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  • FDA approves Yescarta from Gilead's Kite

    FOSTER CITY, Calif. — The Food and Drug Administration has approved the first chimeric antigen receptor T cell, or CAR T, therapy for patients with certain types of lymphoma. Yescarta, from Gilead’s recently acquired company Kite, was approved to treat relapsed or refractory large B-cell lymphoma following two or more lines of systemic therapy.

  • Specialty drugs up share of per-capita spend as sales growth slows

    Even after the boom that the specialty pharmacy sector saw in 2014 with the introduction of new treatments for hepatitis C, the drug class continues to see its share of per-capita spending grow as manufacturers continue to develop more targeted therapies. The changes that the specialty space is seeing have been documented by the Quintiles IMS Institute, both in its report on the use of medicines in 2016 and its issue briefs on the drivers of drug expenditure and the oncology space.

  • With ruling, Restasis could soon face generic competition

    MARSHALL, Texas — Allergan’s recent patent claims on its Restasis eye drops were thrown out Monday with a ruling from the United States District Court for the Eastern District of Texas. The 135-page decision found that Allergan’s patent protection for the drug ended in 2014, and that “Allergan is not entitled to renewed patent rights for Restasis in the form of the second wave of patent protection.”

  • Amgen CEO named PhRMA board chairman-elect

    WASHINGTON — The Pharmaceutical Research and Manufacturers of America has new officers on its board of directors. The organization has named Amgen chairman and CEO Robert Bradway to the chairman-elect position, effective immediately, and named two more industry executives to the board.

  • FDA approves new formulation of Pfizer’s Lyrica

    SILVER SPRING, Md. — Pfizer’s Lyrica has an approved new formulation. The Food and Drug Administration on Thursday approved Lyrica CR (pregabalin) controlled-release tablets. 

    The tablets are indicated as a once-daily treatment for neuropathic pain associated with diabetic peripheral neuropathy and to manage postherpetic neuralgia. It was not approved for fibromyalgia management.

  • Lupin acquires Symbiomix Therapeutics

    MUMBAI, India — Lupin’s U.S. subsidiary’s latest acquisition is set to strengthen its pipeline for gynecologic drugs. The company has acquired Symbiomix Therapeutics for $150 million, which includes an upfront payment of $50 million and closed today.

  • Lilly launches Humalog Junior KwikPen

    INDIANAPOLIS — Eli Lilly’s latest introduction is making half-unit doses of insulin easier for patients with Type 1 and Type 2 diabetes. The company on Wednesday launched its Humalog Junior KwikPen, which it said is the only prefilled, disposable half-unit insulin pen. The Food and Drug Administration approved the product in June to treat diabetes.

  • FDA approves Novo Nordisk’s Fiasp fast-acting insulin

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new fast-acting mealtime insulin from Novo Nordisk. The agency granted approval to Fiasp to treat adults with diabetes.

    The drug is a formulation featuring the company’s NovoLog insulin aspart developed with the aim of achieving properties that more closely match the natural physiological insulin mealtime response of someone without diabetes.

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