Compounder Strikes Preliminary $100M Deal Over Meningitis Outbreak
More than a year after an outbreak of fungal meningitis was traced to the New England Compounding Center and caused the worst public health crisis in the US in decades, the owners, operators and insurers of the bankrupt compounder have reached a preliminary agreement to create a fund that may exceed $100 million to compensate victims. “This is but one chapter in this saga; litigation will continue against medical clinics, doctors, hospitals and other companies who were hired by NECC that bear responsibility to those who were badly injured or who died horrible and painful deaths as a result of having the injection of the ...
Source: Pharmalot - December 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

What Competition? Actelion Loses Case Over Stifling A Rival Drug
For the second time this year, Actelion has been tagged for questionable behavior toward rivals. In the latest instance, a California state court judge has upheld a $407 million jury award that was made after the drugmaker thwarted plans that Asahi Kasei Pharma had to commercialize a drug for treating hypertension. How so? The jury determined that Actelion acted unfairly by purchasing CoTherix, with which Asahi struck a licensing deal in 2006, and then cancelling the agreement. Allegedly, Actelion took this step because it already marketed amedicine called Tracleer, which has typically generated more than $1 billion in ann...
Source: Pharmalot - December 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

The Affordable Care Act Gives Drugmakers A Boost: CMS
What hath the Affordable Care Act wrought? For drugmakers, there looks to be a big boost in spending on prescription medicines. Projected spending is forecast to grow 5.2 percent next year, compared with 0.6 percent growth in 2013, thanks to greater use among Americans who are newly insured or those sign up for accessible insurance plans, according to the US Center for Medicare & Medicaid Services. Specifically, the projected growth in prescription drug spending would be 2.9 percent lower in 2014 without the oomph from healthcare reform, which suggests a clear benefit despite concerns expressed earlier this year by ind...
Source: Pharmalot - December 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Will FDA Widen Use For The Vasecpa Fish Oil Pill, After All?
In a surprising development that has revived intense speculation over the fate of Amarin, the FDA has delayed any decision about whether to widen an indication for the Vascepa prescription fish oil pill. The move was expected last Friday and the delay has now triggered intrigue over what appears to be a complex minuet between the agency and the ‘little drugmaker that could.’ In explaining the rationale for the FDA delay, Amarin released a brief statement saying the agency has not disclosed when a decision may be made on the Vascepa indication. But Amarin attributed the delay to its recent appeal of an FDA decision to r...
Source: Pharmalot - December 23, 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 invigorating, especially for those of you who are resuming something resembling the usual routine this morning. Of course, we recognize this is a holiday break for many - or will be quite shortly - but for now, we are attempting to hunt and gather as we normally do. So please join as we brew a cup of stimulation and keep busy. Have a grand day... United Therapeutics Wins FDA OK For PAH Drug (Bloomberg News) Merck Issues Voluntary Recall Of Gardasail VIals (Fox News) FDA To Review Lantus Biosimilar From Lilly (Pharma Times) FDA Allows Ariad ...
Source: Pharmalot - December 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Novartis Recalls Millions Of Samples Due To Packaging Glitch
Here is a headache no drugmaker wants to endure. Last July, Novartis began recalling a few million bottles of samples of different medicines that were distributed to physicians, because routine testing determined that a chemical used in shrink wrap packaging was found to leech into some tablets. The incident appears to be an unusual instance in which samples given to doctors have been yanked. The voluntary recall amounted to 127 lots of samples for three blood pressure treatments - Exforge, Tekturna and Diovan – as well as the Lescol cholesterol pill and the Stalevo Parkinson’s drug, although a Novartis spokeswoman was...
Source: Pharmalot - December 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

