The confetti from the New Year’s celebrations has settled, and drugmakers are busy planning their activities for 2011. Some people make New Year’s resolutions in hopes of bettering themselves or adopting good habits. After its recent disappointments, the pharmaceutical industry likely will resolve to improve its research and development (R&D) efforts. Read more »

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 »

So, pharma is — arguably — “over the social media hump.” Everyone now “wants to do it”. But how does pharma do it? How can companies successfully use social media to market their messages and their products? That’s the question addressed in Pharm Exec’s new episode of Pharma Faceoff, chaired by Barbara Ryan of Deutsche Bank. Read more »

In January 2011, control of the US House of Representatives will shift to the Republican party. Reducing the federal deficit is one of the party’s top priorities, and Republican leaders have proposed to cut domestic spending as a means to accomplish this end. But should all programs be put on the chopping block? Read more »

Dr. Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke about the growing problem of counterfeit drugs at last Friday’s Counterfeit Drug Interchange Conference in Washington, DC, hosted by the Partnership for Safe Medicines (PSM), a collection of more than 60 non-profit organizations focused on the safety of prescription drugs. Read more »

Johnson & Johnson CEO William Weldon admitted last week that the company “should have handled things differently” in regard to its “phantom recall” of Motrin. The second hearing of The House Committee on Oversight and Government Reform focused on the “phantom recall,” in which outside contractors were hired to pose as customers and buy two lots of 8-caplet Motrin vials to remove them from store shelves. Read more »

Johnson & Johnson Chairman and CEO William Weldon is scheduled to testify at today’s hearing held by the The House Committee on Oversight and Government Reform. Weldon is expected to answer questions about J&J/McNeil Consumer Healthcare’s April 30, 2010, recall of more than 135 million bottles of infants’ and children’s medication. Read more »

Two weeks ago I wrote about GlaxoSmithKline’s Avandia (rosiglitazone) being under the magnifying lens of regulators because of cardiovascular safety concerns and the verdict is now in: the treatment is being pulled completely from the EU market and will face severe restrictions in the US.

Controversy has surrounded Avandia ever since it was first approved but in recent months there has been increasing pressure — including published articles and a UK television documentary highlighting the risks associated with Avandia — on the FDA and the European Medicines Agency (EMA) to take action. Read more »

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted 9–5 against approval of Arena Pharmaceuticals’ (San Diego) appetite-curbing drug candidate lorcaserin hydrochloride. The panel believed that the risks outweigh the benefits of the drug for the treatment of obesity. Concerns focused on increased rates of depression and memory loss in patients as well as the presence of tumors in rats during early testing of lorcaserin. Read more »

Last week, Japanese drugmaker Takeda (Osaka, Japan) struck a deal with biopharmaceutical company Orexigen (La Jolla, CA) for the commercialization of its investigational obesity drug Contrave (naltrexone SR/bupropion SR). Under the terms of the agreement, Takeda will pay Orexigen $50 million cash up front, more than $1 billion in milestone payments, and royalties for rights to commercialize the drug in the US, Canada, and Mexico (Orexigen will co-promote the drug in the US). Read more »