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  • ProStrakan taps two companies to administer REMS program for Abstral

    ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

    ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.

  • MannKind receives complete response letter for Afrezza

    VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

    The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

  • BI purchases Amgen facility

    THOUSAND OAKS, Calif. — German drug maker Boehringer Ingelheim will purchase a manufacturing plant from U.S. biotech company Amgen, the two said.

    The plant, located in Fremont, Calif., is 100,000 sq. ft. and employs around 360 people. BI has been a contract manufacturer for Amgen for more than 10 years. Financial terms of the deal were not disclosed, though BI said it would purchase “substantially all” of the assets at the plant.

  • Genentech appeals FDA's plan to pull Avastin off market

    NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

    The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.

  • Genentech: Advanced skin cancer treatment boosts survival rate

    SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

    The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.

  • Novo Nordisk wins 2010 Good Design Award for NovoPen Echo

    CRAWLEY, England — An insulin pen for children made by Novo Nordisk has won a design award, the company said Wednesday.

    The Danish drug maker won the 2010 Good Design Award from the Chicago Athenaeum Museum of Architecture and Design and the European Centre for Architecture, Art, Design and Urban Studies for its NovoPen Echo, used to treat Type 1 diabetes. The annual award, which the two organizations have given since 1950, are the oldest and among the most coveted for design and innovation, Novo Nordisk said.

  • FDA OKs Natroba

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for head lice, the agency said Tuesday.

    The FDA approved Natroba (spinosad) topical suspension, made by ParaPro, a privately owned drug company based in Carmel, Ind. The drug is used to treat head lice infestation in patients ages 4 years and older.

  • Pfizer's Germano to speak at 2011 Armada Specialty Pharmacy Summit

    FLORHAM PARK, N.J. — Pfizer president and general manager for specialty care and oncology, Geno Germano, will deliver the “State of the Pharma/Biotech Industry Address” at the 2011 Armada Specialty Pharmacy Summit, Armada Health Care said Tuesday.

    The summit, which will take place in Las Vegas in May, is in its seventh year and is expected to bring 1,500 participants representing 400 specialty healthcare organizations, including specialty pharmacy providers, pharmaceutical and biotech companies, wholesale distributors and others.

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