Genzyme shelves kidney drug program; InterMune drops a dosage on tox fears

> In a fresh setback, Genzyme says that it will halt development of a new kidney treatment, saying that while the advanced phosphate binder met its goal in a Phase II/III trial it already has a better therapy in Renvela. Genzyme has been wrestling with bigger issues, plagued by manufacturing troubles. Story [1]

> Concerned by signs of toxicity, InterMune decided to drop one of the dosages being tested in a mid-stage trial of an experimental hepatitis C drug. Its shares slid 18 percent yesterday morning on the news. Report [2]

> Roche has set the stage for a new late-stage trial of dalcetrapib, an experimental therapy for atherosclerosis. It hopes to launch the drug in 2013 or 2014. Story [3]

> The UK's Minister for Science and Innovation says that big drug companies have expressed a strong interest in investing in its 1 billion pound innovation fund. Story [4]

> Asterand says that it has forged a deal to acquire BioSeek, a San Francisco-based outfit that sells assays used in drug discovery programs. BioSeek has 14 workers. Report [5]

> Australia's Starpharma has raised A$15.6 million through a private placement. Starpharma release [6]

> India's Sun Pharmaceutical announced that the FDA has granted its subsidiary an approval for its application for Nicardipine Hydrochloride Injections. Sun release [7]

Pharma News

> Sen. Charles E. Grassley wrote to 10 top medical schools Tuesday to ask what they are doing about professors who put their names on ghostwritten articles in medical journals--and why that practice was any different from plagiarism by students. Report [8]

> As usual, the American Heart Association's scientific meeting is a bonanza of research news and a carnival of sales gimmicks in the exhibit hall. Here's a quick roundup of the latest and greatest developments, with a bit of local color thrown in. It's the next best thing to being there. Report [9]

> The latest news about stomach drugs could give Plavix users a serious case of heartburn. The FDA shocked folks at the American Heart Association meeting with a warning that using the heartburn meds Prilosec and Prilosec OTC interferes with the anti-clotting effects of the blockbuster blood thinner. Report [10]

> Oh, what a tangled web. Drugmakers, doctors, ghostwriters, academic researchers, medical schools, CME providers... they're all linked together by industry money and influence. At least that's the view of 100 medical ethicists, researchers, professors, patient advocates, et al., who are asking the National Institutes of Health to fund studies about conflicts of interest and their effects on patient care. Report [11]

> Where do pharma CEOs go when they've said goodbye? Apparently, they join a private equity firm. Report [12]

Pharma Manufacturing News

> British security software company Sophos says it has intercepted hundreds of millions of fake pharmaceutical spam advertisements this year and found the originating Internet sites, many claiming to sell such antivirals as Tamiflu. Report [13]

> Last Friday--the 13th--the FDA sent Genzyme (GENZ [14]) a complete response letter regarding the company's application to market Pompe disease treatment Lumizyme. Tucked into that letter was a condition: satisfactory resolution of deficiencies at the Allston Landing manufacturing plant prior to approval. Report [15]

> Cambridge, MA-based biotech Alnylam says that its genetics expertise in drug development also may be useful in biologics manufacturing. Report [16]

> As most business travelers will agree, trip reports become much harder to complete once the traveler gets back to the office. So too with warning letters for regulatory inspectors when they return from the subject facility. Report [17]

And Finally... Countering popular theories that hardening of the arteries-atherosclerosis--is a thoroughly modern health trend, researchers say they found the condition in Egyptian mummies that are 3,500 years old. Article [18]