Regulators news from FierceBiotech
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Sanofi: Acomplia demonstrates better glucose control
Sanofi-Aventis said that a trial of Acomplia showed a significant improvement in glucose control in comparison to insulin among patients with type 2 diabetes. Glucose control was three times more Read more...
Committee votes to back GSK/Ligand's Promacta
GlaxoSmithKline and Ligand Pharmaceuticals won a key endorsement for Promacta for the short-term treatment of people with chronic immune thrombocytopenic purpura, or ITP. An FDA expert committee Read more...
Canadian biotech may face funding crisis
Every country's biotech industry is different. And E&Y's report notes that Canada in particular is "facing a real funding crisis," says Rod Budd, Ernst & Young's Canadian biotech industry Read more...
Novartis restructures its development strategy
Novartis CEO Daniel Vasella (photo) tells the Wall Street Journal that he knew Novartis had become too big and too Read more...
FDA's delay of Geron ESC trial raises concerns
Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental Read more...
Intercell snaps up Iomai in $189M deal
The little Maryland-based vaccine developer Iomai, which has posted some impressive data on a new therapy for Read more...
SPOTLIGHT: Silver lining to Big Pharma's cloud?
Some people see the Big Pharma glass as half-full instead of the alternative. In an investor's-eye look at the industry, Kiplinger ticks off the usual criticisms: patent expirations, tough generics Read more...
Eisai wins expert panel's approval for new sedative
Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, Read more...
Astellas faces new delay for Advagraf approval
Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised Read more...
FDA staffers say that Eisai sedative appears safe
FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in Read more...
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