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  • Novo Nordisk names new CEO

    BAGSVAERD, Denmark - Novo Nordisk on Thursday announced that Lars Rebien Sørensen, president and CEO, will retire from the company by the end of 2016. Lars Fruergaard Jørgensen, currently EVP and head of corporate development, will succeed him, effective Jan. 1, 2017.

    The company also announced a number of other executive-level changes, effective immediately.

  • FDA warns against combined use of opioids and benzodiazepines

    SILVER SPRING, Md. - The U.S. Food and Drug Administration announced Wednesday that it is requiring class-wide changes to drug labeling, including patient information, for almost 400 products to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines.

  • 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
     
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