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 »

The American Association for the Advancement of Science (AAAS) and Science recently conducted a survey (at the request of L’Oreal USA) about women in science. The bottom line: “gender still matters with regard to women’s being able to be successful and to move ahead in science,” AAAS Director of Education and Human Resources Shirley Malcom told a Congressional panel on Sept. 23. Read more »

In the keynote address to a conference on Regional Innovation Clusters on Sept. 23, 2010, John C. Lechleiter, Ph.D., chairman, president, and CEO of Eli Lilly, called for federal policies that further encourage regional economic innovation as a key to renewing the nation’s economy. Lechleiter addressed a broad spectrum of policymakers, including members of the Obama administration, at a conference co-hosted by The Brookings Institution, the Center for American Progress, the Council on Competitiveness, and the National Association of Development Organizations. 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 »

Sproxil, a provider of brand-protection services, has developed a program designed to track donated food and healthcare goods as well as prevent illegal diversion. The company will present its Commitment to Action, “Preventing the Diversion of Medical and Food Donations,” at the 6th annual meeting of the Clinton Global Initiative (CGI), taking place September 20–23 in New York City. Read more »

Johnson & Johnson (J&J New Brunswick, NJ) announced last week that it was in “advanced negotiations” for a potential public offer for the Dutch biopharmaceutical company Crucell (Leiden, The Netherlands). Although not yet making a formal bid, J&J said it would consider an offer of EUR 24.75 ($32.49) per share for Crucell in an all-cash transaction of approximately EUR 1.75 billion ($2.30 billion) to acquire all the shares of Crucell that it does not already own. J&J now holds a 17.9% stake in the company. If the deal proceeds as planned, the move would enable J&J to develop a vaccine business, something the company is seeking to build within its biopharmaceutical capabilities. 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 »

Genzyme, Genzyme, Genzyme… Most of us won’t have missed the company’s name splashed across dozens of news stories this week relating to a potential acquisition, the selling of its genetics unit and 1000 layoffs. First of all, there’s the ongoing question of whether Genzyme will succumb to sanofi-aventis’ acquisition offer. Genzyme reportedly rejected the offer of $69 per share at the end of August, but sanofi has yet to offer a higher price. Sanofi CEO Chris Viehbacher is still hoping for a “reasonable price”, according to a Reuters article, though he also added that he expects the process to be slow. A report from Bloomberg also speculated that the offer may have to be upped to $75 per share to please Genzyme investors. Read more »

On the third day of this week’s PDA-FDA Joint Regulatory Conference in Washington, CDER’s Deborah Autor, director of the Office of Compliance, provided additional thoughts and trends regarding pharmaceutical drug manufacturing compliance and enforcement in the US and abroad. She spoke about the growth in globalization and the agency’s ability to inspect existing sites around the world. “Sixty percent of the drug facilities that I care about are not in this country,” said Autor, and we “need a global alliance of regulators” to ensure global product quality, she told the audience. “Nobody can do it alone.” The same concept holds true for industry, whose efforts to share information and collaborate on audits, were praised by Autor. Read more »

Today at PDA-FDA’s Joint Regulatory Conference in Washington, Mary Malarkey and Ilisa Bernstein of CBER and CDER compliance offices, respectively, provided updates on FDA’s regulatory efforts.  Also on the panel was Howard Sklamberg of the agency’s Office of Regulatory Affairs.

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