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  • AstraZeneca gets FDA nod for Calquence

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new lymphoma treatment from AstraZeneca. The company announced this week that its Calquence (acalabrutinib) had been approved to treat patients with mantle cell lymphoma in patients who have received at least one prior therapy.

  • CMP Pharma launches CaroSpir oral suspension

    FARMVILLE, N.C. — Following its August approval, CMP Pharma on Monday launched its CaroSpir, a spironolactone oral suspension. Company leadership said CaroSpir is the first approved oral liquid dosage form of the diuretic.

    The formulation is aimed at meeting the needs of patients with difficulty swallowing. Up to this point, CMP Pharma said these patients have relied on compounded formulations with limited shelf life and potential unreimbursed costs.

  • FDA approves new Bydureon formulation, auto-injector

    SILVER SPRING, Md. — The Food and Drug Administration has approved an auto-injector and new formulation of a once-weekly treatment for Type 2 diabetes from AstraZeneca. Bydureon BCise offers a single-dose auto-injector for adults with Type 2 diabetes whose blood sugar is uncontrolled on one or more oral medicines.

  • GSK Vaccines set to bring Shingrix, the latest shingles vaccination innovation, to market

    LONDON — GlaxoSmithKline on Friday announced that the Food and Drug Administration has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.

  • 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.

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