European Parliament Brokers Deal For Clinical Trial Transparency
After a months-long push, a deal was reached this week at the European Parliament would require drugmakers and academic researchers to upload all results of their European clinical trials to a publicly accessible database (see this). The move comes amid ongoing debate over the extent to which the pharmaceutical industry will agree to disclose clinical trial data in the wake of scandals that indicated safety or effectiveness information had been withheld. “For too long, unflattering studies have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results,” says t...
Source: Pharmalot - December 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Merck Fined $21M By French Regulators For Bad Behavior
In response to some bad behavior by the former Schering-Plough, French antitrust regulators have fined the Merck unit about $21 million for a campaign to thwart the introduction of a generic version of the Subutex drug that is used to treat opioid addiction. The decision was taken after reviewing a complaint filed by Arrow Generiques, which launched the generic in March 2006. The Merck (MRK) unit had previously been warned about its practices, which were described as defamation, and manipulating the market by stock saturation and offering pharmacies discounts and longer payment terms. The drugmaker, which had purchased the...
Source: Pharmalot - December 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... The Weekend Nears
And so, yet another working week will soon draw to a close. Not a moment too soon, yes? As always, this is our treasured signal to daydream about weekend plans. Our agenda is rather modest, although we do look forward to spending time not only with our full roster of short people but some of the Pharmalot ancestors. We also hope to catch up on sundry tasks and catch up on some reading. Why not, you know? But what about you? Given the upcoming holiday break, perhaps this marks the beginning of a longer stretch than usual. Presumably, all sorts of activities and possibilities are in store. Spending time with special people o...
Source: Pharmalot - December 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Continuing Medical Education Deserves More Scrutiny: Study
At a time when increasing scrutiny is applied to funding for continuing medical education, a new study notes that relatively little is known about medical communications companies – the for-profit businesses that exist to provide physicians with up-to-date clinical and scientific information. And the study authors suggest that there is good reason to take a closer at these so-called MCCs. Why? For one thing, 14 drug and device makers provided MCCs with more funds than any other type of entity, including academic medical centers, professional associations and research organizations – MCCs received 26 percent of all fund...
Source: Pharmalot - December 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

The Op-Ed: Antidepressants, Pregnancy & Autism: A Potent Mix
Earlier this year, a study reported a link between antidepressants and autism, the second time in two years that such a relationship has been suggested. This week, a study in The New England Journal of Medicine found that children of women using SSRIs during pregnancy were not at increased risk of autism when compared with other children, although at the same time, the incidence of autism spectrum disorders in children born to women who used the drugs before pregnancy and then stopped was 46 percent than in other children. These results have fueled intensified debate over the extent to which there is cause-and-effect link...
Source: Pharmalot - December 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Bristol-Myers Sells Diabetes JV To AstraZeneca: What The Wags Say
Just 18 months ago, Bristol-Myers Squibb expanded its diabetes franchise by paying $7 billion for Amylin Pharmaceuticals and, simultaneously, broadened a joint venture with AstraZeneca. Now, though, Bristol-Myers is selling its stake in the partnership back to AstraZeneca for as much as $4.5 billion in order to focus on becoming a ‘specialty’ drugmaker. At the time, the deal was seen as a way for Bristol-Myers to develop diabetes products into a growth engine, since Amylin sold the Byetta and Bydureon treatments, while also spreading the risk by expanding its existing deal with AstraZeneca (back story). However, as ana...
Source: Pharmalot - December 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Did Someone Say Hacker? Congress Probes FDA Over Security Breach
After quietly acknowledging to some 5,000 users that its computer systems were hacked two months ago, the FDA is now under increasing pressure from both drugmakers and members of Congress to conduct an investigation because the pharmaceutical industry was not notified of the breach for nearly another month. The episode is raising questions not only about the ability of the FDA to maintain its systems, but also its handling of the incident. As noted by Regulatory Focus, which first reported the hacking, the breach occurred in mid-October while the agency was partially closed due to the congressional budget impasse, but only...
Source: Pharmalot - December 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Top of the morning to you. A glorious sun is warming the chilly Pharmalot corporate campus this morning, where the official mascots are harassing the wild life, the short people are scurrying off to their houses of learning and we are brewing yet another cup of needed stimulation. Although we sense that the world may be slowing down as holiday time nears for many, we remain as busy as ever, which is a good thing. So here are a few items of interest to get you started. Hope you have a smashing day and do stay in touch if you hear anything fascinating... Study Shows Mixed Links Between Antidepressants And Autism (MedPage Tod...
Source: Pharmalot - December 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Novartis May Face Criminal Charges In Japan Over Diovan Research
The Japanese Health Ministry may file a criminal complaint against Novartis over the Diovan research scandal, according to reports. Last fall, you may recall, the ministry convened a panel that found the drugmaker should be held responsible for the imbroglio.  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 conducted there, as well as ties between researchers and Novartis...
Source: Pharmalot - December 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

