Archive for the 'Regulatory' Category

Senators Resurrect Reimportation with New Bill

Two U.S. senators have revived the reimportation debate with a new bill co-sponsored by a bipartisan group of their fellows. Sen. Debbie Stabenow (D-Michigan) is teaming up with Sen. Olympia Snowe (R-Maine) on the proposal, which would allow U.S. pharmacies and drug wholesalers to source products from other countries with “tough safety standards.”

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Doctor-Patient Relationship Compromised by Facebook

Researchers surveyed the Facebook activities of 405 postgraduate trainee doctors at Rouen University Hospital in France and found that almost three out of four had a Facebook profile. One in four logged on to the site several times a day, and half logged on several times a week.

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FDA Loses Battle in War Against e-cigarettes

Electronic cigarettes are nicotine-delivery devices that include a heating element that vaporizes chemicals in replaceable plastic cartridges. Researchers at the University of California, Riverside recently evaluated five e-cigarette brands and, finding design flaws, lack of adequate labeling, and several concerns about quality control and health issues, concluded that e-cigarettes are potentially harmful and urged regulators to consider removing e-cigarettes from the market until their safety is adequately evaluated.

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Docs Must Police Each Other in Social Media

The American Medical Association wants doctors to blow the whistle on their peers who behave badly online. The new policy is likely a response to concerns about patient confidentiality in social media exchanges, writes Colin Zick in the Foley Hoag law blog.  ”When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual,” the policy reads. “If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.”

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The Top 10 Phase III Failures of 2010

By Phase III, researchers are supposed to have a pretty good handle on just how promising an experimental therapy can be. There’s proof-of-concept data in the can and some clear indications of just how big a market a new drug can go on to capture.

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Biotech’s Biggest R&D Spenders 2010

Big Pharma is a global business, with a host of players scattered throughout Europe, the U.S. and Asia. But Big Biotech was born and bred in the U.S. And despite considerable international diversification, the industry still has made-in-the-USA stamped into its DNA.

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FDA’s Top Q4 Blockbuster Drug Decisions

The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.

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New Migraine Use for Botox Could be Worth $1B

Allergan has done it. The FDA finally approved its wrinkle-fighter Botox as a treatment for migraines. The new indication could add $1 billion to its current annual sales of $1.3 billion, analysts say. “This is the most meaningful market expansion that the product has had since it was approved for cosmetic use,” Piper Jaffray’s David Amsellem tells Bloomberg.

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Pharma Protests Indian Licensing Proposal

The Indian pharmaceutical industry has been shaken up lately, worried that multinational drugmakers will come in and completely take over their drug market. The fears aren’t unfounded; Big Pharma, after all, has been targeting the subcontinent as a key location for expansion, as sales-growth slows in the U.S. and Europe.

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GSK, Theravance report promising PhII data for Advair successor

GlaxoSmithKline and partner Theravance (THRX) say that their planned successor for the blockbuster Advair turned in a positive performance in a mid-stage study involving 60 people with COPD. Significantly, the new drug–dubbed Relovair–outperformed Advair on a key measure that gauges lung function. And that bodes well for the therapy, which is now in late-stage trials for both COPD as well as asthma.

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