Whatever Happened To The ADA Request For Data From Pharma?
Last spring, the American Diabetes Association attempted to resolve a burning debate about the safety of various diabetes drugs called GLP-1 inhibitors by asking several drugmakers to release patient-level data that could be used for an independent review. At issue was whether a definitive link exists to developing acute pancreatitis and pancreatic cancer. The questions were raised after a pair of studies caused a stir. One study indicated that two widely used drugs – Merck’s (MRK) Januvia and Bristol-Myers Squibb’s Byetta – can double the risk of developing pancreatitis, which is an inflammation of the pancreas th...
Source: Pharmalot - December 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Supreme Court Rejects Former Biotech CEO Free Speech Argument
After years of battling authorities, W. Scott Harkonen has lost his battle to overturn a 2009 conviction for wire fraud in connection with disseminating false and misleading statements in a press release about clinical trial results for a drug that was sold by a biotech where he had been the ceo. Earlier this week, the US Supreme Court declined to hear his appeal. Although there was considerable uncertainty about whether the justices would act on his petition, the case was, nonetheless, being closely watched if only because Harkonen and his legal team made a point of raising First Amendment and commercial speech rights, wh...
Source: Pharmalot - December 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Another Study Hints At The Death Of The Pharma Sales Rep
Has the pharmaceutical industry finally reached the point where sales reps should be addressed as Willy Loman? A new study suggests the time might be near – 67 percent of physicians say digital media is their preferred source of information from drugmakers, 40 percent believe digital media has the most relevant and personalized content, and 52 percent believe sales reps will eventually become information coordinators. Only 20 percent say reps are their favorite source of information. Meanwhile, more health care providers are shifting toward larger, organized health systems, which make it more difficult for reps to reach ...
Source: Pharmalot - December 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? We are quite busy this morning here on the Pharmalot corporate campus, where another chilly wintry landscape can be seen from our perch. As usual, we are fending off the cold with another cup of piping hot stimulation and invite you to join us. However, we will be busier than usual today, if only because we must take a respite to tend to personal matters, but will return later to resume the usual routine. Meanwhile, here are a few tidibts. Have a grand day and do stay in touch... Pfizer And Teva Reach A Deal Over Generic Viagra (Bloomberg News) Regeneron Pharmaceuticals To Create 300...
Source: Pharmalot - December 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Painful Erections: Another Reason To Worry About ADHD Pills
For parents who worry those ADHD pills may not be appropriate, here is another reason for concern – the FDA has just issued a notice saying methylphenidate products, which include Ritalin and Concerta, may cause prolonged and sometimes painful erections known as priapism. If there is any good news it would be this sort of thing is rare. Still, who wants to learn the hard way? Pardon the pun. The FDA took this step after reviewing the drugs and has now updated labeling and patient Medication Guides.  For those unaware, priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to ...
Source: Pharmalot - December 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

As Pfizer Readies New Business Units, Amy Schulman Exits
Just a few months after Pfizer tapped general counsel Amy Schulman to head one of three so-called innovative business units that are supposed to take shape in January and widen her executive portfolio, the drugmaker disclosed this morning that she is leaving, according to a brief statement. Replacing as head of the the vaccines, oncology and consumer healthcare business will be Albert Bourla, who has spent 20 years at Pfizer, most recently as president and general manager of what the drugmaker calls its established products business unit. For the past five years, Schulman was a rising star at Pfizer. She was hired by forme...
Source: Pharmalot - December 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

