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  • Latest efficacy studies support use of Amgen's Repatha in conjunction with statin

    THOUSAND OAKS, Calif. — Amgen on Monday announced a new analysis from the Repatha (evolocumab) cardiovascular outcomes study (FOURIER) that showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease.

  • BioDelivery Sciences’ longtime president, CEO to retire

    RALEIGH, N.C. — BioDelivery Sciences International will see its longtime president and CEO retire. The company announced Wednesday that Dr. Mark Sirgo, who has served in these roles since 2005, will be retiring at the end of 2017. He will remain vice chairman of the company’s board of directors. The company said that the board and Sirgo would work to find a successor in the coming months.

  • Octapharma gets FDA approval for new product strengths of NUWIQ

    HOBOKEN, N.J. — Octapharma USA today announced that the U.S. Food and Drug Administration has approved new product strengths for NUWIQ. The move potentially reduces the number of vials needed for hemophilia A patients, the company said.

  • Upsher-Smith launches new website for Qudexy XR

    MAPLE GROVE, Minn. — Upsher-Smith Laboratories on Monday announced the launch of its enhanced website for Qudexy XR (topiramate) extended-release capsules.

  • Lynzparza’s new tablet formulation gets FDA approval, expanded indication

    WILMINGTON, Del. — AstaZeneca and Merck’s Lynzparza (olaparib) tablets were approved by the Food and Drug Administration, as well as given an expanded indication by the regulatory agency.

  • FDA approves Pfizer’s leukemia drug Besponsa

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug from Pfizer, Besponsa (inotuzumab ozogamicin). The drug is indicated to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, or ALL.

  • Makers of first ALS drug in 22 years announce availability

    JERSEY CITY, N.J. — The first drug for ALS approved in 22 years is now available. Mitsubishi Tanabe Pharma America this week announced the introduction of its Radicava (edaravone), an intravenous treatment for ALS that the Food and Drug Administration approved on May 5.

  • Teva gets FDA clearance for QVAR RediHaler

    SILVER SPRING, Md. — The Food and Drug Administration has approved Teva’s QVAR RediHaler (beclomethasone dipropionate HFA), the company announced Monday. The QVAR RediHaler is a breath-actuated inhaler for the maintenance of asthma as a prophylactic treatment in patients ages 4 years and older.

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