Dutch manufacturer of Rhucin to apply again for approval
AMSTERDAM, Netherlands After the European Medicines Agency denied approval for Pharming’s angioedema drug, Rhucin, in March, the Dutch biotech says it is ready to try again.
Pharming said Monday that it would apply for regulatory approval with the Food and Drug Administration by the end of this year after a study analyzing more than 300 administrations of the drug found no significant safety issues.
“We have been able to address the issues raised by the European authorities in a very promising way, thereby generating data that confirm the effectiveness and safety of Rhucin in repeat use,” Pharming CEO Francis Pinto said in a statement.
Bristol-Myers Squib ups off for ImClone buyout
NEW YORK Bristol-Myers Squibb announced Monday that it would increase its offer for ImClone after the biotech rejected a previous offer as too low.
Bristol had previously offered $60 a share for the company, but has increased its offer to $62 a share, or $4.7 billion. That’s still far below the $70 a share that ImClone chairman Carl Icahn has said an unnamed pharmaceutical company has offered.
ImClone and Bristol jointly market the cancer drug Erbitux (cetuximab), and Bristol owns 16.6 percent of ImClone’s stock.
Roche assures flu vaccines will be in stock for season
NUTLEY, N.J. Ample supplies of the flu drug Tamiflu will be available throughout the country during the flu season, manufacturer Roche said Tuesday.
The vaccine, known generically as oseltamivir phosphate, is approved for treating and preventing influenza in adults and children aged 1 and older.
The Centers for Disease Control and Prevention considers it an important second line of defense against the flu.
“We understand that pharmacists do their best to stock appropriate amounts of antiviral medications, such as Tamiflu, for use during the flu season,” Roche medical director Dominick Iacuzio said. “However, the incidence and severity of seasonal flu remains unpredictable from year to year, and some pharmacies may still be faced with greater-than-expected demand during the season.”