EMA Again Delays Finalizing Policy For Disclosing Clinical Trial Data
Once again, the European Medicines Agency has delayed finalizing a proposal to release clinical trial data, a step that was taken in response to growing concerns that, without access to this underlying information, it can be difficult, if not impossible, for researchers to otherwise verify the safety and effectiveness of prescription drugs. The EMA had hoped to finalize its policy by the end of this year, but last month, the agency postponed that decision in order to “conduct the appropriate in-depth analysis required.” In a statement today, the regulator now says there is a “need for further analysis and clarificati...
Source: Pharmalot - December 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Glaxo Will Stop Paying Doctors To Promote Its Medicines
In the latest bid to restore its damaged reputation, GlaxoSmithKline has promised to halt payments to doctors for promoting its drugs and is further revamping compensation for its sales reps, who will no longer be paid based on the number of prescriptions that are written by physicians, a practice that was implemented in the US three years ago (see here), but will now be extended globally. The policy changes come at a difficult time for the drugmaker. Last year, Glaxo agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report sa...
Source: Pharmalot - December 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone. Another snowy day is on the way. Already, in fact, the chilly Pharmalot corporate campus makes for a splendid winter scene. Pleasant distractions aside, there is much to be done. So please join us as we brew another cup of piping hot stimulation and ready ourselves for another stab at the to-do list. Meanwhile, here are a few items of interest. Hope your day goes well and you stay warm... Branded Pharma Revenues To Rise 3 Percent In 2014: Fitch (Pharma Times) Roche Shares Drop On Speculation Novartis Will Sell Its Stake (Bloomberg News) New Medicines Arrive, But There Are Fewer Blockbusters (The W...
Source: Pharmalot - December 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

As FDA Decision Nears, Amarin CEO Retires And Investors Petition
Just days before the FDA is expected to decide whether to approve the controversial Vascepa fish oil pill that is sold by Amarin, the little drugmaker has announced that its chairman and chief executive, Joseph Zakrzewski, is retiring at the end of the month. John Thero, who has been Amarin president since 2009, was promoted to replace him (here is the statement). The move caps a disappointing year for Amarin, which has been one of the more interesting biotech stock stories of the past year. Two months ago, an FDA advisory committee voted against recommending broader use of Vascepa until an outcomes study is completed in 2...
Source: Pharmalot - December 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Congressional Bill Would Restrict Pay-To-Delay Agreements
Five months after the US Supreme Court ruled that drugmakers can be subject to antitrust scrutiny for their so-called pay-to-delay deals, a Democratic congressman has introduced legislation that would declare these agreements to be unlawful, although the language differs from a Senate bill that assumes a deal is illegal if challenged by the US Federal Trade Commission. The Supreme Court, you may recall, decided drugmakers can face lawsuits over pay-to-delay patent settlements, although such deals should not necessarily be assumed to be illegal. Also known as reverse settlements, these typically involve a brand-name drugmak...
Source: Pharmalot - December 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

A Japanese University Denies Diovan Research Was Manipulated
For the first time since the scandal erupted in Japan over Diovan research, one of the universities that ran clinical trials to gauge the virtues of the Novartis heart drug is denying any data was manipulated. Late last week, Nagoya University released an interim report refuting the charge, according to The Yomiuri Shimbun. The drugmaker and several Japanese universities have been rocked by a series of retracted papers concerning the medication, a huge seller in Japan that reached $5.6 billion in worldwide sales in 2011 before generics became available. That was also when questions were first raised about Diovan research c...
Source: Pharmalot - December 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

AstraZeneca And Bristol-Myers Pull Diabetes Drug From Germany Over Pricing Decision
Once again, drugmakers are at war with the German authorities over pricing. In the latest row, AstraZeneca (AZN) and Bristol-Myers Squibb (BMY) have yanked their Forxiga diabetes treatment, which was approved in Europe a year ago, over disagreements about the price of the drug, but will reconsider their decision after arbitration has concluded, according to a statement. Specifically, the move comes after the drugmakers were unable to reach an agreement with the National Association of Statutory Health Insurance Funds after the German Federal Joint Committee issued a so-called ‘no additional benefit’ rating for the trea...
Source: Pharmalot - December 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? We hope the weekend was relaxing and you had a chance to enjoy. Now, though, that familiar routine of deadlines and meetings is resuming. And so, on this particularly cold morning, where the Pharmalot corporate campus is feeling a bit chilly. This calls, of course, for a hot cup of stimulation - in this case, we are indulging in what we call a roll-your-own spot of tea. A chance of pace is a good thing, yes? Feel free to join us. Meanwhile, here are some tidbits. Have a grand day and stay in touch... China Arrests 1,300 People For Allegedly Making Fake Drugs (The Guardian) FDA...
Source: Pharmalot - December 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Up And Down The Ladder... Job Changes
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 TherapeuticsMD hired Joel Krasnow as chief scientific officer. Previously...
Source: Pharmalot - December 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs