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Specialty Pharmacy

  • FDA approves 39 new drugs in 2012, a 16-year high

    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.

  • New England Compounding Center files for Chapter 11 bankruptcy protection

    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.

  • FDA approves NDA for Teva's topotecan injection

    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.

  • Mylan generic heart drug suit against FDA dismissed

    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.

  • Diplomat Specialty Pharmacy's Phil Hagerman named one of 13 'Michiganders to Watch'

    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. 

  • Study: Drug shortage linked to greater relapse risk in young Hodgkin lymphoma patients

    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.

  • Walgreens Infusion Services selected as a contracted provider of just-approved long-term treatment for SBS

    DEERFIELD, Ill. — Walgreens Infusion Services has been selected as a contracted provider of a new injectable medication that helps patients with short bowel syndrome get more — or all — of their nutrients orally, reducing their dependence on intravenous parenteral nutrition, the division announced Wednesday.

  • FDA approves biotech drug for reducing symptoms of severe chickenpox infection

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for reducing the severity of chickenpox symptoms, the agency said Friday.

    The FDA announced the approval of Cangene Corp.'s Varizig (varicella zoster immune globulin [human]) for varicella zoster, the virus that causes chickenpox. The FDA said Varizig was the only FDA-approved immune globulin for the virus after exposure.

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