> AstraZeneca says that its biologics division MedImmune has replied to the FDA's complete response letter for the infant lung drug motavizumab. The FDA had sent the letter last November looking for more information on the drug but had not demanded a new trial. "MedImmune will continue discussions with the FDA reviewers as needed throughout the remainder of the registration process," AZ said in a statement. Story
> Shares of Amylin Pharmaceuticals dropped about 10 percent after an analyst reported that the FDA outlined new studies that would be required for the diabetes drug Byetta when it was approved as a standalone therapy at the end of October. Citigroup analyst Yaron Webber says he had obtained a copy of the approval letter and found that it contained undisclosed requirements for animal and human studies that could clarify the risk of pancreatitis. In a statement, Amylin and its partner, Eli Lilly, said that most of the requested studies are being conducted already and have not revealed any new safety issues. Report
> XOMA announced that as a result of an improvement in its financial status and its full repayment of an outstanding loan, its accounting firm, Ernst & Young LLP, has agreed to remove its ‘going concern' warning. Release
> Boston's Kala Pharmaceuticals has secured a $2 million equity financing, according to a regulatory filing. The company, which has yet to reveal what its working on, lists MIT's Bob Langer on its board. Report
> Researchers say that a gene linked to asthma may point the way to a new drug that can be used to treat child asthmatics. Story
Pharma's year in review
> The Pharma industry was front-and-center on healthcare reform. Article
> Layoffs cut deeply into the workforces of the entire industry. Report
> 2009 was the year of the mega-deal for some companies, while others took a different approach. Item
> The H1N1 flu pandemic turned out to be a big boon--and a bit bust--for pharma. Report
> The new year brought us new administration, and a new FDA. FDA report
Special Reports of 2009
> Top 10 Layoffs of 2009
> Top 15 Women in Pharma
> The Top 12 GMP Violations
> The 2009 Biotech Graveyard
> Top Venture Capital Firms
> FierceBiotech's 2009 Fierce 15
> CEO pay of 2008: Who makes what in Big Biotech?
> Top 5 Regions Targeting Biotech Companies - 2009
> Top 15 Big Pharma Paychecks of 2008
And Finally... New research suggests that myhrr--one of the wise men's gifts--may help lower bad cholesterol. Report