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  • FDA gives tentative approval to Intelliject device

    RICHMOND, Va. — The Food and Drug Administration has given tentative approval to an emergency treatment for severe allergic reactions made by Intelliject, the drug maker said.

  • Merrimack gets orphan drug designation for pancreatic cancer treatment

    CAMBRIDGE, Mass. — The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.

    Merrimack announced that it received the designation for MM-398, described as a novel, stable, nanotherapeutic encapsulation of the chemotherapy drug irinotecan.

  • Federal court upholds Lilly patent

    INDIANAPOLIS — A federal court has upheld Eli Lilly's patent covering a drug used to treat attention deficit hyperactivity disorder, Lilly said Friday.

    Lilly said the U.S. Court of Appeals for the Federal Circuit overturned a ruling by the U.S. District Court for the District of New Jersey that had invalidated Lilly's patent for Strattera (atomoxetine) in a patent infringement case that Lilly had filed against generic drug maker Actavis, when the latter sought regulatory approval for a generic version of Strattera.

  • Lilly, Lupin enter diabetes partnership

    NEW DELHI — Eli Lilly’s India division and Indian generic drug maker Lupin will distribute Lilly’s insulin products in India and Nepal under an agreement between the two companies announced Friday.

    Under the collaboration, Lilly and Lupin will promote and distribute Huminsulin R, Huminsulin NPH, Huminsulin 50/50, Huminsulin 30/70 and Humapen Ergo II. The companies said the deal would double the current customer base.

  • FDA approves subcutaneous formulation of Orencia

    PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

    The New York-based drug maker said the approval of Orencia (abatacept) for subcutaneous injection in patients with moderate to severe RA made it the first biotech drug for RA available in self-injectable and intravenous infusion formulations.

  • Teva launches authorized generic of Seasonique

    JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

    Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).

    The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.

  • FDA to Eisai: Redo application for perampanel

    WOODCLIFF LAKE, N.J. — The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

    The drug maker said the FDA issued a refusal to file letter in response to its application for perampanel, designed to treat partial-onset seizures in patients with epilepsy. In the letter, the FDA requested reformatting and reanalyses of some datasets, though Eisai said new studies probably were unnecessary.

  • Merck announces plans to trim workforce

    WHITEHOUSE STATION, N.J. — Merck disclosed plans to reduce its workforce by 12% to 13% by the end of 2015, the company announced Friday in its second-quarter earnings release.

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