BIO 2019 Notebook: Merck; Out-Licensing Deals; RMAT
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; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies.
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Fosmanogepix, with safety and efficacy clearances to continue Phase II, could provide an IV-to-oral option for patients with potentially lethal Candida fungal infections.
CF-focused Vertex will buy Exonics and expand a collaboration with CRISPR Therapeutics, with plans to develop therapies for DMD and myotonic dystrophy type 1. Merck acquires TGFβ-focused Tilos, while Achaogen offloads most of its assets at auction.
BIO 2019 Notebook: Merck On Finding The Right Balance, Sandoz On The Next Wave Of Biosimilars, NORD On Patient Engagement
News and views from day three of the BIO International Convention: Merck’s Frazier champions both social justice and capitalism; Sandoz’s Pike thinks refinement of clinical data requirements will encourage biosimilar sponsors to target more moderate-selling biologics; National Organization for Rare Disorders’ Salstonstall sees impact from FDA reviewers talking to patients.