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 'cephalon'. Sat, 03 Sep 2011 02:10:47 +0100 http://www.medworm.com/index.php?rid=4976205&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtVU0kTPjSIk%2F With concerns about social media front and center, drugmakers can clearly use some guidance when it comes to creating a product web site. Then again, a degree of common sense should already be in place, yes? Cephalon, however, committed a few avoidable blunders with a web site for Trisenox, which was approved to treat acute promyelocytic leukemia. An FDA warning letter dated June 21 notes that in the healthcare professional website for Trisenox, Cephalon overstated the case for its drug in big, bold letters in a prominent location at the top of the web pages. The agency found the claims misleading, “because they suggest that Trisenox is approved to treat patients with any kind of relapsed or refractory APL when this is not the case.” There are, in fact, some important limitati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976205 Tue, 28 Jun 2011 12:02:47 +0100 4976205 http://www.medworm.com/index.php?rid=4893916&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_PKuBogHIcg%2F And so, another working week will soon draw to a close. This is, of course, our signal to daydream about the weekend. Our agenda includes some therapeutic swimming, catching up on our reading and taking in a soccer match with the short people. And you? How about enjoying the weather with a nice bike ride? Or spending time with someone special? Perhaps thinking big thoughts is in order. Whatever you do, have a wonderful time. And be safe. See you soon… Pfizer And Hisun Pharmaceuticals Plan Generic Venture (Bloomberg News) Tianjin Tasly Pharmaceutical To Build A Factory In Maryland (CapitalVue) Drugmakers Bolster US Corporate Philanthropy (Reuters) The New Pricing Game In Germany (Business Week) Endo Sales Reps Granted Class-Action Lawsuit For Overtime (Reuters) Teva Gives Big Golden P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893916 Fri, 03 Jun 2011 12:03:23 +0100 4893916 http://www.medworm.com/index.php?rid=4775604&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqGxzJ5UIotM%2F Hello, everyone, and nice to see you again. We hope your weekend was refreshing. Now, of course, the routine of meetings and deadlines has returned. This calls for the mandatory cup of stimulation, an invigorating way to discuss the news about bin Laden, as well. Meanwhile, here are some other tidbits from around the world. Have a good one and stay in touch… Teva To Buy Cephalon For $6.8M, Outbidding Valeant (Associated Press) Drug Shortages Endangering Patients (The Washington Post) India’s Generic Drugmakers May Test Compulsory Licensing In June (Business Standard) Strides CEO Discusses Oncology Plant & Pfizer Deal (MoneyControl) Abbott Cuts Prices Of AIDS Drugs For Government Programs (Chicago Tribune) Pfizer And Its Radical Surgery (Forbes) Actelion Loses Licensing Dis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4775604 Mon, 02 May 2011 11:53:40 +0100 4775604 http://www.medworm.com/index.php?rid=4762933&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRHai_my_1TA%2F In the latest move by European antitrust regulators to probe patent settlements, the European Union disclosed this morning that an investigation is under way into whether Teva Pharmaceuticals and Cephalon struck an illegal deal to keep a generic version of the Provigil sleep disorder drug off the market (read the statement). Like the US Federal Trade Commission, the EU has been probing so-called pay-to-delay deals in the belief that they stifle competition and, therefore, delay entry to the marketplace of lower-cost medicines (read about the FTC efforts here). The interest among European antitrust regulators followed a report from the European Union competition commissioner saying that delays in bringing generic drugs to the market had cost consumers and healthcare providers billions. Rece... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762933 Thu, 28 Apr 2011 17:28:46 +0100 4762933 http://www.medworm.com/index.php?rid=4684761&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7VtbjQj12Pw%2F Good morning, everyone. Another brand new day is on the way. Of course, this calls for a hearty cup of stimluation - our flavor today is Cinnamon Cream Swirl. Feel free to grab one yourself, or a bottle of water if you prefer, and join us as we peruse the news of the world. As always, we appreciate tips and hints and allegations. So send them our way. Meanwhile, have a great day and see you soon… J&J May Do $10B Deals To Bolster Growth (Bloomberg News) Synthetic Drugs Send Thousands To Emergency Rooms (Associated Press) Merck’s Dutch R&D Unit To Keep Some Jobs After All (Reuters) The Valent Pharma CEO And His Acquisition Binge (Bloomberg News) Where Are The ImClone Alumni? (Xconomy) FDA Approves Restless Legs Syndrome Med (Reuters) AstraZeneca Wins FDA Approval Of Thy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684761 Thu, 07 Apr 2011 12:03:32 +0100 4684761 http://www.medworm.com/index.php?rid=4664476&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxYlfDINAsQc%2F And so, another working week is about to end. This is, of course, the celebrated signal to daydream about weekend plans. Our agenda includes watching one of the short people in a lacrosse match, dining with some of our favorite relatives and promenade with the official Pharmalot mascots. And you? Maybe you can watch that movie you never saw or catch up on some reading. How about spending time with a special someone? Whatever you do, be safe and enjoy. Catch you soon… Sanofi Faces Shareholder Suit Over Acomplia Data (Reuters) Japan Nuclear Crisis Adds Urgency To Radiation Drugs (New York Times) The Rise In Stolen Pharmaceuticals (Fortune) Paxil May Make Adults More Suicidal (Reuters) Fire Damages Roche Warehouse In Hungary (Budapest Business Journal) Fertility Drug May Be Linked To Fa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664476 Fri, 01 Apr 2011 11:49:14 +0100 4664476 http://www.medworm.com/index.php?rid=4658627&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fz32nDiD2ons%2F Good morning, everyone. How are you today? A busy agenda awaits us here on the Pharmalot corporate campus, where we have a pile of meetings and deadlines to attack. We trust you can relate. To cope, yes, we are downing a cup or two of stimulation. As always, we invite you to join us. And to get you started, here are some tidbits from the world at large. Hope your day goes well and do stay in touch… Sonova Execs Resign After Insider Trading Probe (Bloomberg News) Gilead And Yale Former Cancer Research Deal (Reuters) Valeant Offers To Buy Cephalon For $5.7 Billion (Bloomberg News) Glaxo’s Lovaza Partner Pronova Settles Patent Row With Apotex (Reuters) UK’s NICE Rejects Bristol-Myers’ Orencia Drug (Dow Jones) Vertex CF Drug Shows Promising Results (Mass High Tech) Merc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658627 Wed, 30 Mar 2011 11:41:48 +0100 4658627 http://www.medworm.com/index.php?rid=4636662&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlYLOC-LmD10%2F And so another working week soon draws to a close. This is, of course, the signal to dream about weekend plans. Our agenda calls for spending time with the short people and cleaning up around the Pharmalot corporate campus. And you? Will you catch up on some sleep? Read an e-book? Take a walk in the park? Have a good time, whatever you do. And be safe. Meanwhile, here are some tidbits. Catch you soon, everyone… Medical Marijuana Sales Rival Viagra (Time) Cephalon Wins Ruling Over Generic Copy Of Watson’s Fentora (Reuters) Martin Sheen Testifies In Accutane Trial (ABA Journal) Branded Discounts Save Seniors $38M In Two Months (Pharma Times) Prevanar Vaccine To Resume In Japan (Bloomberg News) Pfizer Drugs Shrinks Pancreatic Tumors In Research (Bloomberg News) FDA OKs Merck Shing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636662 Fri, 25 Mar 2011 12:10:36 +0100 4636662 http://www.medworm.com/index.php?rid=4622507&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FenMMgf6D0z8%2F Good morning, everyone, and nice to see you again. Another overcast day here on the Pharmalot corporate campus, where we are, once again, hustling short people off to the local schoolhouse. As you know, this calls for a cup of stimulation or two - our flavor today is pumpkin spice. Please feel free to join us. Meanwhile, here are some tidbits from around your world. Hope your day goes well and do stay in touch… Merck And Sanofi Abandon Animal Health Joint Venture (Reuters) Bristol Reports Positive Results For Ipilimumab Melanoma Med (Associated Press) Pfizer Lipitor Subsidy May Hurt Ranbaxy (Bloomberg News) Cephalon To Acquire Gemin X For $225M (Associated Press) Many Gastric Banding Patients Have Complications (HealthDay News) FDA Agrees To Review Shire Angioedema Drug (Pharma Times... