Specialty Pharmacy

LONDON The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug, the Anglo-Swedish drug maker said Thursday.

AstraZeneca announced the FDA’s acceptance of its application for vandetanib, a drug for treating patients with advanced medullary thyroid cancer. The agency gave the drug priority review status and expected to take action on it in January.

EAST HANOVER, N.J. Swiss drug maker Novartis said its investigational drug is the first to show promise in a late-stage clinical trial for Cushing’s disease, a potentially fatal hormonal disorder.

RIDGEFIELD, Conn. A Food and Drug Administration advisory committee has recommended approval of a drug for patients with atrial fibrillation.

The FDA cardiovascular and renal drugs advisory committee voted unanimously to recommend approval for Boehringer Ingelheim's Pradaxa (dabigatran etexilate), for preventing strokes in atrial fibrillation patients. For the last 50 years, warfarin has been the only oral anticoagulant drug available for this purpose.

SOUTH SAN FRANCISCO, Calif. Biotech company Genentech has amended its application to the Food and Drug Administration seeking an additional approval for one of its drugs, which the FDA has deemed a “major amendment,” Genentech said Monday.

SAN DIEGO An advisory committee of the Food and Drug Administration has given a thumbs-down to a drug for treating obesity.

Eisai and Arena Pharmaceuticals said Thursday that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-5 to recommend against approval of the drug lorcaserin, saying clinical trial data did not adequately show that its benefits would outweigh its risks.

INGELHEIM, Germany Boehringer Ingelheim has started a late-stage clinical trial of a drug for treating breast cancer, the German drug maker said Friday.

The phase 3 trial, dubbed the “LUX-Breast 1” trial, will evaluate the drug afatinib in patients with advanced breast cancer. The drug is a tablet that BI said was the first to inhibit two chemicals involved in tumor growth -- the epidermal growth factor receptor, or EGFR, and the human epidermal receptor, also known as HER2.

WASHINGTON Emergent BioSolutions has landed a $51 million contract from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to develop a new anthrax vaccine.

In the first two years of the contract, Emergent will develop the final vaccine formulation and test its stability. HHS said it can extend the contract annually for up to three years to support scale-up and optimization for large-scale manufacturing, as well as additional animal studies needed to apply for Food and Drug Administration approval of the vaccine.

WOODCLIFF LAKE, N.J. The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said Friday.

The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.