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 'generic'. Sat, 03 Sep 2011 01:54:37 +0100 http://www.medworm.com/index.php?rid=5107514&cid=t_109291_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fphysician-discusses-the-confusing-aspects-of-medicare-part-d%2F2011.08.09 I have discussed Medicare Part B and Part F in recent blogs. A reader asked about Medicare Part D: Dr. Feld “Please discuss Medicare Part D, the drug benefit plan available to seniors. It is very complicated and completely confusing to me. My physician gave me a prescription for Levequin 500 mg once a day for 10 days. The pharmacist told me it would cost me $330 dollars. Medicare Part D would pay an additional $110 dollars for a total of $440 dollars. I asked the pharmacist if there was a generic equivalent. The answer was yes. It cost $10 dollars. This is unconscionable. It is highway robbery. Sincerely a.g.” Several issues are presented in this readers note. It is essential to understand these issues. The issues are an indictment against government “controlled” programs. (m... Better Health blogs http://www.medworm.com/rss/comments.php?id=5107514 Tue, 09 Aug 2011 14:00:44 +0100 5107514 http://www.medworm.com/index.php?rid=4893915&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4kemhBVPFZI%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? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that VeraxisHealth promoted Anthony Durso to senior director for strategic planning and client services. A 16-year marketing and sales veteran, he joined the medical education and communications firm in 2010 after running Elemental Consulting, a str... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893915 Fri, 03 Jun 2011 12:05:51 +0100 4893915 http://www.medworm.com/index.php?rid=4642995&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuZGC-ukK-wc%2F Should generic drugmakers be required to strengthen product labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded med? This question goes to the heart of a pair of state lawsuits filed by two women, who claim generic drugmakers should be held liable for failing to warn of serious side effects. However, the drugmakers, which include Actavis and Pliva, claim federal law preempts the lawsuits, because they would be required to offer labeling that is different from what appears on the label of the brand-name drug. The generic drugmakers further maintain that permitting such lawsuits to proceed in state courts would raise their costs, which would, ultimately, be passed on to consumers. This complicated issue will be heard this coming We... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642995 Mon, 28 Mar 2011 13:12:39 +0100 4642995 http://www.medworm.com/index.php?rid=4570763&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNmT5C8tDVOY%2F Hello, everyone, and nice to see you again. A spot of rain is falling on the Pharmalot corporate campus, but our spirits remain sunny thanks to the Morning Mayor, who would always say: ‘Every brand new day should be unwrapped like a precious gift.’ So while you tug on the ribbon, please join us for a cup of stimulation and help us scan the news of the world. Hope your day goes well and do stay in touch… FDA Approves First New Lupus Drug In 56 Years (Associated Press) Vertex Moves Ahead With Epilepsy Drug (Boston Business Journal) J&J Hip Replacement Has 49 Percent UK Failure Rate (Bloomberg News) Epizyme And Eisai Form A Partnership (Boston Globe) FDA OKs Hospira Generic Of Taxotere Cancer Med (Reuters) Quintiles Eyes More Deals With Credit Facility (Outsourcing Phar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570763 Thu, 10 Mar 2011 12:59:47 +0100 4570763 http://www.medworm.com/index.php?rid=4446032&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqZDR45Q5V5o%2F A trade deal being negotiated between Canada and the European Union could cost Canadians another $2.8 billion annually in drug costs - notably, by delaying the availability of lower-cost generics in Canada by about 3.5 years - if certain proposals are cemented, according to a new report commissioned by generic drugmakers. During the talks, the EU has sought various changes in Canadian laws and regulations governing intellectual property concerning brand-name meds. These include extending the term of patent protection by up to five years if drugs are bogged down in the regulatory approval process; lengthening the period of data exclusivity from eight years to 10 years or more; and strengthening notice of compliance regulations by adding an appeals process. The upshot is that Canadian payers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4446032 Mon, 07 Feb 2011 16:24:19 +0100 4446032 http://www.medworm.com/index.php?rid=4322509&cid=t_109291_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhat%25e2%2580%2599s-wrong-it%25e2%2580%2599s-a-generic-drug-rip-off-thats-what%2F2011.01.07 Cute packaging and product placement in the checkout lane at Duane Reade will get you generic Tylenol for a price equivalent to $50 for 100 tabs, as opposed to $6 per 100 count in the usual package. *This blog post was originally published at tbtam* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=4322509 Fri, 07 Jan 2011 16:00:26 +0100 4322509 http://www.medworm.com/index.php?rid=4225655&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FF-sSQsuvSc0%2F As more big-selling, brand-name meds fall off the patent cliff, lower-cost generics are destined to become more popular, yes? And a known side effect of this development is that more insurers are using this transformation to force doctors and patients to switch to generics. But to what extent? A new survey of 10,842 patients by the non-profit advocacy group shows that up to 70 percent of prescriptions written by doctors are forcibly changed by health insurers. Complete results have not yet been released, but Global Healthy Living Foundation says that, since sometimes generics are not identical to brand-name meds, the findings suggest some patients with chronic conditions are being placed at risk because they relapse after being switched to a cheaper drug. “This disturbing finding is ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225655 Fri, 03 Dec 2010 14:36:41 +0100 4225655 http://www.medworm.com/index.php?rid=4175693&cid=t_109291_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Funintended-consequences-of-cheaper-generic-drugs%2F2010.11.17 There’s an article in the New England Journal of Medicine entitled the “Unintended Consequences of Four-Dollar Generic Drugs.“ Ever one to hone in on unintended consequences of all stripes, I quickly clicked through. Oh, dear! What bad could possibly come of making drugs significantly more affordable? Were more people demanding prescriptions for drugs they didn’t really need now that they were so cheap? (Dream on. I’m still twisting arms to get my high-risk cardiac patients to take their generic statins.) Were pharmacies going out of business, no longer to make ends meet without massive markups on brand name drugs, contributing to skyrocketing unemployment and otherwise adding to the country’s general economic malaise? Were cardiologists’ incomes plummeting because of saggin... Better Health blogs http://www.medworm.com/rss/comments.php?id=4175693 Wed, 17 Nov 2010 21:00:35 +0100 4175693 http://www.medworm.com/index.php?rid=4159239&cid=t_109291_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fis-the-young-pharmaceutical-rep-right%2F2010.11.12 I loved my old status. Perhaps, reveled in it would be a better description. I was a crotchety, generic medicine-only doctor.** Sadly, my status changed today. Dabigatran (brand name Pradaxa) was the culprit. It was a little nerve racking. I wrote the order, looked at it, thought it out again, talking to myself: “John, are you sure you don’t want to do it the old way? [pause to think] No, I am embracing the new.”  And then, I closed the chart and handed it to the nurse. “What’s that? Pradaxa?” asked the nurse. “Stop the Lovenox? You sure?” My face must have told the story. Eight days had passed since dabigatran’s approval. “That’s plenty of time to mourn warfarin’s demise,” I thought. Enough studies, enough bl... Better Health blogs http://www.medworm.com/rss/comments.php?id=4159239 Fri, 12 Nov 2010 19:00:00 +0100 4159239 http://www.medworm.com/index.php?rid=4134274&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2Ft2Lu2Pq6Vj8%2F I’ll take a break from the book to post a question and answer with a reader: My daughter’s doctor recently started prescribing her a pill called only ‘buprenorphine,’ instead of her usual Suboxone. Should I be concerned about the change? My answer: You don’t mention the age of your daughter, but your question raises the issue of how involved should a parent be in the treatment of a child?  Perhaps a more general issue is whether anyone should be closely involved in the treatment of someone with opioid dependence?  After all, I frequently write that opioid addiction should be seen as ‘just another disease,’ and it is hard to make the case that people should share the details of their medical histories with others, at least after reaching adulthood. But opioid dependence, whi... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=4134274 Tue, 02 Nov 2010 23:16:26 +0100 4134274 http://www.medworm.com/index.php?rid=4077592&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyEG2mI_la8Y%2F For those who like to keep track of the revolving door between industry and regulators, it is worth noting that Gary Buehler, who for many years ran the FDA’s Office of Generic Drugs, is joining Teva Pharmaceuticals as vp for regulatory strategic operations. Teva, of course, is the world’s biggest supplier of generics. The move comes just a few months after Buehler was reassigned to run the FDA’s Office of Pharmaceutical Science after FDA commish Margaret Hamburg complained publicly about a backlog of generic drug approvals (back story). The backlog went from 891 in fiscal year 2005 to 1,912 in fiscal year 2010, although Buehler was known inside the FDA to battle for funding for reviewers. To cope, the agency continues to explore the notion of imposing user fees on generi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4077592 Mon, 18 Oct 2010 12:54:18 +0100 4077592 http://www.medworm.com/index.php?rid=4013561&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2FZTDcLVbCLDw%2F It i salways humorous when companies do what Reckitt-Benckiser recently did– make a small change in their product, then trash the old product in favor of the new, more expensive product.  “The OLD formulation is GARBAGE!  It poses huge risks! It is reckless and irresponsible to prescribe that tablet (the one that we’ve been marketing for years, that is…)” The orange rectangle is buprenorphine film For people who are confused, here is what happened…. Reckitt-Benckiser, the makers of Suboxone and Subutex, used to have a stranglehold on the market for buprenorphine.  Profits poured in from selling buprenorphine at ridiculous prices;  $6 per tablet in the Midwest for Suboxone, and over $11 per tablet for Subutex.  The prices were particularly obnoxiou... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=4013561 Tue, 28 Sep 2010 22:25:32 +0100 4013561 http://www.medworm.com/index.php?rid=3994341&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFSDEMvk3Izg%2F Last week, the FDA held its first open meeting about user fees for generic drug makers, an issue that has been around nearly 20 years. The session came as generics continue to grow in popularity – nearly 75 percent of prescription drug volume was generic last year – and the FDA grapples with an inability to approve drugs fast enough. However, the backlog appears to be less of a priority to the agency than having funds to conduct overseas plant inspections. Meanwhile, the generic industry is split – the usual trade group was there along with a new coalition representing a few big players, but Mylan Laboratories spoke for itself. And so we spoke with Ramsey Baghdadi of Provision Policy, a healthcare analysis firm that provides insights to Concept Capital and The RPM Report, about his i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994341 Thu, 23 Sep 2010 13:24:17 +0100 3994341 http://www.medworm.com/index.php?rid=3935799&cid=t_109291_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fgeneric-drugs-not-so-cheap%2F2010.09.05 I received the following e-mail from a patient (paraphrased): Dear Dr. Fisher, Thank you for trying to switch me from lisinopril to generic losartan (Cozaar) to help me with the irritating cough that has been nagging me since I was placed on lisinopril. I did not pick up my prescription, though. At nearly $200 for a three-month supply, I’ve decided to live with the cough, since the same amount of lisinopril costs me about $12. -Ms. Patient Interesting how the generic drug market for some drugs only marginally discounts prices. Since the companies that make generics did not have to absorb research and development costs, how do they justify the exorbitant prices? Simple: The middlemen still have to get theirs. -WesMusings of a cardiologist and cardiac electrophysiologist. *This... Better Health blogs http://www.medworm.com/rss/comments.php?id=3935799 Sun, 05 Sep 2010 16:00:00 +0100 3935799 http://www.medworm.com/index.php?rid=3899649&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2FCqlbix8_Au8%2F Hi all!  Sorry for the lapse in posting… I have been gearing up to blog for Psych Central, an opportunity that I am very excited about, and I have a hard time writing one blog and being excited about a second blog at the same time!  Please be sure to visit my blog at psychcentral.com, called ‘An epidemic of addiction.’ The first few posts will be mostly introducing myself with information that people here already know, so come visit in a couple weeks when I am up to speed. A question/answer post for tonight: As you know, generic Subutex is cheaper than Suboxone. I want my doctor to switch me to Subutex, but I am so afraid to ask him.  Even though my doc is nice to me, what if he is one of those doctors….gets mad at me, and discharges me as a patient?  I can&#8... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=3899649 Wed, 25 Aug 2010 01:02:43 +0100 3899649 http://www.medworm.com/index.php?rid=3780574&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2F8VAO5gQkFwI%2F A question in response to a recent article, and my answer.  My primary point is to address what buprenorphine maintenance CAN do– which is far more than simply ’replace’ opioid agonists.  I recently received a message from an AODA counselor that totally misses the point of buprenorphine;  a message that did what the anti-sub crowd typically does– i.e. present a skewed view of buprenorphine and then tear down that skewed view.  I’m not posting his ‘straw man’ message here, as there is already enough misinformation out there without his contribution.  Instead I’ll share a different, nicer letter: Hi– my name is (Julie) and I’m a member of your site however I never post as I usually find answers to my questions. I too wo... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=3780574 Fri, 23 Jul 2010 04:38:09 +0100 3780574 http://www.medworm.com/index.php?rid=3772469&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjPagjNQJtdw%2F Top of the morning to you. A relatively balmy day here on the Pharmalot corporate campus, where we are preparing for some important events. What about you? Are significant meetings on the horizon? And what about those deadlines? As always, a cup of stimulation is brewing. So please join us in surveying a few interesting tidbits. Have a great day and stay in touch… Advil Ad Account Is Shopped Around (AdWeek) WHO May Declare End To Swine Flu Pandemic (Bloomberg News) Reglan Lawsuits, Generics And Preemption (New Orleans City Business) Pfizer Halts Another Tanezumab Study (Associated Press) Ireland Plans Global Pharma Center Of Excellence (Irish Examiner) People Receiving HIV Treatment Rose 30 Percent In 2009 (Bloomberg News) Paxil Lawsuit Over Heart Birth Defect Is Settled (Associated ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772469 Tue, 20 Jul 2010 11:35:42 +0100 3772469 http://www.medworm.com/index.php?rid=3740825&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7g1p0YcWa0c%2F Some companies will overwhelm you with documents during litigation. Others destroy them. Glenmark Pharmaceuticals, one of India’s large generic drugmakers, is in that second category. We know because the company was sanctioned by a federal judge for destroying more than a year’s worth of potential evidence that could have factored into patent litigation with Abbott Laboratories and Sanofi-Aventis over plans to introduce a generic version of a blood pressure med known as Tarka. In fact, Glenmark produced just three e-mails in response to discovery requests for an entire year’s worth of material and allegedly engaged in a “systematic document destruction policy,” in which documents and e-mails were retained on company servers for only one month. The ruling, whic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3740825 Fri, 09 Jul 2010 12:46:39 +0100 3740825 http://www.medworm.com/index.php?rid=3726788&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2FDsxTw29rNSE%2F Something I haven’t yet come across: Acesulfame Potassium Well, i’ve been clean with the help of Suboxone for 14 months now. Throughout my treatment I’d been getting tongue blisters and ulcers at least two at a time. I’ve probably had them six to eight different times in this 14 month period. I realized something wasn’t right, and started investigating, trying to figure out what the problem was. I watched the foods I ate and the things I drank. Nothing seemed to work; they just kept coming back. So, the only thing I could think of was the Suboxone.  I read the pamphlet that comes with the medication. The artificial sweetener in Suboxone (Acesulfame K sweetener) is what I am allergic to. I have been allergic to artificial sweeteners my entire life. I had been taking a... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=3726788 Mon, 05 Jul 2010 04:58:43 +0100 3726788 http://www.medworm.com/index.php?rid=3724583&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2FDsxTw29rNSE%2F Something I haven’t yet come across: Acesulfame Potassium Well, i’ve been clean with the help of Suboxone for 14 months now. Throughout my treatment I’d been getting tongue blisters and ulcers at least two at a time. I’ve probably had them six to eight different times in this 14 month period. I realized something wasn’t right, and started investigating, trying to figure out what the problem was. I watched the foods I ate and the things I drank. Nothing seemed to work; they just kept coming back. So, the only thing I could think of was the Suboxone.  I read the pamphlet that comes with the medication. The artificial sweetener in Suboxone (Acesulfame K sweetener) is what I am allergic to. I have been allergic to artificial sweeteners my entire life. I had been taking a... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=3724583 Mon, 05 Jul 2010 04:58:43 +0100 3724583 http://www.medworm.com/index.php?rid=3721960&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F28WlTkAyHMw%2F A proposal to end those controversial ‘pay-to-delay’ deals between brand-name and generic drugmakers was passed by the House of Representatives last night as part of a measure to fund wars. Ironic, yes? Or maybe appropriate. In any event, the bill now goes to the Senate, Bloomberg News reports. Under the proposal, drugmakers could be fined if the Federal Trade Commission or the courts determine they struck deals to preserve a brand-name drug patent by delaying introduction of a lower-priced generic equivalent (see page 74). This is “just another signal of the growing support in Congress for ending this unconscionable behavior by some pharmaceutical companies,” FTC chairman Jon Leibowitz tells the news service. The FTC, you may recall, has made a mission of ending these dea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3721960 Fri, 02 Jul 2010 12:55:23 +0100 3721960 http://www.medworm.com/index.php?rid=3718698&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh68KkPeH3gU%2F Rise and shine, everyone. Another day is on the way. This means, of course, that meetings and deadlines beckon. Never mind that a holiday weekend is just around the corner. To cope, we are brewing the mandatory cup of stimulation, and enjoying an unexpectedly cool breeze. So please join us as we peruse the news of the world. Good luck today and catch you soon… AstraZeneca Loses Bid To Overturn Antitrust Fine (Dow Jones) Biogen Names Exelisis’ George Scangos As CEO (Bloomberg News) Recession Hurts Funding For AIDS Drug Program (New York Times) FDA Issues Latest List Of Drug With Possible Risks (Reuters) Quebec To Cut Generic Drug Prices (PharmaTimes) USPTO Denies Request To Re-Examine Plavix Patent (Dow Jones) Michigan Grows CROs (Xconomy) Calistoga Raises $40M To Fund Drug Tria... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718698 Thu, 01 Jul 2010 11:56:22 +0100 3718698 http://www.medworm.com/index.php?rid=3714129&cid=t_109291_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=3683886&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2F6pDf8G5Xkjs%2F Great news from SuboxForum.com, a.k.a. buprenorphorum.com, where today Chris55552 posted the following: Hey everyone, Not sure who all keeps up with pharma news or the reputation/quality of generic drug companies but I recently discovered that Teva Pharmaceuticals (generics) has their version of generic subutex available. Teva USA is the most dominant generic company in the US and is highly regarded as High grade quality. Marketing Start Date:05/10/2010 Tablets will be available in the following: 2 mg: White, oval, flat-faced, unscored tablet. Debossed with 798 on one side and stylized b on the other side. Each tablet contains 2.16 mg of buprenorphine HCl, equivalent to 2 mg of buprenorphine base. Available in bottles of: 30 Tablets NDC 0093-5378-56 100 Tablets NDC 0093-5378-01 8 mg: Whit... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=3683886 Mon, 17 May 2010 21:04:10 +0100 3683886 http://www.medworm.com/index.php?rid=3549567&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI_HEEGxSij0%2F Welcome to the working week. We hope your weekend was pleasant and gave you a chance to refresh. Now, of course, the routine resumes, which means those meetings and deadlines loom once again. To prepare, we have assembled a few interesting items to jumpstart what is, so far, a sunny day. Meanwhile, we will brew yet another cup of stimulation. Have a good one and do stay in touch… NiCox Painkiller Heads For FDA Panel Review (PharmaTimes) Sandoz Building In Denver Catches Fire (The Denver Post) Teva And Baxter To Fight $500M Damages In Propofol Case (Bloomberg News) Spain Should Encourage Docs To Prescribe Generics (PharmaTimes) Cipla Revenue Forecast Misses Target (Bloomberg News) Boehringer Ingelheim To Accelerate M&A In China (Global Times) Merck To Shift India Office To Mumbai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3549567 Mon, 10 May 2010 11:33:24 +0100 3549567 http://www.medworm.com/index.php?rid=3546848&cid=t_109291_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fabout-the-childrens-medication-recall%2F2010.05.08 The [recent] massive recall of some of the most popular [children's] medications is unsettling, disturbing and concerning. Thankfully it was done as a precautionary move before any child was harmed and that there’s a sufficient supply of generic alternatives of the medications recalled. Still, having 40 popular medications recalled by one of today’s most trusted pharmaceutical manufacturers rocks our confidence in the safeguards in place at the core. (more…) *This blog post was originally published at Dr. Gwenn Is In* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3546848 Sat, 08 May 2010 18:00:02 +0100 3546848 http://www.medworm.com/index.php?rid=3534106&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqgrdiktVbGc%2F Kathleen Jaeger, who has been one of the industry’s more visible and vocal personalities for more than a decade, is leaving the Generic Pharmaceutical Association, where she has been the chief executive and president since 2002. Her last day is June 30. She joined the GPhA after it was formed as the result of a merger between three other trade associations (here is the GPhA statement). During her tenure, Jaeger was prominent in the various debates over health care reform and the pay-to-delay issue, in particular; Medicare Part D (see here); user fees and generic drugmakers (see here); and, of course, a pathway for biosimilars (see this). (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3534106 Tue, 04 May 2010 17:09:29 +0100 3534106 http://www.medworm.com/index.php?rid=3342893&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwIIVCswS7LE%2F The move comes just after FDA commish Margaret Hamburg complained out loud about a backlog of generic drug approvals. And so the agency has moved Gary Buehler, who directs the Office of Generic Drugs, to the Office of Pharmaceutical Science. And OPS director Keith Webber will run the OGD until a permanent OGD head is found, The Pink Sheet writes. In a speech last month to the Generic Pharmaceutical Association annual meeting, Hamburg noted that the “unprecedented spike” in applications exceeded the agency’s review abilities. The backlog went from 891 in fiscal year 2005 to 1,912 in fiscal year 2010, according to OGD data presented at the meeting. Hamburg hopes negotiating user fees with generic drug makers will solve the problem (back story). Whether removing Buehler, who... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3342893 Mon, 08 Mar 2010 13:48:01 +0100 3342893 http://www.medworm.com/index.php?rid=3148997&cid=t_109291_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2010%2F01%2F06%2Fthe-proposals-to-implement-generic-substitution-in-primary-care-further-to-the-pharmaceutical-price-regulation-scheme-pprs-2009-consultation-document%2F Title: The proposals to implement ‘generic substitution’ in primary care, further to the Pharmaceutical Price Regulation Scheme (PPRS) 2009. Consultation document Skinny: Consultation on generic substitution which will enable pharmacists and other dispensers to fulfil a prescription for a branded medicine by dispensing an equivalent generic medicine. Provision will be made to allow the prescriber to opt out of substitution where, in his clinical judgment, it is appropriate for the patient to receive a specific branded medicine. 3 options are presented for consultation: Do nothing Introduce dispensing flexibility but with specific exclusions, so that the arrangements do not apply to a selected group of products on an exempt list. Introduce dispensing flexibility but limiting th... Fade Library blogs http://www.medworm.com/rss/comments.php?id=3148997 Wed, 06 Jan 2010 19:22:06 +0100 3148997 http://www.medworm.com/index.php?rid=3108411&cid=t_109291_109_f&fid=35671&url=http%3A%2F%2Fwww.anxietyinsights.info%2Fnot_all_drugs_are_the_same_after_all.htm By LESLEY ALDERMAN LET me start by saying I'm a fan of generic drugs. They save Americans billions of dollars each year and give us access to wonderful drugs at affordable prices. I've recommended generics in this column many times and use them myself when possible. But there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts. More... Copyright 2009 The New York Times CompanyComment:  It works the opther way too. Some people find a generic is better than the brand. I do much better on the generic version of my antidepressant, possibly because the brand tablets have a thick red coating which I may react to. (Source: Latest entries from www.anxietyinsights.info) Latest entries from www.anxietyinsights.info blogs http://www.medworm.com/rss/comments.php?id=3108411 Mon, 21 Dec 2009 06:34:00 +0100 3108411 http://www.medworm.com/index.php?rid=3105062&cid=t_109291_109_f&fid=34730&url=http%3A%2F%2Fpsychiatrist-blog.blogspot.com%2F2009%2F12%2Fdo-generics-work-as-well-as-name-brands.html It's my first night of vacation! I saw my last patient today and then started pulling the pictures off the walls in anticipation of my move. I ran over to see the new place, and it still needs insulation (it's on the floor), paint, and carpet. And doorknobs might be nice.So we're expecting quite the snowstorm here. I'll let you know how it goes tomorrow, but the current forecast is for up to 20 inches. It didn't take me long to float from the weather to the health section of the New York Times, and here's an article by Leslie Alderman about generics versus name brands.Are generics as good as name brands? I don't have any studies, I'm purely running on anecdotes, but this is my thinking: Usually. When I was resident, I learned that 15% of the time (and this isn't science, I don't think, I b... Shrink Rap blogs http://www.medworm.com/rss/comments.php?id=3105062 Sat, 19 Dec 2009 02:35:00 +0100 3105062 http://www.medworm.com/index.php?rid=3092904&cid=t_109291_137_f&fid=35426&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FTheAlzheimersReadingRoom%2F%7E3%2F87ACg4jw32M%2Ffda-approves-generic-aricept-to-treat.html The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablets.This is great news for Alzheimer's patients taking Aricept. I'll try to get more information from the generic drug manufacturer on the pricing and availability as soon as possible. Subscribe to The Alzheimer's Reading Room--via Email The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablet s on Dec. 11. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer’s disease. Orally disintegrating tablets dissolve on the tongue, without having to be swallowed whole. This may make it easier to take the medication for older or disabled patient... Alzheimer's Reading Room, The blogs http://www.medworm.com/rss/comments.php?id=3092904 Wed, 16 Dec 2009 13:47:12 +0100 3092904 http://www.medworm.com/index.php?rid=3012635&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-eNDgyd6tvY%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? XOMA hired James Neal as vp business development; Trubion Pharmaceuticals named Steven Gillis as acting president; Depomed promoted William Callahan to vp; Watson Pharmaceuticals hired Robert Stewart as senior vp global operations; Almac hired Helen McKeever as preclinical program manager; Alticure Research appointed C. Kannan Janakiraman as ceo and president; The European ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3012635 Fri, 20 Nov 2009 13:02:19 +0100 3012635 http://www.medworm.com/index.php?rid=2948486&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2FB-o7JGMb9cY%2F Hey Doc, I went to Walgreens early this morning and they had the drug on hand. So, if there is anyone who still has doubts as to the drug being available at local pharmacies- this shows the 2nd largest drugstore chain has it available in its pharmacies. Note: the writer is referring to a Walgreens in Wisconsin. The tablets themselves are round and white with the imprint of 54 411 on one side and a blank opposite side. Really the best way to describe them, is that they are identical in every feature (minus the imprint code) as the “512 Generic Percocet” tablets. As for taste and texture I found them to be much easier to tolerate than the fake orange Pez flavor laced with formaldehyde that Suboxone leaves in your mouth for hours. To me it was as if chewing a large aspirin and ... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=2948486 Sun, 01 Nov 2009 01:57:22 +0100 2948486 http://www.medworm.com/index.php?rid=2947029&cid=t_109291_129_f&fid=36038&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Ftrevis-life-with-multiple-sclerosis-ms%2Fgive-us-generic-drugs-for-our-ms-treatment%2F The first therapy for MS (Interferon beta-1b) was made available to us nearly 20-years-ago now.  It was followed, in relatively rapid succession (over the next ten years) by two other interferon therapies and Glatiramer acetate.  Most recently, a monoclonal antibody has been added to our MS arsenal. These are all compounds known as biologic drugs, meaning that they are grown, not synthesized.  They must be grown from living cell cultures in a controlled environment with great care and at great cost. These drugs are not the “$500 Million for the first pill, $.05 for the rest.” A cost which is, as we know, passed along to the consumer…us. Like all drugs, they are patent protected so that the proprietary company can recoup research and development expenses and return a profit to ... Life with MS blogs http://www.medworm.com/rss/comments.php?id=2947029 Fri, 30 Oct 2009 19:00:39 +0100 2947029 http://www.medworm.com/index.php?rid=2927571&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2FTE0Y1mdYkn0%2F I may be fanning the flames of rumor, but it was posted on Subox Forum today that generic Subutex (essentially a sublingual buprenorphine tablet) will be available tomorrow at a price of around $2.40 per tablet.    Not the cheapest drug, but a drop in price of over 50%– which would come as great relief to many people.      (Source: Suboxone Talk Zone) Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=2927571 Mon, 26 Oct 2009 00:02:49 +0100 2927571 http://www.medworm.com/index.php?rid=2761962&cid=t_109291_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FamFqwEO_CPw%2F A new report on MSN Health talks about the dangers of generic drugs. While some of them work just fine, others don’t. The article chronicles one woman’s struggle with feeling lousy and going from doctor to doctor before realizing it was the generics. I can relate to this story. I had almost the same thing happen. I had a VERY bad reaction to one generic and was told by the nurse practioner that it “must be in my head” because the “pills are virtually the same.” They weren’t the same. Not at all. I do take some generics and they work out okay. But this one particular drug did not. I think stories like this reinforce that when you’re feeling lousy, you have to be diligent about getting the care and treatment you need. Some people will just bl... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2761962 Wed, 02 Sep 2009 21:25:33 +0100 2761962 http://www.medworm.com/index.php?rid=2580448&cid=t_109291_137_f&fid=35426&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FTheAlzheimersReadingRoom%2F%7E3%2Fo_U81ruUkno%2Feisais-patents-on-alzheimers-drug.html For those of you paying around $166 a month for Aricept there is good news coming soon. The patent for Aricept expires in November, 2010.I would expect the price of Aricept to fall fast once the patent expires.When a patent expires, a single generic drug manufacturer usually gets the competitive edge to manufacture and sell the drug for the first six months. After this six month period of exclusivity, any approved generic manufacturer can jump in and start manufacturing and selling the drug.I would expect the cost of Aricept to plunge to $20 a month in 2011. There should be some good healthy competition in the Aricept market.I remember when Zocor (Simvastatin) went generic. The drug quickly fell from around $120 a month to $20. Now that there is healthy competition it sells around $10. Gue... Alzheimer's Reading Room, The blogs http://www.medworm.com/rss/comments.php?id=2580448 Tue, 07 Jul 2009 17:12:03 +0100 2580448 http://www.medworm.com/index.php?rid=2513151&cid=t_109291_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FEPharmaSummit%2F%7E3%2FGzwv8lw7IKY%2Fobama-to-propose-health-cost-cuts.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=2513151 Fri, 19 Jun 2009 16:19:00 +0100 2513151 http://www.medworm.com/index.php?rid=2512257&cid=t_109291_129_f&fid=36035&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Flife-with-chronic-pain%2Fnot-all-drug-pushers-are-standing-on-the-corner%2F Many of you, our friends who visit us frequently, have expressed concern and exasperation over all the ads on TV and in magazines from the pharmaceutical companies. They have the pretty girls, the singing birds, the sunshine and very robust individuals extolling the virtues of a particular new drug. Our families and friends seem to be more taken in by the ads than we are. It reminds me of all the candy they sell beside the gossip magazines at the supermarket checkout. The candies are for the kiddies to beg off Mommy and the magazines, well, they’re just trash for the brain. Since the drug companies in this country are the largest lobby group in Washington, they have a lot to sell. When their main line drugs reach the termination age and are allowed to become generic, they lose money.... Life with Chronic Pain blogs http://www.medworm.com/rss/comments.php?id=2512257 Thu, 18 Jun 2009 21:11:49 +0100 2512257 http://www.medworm.com/index.php?rid=2441451&cid=t_109291_97_f&fid=35606&url=http%3A%2F%2Fwww.theangriestpharmacist.com%2F2009%2F05%2F30%2Ftheres-a-kick-me-sign-on-pharmacys-back%2F I guess we’re the flavor of the month as the douchbags and assholes are coming out of the woodwork to take a cheap shot at our lovely profession. A loyal reader, known only as Bond, sent me the link to an article titled, “The Great Drug Switcheroo.” This piece of shit article published by “Prevention Magazine” (which has been around since the 50’s). The tagline is, “Your pharmacist may be changing your medication without your knowledge–and what you don’t know could hurt you. Here’s how to stay safe.” Once again, the man behind the counter in the white coat is trying to KILL you — not trying to help you achieve optimal results from your drug therapy. It begins with a story of a lady diagnosed with epilepsy who had troub... The Angriest Pharmacist blogs http://www.medworm.com/rss/comments.php?id=2441451 Sat, 30 May 2009 05:46:57 +0100 2441451 http://www.medworm.com/index.php?rid=2389730&cid=t_109291_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F05%2Fbio-tech-u.html The San Francisco Chronicle just reported that a new Chancellor has been nominated for the University of California - San Francisco (UCSF). UCSF is functionally a health sciences university, and its Chancellor functions as its president. The UCSF medical school is generally considered one of the elite US academic medical institutions.Genentech executive Susan Desmond-Hellmann has been nominated to be the next chancellor of UCSF, making her the first woman or biotech leader ever asked to run the research campus and hospital system that is San Francisco's second-largest employer.Desmond-Hellmann has served most recently as president of drug development at Genentech, the South San Francisco biotech firm that was recently acquired by Swiss drugmaker Roche. She was trained as a physician, did h... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2389730 Mon, 04 May 2009 18:14:00 +0100 2389730 http://www.medworm.com/index.php?rid=2306978&cid=t_109291_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fretirement-of-generic-manager.html A frequent theme on Health Care Renewal has been the adverse effects of health care leadership by generic managers with no background or experience in health care, and no intuitive understanding of its values. This type of leadership arose after some health care economists called for abolishing the supposed physicians' "guild," and transferring power over health care to managers as a way to control health care costs. This has not lead to control of health care costs.The recent coverage by the New York Times of the sudden retirement of the CEO of General Motors suggests that the notion that organizations should be run by generic managers is one whose time ought to be past. Wagoner presided over a dramatic decline in the fortunes of GM.Mr. Wagoner presided over some of the biggest losses in ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2306978 Mon, 30 Mar 2009 20:09:00 +0100 2306978 http://www.medworm.com/index.php?rid=2188070&cid=t_109291_87_f&fid=35052&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FWomensBioethicsBlog%2F%7E3%2F539976257%2Fnews-of-note-this-past-week.html ~ Gender disparities persist in treatment of stroke. Guess which direction this one cuts. ~ TANSTAAFL: Pfizer to disclose payments to doctors, researchers starting in 2010. All right, let’s hear it! ~ Second Stryker sales rep pleads guilty to misbranding a medical device. A felony. ~ Ovaries can be safely saved in some endometrial cancers. ~ 9 flawed genes found in risk of heart attack. Ah, the plot thickens! ~ Are you what you eat?: Mediterranean diet could cut risk of dementia. Quick! Get me some fish and olive oil. ~ Bone drugs may help fight breast cancer. Nice added benefit. ~ Damaged spinal cords in mice improved by transplants of neural stem cells produced with human induced pluripotent stem cells. We can rebuild them . ~ Are fears over bioterrorism stifling scientif... Women's Bioethics Blog blogs http://www.medworm.com/rss/comments.php?id=2188070 Sun, 15 Feb 2009 02:46:35 +0100 2188070 http://www.medworm.com/index.php?rid=2087096&cid=t_109291_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2F-3Cdemw4jKA%2F Brand-name drugs do not offer any advantages, over generic counterparts states the Journal of the American Medical Association. Dr. Aaron Keeselheim of Brigham and Women’s Hospital and Harvard Medical School in Boston found that contrary to the belief, of some doctors and patients that the costly brand-name drugs are no more effective than the generic drugs. There have been 30 studies since 1984 comparing the two types of cardiovascular drugs. The findings of the studies were that there weren’t any advantages to the brand-name drugs. In a interview Dr. Kesselheim said, “if a patient is prescribed a generic drug they should be confident in taking it.” The doctor also stated “that doctors should feel confident in prescribing the generic drugs,” Pharmaceut... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2087096 Thu, 08 Jan 2009 04:51:55 +0100 2087096 http://www.medworm.com/index.php?rid=2056347&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F489813019%2F An interesting battle has been playing out between the little biotech and the agency over a 2006 decision to allow a different standard for permitting generic versions of it Vancocin antibiotic, which is used to treat gastrointestinal infections. And the latest twist has ViroPharma filing a lawsuit yesterday against the FDA and the Department of Health and Human Services to force the agency to turn over its files on its controversial decision. The ruckus began in March 2006 when the FDA’s Office of Generic Drugs responded to an inquiry from Infinium Capital, a Canadian investment firm, about agency standards for allowing generic Vancocin. Dale Conner, the director of the OGD’s division of bioequivalence, wrote an Infinium broker that in vivo, or human studies, would no longer b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2056347 Fri, 19 Dec 2008 16:49:19 +0100 2056347 http://www.medworm.com/index.php?rid=1945607&cid=t_109291_151_f&fid=36896&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FSuboxoneTalkZone%2F%7E3%2F446941292%2F I looked through the search terms that people used today to find my blog and there aren’t many new topics– just the regular old search terms that come up every day: how long to wait after oxy before Suboxone, how long to wait after Suboxone for Oxy, how to get high from Suboxone, how to treat precipitated withdrawal from Suboxone… Except for a pair of searches for ’saving Suboxone spit. I have a patient that does exactly that. He takes it the ‘usual way’, then after about ten minutes he spits it into a cup and puts it in the freezer. He then takes it out of the freezer and reuses it the next day, and so on for about 4 days– he claims that it is still effective for him even at that point. I find the idea a bit disgusting, but I think his logic is s... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=1945607 Sat, 08 Nov 2008 23:52:14 +0100 1945607 http://www.medworm.com/index.php?rid=1945449&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F445478019%2F In a landmark ruling that could have major implications for generic drugmakers in Canada, the Supreme Court of Canada ruled that a selection patent for a key ingredient in best-selling Plavix clot buster is valid and dismissed an appeal from Apotex, which sought to invalidate the patent. In its 7-to-0 ruling, the court decided that Sanofi Synthelabo Canada put significant effort into refining a group of chemical compounds that it discovered and patented many years earlier. And by investing millions of dollars of research into creating this refinement, the drugmaker was entitled it to a new, 20-year period of patent protection, The Globe and Mail reports. The status of patents covering second-generation refinements - known as ‘selection patents’ - have long been a controversial topi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1945449 Fri, 07 Nov 2008 13:25:08 +0100 1945449 http://www.medworm.com/index.php?rid=1826151&cid=t_109291_109_f&fid=35671&url=http%3A%2F%2Fwww.anxietyinsights.info%2Ftevas_generic_wellbutrin_xlreg_comes_under_fda_microscope.htm The FDA is considering a postmarketing study of Teva Pharmaceutical Industries' generic version of the antidepressant Wellbutrin® XL (bupropion) in patients who have reported problems with it, agency spokeswoman Crystal Rice said. More... (Source: Latest entries from www.anxietyinsights.info) Latest entries from www.anxietyinsights.info blogs http://www.medworm.com/rss/comments.php?id=1826151 Thu, 25 Sep 2008 08:38:00 +0100 1826151 http://www.medworm.com/index.php?rid=1709299&cid=t_109291_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F08%2Fgeneric-insulin-in-2008-dont-bet-on-it.html Remember Insmed? Well, back in February, I posted a story I called "Meet Mike Coleman", which was coined from the Pharmalot news story featuring a YouTube video entitled "Meet Mike, Your Generic Biologics Lobbyist". Well, this morning's Washington Post has another story on the company's marketing efforts to advocate legislation passes to permit biogenerics, which quite frankly, seems unlikely to pass in 2008, but I'd never say never when politics are concerned.One has to wonder, since the law currently considers insulin a "drug" not a biotech medicine, and under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, a "generic" doesn't have to be an exact duplicate of the brand-name original in order to be approved by the FDA. So why isn't Insmed applying to make generic insulin an... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1709299 Thu, 14 Aug 2008 14:00:00 +0100 1709299 http://www.medworm.com/index.php?rid=1516776&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F311410649%2F If you answered ‘too long,’ you win a free subscription to Pharmalot. The Office of the Inspector General of the Health and Human Services Department has just issued a report on the FDA’s Office of Generic Drugs and the results are, well, not too stellar. One key reason - the Abbreviated New Drug Application submissions have increased at more than double the rate of review resources in the last 5 years, the OIG notes. We should point out that all drugmakers must submit ANDAs to the OGD, which has three divisions conducting reviews - chemistry, bioequivalence and labeling. However, most disapprovals are handled by the chem squad. Now, to the findings - the FDA “exceeded the 180-day review requirement for nearly half of original ANDAs under review in 2006 because Chem... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1516776 Fri, 13 Jun 2008 21:20:19 +0100 1516776 http://www.medworm.com/index.php?rid=1478031&cid=t_109291_87_f&fid=35052&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FWomensBioethicsBlog%2F%7E3%2F300770199%2Fethics-of-branded-vs-generic-drugs.html On May 15, 2008, an article in the Wall Street Journal reported that a United States appeals court upheld a lower-court ruling striking down patents for Lovenox, an anticoagulant manufactured by... [[ This is a content summary only. Visit my website for full links, other content, and more! ]] (Source: Women's Bioethics Blog) Women's Bioethics Blog blogs http://www.medworm.com/rss/comments.php?id=1478031 Thu, 29 May 2008 20:25:54 +0100 1478031 http://www.medworm.com/index.php?rid=1454756&cid=t_109291_109_f&fid=35671&url=http%3A%2F%2Fwww.anxietyinsights.info%2Fusa_first_generic_paroxetine_extended_release_now_availabl.htm Mylan Pharmaceuticals Inc. has launched its Paroxetine Extended-release (ER) Tablets, the generic version of Glaxo-SmithKline's Paxil CR®. As the first company to successfully file an abbreviated new drug application containing a paragraph IV certification for the 12.5 mg and 25 mg tablets, Mylan has earned 180 days of marketing exclusivity for these two strengths. (Source: Latest entries from www.anxietyinsights.info) Latest entries from www.anxietyinsights.info blogs http://www.medworm.com/rss/comments.php?id=1454756 Tue, 20 May 2008 08:16:00 +0100 1454756 http://www.medworm.com/index.php?rid=1446429&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F290878031%2F European antitrust investigators are expanding the scope of a major inquiry into pharma in a bid to determine whether drugmakers are blocking generic rivals from getting less-expensive meds to market quickly, Reuters reports. Lawyers and European Union officials say that Neelie Kroes, the European Union competition commissioner, is also probing whether efforts to block competitors by extending patents were distracting them from developing new meds, Reuters continues. Investigators, who questioned about 100 companies earlier this year, including Pfizer, Glaxo and Sanofi-Aventis, are now turning to about 80 medical organizations, including associations of doctors, patients and pharmacies, and government agencies that set the prices of prescription drugs in Europe. That could make it the broa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1446429 Thu, 15 May 2008 12:08:31 +0100 1446429 http://www.medworm.com/index.php?rid=1439524&cid=t_109291_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F05%2F13%2Fadhd-and-consumer-reports%2F Attention deficit disorder is a classic example of the medicalization of mental disorders, where virtually everyone “believes” it is some sort of biochemical or brain disorder and so medications are the appropriate (and wildly popular) treatment choice. Medications are the right and appropriate treatment choice for ADHD; not because it is a medical disease, but because the research base is pretty strong in showing that they are effective. But if you can’t trust Consumer Reports to report accurately on this disorder (and other mental disorders), I’m not sure who you can trust anymore. A colleague recently referred me to the “Best Buy Drugs” section of Consumer Reports health website. So I took a look around and started at the beginning of the alphabet. S... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1439524 Tue, 13 May 2008 14:15:38 +0100 1439524 http://www.medworm.com/index.php?rid=1416440&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F282119778%2F Especially if those kickbacks are paid by insurers that give docs incentives to switch to a generic from Lipitor. And that’s the hot issue this week in the Colorado legislature, where a bill would prevent insurers from enticing physicians with cash to prescribe fewer brand-name meds. The bill is opposed by AARP, Kaiser Permanente and the Colorado Association of Health Plans, but backed by patient advocates and Pfizer, the Associated Press reports. Pfizer lobbyist Colin Kennedy, however, declined to comment on whether the bill would benefit Pfizer financially. Nothing like candor to help vet the issues. In fact, Pfizer is scrambling to bolster its best-selling cholesterol pill and has made a point of contacting state medical associations about insurer incentives in hopes of fending o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1416440 Fri, 02 May 2008 13:58:08 +0100 1416440 http://www.medworm.com/index.php?rid=1311477&cid=t_109291_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1591 Forget about championing one side or another. The politically charged “generics vs. namebrand drug” debate offers an opportunity to study the impacts of process and ingredient variability on drug manufacturing and on clinical effects in patients.   (For material to analyze, click here). At IFPAC 2008 in January, FDA’s Dr. Janet Woodcock noted the fact that [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1311477 Tue, 18 Mar 2008 13:20:37 +0100 1311477 http://www.medworm.com/index.php?rid=1245026&cid=t_109291_87_f&fid=34595&url=http%3A%2F%2Fnhsblogdoc.blogspot.com%2F2008%2F02%2Fquacktitioner-direct.html The generic British QuacktitionerHaving started life as a lawyer, the law remains an enduring interest and, watching from the sidelines as the legal profession is dumbed down, I feel the same sadness as I feel about what is happening to medicine. The saddest about the law is that, unlike medicine, the young trainee lawyers think the introduction of second rate pseudo-professional services is altogether admirable.One such young lawyer writes his own blog, Asp Bites, and was so cross with me for criticising the CPS recently that he says he is not going to link to me. Oh! Dear.Now he comments on the article below on the CPS. And he takes the piss. He talks of the introduction of CDS. Criminal Defence Service Direct. I feel I am trapped in a Kafka novel. It has always been a fundamental part o... NHS Blog Doctor blogs http://www.medworm.com/rss/comments.php?id=1245026 Wed, 20 Feb 2008 19:43:00 +0100 1245026 http://www.medworm.com/index.php?rid=1232041&cid=t_109291_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1443 If the recent Science Board report on science within the Agency wasn’t enough and you needed more evidence of the urgent need for better IT infrastructure, staffing and other resources for FDA, the Wall Street Journal released this bombshell this morning.  Click here to read.   Baxter’s recalled generic Heparin may be linked to API manufactured by a [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1232041 Thu, 14 Feb 2008 16:05:10 +0100 1232041 http://www.medworm.com/index.php?rid=1230422&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234616823%2F The agency is challenging deals worth an estimated $200 million with Barr Labs, Ranbaxy Labs, Mylan Labs and Teva to keep a generic version of the Provigil sleep-disorder pill off the market until 2012. In its suit, the FTC asks the US District Court for the District of Columbia to void the agreements, essentially giving the generic drugmakers a green light to start selling their low-priced copycats. The FTC contends Cephalon took that step because Provigil is such an important product - the pill generated $800 million last year, or 40 percent of sales. “The prospect of generic competition was a major financial threat to the company,” according to the FTC, which called the payments “purportedly independent business transactions.” But as a result, Cephalon forced pat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1230422 Wed, 13 Feb 2008 22:45:04 +0100 1230422 http://www.medworm.com/index.php?rid=1222378&cid=t_109291_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F02%2Fmeet-mike-coleman.html This morning, the blog Pharmalot had a posting entitled "Meet Mike, Your Generic Biologics Lobbyist", and I thought it would be appropriate to reiterate the need for Congress to move forward on this very issue. It was indeed a surprise to many (including me), but as I posted last week, even President Bush's 2008 budget calls for Congress to pass legislation to enable generic biopharmaceuticals.Last week, Insmed had one of its scientists, Mike Coleman, offer a "researcher's view" of the value of generic biopharmaceuticals. Coleman makes for an unusual lobbyist. But apparently Insmed, which has projects under way to develop several different generic biopharmaceuticals, is banking on a new 'educational campaign,' another way of saying public relations (PR), to influence Washington and the pub... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1222378 Mon, 11 Feb 2008 17:00:00 +0100 1222378 http://www.medworm.com/index.php?rid=1222431&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F233143829%2F The debate over generic biologics, which some call follow-on biologics, just took an interesting turn. Although the White House budget would give the FDA new funds to approve such drugs, various companies remain frustrated with the lack of a sanctioned FDA-approved pathway, which is needed before copycat versions of these expensive meds can be developed and sold in the US. So one drugmaker is turning to YouTube to press its point. Late last week, Insmed corraled one of its scientists, Mike Coleman, to offer a researcher’s view of the value of generic biologics. With his low-key, matter-of-fact delivery; youthful demeanor and standard-issue white laboratory coat, Coleman makes for an unusual lobbyist. But Insmed, which has projects under way to develop several generic biologics, is ba... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1222431 Mon, 11 Feb 2008 13:43:17 +0100 1222431 http://www.medworm.com/index.php?rid=1216524&cid=t_109291_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F231210557%2Fteva_gets_fda_approval_for_gen.html Teva Pharmaceuticals USA has received U.S. Food and Drug Administration approval to manufacture generic Fosamax.Alendronate sodium tablets are indicated for the treatment of osteoporosis, a condition that causes thinning and weakening of the bones.Approved dosages will be available in three once-daily dosages of 5 milligrams, 10 milligrams and 40 milligrams and the two once weekly dosages of 35 milligrams and 70 milligrams."The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."Generic manufacturers must show that a generic drug h... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1216524 Thu, 07 Feb 2008 20:00:35 +0100 1216524 http://www.medworm.com/index.php?rid=1215341&cid=t_109291_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F02%2Fgood-news-in-last-bush-budget.html You might be surprised to hear me write that. To be sure, I cannot stand the Food and Drug Administration's user-fee system, and some have complained that the Bush budgets have consistently short-changes the FDA. But all things considered, I suspect we won't see any progress on either issue during 2008. But I did find what I believe to be good news in the Bush budget.As my readers know, I chronicled the story about impediments to new competition in the insulin market (see here for the original article, and provided that Google's Blogger cooperates, some fairly extensive follow-up coverage might also be accessible). Unfortunately, last year -- thanks largely to lobbyists for the pharmaceutical industry -- the U.S. Congress delayed passing legislation which would have removed the final imped... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1215341 Thu, 07 Feb 2008 14:00:00 +0100 1215341 http://www.medworm.com/index.php?rid=1194999&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F227359898%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 being announced each month. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? TargetRx hired Craig Scott as ceo and president; Glaxo hired Lon Cardon to head its genetics organization; Interleukin Genetics named Lewis Bender as ceo; RxElite named Rick Schindewolf as vp, business development; TNS Healthcare hired Ceri Thomas as exec vp, global accounts; BioMarin Pharmaceutical hired Gordon Vehar from Genentech as vp of resea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1194999 Fri, 01 Feb 2008 17:36:01 +0100 1194999 http://www.medworm.com/index.php?rid=1188769&cid=t_109291_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1437 We love the progressive thinking that’s going on in pharma. That’s why I enjoy my job and what makes covering this side of the industry so much more interesting and positive than looking at the financial side and all the marketing scandals. As we do every year, we’ve covered this year’s IFPAC process analytics conference, [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1188769 Wed, 30 Jan 2008 18:32:42 +0100 1188769 http://www.medworm.com/index.php?rid=1064626&cid=t_109291_109_f&fid=35671&url=http%3A%2F%2Fwww.anxietyinsights.info%2Fexamining_the_strengths_and_limitations_of_generic_formulati.htm Primary Psychiatry. 2007;14(12):35-38 In Session with Michael E. Thase, MD What factors most commonly influence clinician perceptions of different antidepressants? A clinician's firsthand experiences shape how he or she views a medication's efficacy and tolerability. The first 10 experiences involving the prescription of a new medication is usually what determines whether one values it as a well-tolerated or highly effective medication. More... © 2007 Primary Psychiatry a Publication of MBL Communications (Source: Latest entries from www.anxietyinsights.info) Latest entries from www.anxietyinsights.info blogs http://www.medworm.com/rss/comments.php?id=1064626 Sun, 02 Dec 2007 06:51:00 +0100 1064626 http://www.medworm.com/index.php?rid=1024336&cid=t_109291_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2007%2F11%2Fbig-pharma-lobbyists-delay-generic.html As the D-Blogger community already discovered from Vivian's post, our do-nothing Congress has delayed passing legislation (until 2008) which would remove the final impediments for generic insulin, not to mention other (in the words of the FDA) "follow-on" protein products (that bill is known as S. 623/H.R. 1038, the "Access to Life-Saving Medicine Act of 2007").As I have chronicled throughout the year, the reasons for lack of generic insulin are multi-faceted, but the biggest single reason is that manufacturers of generic products, which include such well-regarded manufacturers such as Novartis' Sandoz unit, Israel-based Teva Pharmaceuticals, and U.S.-based Barr Pharmaceuticals among others are lacking guidance from the U.S. Food and Drug Administration on how to apply for and obtain appro... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1024336 Tue, 13 Nov 2007 15:50:00 +0100 1024336 http://www.medworm.com/index.php?rid=1018961&cid=t_109291_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1381 FDA issued a press release today (see below), noting that the Agency is calling for safety-related labeling changes for three biopharmaceuticals used to treat certain types of anemia. The release suggests that erythropoiesis-stimulating agents (ESAs) may pose serious health risks and have questionable efficacy in alleviating symptoms of anemia and fatigue in cancer patients. In addition to [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1018961 Sat, 10 Nov 2007 15:38:27 +0100 1018961 http://www.medworm.com/index.php?rid=1017860&cid=t_109291_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1381 FDA issued a press release today (see below), noting that the Agency is calling for safety-related labeling changes for three biopharmaceuticals used to treat certain types of anemia. The release suggests that erythropoiesis-stimulating agents (ESAs) may pose serious health risks and have questionable efficacy in alleviating symptoms of anemia and fatigue in cancer patients. In addition to [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1017860 Fri, 09 Nov 2007 21:53:12 +0100 1017860 http://www.medworm.com/index.php?rid=1012491&cid=t_109291_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1370 Installment 5 ISPE management deserve special praise for inviting a high-ranking engineer from a generic pharmaceutical manufacturing company—in this case, the rapidly growing Teva, to speak at this meeting.  As  ISPE vice chair Bruce Davis affirmed, generics manufacturers are not “the enemy,” but an increasingly important part of the global healthcare system.  They also face margin and [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1012491 Wed, 07 Nov 2007 18:02:42 +0100 1012491 http://www.medworm.com/index.php?rid=988451&cid=t_109291_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F176777581%2Ftentative_approval_for_valsart.html Ranbaxy Pharmaceuticals announced that it has received tentative approval to manufacture and market Valsartan Tablets in 40 mg, 80 mg, 160 mg and 320 mg strengths.Valsartan is the generic version of Diovan, a Novartis drug, and is used in the treatment of high blood pressure. I tcan be used alone or in combination with other anti-hypertensive medications. It is also indicated for the treatment of heart failure."We are pleased to receive tentative approval for Valsartan Tablets. We believe, we are first to file a substantially complete ANDA and will stand to gain from the 180 day exclusivity available to the first filer. These product formulations have been developed organically within Ranbaxy and will further expand our product portfolio of affordable generic alternatives," said ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=988451 Mon, 29 Oct 2007 18:15:13 +0100 988451 http://www.medworm.com/index.php?rid=941865&cid=t_109291_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F167996160%2Fglenmark_pharmaceuticals_limited_receives_fda_approval_to_market_generic_version_of_trileptal_.html Glenmark Pharmaceuticals Limited (NSE:GLENMARK)has received final U.S. Food and Drug Administration approval to market generic Trileptal (Oxcarbazepine) tablets.Trileptal is currently manufactured by Roxane Laboratories Inc (Google Finance), Glenmark Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Limited (BOM:524715) in three strength (150 mg, 300 mg and 600 mg) and is used alone or in combination with other drugs in the treatment of partial epileptic seizures in adults and children over the age of 4.Trileptal was the 74th best selling brand name medication in 2005 according to Drug Topics."FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," said Gary J. Buehler, director of FDA's Office of Generic Drugs.... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=941865 Wed, 10 Oct 2007 17:00:36 +0100 941865 http://www.medworm.com/index.php?rid=928093&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F165270801%2F The agency notes that generics are cheaper as it announces GIVE - the Generic Initiative for Value and Efficiency - as a way to move the approval process along. Although the FDA approved or tentatively approved 682 generics in fiscal year 2007, or 30 percent more than the previous year, FDA commish Andy von Eschenbach wants to pick up the pace. And he’s going to hire more people to get it done. (Read more here). Faced with a backlog of 1,300 applications, up from about 800 about a year ago, the FDA is revising the review order for certain drug applications. For example, the agency says first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=928093 Thu, 04 Oct 2007 15:57:32 +0100 928093 http://www.medworm.com/index.php?rid=908619&cid=t_109291_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162038583%2Fwalmart_stores_inc_launches_phase_2_of_4_prescription_program.html WalMart Store Inc. (NADSAQ: WMT) announced the launch of the second phase of their $4 prescription drug program. Phase 2 offers more medicines in more categories like attention deficit disorder, glaucoma, fungal infections and acne. Fertility and prescription birth control will also be included at a price of $9 for a month's supply. Also included is savings on new-to-market generic drugs such as Carvedilol and Coreg.Walmart now offers 361 prescription products that cover up to 95% of the prescriptions written and includes a list of cover medications on its website."This program has exceeded all of our expectations," said Bill Simon, executive vice president, chief operating officer, Wal-Mart Stores Division. "So many Americans rely on our $4 prescription program to ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=908619 Thu, 27 Sep 2007 16:30:04 +0100 908619 http://www.medworm.com/index.php?rid=891625&cid=t_109291_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F159594569%2Fwhat_is_the_walmart_effect.html An article today in The New York Times, by Stephanie Saul, debates different reasons for the slowing of inflation in drugs cost.One of the aspects she discusses is "the WalMart effect" which is the initiative that was launched last fall where many generic prescriptions were made available at a cost of $4 a month. Other stores such as Target, Kmart and other retailers quickly followed suit with similar offers."A Labor Department economist, Francisco Velez, said his office noted a drop in generic drug prices shortly after the large stores’ promotions began, particularly in the South, where Wal-Mart started its program. His colleague, Mr. Ginsburg, called the drop in prices for generic drugs “dramatic.” Wal-Mart and other large chain stores make up 15 to ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=891625 Fri, 21 Sep 2007 20:00:34 +0100 891625 http://www.medworm.com/index.php?rid=888776&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F159186869%2F We are posting our usual round-up a wee bit early this evening due to a speaking engagement, of all things. The New Jersey Intellectual Property Lawyers Association - that’s right, a group of patent lawyers - has asked us to chat about patents and how these are perceived by the media and the public. We don’t pretend to be experts, but we expect to have a good time discussing the issue and making acquaintances. And if we come across anything interesting, you can be certain we will pass it along, to you. Meanwhile, here a few items to keep you occupied until we return…. Generic Biotech Agreement Proves Elusive (Yahoo/AP) Wyeth Gets Mixed News From European Regulatory Panel (Bloomberg News) China Drafts Drug-Safety System (The International Herald Tribune) Share / E-mail (S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=888776 Thu, 20 Sep 2007 21:22:01 +0100 888776 http://www.medworm.com/index.php?rid=883877&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158515595%2F In a teleconference chat yesterday afternoon with a few bloggers, Jim Greenwood spent some time sharing the BIO point of view on the pressing matters of the day - follow-on biologics legislation, patent reform legislation and the FDA reform bill, which is otherwise known as PDUFA. Here are some excerpts…. FDA Reform: We think we’ve done pretty well…We’re not happy that Congress included $250 million in PDUFA fees after we spent last year negotiating with Congress…But PDUFA expires in 12 days and morale at the FDA is not good. If Congress doesn’t grant a temporary extension, it’ll be another morale killer. They (FDA staffers) really do start thinking about other offers, since government doesn’t pay.” Follow-on Biologics: This is “... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=883877 Wed, 19 Sep 2007 11:14:22 +0100 883877 http://www.medworm.com/index.php?rid=848530&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F153411914%2F Lawmakers are unlikely to add generic biologics legislation to an FDA bill that’s expected to receive congressional approval this month, two key U.S. congressmen said on Thursday, reports Reuters. Generic drugmakers have been pushing legislation that would chart a specific path for the FDA to approve cheaper copycat versions of biotech meds. The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference. Rep. Frank Pallone, a New Jersey Democrat, also said it was unlikely that House and Senate negotiators could agree on an approach for generic biologics in time to include it in the FDA bill. The FDA legislation, which i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=848530 Fri, 07 Sep 2007 11:44:42 +0100 848530 http://www.medworm.com/index.php?rid=822306&cid=t_109291_87_f&fid=34866&url=http%3A%2F%2Fwww.thecardioblog.com%2F2007%2F08%2F25%2Fplavix-and-thailand-why-you-should-care%2F Filed under: Drugs, Daily newsThe Thai government says the heart drug Plavix is way overpriced. And it's going to do something about it: it will begin importing generic versions of Plavix from India. The first batch of two million pills will arrive soon, says the chairman of Thailand's Government Pharmaceutical Organisation. The imported version of Plavix, a blood-thinner, will cost only the equivalent of three US cents per pill. Compare this with the current cost for Thai heart patients: two US dollars per pill!In order to do all this, the Thai government approved a temporary suspension of patent protections for expensive medications. Needless to say, this has seriously ticked off the big pharmaceutical companies! (Plavix, by the way, is sold by Sanofi-Aventis and Bristol Myers-Squibb.) H... The Cardio Blog blogs http://www.medworm.com/rss/comments.php?id=822306 Sat, 25 Aug 2007 04:00:00 +0100 822306 http://www.medworm.com/index.php?rid=797933&cid=t_109291_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F08%2F14%2Ftry-cutting-your-health-care-bills%2F Filed under: All Cancers, Daily newsHealth care is expensive, even for those with insurance. My treatment with the breast cancer drug Herceptin cost $5,000 every three weeks for 52 weeks. Insurance paid 80 percent; I was responsible for 20. That's $1,000 every three weeks. Not exactly affordable.What many of us don't know is that we can play an active role in cutting our health care bills. We can shop around for everything, for example. Before filling a prescription, consider comparing prices offered at mail-order and online pharmacies with those of larger retailers. You may even find that mom and pop shops offer competitive rates since they can set their own pricing. Don't forget about generic drugs too. Ask your doctor if a generic version of your medication is just as good as a brand na... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=797933 Tue, 14 Aug 2007 04:00:00 +0100 797933 http://www.medworm.com/index.php?rid=790608&cid=t_109291_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2007%2F08%2Fdebate-over-generic-biopharmaceuticals.html This morning, The Wall Street Journal Health Blogger David Armstrong had an interesting post that pertains to generic biopharmaceuticals. Specifically, he writes about Genzyme's (a Boston-area biopharmaceutical company) struggle to produce enough of a promising drug to treat a rare genetic disorder which he believes adds more fuel to the raging debate about generic biotech drugs. Specifically, he notes that Genzyme is having trouble persuading the FDA to sign off on its medicine known as Myozyme made in big batches because the FDA wants to be sure the drug produced in large tanks is the same as the stuff Genzyme made successfully on a smaller scale. Thats a legitimate concern, but its really up to the FDA to inform the drug maker how they are to address those concerns to ensure patient saf... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=790608 Thu, 09 Aug 2007 16:00:00 +0100 790608 http://www.medworm.com/index.php?rid=788409&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F142049249%2F Last week, we posted a segment from a Boston television station about insurers offering payments to docs for switching a patient from a brand-name to a generic, particularly from Lipitor to a generic Zocor. There’s nothing new about managed care offering incentives to docs to lower costs and improve health outcomes. But we asked you whether docs should disclose payments and take our poll. We received 75 responses. Although unscientific, the results suggest that docs should think hard about this topic. Yes - 64 votes, or 85 percent, say docs should disclose the payments; No - 11 votes, or 15 percent. To watch the segment, in case you missed it, please click here. Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=788409 Wed, 08 Aug 2007 16:52:12 +0100 788409 http://www.medworm.com/index.php?rid=776243&cid=t_109291_109_f&fid=35671&url=http%3A%2F%2Fwww.anxietyinsights.info%2Fabstract__symptom_relapse_following_switch_from_celexa_to_g.htm This study examines the potential risks posed by a switch from Celexa to generic citalopram. Twenty patients at an Anxiety Disorders Clinic who were unknowingly switched to generic citalopram, from Celexa (Lundbeck, Montreal, Quebec, Canada) and experienced a re-emergence of their anxiety symptoms or development of new adverse events are described in this case series report. The mean time for re-emergence of symptoms or development of adverse events was 3.4 +/- 1.6 weeks (range 0.5-8 weeks). All patients reestablished previous treatment response with a change back to Celexa in a mean time of 3.8 +/- 2.6 weeks (range 0.7-12 weeks). Given these results, it is important for clinicians to be aware of the potential for loss of treatment effect or symptom re-emergence posed by a switch to a gene... Latest entries from www.anxietyinsights.info blogs http://www.medworm.com/rss/comments.php?id=776243 Fri, 03 Aug 2007 08:37:00 +0100 776243 http://www.medworm.com/index.php?rid=775566&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F140064688%2F Actually, there’s nothing new about managed care offering incentives to docs to lower costs and improve health outcomes. But a Boston television station ran a segment this week raising this question: is it ethical for docs to receive a payment for switching a patient from, say, Lipitor to generic Zocor if the patient isn’t informed? What do you think? Watch the segment and then answer our poll below… Note: There is a poll within this post, please visit the site to participate in this post’s poll. Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=775566 Thu, 02 Aug 2007 20:23:26 +0100 775566 http://www.medworm.com/index.php?rid=749425&cid=t_109291_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F07%2F22%2Fsunday-seven-seven-ways-for-safe-and-effective-drug-use%2F Filed under: Drug, All Cancers, Sunday SevenIt is important to question your physician about the prescriptions you are given. Most doctors will talk to you about the medication prescribed, but it is still important that you know what you're taking and ask appropriate questions. Know the name of the drug. This will enable you to look up information about the drug on your own. It will also enable you to discuss the drug with your doctor or another doctor for a second opinion. What is the purpose of the drug? This information will help you to know and understand what this drug is supposed to do and will let you know if the treatment is actually working. What are the side effects? It is helpful to be aware of the most common side effects. All drugs have some side effects. Information ... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=749425 Sun, 22 Jul 2007 04:00:00 +0100 749425 http://www.medworm.com/index.php?rid=744960&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F135408878%2F The fragile support for a Senate bill that would allow the FDA to approve generic versions of biologic drugs is deteriorating at the same time House lawmakers are trying to persuade leaders not to allow for such a provision in an FDA bill. Generic and brand name lobbyists say generic makers miight threaten to pull their support for the bill if a provision they say would give brand companies continuous monopoly rights is not changed, Congress Daily reports (subscription required). A sticking point was how long to give brand-name drugmakers exclusive rights to sell free of generic competition. The senators settled on 12 years, a number most believe can’t change without crumbling the entire deal. (more…) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=744960 Thu, 19 Jul 2007 20:56:47 +0100 744960 http://www.medworm.com/index.php?rid=734025&cid=t_109291_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F133346589%2F The pattern is predictable. A few big-selling drugs face generic competition and drugmakers scramble to guard the gold. One way is to make it harder to pharmacists to switch. And that’s the tactic being pursued by the Epilepsy Foundation, which receives substantial funding from a few drugmakers and has pharma execs on its board, plus PhRMA’s Billy Tauzin. Four major brand-name drugs lose patent protection next year and 2010, but generated $5 billion in US sales last year, The Wall Street Journal reports (subscription required). In May 2006, the foundation convened a committee that found a lack of authoritative studies showing that such drug switches cause problems, says its chairman, Steven Schachter, a Harvard Medical School neurologist. Nonetheless, the foundation still recom... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=734025 Fri, 13 Jul 2007 13:15:55 +0100 734025 http://www.medworm.com/index.php?rid=733625&cid=t_109291_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F07%2F13%2Finformation-you-need-to-know-about-generic-drugs%2F Filed under: Drug, All CancersA generic drug is exactly the same dosage, safety, strength and quality as a brand named drug. Generic drugs also do not take longer to work in the body, again, its the same ingredients as the name you are more familiar. The reason generic drugs are cheaper is because the makers of these drugs don't have the costs of the original developer of the drug. When the patent on the developer expires, 20 years, other manufactures can introduce competitive generic versions to the FDA for approval. This also creates greater competition in the industry once generic drugs are approved and keeps costs lower. A great place to go is here for more information on your generic drugs. Permalink | Email this | Linking Blogs | Comments (Source: ... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=733625 Fri, 13 Jul 2007 04:00:00 +0100 733625 http://www.medworm.com/index.php?rid=713239&cid=t_109291_109_f&fid=35671&url=http%3A%2F%2Fwww.anxietyinsights.info%2Ffda_approves_generic_paroxetine_paxilreg.htm Detroit based generic drug maker Caraco Pharmaceutical Laboratories, Ltd has announced U.S. Food and Drug Administration (FDA) final approval for its generic paroxetine tablets in 10, 20, 30 and 40 milligram strengths. The approval follows expiration of GlaxoSmithKline's patent on June 29. Paroxetine is indicated for the treatment of major depressive disorder, panic disorder, obsessive compulsive disorder, social anxiety disorder, generalized anxiety disorder and posttraumatic stress disorder. (Source: Latest entries from www.anxietyinsights.info) Latest entries from www.anxietyinsights.info blogs http://www.medworm.com/rss/comments.php?id=713239 Wed, 04 Jul 2007 08:15:00 +0100 713239 http://www.medworm.com/index.php?rid=702132&cid=t_109291_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2007%2F06%2Fpath-for-generic-biologics-clears.html As I noted in my post on Tuesday when I said a vote could come as early as this week, yesterday, the Senate panel voted to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines. I believe the 12-year period of marketing exclusivity seemed excessive. Fortunately, generic insulins including analogs now covered by patent protection, are considered by the FDA to be small-molecule drugs and are therefore only entitled to 7 years exclusivity protection. What this bill does, however, is eliminates any excuses the FDA may have and outlines clear procedures for generics, thus increasing the liklihood that generic versions of regular and NPH insulin could soon emerge from companies including Teva, Novartis (through its Sandoz generics un... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=702132 Thu, 28 Jun 2007 15:00:00 +0100 702132 http://www.medworm.com/index.php?rid=696946&cid=t_109291_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2007%2F06%2Fmixed-results-on-bill-to-enable-generic.html As my readers know, I've followed the issue of legislation to support the introduction of generic insulin and I've given this topic ongoing coverage. Past coverage has included my original post, a follow-up based on NYT coverage, the news that legislators had finally introduced legislation to permit generic biopharmaceuticals, as well as a few relevant follow-ups, including a story that a coalition of businesses' expressed their support for the bill, another story that outlined the estimated savings that generic insulin could have on the nation's healthcare budget, and finally a story that the FDA believes that simple generic biologics like insulin may require less data for approval.Yesterday, a story was published in The Wall Street Journal that several key Senators (including both Republ... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=696946 Tue, 26 Jun 2007 14:10:00 +0100 696946 http://www.medworm.com/index.php?rid=655712&cid=t_109291_109_f&fid=35671&url=http%3A%2F%2Fwww.anxietyinsights.info%2Fphysicians_question_fdas_confidence_in_generic_drugs_safet.htm Mark Moran Patients can contact their pharmacy and ask whether they have changed manufacturers and request the original formulation. Typically, pharmacies can accommodate such requests. The call came out of the blue. "It was a patient I had seen years ago for depression," APA President-elect Nada Stotland, M.D., told Psychiatric News. "She had been completely stabilized on a medication and had in fact decided to let her primary care physician prescribe it. That was her decision, and she did well for several years. But when she called, she said she was extremely depressed and asked to come and see me." Predictably, Stotland said, there were events in the patient's life that might have touched off a relapse, in particular the anniversary of a painful loss. But the patient had lived through t... Latest entries from www.anxietyinsights.info blogs http://www.medworm.com/rss/comments.php?id=655712 Mon, 04 Jun 2007 08:56:00 +0100 655712 http://www.medworm.com/index.php?rid=598707&cid=t_109291_85_f&fid=34662&url=http%3A%2F%2Fscienceblogs.com%2Fdrcharles%2F2007%2F05%2Fchantix_really_helps_people_qu.php In my anecdotal experience, I've been seeing tremendous success with a medicine called Chantix. It helps people quit smoking by binding to nicotine receptors, which reduces cravings, and when combined with smoking makes you very nauseous. I would estimate that this reduced craving and negative feedback seems to be working in about 70% of my patients, although the clinical trials showed only 44% quit rates versus 17% for placebo and 30% for Zyban. If you smoke, or care for someone who smokes, get your doctor's opinion on Chantix. Disclosure: None. Except that I had two grandparents die of lung cancer, and it's not a good way to die. Read the comments on this post... (Source: The Examining Room of Dr. Charles) The Examining Room of Dr. Charles blogs http://www.medworm.com/rss/comments.php?id=598707 Mon, 07 May 2007 23:40:48 +0100 598707 http://www.medworm.com/index.php?rid=574096&cid=t_109291_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F112395276%2Fadventrxs_anx514_docetaxel_emu.html Preclinical pharmacokinetic testing of ANX-514 (docetaxel emulsion) in a well recognized animal model, yielded positive data as recently announced by ADVENTRX Pharmaceuticals, Inc. (Amex: ANX). Results of the study indicated the following: Bioequivalent pharmacokinetics between ANX-514 and the FDA-approved version of docetaxel: Taxotere® ANX-514 administered intravenously did not cause hypersensitivity reactions in this study, as opposed to acute hypersensivity reactions observed following intravenous treatment with Taxotere®. ANX-514 is a novel emulsion formulation of docetaxel - an agent for the treatment of breast, non-small cell lung, prostate and gastric cancers. According to Evan M. Levine, chief executive officer for ADVENTRX: "These preclinical results are important a... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=574096 Fri, 27 Apr 2007 08:37:42 +0100 574096 http://www.medworm.com/index.php?rid=556585&cid=t_109291_85_f&fid=34662&url=http%3A%2F%2Fscienceblogs.com%2Fdrcharles%2F2007%2F04%2Fis_most_blogging_a_display_of.php Ben Stein wrote a great article on how to have a conversation with another person. He specifically wrote about how to do it well, and how essential effective communication is for anyone looking to succeed. He lists the following 10 conversation tips (abbreviated here, read his article for the full text): 1. Begin by knowing that the people you're talking to mostly want to talk about themselves... Read the rest of this post... | Read the comments on this post... (Source: The Examining Room of Dr. Charles) The Examining Room of Dr. Charles blogs http://www.medworm.com/rss/comments.php?id=556585 Fri, 20 Apr 2007 14:13:58 +0100 556585 http://www.medworm.com/index.php?rid=516443&cid=t_109291_113_f&fid=34933&url=http%3A%2F%2Fpalmdoc.net%2F%3Fp%3D1236 Here’s another freebie to log your CME points. MCE 2.1 is a free application which is designed for professionals to record CME points earned. It’s rather generic but it may suit you. You may also want to check out CME Watch 1.74 (Source: The Palmdoc Chronicles) The Palmdoc Chronicles blogs http://www.medworm.com/rss/comments.php?id=516443 Mon, 02 Apr 2007 23:10:46 +0100 516443 http://www.medworm.com/index.php?rid=503602&cid=t_109291_85_f&fid=34662&url=http%3A%2F%2Fscienceblogs.com%2Fdrcharles%2F2007%2F03%2Fthe_top_14_most_counterfeited.php The National Association of Boards of Pharmacy has created the National Specified List of Susceptible Products, which identifies 32 drugs that are most susceptible to adulteration, counterfeiting or diversion and that pose the greatest risk to public health: 1. Combivir (lamivudine/zidovudine - used in the treatment of HIV) 2. Diflucan (fluconazole - used in the treatment of fungal infections, often in those with HIV) 3. Epivir (lamivudine - used in the treatment of HIV) 4. Epogen (epoetin alfa - often used in the treatment of those with HIV, receiving chemotherapy, or with renal failure) 5. Lamisil (terbinafine - used in the treatment of toenail fungus, and often not covered by insurance plans) 6. Lipitor (atorvastatin - used in the treatment of high cholesterol) 7. Norvasc (amlodi... The Examining Room of Dr. Charles blogs http://www.medworm.com/rss/comments.php?id=503602 Tue, 27 Mar 2007 13:50:39 +0100 503602