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

Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week is drawing to a close. As you may recall, this is our treasured signal to daydream about weekend plans. And our agenda is rather modest. We hope to spend time with our short people, catch up on some reading and take a few naps. Then again, Mrs. Pharmalot may have other ideas. We shall see. But what about you? Anything interested planned? A shopping trip, perhaps? If so, you may want to buy a nice warm sweater. Maybe this is a chance to finalize plans if you have a few days off later this month. Or think about how next year will be different. Existential thoughts aside, have a wonderful time, bu...
Source: Pharmalot - December 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Court Evades US Concern Over False Claims And Side Effect Reports
Here is a ruling that is nothing but anticlimactic. After a few months of anticipation, a federal appeals court decided not to rule on an issue raised last summer by the US Department of Justice in a whistleblower case against a drugmaker – whether the failure to report adverse events can form the basis for filing a lawsuit citing the False Claims Act. Here is the background, all of which is from our earlier story: A year ago, a federal court judge tossed a pair of whistleblower lawsuits that were filed by a former safety consultant, Helen Ge, who alleged Takeda misrepresented or altered descriptions of adverse events fo...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Attorneys General Want FDA To Rescind Painkiller Approval
Two months ago, the FDA caused a stir by ignoring the advice of its own advisory panel and approving the first opioid to contain only hydrocodone. The move was quickly criticized by patient advocates, because Zohydro ER is designed to be released slowly over a 12-hour period, but can be crushed, chewed or mixed with alcohol to provide a kick. In other words, there is potential for abuse and misuse. Ironically, the approval came just days after recommending that commonly used prescription painkillers that contain hydrocodone, such as Vicodin, should be reclassified to a more restrictive ranking on the national law enforceme...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Japan Probes Pharma Magazine Ads Masquerading As Articles
The Japanese government is investigating whether numerous magazine articles intended to attract cancer patient may actually have been nothing more than embellished advertisements for cancer medicines and that several drugmakers paid the publisher of a monthly magazine to run the information, according to The Yomiuri Shimbun. The Health, Labor and Welfare Ministry is determining whether the arrangement violated the Pharmaceutical Affairs Law, which bans advertising of cancer drug. And the paper reports that the ministry plans to urge the pharmaceutical industry to adopt voluntary rules to prevent a recurrence, although the ...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

FDA Says Female Sexual Dysfunction Pill May Not Be So Hot
Sprout Pharmaceutical has not lost desire for its female sex pill. Despite receiving a complete response letter from the FDA, the little drugmaker is appealing the agency decision. Nonetheless, the agency decision is only the latest instance in which the pharmaceutical industry has come up empty trying to market a drug to treat Hypoactive Sexual Desire Disorder in pre-menopausal women. In fact, the Sprout once-a-day pill, which is called flibanserin,  is the same drug that Boehringer Ingelheim failed to get approved three years ago. An FDA panel voted 10-to-1 the drug was not effective in increasing female libido, and the...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? Once again, a shiny sun is hovering over the freezing cold Pharmalot corporate campus, which we hope will soon warm up enough so we may effectively tackle our to-do list. To help us along - you guessed it - we are brewing another cup of steaming hot stimulation. Our flavor is Southern Pecan, if you care. In any event, time to get cracking. So here are some tidbits. Hope your day goes well and be in touch... Novartis CEO Envisions Tiered Pricing Plans For Africa (This Is Africa) FDA Approves First Generic Of Cymbalta Antidepresssant (Associated Press) Roche Signs Deal Worth Up To $600...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Boehringer Is Fined Nearly $1M For Disappearing Documents
How much does it cost if potentially damaging documents disappear? How about $931,000? This is what Boehringer Ingelheim must pay in fines after a US federal court judge expressed dismay and outrage that the drugmaker failed to preserve “countless” files sought by patients who filed lawsuits claiming the Pradaxa bloodthinner caused excessive and, sometimes, fatal bleeding. In a ruling this week, US District Judge David Herndon, who is overseeing more than 1,700 lawsuits, found that Boehringer executives acted “in bad faith” by failing to ensure that documents and files about Pradaxa development and marketing were p...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

