Drug maker’s shares fall after HHS requests regulatory filing
NEW YORK A Department of Health and Human Services request that companies bidding on a government contract to provide anthrax vaccines give a regulatory plan to the Food and Drug Administration in 15 days caused shares of one of the companies to fall by 5.5% in afternoon trading on Friday, according to published reports.
The Associated Press reported Thursday that PharmAthene submitted a regulatory filing saying that HHS did not provide sufficient information. The HHS request caused PharmAthene’s shares to fall by 15 cents, to $2.56.
The Annapolis, Md.-based company makes the anthrax vaccine SparVax.
FDA approves hypertension generic
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Abbott’s Oretic, agency records show.
The FDA approved Ipca Labs’ hydrochlorothiazide capsules in the 12.5 mg strength. The drug is used to treat hypertension.
Oretic was originally approved in 1959, and its active pharmaceutical ingredient is used in a number of hypertension drugs.
Biogen Idec receives FDA approval for multiple sclerosis, Crohn’s disease treatment
CAMBRIDGE, Mass. The Food and Drug Administration has given approval to a drug for treating multiple sclerosis and Crohn’s disease.
Biogen Idec announced Thursday that the FDA had approved Tysabri (natalizumab), which already has approval in more than 40 countries as a treatment for moderate to severe Crohn’s disease and relapsing forms of multiple sclerosis. Biogen Idec co-markets the drug with Ireland-based Elan Corp.
Biogen Idec will use a high titer process for which it received approval in the European Union in December to manufacture the drug in higher quantities at its plant in Research Triangle Park, N.C.
“Developing this high titer process is another example of our world-class expertise and leadership in biologics manufacturing,” Biogen Idec COO Bob Hamm said. “We expect this new process to result in about a four-fold increase in yield.”