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4622507 Tue, 22 Mar 2011 11:55:44 +0100 4622507 http://www.medworm.com/index.php?rid=4611003&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWXsonFvU_bM%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 MTI Information Technologies, which provides marketing services to healthcare providers, hired Brian Tvenstrup as sr vp of business analytics. Previously, he headed analytics for First Equity Card, a commercial lender to small businesses, and w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4611003 Fri, 18 Mar 2011 12:03:11 +0100 4611003 http://www.medworm.com/index.php?rid=4377787&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcjCmn3mBJKE%2F Two years ago, the US Federal Trade Commission filed a highly publicized lawsuit against Cephalon over pay-to-delay deals worth an estimated $200 million with some generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharmaceuticals - to keep a copycat version of its Provigil sleep-disorder pill off the market until 2012 (read this). Now, though, more than three dozen other drugmakers have raced to court to try to keep details of their own deals from being disclosed as a result of this battle. In a motion filed in federal court in Philadelphia this week, no fewer than 37 drugmakers - including Abbott Laboratories, Merck, Novartis, Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline, Pfizer, Bayer, AstraZeneca, Johnson & Johnson, Actavis, Waston Pharmaceuticals, Dr. Reddy’s, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377787 Thu, 20 Jan 2011 20:48:02 +0100 4377787 http://www.medworm.com/index.php?rid=4361304&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIiODttpjxnE%2F In an embarassing comeuppance, Cephalon was slapped around by the Association of British Pharmaceutical Industry for discrediting its species by providing inappropriate hospitality to 13 healthcare professionals during a medical congress in Lisbon, Portugal, in 2009. The move came after a complaint was filed anonymously by a perturbed employee, who works as a hospital specialist, and noted a subject of discussion was the Fentora pain patch. Among the transgressions that prompted the ABPI to admonish one of its own: an official feedback document that was distributed to Cephalon employees, including reps, that had such interesting comments as “Dinner was fantastic,” “great night again,” “took them clubbing,” and “we then went to a few bars and to a c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4361304 Tue, 18 Jan 2011 16:04:53 +0100 4361304 http://www.medworm.com/index.php?rid=4322693&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTPqRZ55bYTQ%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 Huron Consulting promoted Manny Tzavlakis to managing director in the Life Sciences Advisory Services practice, where he focuses on disclosure reporting, aggregate spend, transparency, sales and marketing compliance, commercial operations and b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4322693 Fri, 07 Jan 2011 13:26:38 +0100 4322693 http://www.medworm.com/index.php?rid=4294996&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhR5RWJ7W9YE%2F For the second time this year, the FDA has issued a complete response letter for Cephalon’s Nuvigil sleep disorder pill, which the drugmaker hoped to market as a treatment for jet lag resulting from eastbound travel. However, the agency had concerns about efficacy and certain patient data that effected statistical significance. Consequently, the drugmaker is no longer pursuing this indication (see the statement). This is not terribly surprising, given that Wall Street was told recently that total revenue for treating jet lag may not exceed $100 million. But this clearly adds pressure on Cephalon, which recently lost its ceo due to an untimely death (see here), because it must find ways to differentiate Nuvigial as a follow-up to Provigil, which faces generics in April 2012. As RW Baird a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4294996 Mon, 27 Dec 2010 16:39:27 +0100 4294996 http://www.medworm.com/index.php?rid=4266260&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc2OE8BeeFA4%2F After being away several months for an unexplained medical leave, Cephalon ceo Frank Baldino passed away yesterday. He was 57 and was one of the founders of the drugmaker, which got its start in 1987. J. Kevin Buchi, the coo, who has been filling in for Baldino, will continue to do so, although no succession plan has been discussed (see the statement). Until last week, Baldino had been expected to return by year’s end. Baldino, who received a PhD in pharmacology from Temple University in Phildelphia, began his career as a research biologist at EI DuPont de Nemours, where he worked from 1981 to 1987 and identified research strategies for identifying novel molecules. He then left to start Cephalon (you can read the complete bio here). Since its founding, Cephalon has grown into a $2.2 ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266260 Fri, 17 Dec 2010 17:06:23 +0100 4266260 http://www.medworm.com/index.php?rid=4266263&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6XIlWnTjkZk%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 GCI Health, a healthcare public relations agency, hired Robert Eakins to head its Canadian operations. Most recently, he was senior vp and healthcare practice leader at MS&L Canada, where he managed such clients as Sanofi-Aventis, Sanofi P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266263 Fri, 17 Dec 2010 13:13:25 +0100 4266263 http://www.medworm.com/index.php?rid=4241952&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FM-_2VCTpo0I%2F Good morning, everyone. Our apologies for the late start but we are having technical difficulties and attempting to resolve them. Nonetheless, we are endeavoring to provide you with the usual flow of interesting items. Here are a few to get us all started. We hope your day goes well. As for us, we are going to down a much-needed cup of stimulation. Stay in touch… Merck Drops Fast-Acting Claim For Allergy Pill (Dow Jones) US Moves Toward Drug Development Center (Reuters) Orphan Drug Discounts Ended For Kids Hospitals (New York Times) Cephalon Buys Rights To Stem Cell Therapies (Bloomberg News) Caraco Pharma Considers Going Private (Detroit News) China To Prices On Some Drugs By 19 Percent (PharmaTimes) Sanofi-Aventis Signs Licensing Deal For HIV Drug (Montreal Gazette) (Source: Pharma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4241952 Wed, 08 Dec 2010 13:54:02 +0100 4241952 http://www.medworm.com/index.php?rid=4233422&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC-wivyYh71k%2F For the past year, Watson Pharmaceutical ceo Paul Bisaro has argued the Federal Trade Commission abused its power in attempting to stop a pay-for-delay deal. And he giddily thumbed his nose at the agency by refusing to comply with a subpoena that sought to compel him to testify in connection with an investigation into the deal. Late last week, however, a federal judge burst his bubble by ruling that he failed to demonstrate” the subpoena “would be burdensome at all, let alone unduly so.” Here’s the background: in court papers, Bisaro claimed the FTC harassed Watson and used confidential FDA info to force Watson into a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. Bisaro asserted the FTC initiated its investigati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233422 Mon, 06 Dec 2010 13:34:19 +0100 4233422 http://www.medworm.com/index.php?rid=4082329&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU8e0B1NqNTw%2F An in-depth analysis of the money paid by drugmakers to doctors has been undertaken by ProPublica, which has just published a detailed look that is sorted by company, doctor, state and activities for which docs were compensated. The database includes payments made by seven drugmakers in 2009 and early 2010 - $257 million went to about 17,700 docs. Although as ProPublica notes, more than 70 companies have yet to publicly disclose their payments but will be required to by 2013 under the federal health care reform law. And existing disclosure are not done so on a uniform basis - travel fees and research payments rarely show up. To give you a taste of the dollars shelled out, Pfizer paid out nearly $10 million, on average, during the third and fourth quarters of 2009 (see here), and a doctor i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4082329 Tue, 19 Oct 2010 17:21:31 +0100 4082329 http://www.medworm.com/index.php?rid=4031185&cid=t_127670_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F10%2Fpay-for-what-redux-surrealistic-pay-for.html Pay-for-performance has been a persistently fashionable mantra for health care business leaders and policy advocates, particularly as applied to physicians to control costs and perhaps even improve quality.  