FDA posts list of drug-safety probes; China to cut 2,300 drug prices;
More than a dozen drugs including a Pfizer cancer therapy and a Wyeth bowel medicine are under early scrutiny for potential side effects, FDA said in its quarterly list. Report
FDA chief Dr. Margaret Hamburg told a Cleveland Clinic audience that her top priority is restoring public trust in the agency, which has been beset by food and drug safety issues. Report
European Union discussions on new pharmaceutical legislation will not be concluded this year according to the Swedish chair. Report
Shire's Fosrenol could have a clinical advantage over rival drug Renagel from Genzyme, according to the first head-to-head study looking at their efficacy in dialysis patients. Report
APP Pharmaceuticals got the FDA nod for its generic version of GlaxoSmithKline's migraine drug Imitrex. Report
Spain's Zeltia said it had decided not to expand capital after European regulators recommended the loss-making pharmaceutical firm's Yondelis drug for use in the treatment of ovarian cancer. Report
AspenBio Pharma said it priced a public offering of 4.5 million common shares at $1.70 per share. Report
Biotech News
Omeros prices IPO as it fends off ex-CFO's accusations. Report
Biotech fund-raising spikes as M&A deals crater. Report
Boston-based Paratek Pharmaceuticals scored a $485 million worldwide licensing deal with Novartis for its late-stage antibiotic, PTK 0796, which some analysts peg as a likely blockbuster. Article
Disgraced Biopure executive Howard Richman has been sentenced for making a fake cancer claim. Report
Cambridge, MA-based Epizyme garnered $32 million in a Series B financing round. New investors Bay City Capital, Amgen Ventures, and Astellas Venture Management were joined by existing investors MPM Capital and Kleiner Perkins Caufield and Byers. Article
Vaccine News
An experimental vaccine designed to combat cocaine addiction demonstrated some promising results in a small human trial. Scientists in Texas say that the vaccine triggers the production of antibodies that bind to drug molecules, making them too big to enter the brain. But the trial was hardly an unqualified success. Item
Glaxo is seeing a huge rush for Pandemrix supplies. Report
Sanofi-Aventis says a single dose of its new swine flu vaccine kicked up just the kind of immune response it was hoping to see in children as well as adults. And the new data offers some added proof that the world's growing stockpile of pandemic vaccines will go twice as far as originally predicted. Report
And Finally... China will cut the prices of more than 2,300 medicines by an average of 12 percent on October 22, the government announced. Report
Summary
> More than a dozen drugs including a Pfizer cancer therapy and a Wyeth bowel medicine are under early scrutiny for potential side effects, FDA said in its quarterly list. Report > FDA chief