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  • FDA approved 22 new drugs in lower-than-average 2016

    SILVER SPRING, Md. — The Food and Drug Administration’s Center for Drug Evaluation and Research’s number of new drug approvals came in low in 2016, according to the agency’s year-end review of the new therapies that passed regulatory muster. The number of drugs the FDA approved last year, 22, is less than half of the 45 approved in 2015 and lower than the average of the last 10 years of approvals, which is 29. 
     

  • Female Health Company names chief commercial officer

    MIAMI — The Female Health Company/Veru Healthcare on Thursday named Brian Groch the company's chief commercial officer. He will report to Mitchell Steiner, president and CEO of The Female Health Company/Veru Healthcare.

  • Regeneron names new SVP portfolio management

    TARRYTOWN, N.Y. — Regeneron Pharmaceuticals announced Wednesday the addition of Dr. Jay Markowitz to its leadership team as its new SVP portfolio management. He joins the pharma company from Capital World Investors, where was a U.S. pharmaceutical and biotechnology analyst and portfolio manager. 
     

  • Sanofi announces U.S. availability of Soliqua 100/33

    PARIS — Sanofi on Wednesday announced the U.S. availability of its Soliqua 100/33  (insulin glargine 100 units/mL and lixisenatide 33 mcg/mL) injection pen. The drug, approved by the Food and Drug Administration in November, is indicated to treat adults with Type 2 diabetes that’s inadequately controlled on basal insulin or lixisenatide. 
     

  • Forbes: Pharma innovation getting harder as approvals fall

  • Sanofi sues Novo Nordisk over diabetes drug availability claims

    BRIDGEWATER, N.J. — Sanofi filed a lawsuit against Novo Nordisk for allegedly falsely claiming Sanofi insulin drugs would no longer be available for many U.S. patients, in an effort to promote Novo Nordisk’s competing drug, Reuters reported.

  • FDA approves Biogen’s spinal muscular atrophy drug

    WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Biogen’s Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.

  • FDA approves first continuous glucose monitoring system that does not require fingerstick test

    WASHINGTON, D.C. — The U.S. Food and Drug Administration approved its first continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation via a traditional fingerstick test. The FDA announced it expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.

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