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  • FDA approves expanded use of Saphris

    WHITEHOUSE STATION, N.J. Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.

    Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.

  • GSK inks deal with Lonza, announces CFO's exit

    LONDON Swiss drug maker Lonza will help British drug maker GlaxoSmithKline manufacture five biotech drugs in early- and mid-stage clinical trials, the two companies said Wednesday.

     

    Lonza will manufacture clinical trial batches of the drugs, all monoclonal antibodies in phase-1 and phase-2 testing, and provide additional access to manufacturing capacity so GSK can fulfill future demands. The two companies said other details of the agreement remain confidential.

     

     

  • Silenor now available by prescription

    SAN DIEGO Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company said Tuesday.

     

    Somaxon announced the availability of Silenor (doxepin), which received approval from the Food and Drug Administration in March as a treatment for insomnia characterized by difficulty with sleep maintenance.

     

     

  • Cost of health care on the rise

    WASHINGTON Workers on average are paying nearly $4,000 this year toward the cost of family health coverage — an increase of 14%, or $482, above what they paid last year, according to the benchmark "2010 Employer Health Benefits Survey" released Thursday by the Kaiser Family Foundation and the Health Research and Educational Trust.

  • Bionovo, Berkeley researcher receive NIH grant to develop obesity drugs

    EMERYVILLE, Calif. The National Center for Complementary and Alternative Medicine's small-business technology transfer program, part of the National Institutes of Health, has given a researcher and a drug maker a grant to develop drugs for obesity and metabolic syndrome in women.

     

  • FDA expedites review of Alimera's Iluvien

    ATLANTA The Food and Drug Administration has granted priority review for a diabetic macular edema treatment.

  • Allergan's elevated intraocular pressure treatment gets nod from FDA

    IRVINE, Calif. Allergan's optimized reformulation of Lumigan has received approval from the Food and Drug Administration, the drug maker said Wednesday.

    Lumigan 0.01% (bimatoprost ophthalmic solution) is a first-line therapy indicated for the reduction of elevated intraocular pressure with open-angle glaucoma or ocular hypertension, Allergan said. Lumigan 0.01% will be available in fourth quarter 2010 as the newest addition to Allergan’s comprehensive glaucoma portfolio.

     

  • IMS Health exec to NACDS conference attendees: Expect opportunities, uncertainties for drug market

    SAN DIEGO The U.S. drug market will present opportunities as well as uncertainties over the next decade, according to remarks made by IMS Health VP industry relations Doug Long at the National Association of Chain Drug Stores’ 2010 Pharmacy and Technology Conference held here on Monday.

     

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