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Latest From Merck & Co., Inc.
After ODAC: The State Of Accelerated Approval At The US FDA
US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.
Merck’s Keytruda: The ‘Wall Of Data’ Still Holds After ODAC Look Back
Merck has pulled one Accelerated Approval indication for Keytruda already this year, and a second may have to be withdrawn as well. That will leave the product with 27 indications in the US – unless, of course, more are approved before the AA indications are formally pulled.
UK As New Global Base, Serum Institute Mulls Acquisition Or Greenfield Unit
After setting up a sales base in the UK, Serum Institute could consider an acquisition in Europe or investment in an Oxford facility as it ties up production for its multiple COVID-19 vaccines. Is Wockhardt’s Wrexham facility an option?
As Natco Ups The Ante Lilly Readies Voluntary Licensing For Olumiant
Eli Lilly responds with baricitinib donation plan and efforts to sew up royalty free voluntary licenses with local Indian firms as challenger Natco seeks a compulsory license for its version of the JAK inhibitor, which it is ready to launch.
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