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  • Reports: Financial analysts say new cholesterol guidelines could mean lower use of still-experimental cholesterol-lowering biologics

    NEW YORK — New cardiovascular health guidelines released this week could dampen the potential popularity of an up-and-coming class of cholesterol drugs, according to published reports.

  • Number of drugs approved by FDA in 2013 fewer than 2012, but higher in value, study finds

    NEW YORK — The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

  • FDA grants special status to GW Pharmaceuticals' drug for rare epileptic disorder

    LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

    GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.

  • FDA approves one-week antifungal drug made by Valeant

    LAVAL, Quebec — The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

    The company announced the FDA approval of Luzu (luliconazole) cream in the 1% strength for treatment of athlete's foot, jock itch and ringworm in adults.

  • Effective marketing needed to ensure uptake of Merck's newest HPV vaccine, report finds

    LONDON — An experimental human papillomavirus vaccine made by Merck could offer a boost to the vaccine market, but the company will have to use effective marketing efforts to ensure uptake, according to a new study.

    The London-based research and consulting firm GlobalData said Merck's V503 vaccine, currently in phase-3 clinical trials, had strong potential because it protects against five HPV types not covered by current vaccines and demonstrates 97% efficacy against precancerous lesions caused by the additional virus types it contains.

  • Avella Specialty Pharmacy joins limited distribution network for Imbruvica

    PHOENIX — Drug makers Johnson & Johnson and Pharmacyclics have added Avella Specialty Pharmacy to their limited-distribution network for a newly approved blood cancer drug.

    Avella said Thursday that it had joined the limited-distribution network for Imbruvica (ibrutinib), which the Food and Drug Administration approved this week for mantle cell lymphoma. Avella is one of five specialty pharmacies to join the network, the company said.

  • New law encourages schools to stock epinephrine for allergic reactions

    NEW YORK — New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

    Barack Obama signed the School Access to Emergency Epinephrine Act, under which schools could maintain a supply of epinephrine, which is the only first-line treatment for life-threatening allergic reactions, also known as anaphylaxis.

    The legislation received praise from Mylan, a drug maker that produces EpiPen, a popular epinephrine injector pen.

  • J&J, Pharmacyclics add Diplomat to limited distribution network for Imbruvica

    FLINT, Mich. — Diplomat has joined the limited distribution network for a rare form of blood cancer drug marketed by Johnson & Johnson and Pharmacyclics.

    The specialty pharmacy said Thursday that J&J subsidiary Janssen Biotech and Pharmacyclics had added it to the limited distribution network for Imbruvica (ibrutinib), which the Food and Drug Administration approved this week for mantle cell lymphoma.

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