FDA is close to receiving the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well. Read more »
After rejecting two obesity-drug candidates in recent months, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended two weeks ago that the agency approve a third drug, Contrave (naltrexone sustained release [SR]/bupropion SR) by Orexigen Therapeutics (San Diego). Members of the expert panel voted 13–7 to approve the drug, but recommended that additional studies be conducted to investigate potential heart risks. Read more »
The Presidential Commission for the Study of Bioethical Issues released a report last week that supported continuing research in the emerging field of synthetic biology with some additional federal oversight. President Obama had asked the Commission in May 2010 to study the implications of synthetic biology following the announcement by the J. Craig Venter Institute, a genomic-research organization founded and headed by J. Craig Venter, who helped map the human genome, that his group had successfully constructed the first self-replicating synthetic cell. Venter’s work, while viewed as a scientific accomplishment, has engendered a strong debate on the bioethics of synthetic biology. Read more »
Big Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. Read more »
McNeil Consumer Healthcare, a business unit of Johnson & Johnson (New Brunswick, NJ), failed to ensure the quality of over-the-counter consumer products, according to the Form 483 report released by the US Food and Drug Administration on Wednesday. Read more »
“Just because an idea is true doesn’t mean it can be proved. And just because an idea can be proved doesn’t mean it’s true.” This quote is part of an article by Jonah Lehrer appearing in the Dec. 13, 2010, New Yorker Annals of Science column, in which Lehrer questions the validity of the scientific method.
This week, another pharmaceutical executive has stepped down, Elmar Schnee, head of the pharmaceutical division of Merck KGaA (Darmstadt, Germany). His departure follows other high-profile changes among the pharmaceutical executive ranks, namley Jeffrey Kindler leaving as head of Pfizer (New York) and Richard Clark turning over the helm of Merck & Co. (Whitehouse Station, NJ). These former executives and their successors face an all-too familiar challenge—the pressure for successful product development in light of looming patent expirations and the need to implement new strategies for revenue growth. Read more »
There was no joy in Paris, at least at sanofi-aventis (Paris) headquarters, on Friday. When the company’s offer to acquire Genzyme (Cambridge, MA) at $69 per share expired that day, fewer than 1% of the biopharmaceutical company’s outstanding shares had been tendered. In response, sanofi extended its deadline to January 21, 2011 without modifying the terms of its offer. Why should the company expect a different result in six weeks’ time? Read more »
Recently, I spoke to R. Arun Kumar about the wider applications of cloud computing. Arun Kumar is Vice President and Head of the Global Life Sciences Business Unit at Infosys, an IT, business consulting and outsourcing services provider. Read more »
Last month, the China Pharmaceutical Industry Research and Development Association (SINO-PhIRDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) signed a cooperation framework that embodies the intent of multinational pharmaceutical and Chinese pharmaceutical companies to continue a regular dialogue to facilitate the two organizations working together. So what is the status of China–US pharma relations? Read more »
From PharmTech.com