Sanofi Files 'First-Of-A-Kind' Lawsuit Against FDA Over OTC Drug
In a bid to blunt competition to its newly approved over-the-counter Nasacort allergy spray, Sanofi has filed a lawsuit against the FDA in hopes of preventing the agency from publicly releasing labeling and packaging information. The drugmaker claims this material is proprietary and doing so would spill trade secrets, even though the FDA is required to publish approval information on its web site.
The move appears to be a “first-of-its-kind lawsuit,” according to Kurt Karst, a director at the Hyman, Phelps & McNamara law firm, who also runs the FDA Law blog, where the action was first reported. He noted “FDA proc...
Source: Pharmalot - November 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? A few flurries are descending on the Pharmalot corporate campus this morning, which is a mixed bag. We would prefer balmier temperatures, but it does make for some pretty scenery. In any event, time to turn our attention to the day ahead, which is already shaping up to be a busy affair. We trust you can relate. So please join us as we reach for that needed cup of stimulation and attack the to-do list. As usual, here are some tidbits to get you started. Have a smashing day and keep us in mind if something interesting erupts...
Actavis To Close Plant And Eliminate 300 Jobs (Char...
Source: Pharmalot - November 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Glaxo Unit And Former CEO Win Lawsuit Over Alleged Fraud
A federal jury in Miami last week decided that Stiefel Laboratories and its former ceo, Charles Stiefel, did not commit securities fraud in connection with the sale of company stock prior to the $2.9 billion purchase of the family-owned business by GlaxoSmithKline in 2009 (here is the jury verdict form).
The lawsuit, which was filed by former Stiefel cfo Richard Fried, was one of several in which former employees alleged that Stiefel stock was deliberately undervalued as part of a buyback through an employee stock plan prior to the sale to Glaxo (here is his lawsuit). As a result, the lawsuits claimed their holdings suffer...
Source: Pharmalot - November 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
A Slip Of The Tongue? FDA Scolds Aegerion CEO For TV Remarks
File this under ‘the ceo should know better.’ Twice this year, Aegerion Pharmaceuticals ceo Marc Beer appeared on the CNBC television show ‘Fast Money’ to discuss Juxtapid, a pill that was approved late last year to treat homozygous familial hypercholesterolemia, a rare and life-threatening form of high cholesterol than can lead to heart attacks and early death. There are about 3,000 people in the US.
The $295,000 annual price tag has been controversial, but Aegerion shares have more than quadrupled this year, which made Beer a desirable guest. But someone should have taken some of the profits and paid for media co...
Source: Pharmalot - November 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
How Much? A Battle Over The Cost Of The New Hepatitis C Drugs
As excitement mounts among physicians and investors over a new crop of drugs for treating hepatitis C, there is also concern that patients in developing countries may not have sufficient access due to high prices. But a recent poster presentation at a medical conference suggests that drugmakers can produce these new medicines for relatively little cost and should be compelled to do so.
The analysis, which was displayed at the American Association for the Study of Liver Diseases gathering last week in Washington, DC, concluded that large-scale production of direct acting antivirals may be possible for as little as $100 to $...
Source: Pharmalot - November 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
UK Pharma Trade Group Code To Improve Payment Disclosures
Once again, the pharmaceutical industry trade group that represents drugmakers in the UK is inching closer to developing a plan for disclosing payments to physicians. In a statement issued late last week, the Association of the British Pharmaceutical Industry saying its members agreed to make changes to the official code of practice in order to include “greater transparency.”
The decision comes after a recent survey showed that 89 percent of 1,055 individuals – including physicians, companies and healthcare organizations - agreed that payments to healthcare professionals should be transparent. Separately, 77 percent ...
Source: Pharmalot - November 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and welcome to another working week. Once again, another weekend respite has come and gone. Hopefully, you enjoyed yourselves. In any event, that familiar routine of meetings and deadlines has now resumed. To cope, we are brewing a cup of stimulation, although our choice today is a spot of tea. A little variety can be a good thing, yes? So please join us as we hunker down for a busy day. As always, here are some items of interest. Hope your day goes well and do stay in touch...
Shire To Pay $4.2 Billion For ViroPharma To Add Orphan Drugs (Bloomberg News)
J&J And Amazon Clash Over Third-Party Product Sa...
Source: Pharmalot - November 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Proposes Rule To Allow Generic Drugmakers To Change Labeling
Two years ago, the US Supreme Court ruled that generic drugmakers are not required to update product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine. The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications.
Now, the FDA has proposed a rule to revise regulations that prevent generic drugmakers from updating labeling, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugmakers are currently allowed to update ...
Source: Pharmalot - November 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
India Cracks Down: Sun Pharma Clinical Work At Lab Is Halted
In a sign that the Indian government may be cracking down on clinical trial work conducted by its domestic pharmaceutical industry, the Drug Controller General of India ordered Sun Pharmaceuticals, which is one of the country’s largest drugmakers, to suspend clinical research activities at a key laboratory in Mumbai, according to reports.
The regulator took this step after discovering that Sun did not have needed approval from the central government to operate the lab, The Economic Times writes. And the DCGI will not accept any future applications or process existing new filings made by the Mumbai lab until Sun receives ...
Source: Pharmalot - November 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
South Africa Embraces Compulsory Licensing Over AIDS Crisis
Two months after releasing a draft policy for governing intellectual property, South Africa has decided to amend its patent legislation so the government can use parallel importing and compulsory licensing that is allowed under international agreements, according to a statement by Rob Davies, who is National Policy on Intellectual Property, Trade and Industry Minister (here is the draft policy and here is the statement).
The move comes after patient advocacy groups complained that South Africa has not amended its patent laws to incorporate or implement the 2001 WTO agreement on Trade Related Aspects of Intellectual Propert...
Source: Pharmalot - November 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Amarin Appeals FDA Rescission Of Special Protocol Agreement
File this under ‘best of luck.’ One week after the FDA rescinded a special protocol agreement that Amarin was counting on to significantly widen usage for its Vascepa prescription fish oil pill, the drugmaker has filed an appeal (see page 18). Whether the agency will change its collective mind is unclear, but a reversal is likely to be a long shot, at best.
The effort is the latest twist in what has been one of the more closely watched biopharma stock stories on Wall Street this year. Investors were captivated by the possibility that the drugmaker might have been able to market a potential blockbuster amid a heated deb...
Source: Pharmalot - November 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Bristol-Myers Ends Some Discovery Work And Cuts R&D Jobs
Yet another drugmaker is reworking its R&D operations and shedding jobs. The latest is Bristol-Myers Squibb, which is ending drug discovery in three areas – hepatitis C, diabetes and neurological disorders – and cutting up to 75 researchers, or about 1 percent of its R&D workforce of approximately 8,000 people, according to a spokeswoman.
The drugmaker plans to increase investments in research in immuno-onocology, as well as continuing a focus on HIV, heart failure, oncology and hepatitis B, among others. There is no change in the late-stage pipeline support. “We are focusing our R&D organization on deliv...
Source: Pharmalot - November 8, 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 Aurinia Pharmaceuticals hired Stephen Zaruby as ceo and president. Previo...
Source: Pharmalot - November 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week will soon draw to a close. This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is somewhat uncertain at the moment, although there is a soccer match involving one of the short people. We also hope to tidy up around the mansion and, perhaps, catch up with some old friends. And you? Anything interesting planned? If the weather is accommodating, this may be an opportunity to enjoy the great outdoors. Or maybe plan a trip to Portland, Maine, to enjoy the new recreational law. You could also contemplate the future of your health insurance. Whatever you do, have a g...
Source: Pharmalot - November 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
NIH Rejects Petition About AbbVie Pricing For Norvir AIDS Drug
The US National Institutes of Health has rejected a so-called march-in petition that was sought by several non-profit groups that hoped to make and sell the Norvir HIV medication sold by AbbVie (ABBV). They sought to do so because the drug was created with federal funds and is currently much more expensive in the US than in other countries with comparable incomes (here is the petition).
Norvir is commonly used in HIV drug cocktails, including the Kaletra AIDS pill. Abbott Laboratories, which last year spun off AbbVie, battled patient advocates, consumers and even a rival drugmaker after raising the price by some 400 percen...
Source: Pharmalot - November 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