We have been highly critical of current methods proposed to measure performance and tie pay to it (e.g., here), and other bloggers, notably Dr Robert Centor at DB's Medical Rants, have vigorously pursued this issue (e.g., here).It is beyond ironic that meanwhile, the pay of health care organizations' leaders seems less and less related to their performance.  For example, in a recent series on local executive pay in the Boston Globe there were these examples:HologicHologic Inc. gave its chief executive, John W. Cumming, a $1.5 million “retention payment’’ ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4031185 Mon, 04 Oct 2010 20:51:00 +0100 4031185 http://www.medworm.com/index.php?rid=3907785&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnOh-g8JZPUg%2F A sunny day is unfolding here on the Pharmalot corporate campus, where the mascots are happily frollicking among the weeds. As for us, we are brewing the mandatory cup of stimulation. What about you? Heading off toward your own campus? Prepping for those meetings and deadlines? Whatever you encounter, we hope your day goes well. One housekeeping note: we will break early today to shuffle one of the short people off to an institution of higher learning. See you soon… Advanced Melanoma Treatment Shrinks Tumors: Study (Reuters) Cephalon CEO Takes A Medical Leave Of Absence (Bloomberg News) Drugmakers Experiment With Design (The Financial Times) Celgene Has Been Plotting Revlimid Challenge (The Wall Street Journal) CVS/Caremark Closes Mail-Order Facility And Cuts 400 Jobs (The Birmingham... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3907785 Thu, 26 Aug 2010 11:32:58 +0100 3907785 http://www.medworm.com/index.php?rid=3802587&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsYwntWuqtGs%2F Despite various legislative and courtroom setbacks, FTC commish Jon Leibowitz insists there is reason to be optimistic that so-called pay-to-delay deals may soon be a thing of the past. In testimony this week before the House Committee on the Judiciary’s Subcommittee on Courts and Competition Policy, he appeared to see blue skies on his horizon and went so far as to say the ‘tide may be turning.’ For instance, he cited a recent ruling by the US Second Circuirt Court of Appeals, which actually upheld the legality of pay-for-delay deals, but at the same time, took the unusual step of inviting entities that purchase drugs and had challenged a particular deal to ask for that case to be reviewed by the full circuit, citing the “exceptional importance” of the antitrust impl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3802587 Thu, 29 Jul 2010 12:47:40 +0100 3802587 http://www.medworm.com/index.php?rid=3784499&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUcVv-aO71-o%2F European regulators just announced a decision that may keep Cephalon execs awake at night, but taking their own Provigil sleep-disorder pill may not be such a good idea. Here’s the scoop: the European Medicines Agency yesterday recommended restricting Provigil (modafinil) to treat sleepiness associated with narcolepsy, but not idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnea and chronic shift work sleep disorder. Why? Safety concerns over psychiatric disorders, skin and subcutaneous tissue reactions (see statement). There is an irony here made clear on Cephalon’s unbranded web site - The Wake Up Squad. Among those who work odd shifts and may have trouble sleeping are cops. You wouldn’t want a cop developing a psychiatric disorder now, w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3784499 Fri, 23 Jul 2010 13:16:55 +0100 3784499 http://www.medworm.com/index.php?rid=3780562&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FG23aTRf-kJE%2F Last week, a federal judge ruled there is a “strong possibility” the Federal Trade Commission abused its power in attempting to stop a pay-for-delay deal. Specifically, Watson Pharmaeutical ceo Paul Bisaro claimed the FTC harassed his company and used confidential FDA info to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. The FTC issued a subpoena last year and sought to compel Bisaro to respond to questions in connection with an investigation into that deal, although he refused to testify. Bisaro claims the FTC improperly tried to broke... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3780562 Thu, 22 Jul 2010 20:09:29 +0100 3780562 http://www.medworm.com/index.php?rid=3767314&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVAkuw91uRH4%2F Two months ago, Paul Bisaro, the ceo of Watson Pharmaceuticals, made a sensational charge against the Federal Trade Commission - in court papers, he accused the agency of abusing its power in attempting to stop pay-for-delay deals. Bisaro claimed the FTC harassed his company and used confidential FDA info to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. The FTC issued a subpoena last year and sought to compel Bisaro to respond to questions in connection with an investigation into that deal, although he refused to testify. Bisaro claims the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3767314 Mon, 19 Jul 2010 12:23:08 +0100 3767314 http://www.medworm.com/index.php?rid=3625776&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJ60e5coru9I%2F For the past couple of years, Cephalon has been scrambling to bolster its Nuvigil sleep-disorder pill as a successor to its older Provigil medication, which is marketed to treat the same problem, but faces generic competition in 2012. To cope, the drugmaker has been steadily raising the price on Provigil and trying to win new indications for Nuvigil. Yesterday, though, Cephalon took a big hit because a Phase IIb study found Nuvigil failed to meet its primary endpoint for treating schizophrenia symptoms. This follows a complete response letter issued in March by the FDA for using the drug to treat jet lag disorder (see this). Meanwhile, Nuvigil is being tested to treat excessive daytime sleepiness related to traumatic brain injury and as an add-on therapy for bipolar disorder, but these are... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3625776 Thu, 03 Jun 2010 12:12:12 +0100 3625776 http://www.medworm.com/index.php?rid=3607817&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTSbBPhHxMwU%2F Here’s a sensational accusation for you. Paul Bisaro, the ceo of Watson Pharmaceuticals, filed papers in federal court the other day accusing the Federal Trade Commission of abusing its power in attempting to stop pay-for-delay deals, which the agency argues are anti-competitive and, therefore, harm consumers (see background). Bisaro claims the FTC harassed his company and used confidential FDA info in an effort to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. His charge follows a subpoena sought last year by the FTC to compel Bis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3607817 Thu, 27 May 2010 18:06:48 +0100 3607817 http://www.medworm.com/index.php?rid=3468020&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FX2JmApk8MdI%2F Several widely used anticonvulsants, including Pfizer’s Neurontin, may increase the risk of suicide, attempted suicide and violent death in patients taking them for the first time, according to a study in the Journal of the American Medical Association. Compared with Johnson & Johnson’s Topamax (known generically as topiramate), the study found increased suicide risks for new patients using Neurontin (sold generically as gabapentin); GlaxoSmithKline’s Lamictal; Novartis’ Trileptal, or Cephalon’s Gabitril. Researchers also found an increased risk with Abbott Labs’ Depakine and Epilim, which is sold by Sanofi-Aventis. The findings come two years after the FDA required anticonvulsants to carry a warning they double the risk of suicidal thoughts and beh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468020 Wed, 14 Apr 2010 12:04:48 +0100 3468020 http://www.medworm.com/index.php?rid=3437925&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8bYtDhtzVKQ%2F Last week, Pfizer began posting payments to doctors for consulting, speaking and clinical trial work, as well as meals and other goodies worth more than $25 (more details). In doing so, the drug giant joins Merck, Eli Lilly and GlaxoSmithKline in publishing such lists, as well as Cephalon (which like Pfizer, did so to satisfy a Corporate Integrity Agreement). The move also comes just after passage of the health care reform bill, which includes a provision known as Physician Payments Sunshine, which requires drugmakers each year to record - starting 2012 - all gifts and payments to docs and teaching hospitals. Posting begins in 2013 (see more here and here). We spoke with Allan Coukell, director of the Pew Prescription Project, which worked for passage of the provision and pushes safety iss... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3437925 Mon, 05 Apr 2010 14:20:30 +0100 3437925 http://www.medworm.com/index.php?rid=3420755&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FO43H7wrgtxI%2F The FDA issued a complete response letter for Cephalon’s Nuvigil sleep disorder pill, which the drugmaker hopes to market as a treatment for jet lag. The agency, however, questioned some of the study data. Nuvigil, which is a follow-up to Cephalon’s Provigil drug, is approved to treat sleep apnea, narcolepsy and shift work sleep disorder. The drugmaker wants approval for Nuvigil to treat excessive sleepiness associated with jet lag stemming from eastbound travel. “Although we reached statistical significance on both primary endpoints (in clinical trials), the Complete Response letter raised questions regarding the robustness of the PGI-S data,” Lesley Russell, Cephalon’s chief medical officer, says in a statement. “We have already reviewed this issue wit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420755 Tue, 30 Mar 2010 12:13:30 +0100 3420755 http://www.medworm.com/index.php?rid=3267201&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpLl4t9dgrIw%2F And so the week is gradually coming to an end. Most likely, many of you will celebrate, given the disruptive snowstorms in many parts of the U.S., which by the way, has a long weekend. What will you do? Go sledding? Walk the dog? Read a book? We have a long list. Whatever you do, we hope you have a relaxing and productive time. Meanwhile, here are a few items to help you through the day. Enjoy, everyone… AstraZeneca CEO: Don’t Judge Us On Earnings (Bloomberg News) Pfizer Fails To Stop Unilab In Lipitor War (Manila Standard) Cephalon Profit Jumps On Higher Sales (Associated Press) Roche Diagnostics Unit Sues Qiagen Unit (Reuters) pic thx to sonnysideup at flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3267201 Fri, 12 Feb 2010 12:53:21 +0100 3267201 http://www.medworm.com/index.php?rid=3262896&cid=t_127670_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2Fy3BHcmd-v8Y%2Fepharma-summit-2010-case-study-speed-to.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3262896 Wed, 10 Feb 2010 19:07:00 +0100 3262896 http://www.medworm.com/index.php?rid=3244045&cid=t_127670_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Fdid-cephalon-pay-james-mcmillen-101650.html In a recent post, I wondered why a doctor from Dillsberg, PA, a town with a total area of 0.8 square miles and only 2,063 people, would be the 5th highest paid physician on Cephalon's list of payments to physicians. That doctor -- James Mcmillen -- received $101,650 in 2009 (see "Transparency Vs. Translucency in Reporting Physician Payments").Since I first posted this bit of information, I learned that:(1) Cephalon agreed to plead guilty to promoting painkiller Actiq, narcolepsy pill Provigil and the epilepsy treatment Gabitril for uses that weren’t approved by FDA. As a result of the plea agreement, Cephalon was REQUIRED to post all payments it made to physicians in 2009 and quarterly thereafter.(2) Dr. James Mcmillen is a member of the National Fibromylgia Association (he's listed on t... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3244045 Thu, 04 Feb 2010 22:08:00 +0100 3244045 http://www.medworm.com/index.php?rid=3231802&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU1cLkQZa2uc%2F Cephalon has joined the growing ranks of drugmakers disclosing payments to docs - and is the first to do so thanks to a Corporate Integrity Agreement. And as The Pink Sheet’s Brenda Sandburg points out, Cephalon discloses a longer time range than the voluntary efforts made by others, but its list only covers doctors, not all health care providers (see the full story here). Why? The CIA required payments only to docs. All totaled, Cephalon paid 937 docs for consulting and speaking services during 2009, with its top-paid doctor earning $149,900 (see list). By contrast, Merck, Lilly and Glaxo list other healthcare providers getting money. The CIA was part of a $425 million settlement with the Department of Justice to resolve criminal charges that Cephalon engaged in off-label marketing ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3231802 Tue, 02 Feb 2010 13:55:18 +0100 3231802 http://www.medworm.com/index.php?rid=3228009&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6b_ZGVYohXY%2F And welcome to the working week. Hope your weekend was relaxing and fruitful, although most likely, it went too fast, yes? Sigh… Well, once again, you must steel yourself for those meetings and deadlines. To help you cope, we have assembled a few interesting items. So dig in and the day will speed by. Meanwhile, please stay in touch…. Cephalon To Buy Mepha Generic Maker For $590M (Reuters) Prices For Commonly Prescribed Meds Drop In Ireland (IrishTimes) Judge Refuses To Dismiss Fosamax Case (Reuters) Philippines To Release Second List Of Drug Price Cuts (Bloomberg) Defense Aims At Causation In HRT Opening Arguments (Law.com) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3228009 Mon, 01 Feb 2010 12:58:48 +0100 3228009 http://www.medworm.com/index.php?rid=3220739&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FclnNZ5t5YXQ%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 something we hope to make a regular feature. Send us a photo (something nice, please) and we will spotlight a different person each week. This time around, we note that Bruce McCarthy joined Afferent Pharmaceuticals as chief executive. He was previously a vp of neuroscience development at Pfizer, where he led neuroscience drug development programs of new molecul... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3220739 Fri, 29 Jan 2010 12:32:09 +0100 3220739 http://www.medworm.com/index.php?rid=3178984&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhEbzKBKIvfk%2F For those who missed Dr. Stephen Colbert, Doctor of Fine Arts, explain the other night how he cheats death, we thought you may enjoy his humble musings about various meds designed to improve lives. For instance, he notes Cephalon’s Nuvigil, which may soon be approved to treat jet-lag disorder, is “so much effective than the old remedy – going to sleep.” There’s also Vaxistare for restless eyelid syndrome and, for women with libido issues, he introduces Vaxawang, which causes women to grow a penis but, Colbert cautions, one should “consult a physician if your penis lasts more than four hours.” Thanks to Drug Channels’ Adam Fein (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3178984 Sat, 16 Jan 2010 15:40:39 +0100 3178984 http://www.medworm.com/index.php?rid=3172202&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5x3gAtaxrKg%2F Earlier this week, the FDA posted warning letters on its site to four drugmakers - Lilly, Bayer, Amylin Pharmaceuticals and Cephalon - for making inaccurate or incomplete statements while promoting their drugs. Amylin, for instance, was tagged because its reps made remarks that Byetta can be used as a stand-alone therapy, which was before the drug received that approval. Bayer was chastised for suggesting its Mirena contraceptive women help would feel more romantic or intimate when, in fact, the side effects indicate the opposite may occur. A dosing card for Cephalon’s Treanda, which treats chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, minimized risk and a Lilly promotional piece for its Cymbalta antidepressant minimized risk and overstated efficacy. As The Pink She... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3172202 Thu, 14 Jan 2010 12:02:03 +0100 3172202 http://www.medworm.com/index.php?rid=3167443&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzFPXsQVcoi8%2F In his never-ending quest, FTC commish Jon Leibowitz will hold a press conference today to ask Congress to include a provision in the health care reform bill to end deals in which brand-name drugmakers offer payments or other inducments to generic rivals to delay copycat versions of best-selling meds. He’ll be appearing at the Rayburn House Office Building in Washington, DC, at 12:30 along with several members of the House, which has already included a ban in its own bill. The Congressional Budget Office, you may recall, recently estimated that the House provision could save the government $1.8 billion in health costs over the next 10 years (see here). The Senate version does not include a ban (see here), although nine Democrats last month sent a letter to majority leader Harry Reid ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3167443 Wed, 13 Jan 2010 15:15:00 +0100 3167443 http://www.medworm.com/index.php?rid=3167447&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkUGyOqgkCw8%2F Hello, everyone. For those struggling with the mid-week blues, we are reminded of that uplifting comment from the Morning Mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So keep that in mind as you attempt to attack those meetings and projects. You will prevail. Meanwhile, we will arm ourselves with a cup of stimulation. Here’s to a good day… Novo Starts Testing Victoza Diabetes Pill (Reuters) FDA Send Warnings To Bayer, Lilly, Cephalon & Amylin (Associated Press) Will Novartis Raise Its Bid For Alcon? (Reuters) Charles River Labs To Cut 300 Jobs (OutsourcingPharma) WHO To Review Swine Flu Response (Bloomberg News) Coffee thanks to chichcacha Flickr Common Creative (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3167447 Wed, 13 Jan 2010 13:23:06 +0100 3167447 http://www.medworm.com/index.php?rid=3153627&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F10sCFWCMz-w%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 something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Dan Schultz, a former director of the FDA’s Center for Devices and Radiological Health, has joined Greenleaf Health, a consulting firm, as senior vice president, medical devices and combo products. He’s based... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3153627 Fri, 08 Jan 2010 13:12:12 +0100 3153627 http://www.medworm.com/index.php?rid=3149319&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FR5q806tnp4M%2F For those of you who were unaware, Cephalon is anxiously awaiting FDA approval to sell Nuvigil, a slightly modified form of its Provigil narcolepsy pill, to combat jet-lag disorder. The drugmaker had hoped for a regulatory okay last month, but the agency delayed a decision in order to review data. Ostensibly, Nuvigil would be aimed at eastbound business travelers, not folks with garden-variety sleep disorders, but as The New York Times notes, FDA approval would enable Cephalon to promote Nuvigil to a broad array of doctors, not just those who treat sleep disorders. “What a jet lag indication allows you to do is go to virtually every doctor,” Corey Davis, a Jefferies & Co. analyst, tells the paper, “because every physician will, at some point, treat a patient who will have j... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3149319 Thu, 07 Jan 2010 12:08:14 +0100 3149319 http://www.medworm.com/index.php?rid=2989409&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfwMa_oLZ8dU%2F And so another work week is drawing to a close. And not a moment too soon, yes? What will you do this weekend? Our favorite sport is raking leaves - the exercise is worth the effort. Of course, there are errands to run and keeping up with the short and not-so-short people is a favorite pre-occupation. Meanwhile, though, today beckons. So time to get moving. Have a nice weekend, everyone… Pfizer May Have To Repay Missouri Tax Breaks (St.LouisToday) Cephalon And Barr Settle Fentora Patent Dispute (Reuters) Abbott Grabs Experimental Pain Drug (Chicago Tribune) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2989409 Fri, 13 Nov 2009 13:04:41 +0100 2989409 http://www.medworm.com/index.php?rid=2944096&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F71wbHZG0du0%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 something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Qforma, which traffics in analytics and predictive modeling, hired Erin McLaughlin as director of field operations. She last worked as an account manager at Surveillance Data Inc (SDI) and before that was with NDCHealth ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2944096 Fri, 30 Oct 2009 11:07:44 +0100 2944096 http://www.medworm.com/index.php?rid=2510428&cid=t_127670_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F06%2Fpracticing-clinical-trials-medicine.html Another story of dubious clinical research, this time reported by the St Petersburg (Florida, US) Times:Vladimir Martin called himself 'doctor' and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license.The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, Martin, 43, was arrested on charges of practicing medicine without a license. He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000.The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hos... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2510428 Tue, 23 Jun 2009 18:50:00 +0100 2510428 http://www.medworm.com/index.php?rid=2187687&cid=t_127670_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F02%2Fwhat-ruc-again-one-of-worlds-most.html With health care reform continuing as a hot topic in the US, more discussions of issues of interest to Health Care Renewal are appearing. We previously posted about a prominent expert's discussion of how the US Medicare system pays physicians. We noted that he seemed to avoid critical issues, and thus may have failed to suggest changes that would address the real problems. Finally, we noted that his undisclosed financial relationships with several companies which have profited from the status quo may have affected his arguments, and failure to disclose these apparent conflicts of interest muddied the discussion.In a similar vein, we will discuss an article just published entitled "Reforming Medicare's Physician Payment System," by Gail R Wilensky, PhD(1). [Note that the discussion will be ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2187687 Fri, 13 Feb 2009 21:28:00 +0100 2187687 http://www.medworm.com/index.php?rid=1969322&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F457170109%2F Twice this year, Cephalon has sharply raised the price of its Provigil narcolepsy drug, which is now 28 percent more expensive than in March and 74 percent more expensive than four years ago, and the drugmaker said recently it plans to continue raising the price, The Wall Street Journal writes. The Provigil price increases - the average wholesale price is now $8.71 a tablet - are an extreme example of a common tactic drugmakers employ in the US to boost profits and steer patients away from cheaper generics, the paper continues. Here’s how it works: Knowing that Provigil will face generic competition in 2012 as its patent nears expiration, Cephalon is planning to launch a longer-acting version of the drug called Nuvigil next year. To convert patients from Provigil to Nuvigil, Cephalon... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1969322 Tue, 18 Nov 2008 13:26:37 +0100 1969322 http://www.medworm.com/index.php?rid=1921199&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F435691396%2F ‘Tis the middle of the week and that means we are all caught up in meetings, deadlines and projects. Of course, there are always conferences. In fact, we will break shortly to speak at the Pharmaceutical Regulatory and Compliance Congress (look here) about the usual - pharma and blogging. We appear right after former FDA commish Mark McClellan, in fact. But we promise not to be gone long. Meanwhile, here are a few items to tide you over… Bayer Profit Falls On Tax Benefit (Bloomberg News) Schering-Plough’s Sugammadex Beats The Competition (Associated Press) Swiss Approve Novartis Blood Pressure Drug (Reuters) Cephalon Boosts Its Full-Year Forecast (TheSteet.com) Parexel Slides As Spending Slows (Forbes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1921199 Wed, 29 Oct 2008 10:23:37 +0100 1921199 http://www.medworm.com/index.php?rid=1841010&cid=t_127670_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F407457566%2Fgabitril-goes-down.html Gabitril (tiagabine) is an antiseizure medication from Cephalon, which just forked out a cool $425 million to settle charges that it marketed several drugs for unapproved conditions, including Provigil and Gabitril. Government investigators claimed that Gabitril was marketed as a treatment for anxiety, which is too bad considering that it struck out in three clinical trials against a placebo. Each study found no evidence that Gabitril was better than a sugar pill. Gabitril was also allegedly marketed as a treatment for pain. I was unable to locate a single controlled study examining the efficacy of Gabitril for pain, though there were a small number of uncontrolled (i.e., not very useful) studies suggesting that maybe Gabitril could be used to treat pain. Regarding sleep, the placebo-contr... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1841010 Tue, 30 Sep 2008 17:14:00 +0100 1841010 http://www.medworm.com/index.php?rid=1837165&cid=t_127670_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Fcephalon-whistleblowers-reward.html Drug rep Bruce Boise, refused to follow company-ordered sales strategies to convince doctors to prescribe Cephalon's Actiq, Gabitril and Provigil drugs for unapproved ("off-label') uses because he was worried the sales practices were illegal and the "off-label" uses were dangerous for patients. He and 3 other whistleblowers will receive a reward totaling $46 million for their information and the work on the case they did with their attorneys on the federal case and roughly an additional $11 million for the state cases. More (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1837165 Tue, 30 Sep 2008 11:36:00 +0100 1837165 http://www.medworm.com/index.php?rid=1837172&cid=t_127670_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Fcephalon-425-million-thats-expensive.html Federal authorities have announced a $425 million civil settlement with Cephalon, who were charged with off-label drug marketing.Authorities say Cephalon marketed one of the drugs, Actiq, for maladies including migraines and injuries. The fentanyl lollipop is a highly addictive narcotic only approved for cancer pain.More Ed at Pharmalot has even more! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1837172 Mon, 29 Sep 2008 16:10:00 +0100 1837172 http://www.medworm.com/index.php?rid=1841253&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F406366468%2F This looks to be the biggest such case involving a biotech. And this involves three - count ‘em, three - drugs that were allegedly marketed for years on an off-label basis in order to greatly widen the potential patient populations, according to court documents. The Cephalon payment includes $375 million in a nationwide Medicaid fraud settlement and $50 million for a corporate criminal plea (here’s the settlement agreement). The drugs in question - Actiq, a “medicated lozenge on a handle” approved only for pain in cancer patients and later linked to some 100 deaths; the Gabitril epilepsy med for adults and children over 12 years, but was pitched as an alternative to Valium and Zanax, and for treating for depression; and Provigil, a narcolepsy med that was promoted f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1841253 Mon, 29 Sep 2008 15:43:39 +0100 1841253 http://www.medworm.com/index.php?rid=1769140&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F383154631%2F Much to do this morning, especially as we ready the short people for school and rifle through various documents you may find interesting. Meanwhile, a few tidbits have surfaced on our radar. So grab some coffee or water and dig in… Astellas Cutting 200 Jobs As Flomax Patent Expires (OK.com) Israeli Court Blocks Sun’s Takeover Bid For Tara (The Economic Times) Merck KGgA And Ablynx Sign $484M Development Deal (Yahoo/Reuters) Cephalon Ends Provigial Promotion Deal With Takeda (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1769140 Thu, 04 Sep 2008 10:42:05 +0100 1769140 http://www.medworm.com/index.php?rid=1720545&cid=t_127670_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2008%2F08%2F21%2Fceph-n-pcop-got-c-met%2F The 15M Pharmacopeia and Cephalon deal from a couple years ago was likely for compounds like these c-Met / Alk inhibitors: O=C(NC)C1=CC=CC(F)=C1NC2=NC(NC3=CC=C4C(C)(C)CC(NCCOC)CNC4=C3)=NC=C2Cl WO/2008/051547 yeh, its 1300 pages and I know they’re old, but I got some catching up to do… (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=1720545 Thu, 21 Aug 2008 05:19:18 +0100 1720545 http://www.medworm.com/index.php?rid=1720546&cid=t_127670_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2008%2F08%2F20%2Fat-least-its-free%2F The new ‘Perspective‘: Some useful information bracketed by useless commentary. Affinity is not even a check-box on the road to an approved drug.  What’s stopping 99.9% of real compounds coming from real programs isn’t potency.  This makes a discussion of how many hydrogen bonds to the hinge are in approved drugs totally irrelevant. Fact Check: >> Ruboxistaurin is not an approved drug. >> Fasudil is only approved in Japan. >> And you forgot Tasigna (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=1720546 Thu, 21 Aug 2008 01:08:19 +0100 1720546 http://www.medworm.com/index.php?rid=1531694&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F316159558%2F The US Drug Enforcement Agency is getting ready to allow highly addictive meds, including powerful painkillers, to be prescribed online, something that health insurers and large employers have been pushing, the Associated Press reports. Under current government rules, docs are required to write out by hand prescriptions for controlled substances, which include attention-deficit disorder drugs like Shire’s Adderall and painkillers like Cephalon’s Fentora. The concern is that patients are more likely to abuse these treatments, and their prescriptions should be monitored more closely. But the DEA will soon publish a proposal that would allow docs to prescribe such drugs electronically, according to an agency spokeswoman Rogene Waite, while declining to say which specific drug clas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1531694 Fri, 20 Jun 2008 11:03:20 +0100 1531694 http://www.medworm.com/index.php?rid=1461247&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F295333252%2F Drugmakers win, consumers lose. That’s the message from the Federal Trade Commission, which released its latest annual report on the deals between brand-name and generic drugmakers. In fiscal year 2007, which ended September 30, 2007, there were 33 final settlements. Of those, 14, or 42 percent, included both compensation to the generic company and a restriction on the generic’s ability to market its product. Of those 14 settlements, 79 percent involved agreements with first-filer generic makers. Unlike the previous fiscal year, most of the agreements involving restrictions on generic entry did not include a side deal involving elements not directly related to the resolution of the patent dispute. Instead, the majority involved compensation to the generic firm through an agreemen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1461247 Wed, 21 May 2008 21:16:41 +0100 1461247 http://www.medworm.com/index.php?rid=1426774&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F285330212%2F Do you remember what the Morning Mayor used to say? Every brand new day should be unwrapped like a precious gift. So go ahead, open yours. And after you do so, grab a cup of something refreshing and take a peek at these… Baxter Says Heparin Legal Costs Are Insignificant (The Chicago Tribune) Roche Targets Diabetes To Replace Cancer Sales (Bloomberg News) FDA Panel Rejects Wider Use of Cephalon Drug (Yahoo/Reuters) Teva Seeks Judgment On Nexium Patents (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1426774 Wed, 07 May 2008 11:54:58 +0100 1426774 http://www.medworm.com/index.php?rid=1416439&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F282207916%2F The agency is concerned that the powerful Fentora pain drug will be easily abused if made available on a widespread basis. Right now, the Cephalon lozenge is used to treat pain associated with acute pain suffered by cancer patients, but the drugmaker wants FDA approval to sell the narcotic to treat sudden pain in others. Last September, the FDA issued an advisory linking Fentora to four deaths, and Cephalon blamed inappropriate prescribing for such ailments as back pain. The drugmaker, however, denied off-label marketing activities, which came under investigation by the US attorney in Philadelphia, the Connecticut attorney general, and a congressional committee. But next Tuesday, an FDA advisory committee will meet to review Cephalon’s request for wider approval. “We are concer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1416439 Fri, 02 May 2008 16:32:48 +0100 1416439 http://www.medworm.com/index.php?rid=1416444&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F282053758%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 downsizing, there is movement. Here are some of the latest changes. Recognize anyone? AssureRx hired Al Lucas as vp of sales and marketing; Oragenics added Marc Siegel and Kevin Sills to its board; Noven Pharmaceuticals hired Peter Brandt as ceo and president; Hyperion Therapeutics hired Bruce Scharschmidt as chief medical officer; Cephalon hired Jerry Pappert as exec vp and general counsel; MedThink Communications hired Steve Palmisan... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1416444 Fri, 02 May 2008 11:42:29 +0100 1416444 http://www.medworm.com/index.php?rid=1407333&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F280048592%2F Nice to see you again. As the rain moves away from the nation’s medicine chest, we have been scurrying to deposit short people at schools and gather items of interest. Now, we are settling down with our beloved cup of stimulation. So take a pause and join us. And best of luck today… Medco Profit Beats Wall Street Estimates (Yahoo/AP) FTC’s Cephalon Suit Moved To State Court (Yahoo/Reuters) Fosamax Linked To Atrial Fibrillation - Again (Seattle Post-Intelligencer) Lundbeck Names Wyeth Exec As CEO (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1407333 Tue, 29 Apr 2008 12:08:49 +0100 1407333 http://www.medworm.com/index.php?rid=1327469&cid=t_127670_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F03%2Fblogscan-imperial-pharmaceutical-ceos.html On the PharmaLot blog, Ed Silverman has two posts about how pharmaceutical executives continue to rake in humongous compensation whose magnitude seems unrelated to their performance or the performance of their companies. The CEO of Cephalon got more than $15.8 million, including the value of stock options, while the company is dealing with an Federal Trade Commission lawsuit which contends the company blocked sales of a generic competitor, and despite settling a suit about off-label marketing (see post here.) The CEO of Bristol-Myers-Squibb got $13.5 million after the company's stock price fell, the company took a charge for losses on sub-prime mortgages, and several top financial officers left (see post here.) Again, as we noted earlier, imperial CEOs seem rampant in health care organizat... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1327469 Tue, 25 Mar 2008 20:38:00 +0100 1327469 http://www.medworm.com/index.php?rid=1325481&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F257629496%2F Maybe the Cephalon board should take its own Provigil, which is supposed to treat excessive sleepiness. The drugmaker gave Frank Baldino Jr. a salary of $1.2 million, a bonus of $2.2 million and other compensation of nearly $77,000, which included $33,240 for a car allowance and $14,500 in financial planning expenses. Then there were stock and option awards valued at $12.4 million on the date they were granted, the Associated Press writes. And this is interesting - from 2004 to 2006, Baldino’s average annual pay was 140 percent above the median CEO pay of Cephalon’s peer group, according to Proxy Governance, the AP reports. His recent tenure is distinguished for other reasons - Cephalon is fighting a lawsuit filed by the Federal Trade Commission, which accused the drugmaker of ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1325481 Tue, 25 Mar 2008 12:25:48 +0100 1325481 http://www.medworm.com/index.php?rid=1255191&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F240867149%2F Earlier this month, the US Federal Trade Commission filed a lawsuit accusing Cephalon of paying more than $200 million to four rivals for keeping generic versions of its Provigial sleep-disorder pill off the market. The move was the latest effort in a long-running battle by the agency to thwart settlements it labels costly to consumers. Brand-name drugmakers, however, say the deals make sense if patent litigation can be minimized. In an editorial in The Washington Post, Jon Leibowitz, one of five FTC commissioners, says the Cephalon case may land before the Supreme Court. Here is an excerpt… “Getting health-care costs under control is a daunting and multifaceted challenge. But one simple approach could save consumers billions of dollars annually: stopping pharmaceutical compani... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1255191 Mon, 25 Feb 2008 13:02:23 +0100 1255191 http://www.medworm.com/index.php?rid=1245073&cid=t_127670_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F02%2Fftc-generics-and-war-in-iraq.html The Federal Trade Commission (FTC) is trying to "crackdown" on Big Pharma payments to generic manufacturers that agree not to bring lower-cost generic versions of brand name drugs to market (see "Crackdown by FTC on Big Pharma").As reported in the above cited article, "last week the Federal Trade Commission launched a high-profile battle against Cephalon (CEPH), the maker of the blockbuster narcolepsy medication Provigil, over a $200 million payout it gave to four generic companies in exchange for an agreement not to develop a competing medication. In a lawsuit filed in federal court in Washington, D.C., the FTC claims that the deal violates antitrust law."This is interesting because I recall attending an industry conference in Boston in late 2001 during which a Cephalon representative fro... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1245073 Wed, 20 Feb 2008 13:22:00 +0100 1245073 http://www.medworm.com/index.php?rid=1245062&cid=t_127670_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F02%2Fftc-crackdown-on-big-pharma-fortune.html For years, Big Pharma has kept competition from generic drug makers at bay by essentially paying its would-be rivals to stay out of its business. Now government watchdogs have declared war on these financial deals - a move that could bring cheaper drugs to market faster while costing giant drug developers billions in lost revenue.Just last week the Federal Trade Commission launched a high-profile battle against Cephalon, the maker of the blockbuster narcolepsy medication Provigil, over a $200 million payout it gave to four generic companies in exchange for an agreement not to develop a competing medication. In a lawsuit filed in federal court in Washington, D.C., the FTC claims that the deal violates antitrust law.The deals behind the FTC crackdown have become increasingly common ever sinc... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1245062 Wed, 20 Feb 2008 11:07:00 +0100 1245062 http://www.medworm.com/index.php?rid=1230422&cid=t_127670_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=1218236&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F231582785%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? Cephalon says general counsel John Osborn has resigned; Xanodyne Pharmaceuticals hired Gary Shangold as chief medical officer; Xanodyne Pharmaceuticals also hired Tim Arendt as vp of sales; Synosia Therapeutics hired Philippe Lutz as cfo; The Corporate Council on Africa named Jeff Sturchio, a senior vp of corporate responsibility at Merck, as its ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1218236 Fri, 08 Feb 2008 12:42:56 +0100 1218236 http://www.medworm.com/index.php?rid=1124947&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F209857055%2F Nice to see you again. Like many of you, we were off much of the past week or so, catching up on all sorts of things. Now, we are settling back into the usual routine and we imagine you are doing the same. As you find your way, here are a few items to help you acclimate….. Merck Sells Chemical Plant In Pennsylvania (Reuters) Sanofi Ends Melanoma Collaboration with IDM Pharma (PharmaTimes) Testosterone Won’t Make Older Men Smart Or Strong (Bloomberg News) Sri Lanka Bans Reps From State Institutions (Colombopage.com) Cephalon Seeks Second Use For Chemo Drug (Yahoo/AP) Chinese Official Gets 7 Years In Pharma Scandal (The Times of India) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1124947 Wed, 02 Jan 2008 12:01:20 +0100 1124947 http://www.medworm.com/index.php?rid=1072406&cid=t_127670_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195734875%2Ffda_warns_of_potential_side_ef.html September 2007The U.S Food and Drug Administration alerted healthcare professionals and consumers of the possible side effects of Fentora (fentanyl buccal) after reports of deaths and other adverse events.Fentora, an opiod pain medication, is used only for the treatment of breakthrough pain in cancer patients already receiving opiod treatment who have become tolerant to it. Those who have not developed a tolerance for opiods are at risk of suffering the dangerous side effects associated with this drug. All deaths reported were a result of improper selection of patients, dosing, or improper product substitution."FDA is monitoring this issue very closely," said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. "We are working with th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072406 Wed, 05 Dec 2007 19:00:20 +0100 1072406 http://www.medworm.com/index.php?rid=1068797&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F194961311%2F In case you missed it, this has been quite a year for high-profile safety news. And so FiercePharma has compiled a list for the cocktail set, who want to keep track of such things. These are the 10 biggest drugs that were withdrawn or were issued new warnings by the FDA this year. The drugs are ranked by 2006 worldwide sales, which explains why such headline grabbers as Bayer’s Trasylol doesn’t appear - sales were already tanking on bad news. 1. Antidepressants - Various companies 2. Epogen/Aranesp - Amgen 3. Zyprexa - Lilly 4. Avandia - Glaxo 5. Actos - Takeda 6. Provigil - Cephalon 7. Zelnorm - Novartis 8. Byetta - Amylin 9. Xolair - Genentech 10. Fentora - Cephalon Source: FiercePharma Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1068797 Tue, 04 Dec 2007 14:15:23 +0100 1068797 http://www.medworm.com/index.php?rid=1057467&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F192092265%2F An FDA panel recommends that Provigil, which is supposed to be prescribed only to adults who suffer from narcolepsy, should carry stronger warnings to discourage docs from prescribing the med to kids, even though labeling already says the drug isn’t for pediatric use. The Provigil label was recently updated to warn of the possibility of serious skin reactions and psychological problems such as hallucinations, anxiety and suicidal thoughts. Cephalon last month sent doctors a letter detailing the change and noted the drug is not approved for use in children. However, the FDA panel worried that Provigil is sometimes used off label for use in treating attention deficit hyperactivity disorder in kids. In fact, last year an FDA panel rejected a bid by Cephalon to have Provigil approved for... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1057467 Wed, 28 Nov 2007 23:03:08 +0100 1057467 http://www.medworm.com/index.php?rid=1021393&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F183627204%2F As always, Monday mornings are busy. And so while we pursue various strands of information, we thought we would keep you up to date on other matters. Besides, what better way to enjoy a cup of coffee or tea than with something interesting to read? Cephalon Seeks FDA Approval For Expanded Use Of Fentora (bizjournals.com) Medco To Spend $140M On Automated Plant In Indiana (Yahoo/Reuters) AstraZeneca Axes South Africa Packaging Plant (OutsourcingPharma) Finnish Gunman Claimed To Have Used Antidepressants (Helsingin Sanomat) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1021393 Mon, 12 Nov 2007 16:05:12 +0100 1021393 http://www.medworm.com/index.php?rid=1015911&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F181979143%2F The drugmaker struck a deal with the US Attorney in Philadelphia, and will sign a corporate integrity agreement after agreeing to a misdemeanor violation of the Food, Drug and Cosmetic Act. The probe reportedly focused on whether Cephalon sales reps were improperly marketing its Provigil narcolepsy drug, which docs have prescribed to treat depression and ADHD. The settlement doesn’t come as a surprise. Cephalon has been under a microscope for off-label marketing for awhile. Last February, the FDA sent the drugmaker a warning letter ordering an end to promotional material for Provigil that included claims that the drug could be used to treat fatigue, which isn’t an approved use. Two months ago, Cephalon sent letters to docs this week warning that several deaths have been linked... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1015911 Fri, 09 Nov 2007 03:30:39 +0100 1015911 http://www.medworm.com/index.php?rid=979219&cid=t_127670_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F174933720%2Fcephalon_incs_provigil_gets_stronger_fda_warning.html The sleep-disorder drug, Provigil, by Cephalon Inc.(NASDAQ:CEPH) will soon carry more severe warnings on its packaging.  The U.S. Food and Drug Administration has decided that the drug must now include warnings of life-threatening rashes and psychiatric symptoms.Prescribing information must now include warnings of rare skin rashes, including Stevens-Johnson Syndrome, which can be deadly. Also the possibility of hallucinations, mania, anxiety and suicidal thoughts must be included.It has been expected that Provigil would have to increase the strength of the warnings due to the fact that Nuvigil, a long acting version of the drug, was approved, in June, with stronger warnings.The company has already sent letters to doctors to apprise them of the changes in labeling.Provigil an... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=979219 Thu, 25 Oct 2007 17:15:49 +0100 979219 http://www.medworm.com/index.php?rid=976544&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F174520414%2F And so the FDA added new warnings about these rather dangerous side effects associated with Provigil, the sleep-disorder med made by Cephalon. The drugmaker sent a letter to docs saying there were reports of life-threatening rashes - The agency, which approved the drug in 1998, says there were instances of Stevens-Johnson Syndrome, which begins as a red rash but can eventually cause skin to peel off the body, resulting in deadly infections. Nearly all cases of the disorder occurred within five weeks of patients starting therapy with Provigil. The agency also cautioned doctors that reports of hallucinations, anxiety and suicidal thoughts have been reported with Provigil. Psychological problems generally stopped within 36 hours of discontinuing use. The labeling change announcement comes le... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=976544 Wed, 24 Oct 2007 21:31:21 +0100 976544 http://www.medworm.com/index.php?rid=906264&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F161618371%2F The agency is cautioning patients and docs about about potentially fatal risks connected with Fentora, a powerful painkiller, because off-label use could result in fatal overdoses. The FDA approved the highly addictive narcotic last year to treat acute pain suffered by cancer patients. Since then, Fentora has been linked to four deaths and Cephalon is blaming inappropriate prescribing for such ailments as back pain. The drugmaker, however, denies off-label marketing activities. But its being investigated by the US attorney in Philadelphia and the Connecticut attorney general (see page 11 of the latest SEC filing), and faces a congressional probe into off-label treatments. FDA stressed that Fentora shouldn’t be used to treat short-term pain such as migraines and shouldn’t be use... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=906264 Wed, 26 Sep 2007 17:35:21 +0100 906264 http://www.medworm.com/index.php?rid=873929&cid=t_127670_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F156847082%2F The drugmaker argues the problem is all about inappropriate prescribing. So Cephalon sent letters to docs this week warning that several deaths have been linked to Fentora, a highly addictive narcotic used to treat acute cancer pain. Here’s the catch - Fentora and its predecessor, Actiq, are approved only for use in cancer patients, but are often prescribed off-label for headaches and back pain. Cephalon has always denied any off-label marketing, but its being investigated by the US attorney in Philadelphia and the Connecticut attorney general (see page 11 of the latest SEC filing), and a congressional probe into off-label treatments. (In the wake of the OxyContin scandal, this shouldn’t come as a surprise). A Cephalon press release wasn’t specific about the number of de... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=873929 Sat, 15 Sep 2007 13:04:48 +0100 873929 http://www.medworm.com/index.php?rid=870397&cid=t_127670_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F09%2F14%2Ffentora-cancer-related-drug-deaths-confirmed-by-cephalon%2F Filed under: Drug, All CancersIt's never a good thing when a drugmaker sends letters to doctors saying that a drug they are prescribing has resulted in confirmed deaths.But that is what Cephalon did this week, as it admitted its cancer drug -- Fentora - has been linked to some patient deaths. Fentora, used to treat acute cancer pain, are sometimes prescribed for other pain-related ailments.Cephalon took issue with the apparent claim that it markets Fentora for uses other than cancer pain, even though some doctors use it "off label" in normal practice.Read | Permalink | Email this | Linking Blogs | Comments (Source: The Cancer Blog) The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=870397 Fri, 14 Sep 2007 04:00:00 +0100 870397 http://www.medworm.com/index.php?rid=728727&cid=t_127670_150_f&fid=35781&url=http%3A%2F%2Fwww.qdinformation.com%2Fqdisblog%2F2007%2F03%2F20%2Frep-waxman-requests-information-from-pharmaceutical%2F Seems Representative Henry Waxman (D, CA) wants to hear from the following companies about the following drugs for the following reasons: Lilly: Zyprexa (bipolar). Inappropriate promotion for off-label use AstraZeneca: Seroquel (schizophrenia). Inappropriate marketing Boston Scientific: drug coated stents. Safety and off-label use Cordis: drug coated stents. Safety and off-label use Cephalon: Actiq (narcotic lollipop) and Fentora (narcotic lozenge). Inappropriate marketing PharmaLive: Rep. Waxman Requests Research and Marketing Information from Pharmaceutical and Medical Device Companies : Here are the letters that were sent. WaxmanLilly.pdf WaxmanAZ.pdf WaxmanBoston.pdf WaxmanCordis.pdf WaxmanCephalon.pdf The longest letter went to Cephalon over their narcotic products . All the letters a... QDIS Blog blogs http://www.medworm.com/rss/comments.php?id=728727 Tue, 20 Mar 2007 15:19:56 +0100 728727