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  • Regulatory NewsRegulatory News

    The Battle Over Neulasta Biosimilars in the US: What's Coming in 2018

    2016 and 2017 were difficult years for companies trying to win US Food and Drug Administration (FDA) approval for biosimilars of Amgen's blockbuster for treating side effects from chemotherapy. Last June, Coherus Biosciences received a complete response letter (CRL) for its biosimilar of Neulasta (pegfilgrastim), with FDA requesting "a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing re...
  • Regulatory NewsRegulatory News

    House E&C Offers Recommendations to Improve 340B Drug Pricing Program

    The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues and recommendations to improve the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients. The 80-page report follows an October House E&C hearing in which hospital executives pushed back on the idea that the 340B program should be narrowed o...
  • Regulatory NewsRegulatory News

    340B: Health System Execs Push Back on Narrowing of Drug Discount Program

    The House Energy & Commerce's subcommittee on Oversight and Investigations on Wednesday discussed the federal 340B drug discount program, which provides participating hospitals and other medical providers deep discounts on outpatient drugs.  Background In 1992, Congress created the 340B program to mandate that pharmaceutical manufacturers provide discounts for certain drugs, which can range between 25% and 50% for average wholesale prices. The Health Services and ...
  • Regulatory NewsRegulatory News

    Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals

    The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program. The finalization of the rule, first proposed in 2010, follows fierce criticism of the plan from industry groups PhRMA, BIO and companies including Bayer and Teva. The final rule calls on drug companies to: calculate the 340B ceiling price on a quarterly...