Specialty Pharmacy

NEW YORK Pfizer has halted a late-stage trial of a drug therapy in men with prostate cancer, the drug maker said.

Pfizer announced the discontinuation of “SUN 1120,” a phase-3 trial of Sutent (sunitinib malate) combined with the generic drug prednisone in men with advanced castration-resistant prostate cancer that had progressed despite chemotherapy. An analysis of data from the trial found that the men were not more likely to improve overall survival when taking the two drugs together than when they took prednisone alone.

NEW YORK The Hart-Scott-Rodino waiting period for Bristol-Myers Squibb’s acquisition of Seattle-based biotech company ZymoGenetics has expired, enabling Bristol’s acquisition to go through, the drug maker said Tuesday.

The drug maker announced the deal to acquire ZymoGenetics for $885 million, or $9.75 per share, earlier this month.

RARITAN, N.J. An investigational drug made by Johnson & Johnson for treating pain showed significant reduction in pain intensity compared with placebo in patients with moderate to severe lower back pain, according to results of a late-stage clinical trial announced Monday.

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.

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.