Specialty Pharmacy

WESTON, Mass. — An experimental drug for Lou Gehrig's disease made by Biogen Idec has failed in a late-stage clinical trial, the drug maker said Thursday.

Biogen announced results of its phase-3 trial of dexpramipexole in patients with the disease, known technically as amyotrophic lateral sclerosis, or ALS. The drug failed to improve functioning and survival in patients and failed to show efficacy in key secondary endpoints as well, the company said.

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

NEW YORK — In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years. The wave of approvals poises pharmaceutical makers to see big gains after billions in losses in recent years to generic drug makers because of patent expirations.

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.

FRAMINGHAM, Mass. — New England Compounding Center announced the company has filed for Chapter 11 bankruptcy protection under the U.S. Bankruptcy Code. The filing seeks to establish a fund to compensate individuals and families affected by a nationwide meningitis outbreak. In papers filed with the United States Bankruptcy Court for the District of Massachusetts, the company said its goal is to provide a greater, quicker, fairer payout to its creditors than could be achieved through piecemeal litigation.

FLINT, Mich. — Diplomat Specialty Pharmacy on Thursday announced that CEO and co-founder Phil Hagerman has been named one of 13 "Michiganders to Watch" by MLive Media Group, a collaborative network of local and statewide Michigan news outlets. The MLive profile on Hagerman can be viewed here. 

MEMPHIS  — A national drug shortage has been linked to a higher rate of relapse among children, teenagers and young adults with Hodgkin lymphoma enrolled in a national clinical trial, according to research led by St. Jude Children's Hospital.

The study found the estimated two-year cancer-free survival for patients enrolled in the study fell from 88% to 75% after the drug cyclophosphamide was substituted for mechlorethamine for treatment of patients with intermeidiate- or high-risk Hodgkin lymphoma. The study was launched before the drug shortages began.