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  • 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. 
     

  • 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. 
     

  • Forbes: Pharma innovation getting harder as approvals fall

  • 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.

  • 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 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.

  • Janssen seeks approval of Simponi Aria for psoriatic arthritis and ankylosing spondylitis

    HORSHAM, Pa. — Janssen Biotech submitted two Supplemental Biologics License Applications to the U.S. Food and Drug Administration seeking approval of its Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis. Psoriatic arthritis and ankylosing spondylitis are chronic, systemic inflammatory conditions that combined affect more than 2 million Americans.

  • Walgreens expands availability of naloxone without a prescription

    DEERFIELD, Ill. — Walgreens has expanded the availability of prescription-free naloxone to 33 states and the District of Columbia.

    The medication can be dispensed in accordance with each state’s pharmacy regulations at nearly 5,800 Walgreens pharmacies. Naloxone can be used in the event of an overdose to reverse the effects of heroin or other opioid drugs, and is administered by injection or nasal spray.

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