/FDA posts list of drug-safety probes; China to cut 2,300 drug prices;
NEWS

FDA posts list of drug-safety probes; China to cut 2,300 drug prices;

FiercePharma
2009/10/08

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