BIO 2019 Notebook: Merck On Finding The Right Balance, NORD On Patient Engagement, Sandoz On The Next Wave Of Biosimilars
News and views from day three of the BIO International Convention: Merck’s Frazier champions both social justice and capitalism; National Organization for Rare Disorders’ Salstonstall sees impact from FDA reviewers talking to patients; Sandoz’s Pike thinks refinement of clinical data requirements will encourage biosimilar sponsors to target more moderate-selling biologics.
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Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’
News and views from day two of the BIO International Convention: US FDA's Sharpless decries the focus on the price of "medical miracle" Zolgensma; CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates; and Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout.
News and views from day one of the BIO International Convention: Merck reaffirms commitment to antibiotic space the same day Zerbaxa picks up a new indication; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018.