Specialty Pharmacy

SWIFTWATER, Pa. The Food and Drug Administration has accepted a regulatory approval application for a flu vaccine administered in the skin.

Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis, announced Monday that the FDA had accepted its application for Fluzone Intradermal (influenza virus vaccine). The company expects the FDA to take action on the vaccine in the first half of next year.

PHILADELPHIA The Food and Drug Administration did not completely withdraw from the market a drug used to treat a dangerous low blood pressure condition, but merely proposed to do so as a “step in the regulatory process,” according to a document posted on the agency’s website Monday.

The agency said its proposal last month to withdraw approval for Shire’s drug ProAmatine (midodrine) did not represent the actual withdrawal of the drug from the market, while calling for more data on the drug to verify its clinical benefit.

BOSTON Close to 400 drugs and vaccines are in development for fighting infectious diseases, according to one of the pharmaceutical industry’s largest lobbying groups.

The Pharmaceutical Research and Manufacturers of America announced Friday that drug makers have 395 new medicines and vaccines in clinical development or under review by the Food and Drug Administration. These include five vaccines and six drugs for malaria, as well as agents for infections like cholera, methicillin-resistant Staphylococcus aureus and the Ebola virus.

NEW YORK British drug maker GlaxoSmithKline and biotech company Genmab have started a late-stage trial of a biotech drug for treating cancer, the two companies said.

CAMBRIDGE, Mass. British drug maker Shire is working with Cambridge, Mass.-based Acceleron Pharma to develop treatments for serious muscular disorders, Shire said Thursday.

The drug maker announced that the two companies would investigate ACE-031, a drug in mid-stage clinical trials as a treatment for Duchenne muscular dystrophy, a rare and fatal muscle disorder with no current treatment. The drug belongs to a class known as activin receptor type IIB, or ActRIIB molecules.