BIO 2019 Notebook: Sharpless On Pricing, Takeda M&A Strategy, FDA Cell And Gene Therapy Staffing
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; Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout; and CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates.
You may also be interested in...
While an orphan indication in the US and EU, IgAN accounts for 40% of glomerular disease in China; deal also confers rights in Hong Kong, Macau, Taiwan, Singapore. Also, Y-Biologics teams with Dualogics on bispecific antibodies for cancer.
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.
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.