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  • FDA approves Erelzi, a biosimilar to Enbrel

    WASHINGTON -- The U.S. Food and Drug Administration has approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases.

    Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
    Erelzi is administered by injection for the treatment of:

  • Seqirus' Afluria Quadrivalent influenza vaccine approved by FDA

    CAMBRIDGE, Mass. - Seqirus announced today that the U.S. Food and Drug Administration has approved Afluria Quadrivalent (Influenza Vaccine) for use in persons 18 years of age and older. Afluria Quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

  • FDA rejects Amgen’s application for Parsabiv

    THOUSAND OAKS, Calif. — The Food and Drug Administration has rejected Amgen’s application for the approval of its Parsabiv (etelcalcetide) , issuing a Complete Response Letter, the company said Wednesday. The drug is aimed at treating secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

  • Mylan takes steps to reduce patients costs for EpiPen, increase access
    HERTFORDSHIRE,  England and PITTSBURGH — Following recent scrutiny on the increased price of its EpiPen epinephrine auto-injector, Mylan on Thursday announced new steps it was taking to make the product more affordably accessible. The company has introduced a $300 savings card and increased eligibility for its patient assistance program while continuing to donate EpiPens through its EpiPen4Schools program. 
     

  • Pfizer to acquire AstraZeneca’s small-molecule anti-infectives
    NEW YORK — Pfizer announced Wednesday that it would be acquiring the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infectives business, largely outside the United States. 
     

  • CVS Health Research Institute study touts savings through adherence interventions
    CVS Health Research Institute study touts tailored adherence interventions
     

  • Seqirus targets senior population with new flu shot

    HOLLY SPRINGS, N.C. - Seqirus has begun shipping FLUAD, the company announced Tuesday, for the 2016-2017 flu season since gaining approval from the Food and Drug Administration late November last year. FLUAD is the first and only adjuvanted seasonal influenza vaccine approved in the United States, and was specifically developed to help protect adults aged 65 and older from the flu.

  • Mayne Pharma acquires dermatology foam portfolio from GSK
    GREENVILLE, N.C. — Mayne Pharma on Thursday announced that it had acquired a portfolio of dermatology foam products from GSK in $50.1 million deal. Among the portfolio’s products are U.S. rights to acne treatment Fabior (tazarotene) foam and plaque psoriasis treatment Sorilux (calcipotriene) foam. The company also gains the Canadian rights to Luxiq and Olux-E, as well as Mexican rights to betamethasone foam. 
     
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