodgkins lymphoma and rheumatoid arthritis, failed to prompt a response in patients when compared with placebo in a late-stage, 52-week study. Not only that, the drug failed to meet any of its six secondary goals. Genentech and Biogen Idec shares dove on the disclosure. “We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus,” Hal Barron, Genentech’s senior vp of development and chief medical officer, says in a statement. Rituxan generated sales of nearly $2.3 billion last year and the expanding its use to treat Lupus may have added another $1 billion. Meanwhile, another late-sta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1407328 Tue, 29 Apr 2008 15:49:24 +0100 1407328 http://www.medworm.com/index.php?rid=1399364&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F277577184%2F Genentech must pay the City of Hope National Medical Center $300 million for withholding royalties from the sale of breakthrough gene-splicing technology developed by the center’s scientists, the California Supreme Court ruled, The San Francisco Chronicle reports. The unanimous ruling upheld a Los Angeles jury’s verdict that Genentech had breached a 1976 contract to pay the medical center 2 percent of all income Genentech received from licensing the technology to other companies. But the court also handed a significant victory to Genentech, and to numerous business organizations that filed supporting arguments, the paper writes, by striking down the jury’s earlier $200 million punitive damage award and reducing the damages to $300 million in lost royalties, down from the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1399364 Fri, 25 Apr 2008 11:50:54 +0100 1399364 http://www.medworm.com/index.php?rid=1365017&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F267954994%2F Once again, we are rolling in the sidewalks earlier than usual. This time, we are headed off to speak to the American Association of Indian Pharmaceutical Scientists about pharma and, yes, blogging. Rupee for us, you say? Thank you, but, no, there is no payment. But we do expect to enjoy some some chicken tandoori. So until tomorrow, we hope your world remains calm and interesting. See you in the morning… Genzyme CEO Gets $12.6 Million In Pay (Associated Press) Genentech Profit Beats Wall Street Expectations (TheStreet.com) Will Takeda Sharerholders Like The Millenium Deal? (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1365017 Thu, 10 Apr 2008 21:09:18 +0100 1365017 http://www.medworm.com/index.php?rid=1303457&cid=t_111612_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_111612_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_111612_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_111612_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_111612_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=1258592&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F241506444%2F The biotech disclosed the rejection last night. At issue is its Cabilly patent, which governs the method of producing some of its drugs. And so Genentech, which also receives licensing revenue from other drugmakers that use its methodology, plans to file a response and, if necessary, appeal the decision to the US Patent and Trademark Office. In a brief statement (look here), Genentech says the patent remains valid and enforceable through the appeals process, which could take one to two years, or longer. The PTO decision covers two separate reexaminations of the patent and was initiated after a challenge filed by MedImmune, which is now owned by AstraZeneca, Reuters notes. The patent, which involves the method of producing antibodies and antibody fragments, a crucial step in the manufactur... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1258592 Tue, 26 Feb 2008 14:15:37 +0100 1258592 http://www.medworm.com/index.php?rid=1251173&cid=t_111612_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=1232039&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234942413%2F After all the rain that fell on the nation’s medicine chest, the shining sun is a welcome sight here at the Pharmalot corporate campus. We apologize for what appears to be a later start than usual, but we were shuttling short people to various schools. Now, though, the time has come for a hot cup of coffee. We hope you’ll join us and, while you do, take a peek at a few items that should help you with your day… Smaller biotechnology companies are ready to take the lead away from big pharma in developing antibiotics that can take on a new generation of deadly superbugs, writes CNNMoney.com. Targanta Therapeutics just submitted its application to the FDA. Cethromycin from Advanced Life Sciences finished late-stage studies and is on track for FDA submission. Faropenem, from R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1232039 Thu, 14 Feb 2008 13:01:03 +0100 1232039 http://www.medworm.com/index.php?rid=1229433&cid=t_111612_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=1207509&cid=t_111612_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F02%2Fbook-review-invisible-frontiers-race-to.html A True Story of Oversized Egos, Incredible Greed ... and Insulin!Its been a while since I last did a book review, in part, because of the holidays and the time it took me to finally sit down and read a book. My review is on the 1987 book "Invisible Frontiers: The Race to Synthesize a Human Gene" by Stephen S. Hall. Although it took me a while to get around to reading it, this now out-of-publication book is one I highly recommend checking out at your local library if you're so inclined, or you can find it used at online bookstores, too. Just what is Invisible Frontiers all about? Not really a topic I expected to find terribly interesting reading, but the story turned out to be one of the most interesting stories which just happened to chronicle the development of synthetic "human" insulin b... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1207509 Wed, 06 Feb 2008 03:45:00 +0100 1207509 http://www.medworm.com/index.php?rid=1170215&cid=t_111612_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=1152860&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F216991079%2F For the past 36 hours, the Pharmalot corporate campus has been without water due to a break in a very big pipe in the vicinity. Nonetheless, we have managed to remain squeaky clean as we sort through this messy world. Here are a few items that filtered through… Biogen’s Tysabri Approved For Crohn’s Disease (Yahoo/Reuters) Deadline Is Today For Vioxx Settlement (Bloomberg News) Genentech’s Avastin Sales Called Disappointing (Bloomberg News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1152860 Tue, 15 Jan 2008 12:00:45 +0100 1152860 http://www.medworm.com/index.php?rid=1146763&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F214955028%2F We are easing back into our routine and, like many of you, look forward to the end of the work week. There is, however, much to track. Grab a cup of something hot and dig in….. Genentech Likely To Report Slowed Growth (The Wall Street Journal) Forest Sues Generic Makers Over Alzheimer’s Drug (Yahoo/Reuters) Gilead, Gladstone Institute Strike Research Deal (bizjournals.com) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1146763 Fri, 11 Jan 2008 12:31:34 +0100 1146763 http://www.medworm.com/index.php?rid=1108782&cid=t_111612_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_111612_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=1072407&cid=t_111612_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195660439%2Fblackbox_warning_for_genetechs.html Proposed in February and approved in July, Xolair (omalizumab) will be sporting a new, upgraded black box warning as per U.S. Food and Drug Administration recommendation. The warning will emphasize that Xolair, an injectable, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may cause chest tightness, dizziness, fainting, trouble breathing, itching and hives and swelling of the mouth and/or throat.  The FDA has also asked Genetech to revise the Xolair label and provide patients with an updated medication guide with the strengthened warning.Xolair is indicated for the treatment of asthma patients, over the age of 12, who have severe persistent asthma and who have tested positive for a perennial aerial allergen such as polled, grass or dust... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072407 Wed, 05 Dec 2007 18:00:20 +0100 1072407 http://www.medworm.com/index.php?rid=1068797&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F194961311%2F In case you missed it, this has been quite a year for high-profile safety news. And so FiercePharma has compiled a list for the cocktail set, who want to keep track of such things. These are the 10 biggest drugs that were withdrawn or were issued new warnings by the FDA this year. The drugs are ranked by 2006 worldwide sales, which explains why such headline grabbers as Bayer’s Trasylol doesn’t appear - sales were already tanking on bad news. 1. Antidepressants - Various companies 2. Epogen/Aranesp - Amgen 3. Zyprexa - Lilly 4. Avandia - Glaxo 5. Actos - Takeda 6. Provigil - Cephalon 7. Zelnorm - Novartis 8. Byetta - Amylin 9. Xolair - Genentech 10. Fentora - Cephalon Source: FiercePharma Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1068797 Tue, 04 Dec 2007 14:15:23 +0100 1068797 http://www.medworm.com/index.php?rid=1067904&cid=t_111612_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_111612_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_111612_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=1041884&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F188255331%2F Despite excitement among some scientists - and at the White House - about an embryo-free technique for creating human stem cells, reaction from companies that might turn the research into treatments is subdued, the Associated Press reports. In two papers published yesterday, researchers reported successfully programming ordinary human skin cells to behave like embryonic stem cells, which can theoretically be transformed into a variety of human tissues. But while biotech execs say the announcement is scientifically interesting, they also add that the new technique is even less likely to yield meaningful results soon than using embryonic cells - which requires destroying embryos. One exec, whose company’s stem-cell treatments may soon enter human clinical trials, notes that the FDAS is... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1041884 Wed, 21 Nov 2007 12:33:21 +0100 1041884 http://www.medworm.com/index.php?rid=1037066&cid=t_111612_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=1021388&cid=t_111612_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=1012493&cid=t_111612_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1366  Installment 3 (and, no, sorry, that is not me) ISPE announced the Facility of the Year 2007 winners at its annual meeting in Las Vegas. One of our competitors is part of this competition, but there is room for many awards in this sphere. Excellence is excellence, and the Facility of the Year winners have changed the [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1012493 Wed, 07 Nov 2007 16:47:54 +0100 1012493 http://www.medworm.com/index.php?rid=1003724&cid=t_111612_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=998822&cid=t_111612_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1363 Pharmaceutical companies are constantly being berated/fined for overzealous salespeople selling drugs off label to doctors/pharmacies. In the recent case of Genentech’s Avastin, the shoe appears to be on the proverbial other foot. Earlier this month, Genentech made the decision to restrict the availability of Avastin to compounding pharmacies. It seems that they were dividing and repackaging [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=998822 Thu, 01 Nov 2007 20:13:21 +0100 998822 http://www.medworm.com/index.php?rid=992036&cid=t_111612_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_111612_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=952285&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170382330%2F Another busy day winds down. We thank you for stopping by, and for the ideas, story tips and feedback many of you have offered over the past week, since we unveiled our latest design. Improvements are always under way and stories are being pursued. Meanwhile, here are a few items to tide you over until the morning… Genentech Profits Report Higher Profits (Yahoo/AP) ‘Bitter Exchange’ At WTO Fans China Trade Tensions (Yahoo/Reuters) Bristol-Myers Spent $2.8M To Lobby DC (Yahoo/AP) Teva Paid $100K To Lobby DC On Generic Issues (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=952285 Mon, 15 Oct 2007 23:42:55 +0100 952285 http://www.medworm.com/index.php?rid=952292&cid=t_111612_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1330 Boehringer Ingelheim narrowly beat out Genentech and Amgen in Science’s annual survey of top employers in the biotechnology, biopharmaceutical, pharmaceutical and related industries. The survey was based on industry responses by participants to whom they regarded as the best, average and worst employers in the field. Respondents then rated the companies that they had chosen [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=952292 Mon, 15 Oct 2007 19:29:32 +0100 952292 http://www.medworm.com/index.php?rid=944707&cid=t_111612_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=911905&cid=t_111612_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162457276%2Fbreast_cancer_drug_herceptin_eradicates_tumors.html Results of a study of Herceptin have shown that, when combined with chemotherapy, the drug has let to complete disappearance of tumor in the breast or lymph nodes in three times as many women as with chemotherapy alone. Prof. Dr. med. Wolfgang Eiermann, Medical Director of the Red Cross Women’s Hospital in Munich, Germany stated “Herceptin has been proven to extend lives across the spectrum of HER2-positive disease, so these latest findings will be welcome news for the unfortunate few with inflammatory breast cancer, which is an especially devastating form of the disease.” HER2-positive disease is found in up to 30% of women diagnosed with breast cancer and the tumors associated with HER2 are fast growing with a high likelihood of reoccurence. The posi... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=911905 Fri, 28 Sep 2007 15:10:16 +0100 911905 http://www.medworm.com/index.php?rid=897083&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F160791153%2F The country’s National Health Security Office is renewing its threat to issue compulsory licenses on at least three cancer meds if negoiations with drugmakers don’t yield lower prices, The Bangkok Post reports. The drugs that could be affected include Genentech’s Tarceva; Taxotere from Sanofi-Aventis; and Novartis’ Femara. The meds are used to treat various cancers, ranging from tumors, breast and lung cancer. Thailand’s Public Health Minister, Mongkol Na Songkhla confirmed the government will carefully and thoroughly consider its move to effectively “break the patents” of the cancer med, but stressed the move was necessary if the government wanted to ensure broader access to necessary drugs. “To apply the CL is Thailand’s last resort,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=897083 Mon, 24 Sep 2007 21:42:50 +0100 897083 http://www.medworm.com/index.php?rid=888777&cid=t_111612_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F159179152%2F Not even AstraZeneca execs seem certain. But the drugmaker hopes to run MedImmune separately - yet at the same time, coordinate research so there’s no duplication, The Wall Street Journal writes (subscription required). And AZ execs will also get involved in marketing strategy early on with the drugs that MedImmune is developing. This hardly sounds like independence. As the paper points out: The AZ “approach differs from what, until now, has been the industry’s standard model - Roche’s control of Genentech, which operates as an entirely separate entity.” AZ has created an executive R&D committee to coordinate work and encourage rank-and-file scientists on both sides to swap info regularly. Jan Lundberg, AZ’s executive vp of discovery research, tells... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=888777 Thu, 20 Sep 2007 21:01:17 +0100 888777 http://www.medworm.com/index.php?rid=886434&cid=t_111612_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2007%2F09%2F19%2Fwo2007103308%2F It’s an Array / Genentech c-Met app: (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=886434 Thu, 20 Sep 2007 02:50:47 +0100 886434 http://www.medworm.com/index.php?rid=864406&cid=t_111612_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=539095&cid=t_111612_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