Right now, many of us are thinking of how we could improve ourselves during the new year. Others, such as Ranbaxy, will be forced to improve themselves in 2012. The company signed a consent decree last week, and its management must be eager to put its ugly past behind it. Read more »

According to a recent press release from the Department of Justice, the government has reached record highs in the recovery of fines settled under the False Claims Act. In 2011, over $3 billion were collected, bringing the total since January 2009 to $8.7 billion. This year’s total included $2.4 billion in recoveries involving fraud committed against federal health care programs. Read more »

Drug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »

Earlier this week I read a great article on Reuters about how pharma companies are looking to the automobile industry for innovation by transferring some of the lean methodologies learned in car manufacturing to pharmaceuticals. As a pharmaceutical journalist, I read a lot of news stories and articles about innovative new products, R&D projects and partnerships, and sometimes it’s too easy to let your eyes gloss over these as everyday business. Earlier this year though, the partnership between GlaxoSmithKline the McLaren Group really grabbed my attention. Pharma… and a racing-car maker? That’s definitely not an everyday occurrence. Or is it? Read more »

This post was written by Eric Langer, Managing Partner, BioPlan Associates, Inc.

Yes, doing surveys is a pain.  So there’d better be a darn good reason.  Here’s a survey with 7 good reasons that I consider worth the effort.  The industry and participants benefit from the 9th Annual Report and Survey of Biopharmaceutical Manufacturing, and here’s why. Read more »

Just when it seemed that controversy over the Plan B contraceptive was a thing of the past, the drug returned to the headlines. In an unprecedented action, Health and Human Services Secretary Kathleen Sebelius overruled FDA’s decision to allow Teva’s Plan B One-Step to be sold over the counter to girls under the age of 17. In a public statement, Sebelius said that about 10% of girls can bear children by 11.1 years of age. Teva’s “label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” she said. But FDA sees the matter differently. Read more »

Just over a week ago, I decided to hop on the early train to Glasgow, Scotland, so that I might catch at least half of the 8th bioProcess UK conference, focusing on advancing next generation therapies. The meeting was held in the very fitting Glasgow Science Center and, given the strikes over public sector pensions that day, there were plenty of youngsters mingling with the crowds—the next generation of bioprocess engineers perhaps? Amazingly, presentations were delivered in the IMAX theatre—I have never seen PowerPoint slides on such a scale before—but given the eminence of some of the keynote speakers involved, it too was quite apt. Read more »

This week’s announcement of a public meeting to discuss a user fee structure for biosimilars marks another step towards implementation of the Biologics Price Competition and Innovation Act of 2009, which mandates that FDA establish an approval pathway for biosimilars. The question on everyone’s mind regarding the definition of a biosimilar has yet to be answered, but the fee announcement and the accompanying proposed review of performance goals and procedures provides some welcome information about what the approval process will look like. Read more »

A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »

The day of reckoning is here. As patent protection expires for top-selling drugs, some firms are scrambling to stay one step ahead of generic-drug competitors. As Amy Ritter wrote last week, Pfizer is drawing scrutiny by asking pharmacy benefit managers to block pharmacies from filling prescriptions with generic alternatives to Lipitor, in exchange for a discount on the product. Rep. John Sarbanes (D-MD) asked the Federal Trade Commission to take action against this arrangement, but another tactic is also causing concern. Read more »