FDA Has Plan To Limit Antibiotic Use In Food-Producing Livestock
After increasing debate, the FDA has implemented a plan to phase out the use of antibiotics in food-producing livestock, an issue that has generated mounting concern over the past few years that the widespread and, allegedly, inappropriate use of these medications jeopardize human health by causing resistance to the drugs. Not surprisingly, the plan was met with mixed reactions. About 70 percent of medically important antibiotics sold in the US are for food animals, and most are used in feed without supervision of a veterinarian, according to Pew Charitable Trusts. The US Centers for Disease Control and Prevention recently...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Are Vicodin T-Shirts Just Pop Culture Or Tasteless And Harmful?
During an era when the abuse and misuse of prescription painkillers is a troubling and controversial issue, what should we make of shirts that boldly sport the names Vicodin, Adderall and Xanax? Are these drugs so widely accepted that the shirts are merely an ordinary barometer of popular culture? Or are these an inappropriate and tasteless attempt to glorify behavior that trivializes a serious problem? As part of its argument to protest its Vicodin trademark, AbbVie recently filed a lawsuit against Kitson, a trendy Los Angeles retailer that has been marketing these t-shirts. And the drugmaker argues that the ‘designer d...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Task Force: Ban Sales Reps From Academic Medical Centers
In hopes of tightening conflict-of-interest policies at academic medical centers, a task force organized by the Pew Charitable Trusts has developed a new set of 15 recommendations that are more stringent than what was issued five years ago by the American Association of Medical Colleges. And one of the biggest recommended changes is banning pharmaceutical sales reps from campuses altogether (here are the recommendations). “Effectively implementing strong, well-enforced COI policies at AMCs is critical to ensure that academic medicine can continue to engage in principled partnerships with industry, while protecting the in...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another busy day is on the way. And while this is shaping up to be a rather cold one, in fact, the sun is shining strongly over the hectic Pharmalot corporate campus, where the short people are enduring their usual ritual of hustling off to their houses of learning. As for us, we are, of course, indulging with a cup of needed stimulation as we sort through our to-do list and decide what to leave in and what to leave out. Perhaps you can relate. In any event, here are some items of interest to help along your own ride. Have a smashing day and drop us a line if something interesting occurs... CVS An...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

A Medical Conference, A Tweet & A Drugmaker's Belated Response
Here is a real-life scenario that will give pause to any and every drugmaker that posts information at a medical conference. Last March, someone at a research conference held in Atlanta snapped a picture of the interim results from the first part of a Phase II study for a Medivir drug and then sent a Tweet. This apparently caused Medivir stock to jump and the NASDAQ OMX in Stockholm to halt trading. Three hours later, Medivir issued a press release that contained actual study results and trading resumed. But the stock exchange was not pleased and has fined the drugmaker nearly $59,000, which is equal to twice the annual fe...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Some Democrats Scold Obama Over His Position On Trade Talks
In a rebuff to President Barack Obama, a half dozen Congressional Democrats have written to complain at the terms being proposed by the US Trade Representative in the ongoing Trans Pacific Partnership talks which are being held this week in Singapore. Specifically, they object to provisions pertaining to patents on prescription drugs they claim would affect the availability and cost of generic medicines. The letter was delivered to the White House following the recent disclosure by WikiLeaks that the US Trade Rep was pushing various proposals that angered and upset a raft of consumer groups and patient advocates, who are c...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Supreme Court Rejects Pfizer In Neurontin Off-Label Marketing
In a setback to Pfizer, the US Supreme Court has left intact a $142 million award to Kaiser Foundation Health plan for marketing the Neurontin epilepsy drug for unapproved uses (back story). The court also allowed two other lawsuits – one brought by Aetna, the large insurer, and a class action that was filed on behalf of union health plans and other insurers – to proceed (see this). The decision opens Pfizer to potentially still more payouts, especially if additional lawsuits are filed by other insurers or health plans that make similar claims. The lawsuits charged that Pfizer engaged in racketeering and induced physic...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

EU Says Pay-To-Delay Deals Drop; Fines J&J And Novartis
After applying greater scrutiny of pay-to-delay deals between brand-name and generic drugmakers, the European Commission finds that fewer such troubling patent settlements took place last year. At the same time, though, the agency has fined Johnson & Johnson nearly $15 million and Novartis about $7.5 million for allegedly conspiring to delay the generic introduction of a prescription pain patch in the Netherlands. European antitrust regulators over the last few years have been cracking down on certain deals, in which a brand-name drugmaker offers a payment to a generic rival that then agrees to delay the launch of a co...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Novo Nordisk Probed By Danish Police Over Tresiba Disclosure
Last February 10, Novo Nordisk issued a statement saying the FDA had rejected its Tresiba insulin and wanted a cardiovascular outcomes trial before a new review can be completed, a move that was a difficult setback for the drugmaker because such a trial would likely delay regulatory approval of an important new product for at least two years (back story). That Sunday disclosure, however, did not sit well with the Danish Financial Supervisory Authority, which has reported Novo Nordisk to the police for violating reporting obligations under the Danish Securities Trading Act to disclose inside information as soon as possible,...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Merck Proposes Paying $28M To Settle Fosamax Jaw Bone Suits
Three months ago, a federal judge ordered hundreds of lawsuits charging a Merck drug called Fosamax caused osteonecrosis, which is a painful death of jawbone tissue, to be dispersed to courts around the country for trial (back story). The move seems to have had the desired effect. Yesterday, Merck proposed paying nearly $28 million to settle 1,140 pending lawsuits. “We hope to bring this to a successful conclusion," PaulStrain, a lawyer for Merck, said at a hearing in federal court in Manhattan before Judge John Keenan, who has presided over mushrooming litigation and would have to approve the settlement. The drugmaker n...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? We have returned from a brief moment of mourning, which took us away from our usual routine yesterday, and have awoken to an impressive amount of snow blanketing the Pharmalot corporate campus. This makes for some pretty scenery while we organize the day ahead. Meanwhile, we are brewing that trusty cup of stimulation and invite you to join us, as always, as we dig in - and get ready to dig out. And so, here are some tidbits. Have a grand day and do stay in touch... United Therapeutics Receives A Subpoena For Marketing Practices (Reuters) Shanghai Official Suspended In Connecti...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Biogen Plant That Makes Older MS Drugs Fails An FDA Inspection
Biogen Idec may impressing Wall Street with its new Tecfidera treatment for multiple sclerosis, but the drugmaker is not impressing regulators with some of its practices for manufacturing a pair of older treatments – Tysabri and Avonex. A recent inspection report issued by the FDA, which examined a facility last summer, noted that the drugmaker did not always challenge the validity of all testing results provided in certificates of analysis as part of qualification procedures. In other words, Biogen (BIIB) did not always ensure that active pharmaceutical ingredients were sterile, as suppliers claimed. In addition, Biogen...
Source: Pharmalot - December 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

University Faculty Votes To Probe A Seroquel Study Suicide
In response to a call from dozens of leading academics in different countries, the University of Minnesota faculty senate late last week voted to conduct an inquiry into how the institution runs clinical trials involving human subjects. The 67-to-23 vote was described as a “rare victory” by one academic who has pushed for the university to investigate one controversial case that prompted sustained scrutiny of university practices and negative publicity. That case involved the 2004 death of Dan Markinson, a troubled 26-year old who committed suicide while participating in a clinical trial that was run by university rese...
Source: Pharmalot - December 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs