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