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  • Garamycin ophthalmic solution enters market

    NEW YORK — Fera Pharmaceuticals has launched an ocular bacterial infections treatment.

    The company announced the launch of Garamycin (gentamicin sulfate) ophthalmic solution USP, designed to treat such infections as conjunctivitis, keratitis and blepharitis.

    Last year, Fera broadened its Garamycin product offerings with the launch of preservative-free Garamycin ophthalmic ointment.

  • Study: Insulin lispro premixed insulin analogs may be more cost-effective Type 2 diabetes treatment

    SAN DIEGO — An insulin product made by Eli Lilly appears likely to be more cost-effective than long-acting insulin analog, according to a study presented Friday at the American Diabetes Association’s 71st Scientific Sessions in San Diego.

    The company conducted a study comparing the cost-effectiveness of LAIA, insulin lispro mix 75/25 and insulin lispro mix 50/50 in patients with Type 2 diabetes. Lilly sells insulin lispro under the brand name Humalog.

  • FDA accepts regulatory filing for Prochieve

    LIVINGSTON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

    Columbia Labs and Watson Pharmaceuticals announced Monday that the FDA would review their application for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the third trimester of pregnancy.

  • Novo Nordisk's Victoza helps patients achieve blood-sugar control when switching from exenatide or sitagliptin

    SAN DIEGO — Novo Nordisk unveiled data from two extension studies at the 71st annual Scientific Sessions of the American Diabetes Association in San Diego that show its diabetes drug, when combined with other medications, may help patients achieve blood-sugar control.

    The drug maker found that combining Victoza (liraglutide [rDNA origin] injection) with metformin and/or sulfonylurea helped patients achieve blood-sugar control.

  • Adding Byetta to diabetes regimen could cut heart failure risk

    SAN DIEGO — Use of a drug for Type 2 diabetes made by Eli Lilly and Amylin Pharmaceuticals may lower patients’ risk of heart failure, according to a new study.

    The study of more than 778,000 patients taking the injected drug Byetta (exenatide) found that adding the drug to a pre-existing diabetes regimen, especially if that regimen included insulin, was associated with reduced likelihood of heart failure. Results were presented Saturday at the 71st Scientific Sessions of the American Diabetes Association in San Diego.

  • FDA accepts Endo's resubmission for Opana ER

    CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

    The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

  • FDA panel recommends approval of Shire's Firazyr

    DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.

    Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.

    HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.

  • BMS donates grants to help African-American women fight Type 2 diabetes

    NEW YORK — The charitable arm of Bristol-Myers Squibb has awarded five grants totaling $1.5 million to organizations that encourage African-American women with Type 2 diabetes to better manage their disease.

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