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  • GSK's, Theravance's Anoro Ellipta receives FDA approval

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

    The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.

  • Actelion launches Valchlor

    SOUTH SAN FRANCISCO, Calif. – Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

    Actelion announced the launch of Valchlor (mechlorethamine), which the Food and Drug Administration approved in August for treating stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patient who have received skin-directed therapy before. Actelion acquired rights to the drug when it merged with Ceptaris Therapeutics. Accredo Specialty Pharmacy distributes the drug in the United States.

  • Mylan Specialty announces winners of anaphylaxis awareness campaign

    PITTSBURGH — Four school districts have won a competition sponsored by Mylan to raise awareness about dangerous allergic reactions, the company said Wednesday.

    Mylan, whose Mylan Specialty division makes the EpiPen injector pen for severe allergic reactions, known as anaphylaxis, announced the winners of the Raise Your Hand for Anaphylaxis Awareness competition, for which it hired actress Julie Bowen as a celebrity spokeswoman.

  • Amneal launches new GERD treatment

    BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

    Amneal announced Tuesday the launch of esomeprazole strontium delayed-release capsules in the 49.3-mg strength, which it is marketing in the United States under a contract with Hanmi Pharmaceutical Co. The drug is expected to begin shipping Wednesday in 30-count bottles.

  • NCPA: CMS policy change — pharmacies to affirmatively obtain consent from a beneficiary prior to shipping

    ALEXANDRIA, Va. — Nearly 1,200 seniors have complained to Medicare this year about a litany of problems with mail-order pharmacies, including shipping unneeded medication and going without medication due to delayed shipments, the National Community Pharmacists Association noted Tuesday citing documentation recently released by the U.S. Centers for Medicare & Medicaid Services.

  • Merck KGaA, National MS Society distribute $1.3 million for early-stage drug research

    NEW YORK — Three organizations will receive part of $1.3 million in funding that German drug maker Merck KGaA and the National Multiple Sclerosis Society are distributing for MS research.

    EMD Serono, the name the Merck KGaA uses in the United States to avoid confusion with U.S.-based Merck & Co., and the National MS Society said the money will help encourage early-stage drug discovery for the autoimmune disease.

  • EMD Serono releases redesigned injector pen for infertility

    ROCKLAND, Mass. — A redesigned version of an injector pen used to treat infertility is available for distribution in the United States, the manufacturer said Monday.

    EMD Serono, a subsidiary of German drug maker Merck KGaA, said that Gonal-f RFF Redi-ject, a disposable, pre-filled pen used for the drug Gonal-f RFF (follitropin alfa), had become available. The Food and Drug Administration approved the redesigned pen in October. Merck KGaA operates in the United States under the name EMD in order to avoid confusion with U.S.-based Merck & Co.

  • Endo acquires NuPathe for $105 million

    MALVERN, Pa. – Endo Health Solutions will acquire the maker of a patch used to treat migraines that received Food and Drug Administration approval at the beginning of this year.

    Endo said Monday that it would buy NuPathe for $105 million. In January, the FDA approved NuPathe's patch, Zecuity, a disposable, single-use, battery-powered transdermal patch that delivers the drug sumatriptan, the most widely prescribed migraine medication.

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