The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
DUBLIN – Kiadis Pharma BV has parlayed its €31.9 million (US$37.2 million) stock-based acquisition of Cytosen Therapeutics Inc. last year, which involved an initial outlay of just €14.5 million worth of shares, into a €308 million payday with Sanofi SA.
The latest global regulatory news, changes and updates affecting biopharma, including: Retiring lawmakers urge 340B modernization; How human are ‘human antibodies’?; ANDA suitability MAPP updated; MHRA: Drug interactions possible with COVID-19.
Given the minimal accountability written into the 340B prescription drug discount program, a few biopharma companies recently began taking oversight into their own hands by demanding data claims or refusing to extend the mandated discounts to contract pharmacies.
HONG KONG – Sanofi SA has finally ended its clinical development of Hanmi Pharmaceutical Co. Ltd.’s efpeglenatide as a type 2 diabetes treatment, and the Korean firm is now considering how to move forward with developing the once-weekly GLP-1 receptor agonist, which employs Hanmi's Lapscovery delivery technology.
HONG KONG – Sanofi SA has finally ended its clinical development of Hanmi Pharmaceutical Co. Ltd.’s efpeglenatide as a type 2 diabetes treatment, and the Korean firm is now considering how to move forward with developing the once-weekly GLP-1 receptor agonist, which employs Hanmi's Lapscovery delivery technology.
DUBLIN – Sanofi SA and Regeneron Pharmaceuticals Inc. are terminating all further development in COVID-19 of their interleukin-6 receptor inhibitor, Kevzara, following the antibody’s failure to meet the primary endpoint, as well as a key survival endpoint.
Sanofi SA is acquiring Principia Biopharma Inc. in a $3.68 billion deal that brings Sanofi three clinical-stage BTK inhibitors and simplifies a partnership that began three years ago. Paris-based Sanofi plans to acquire all outstanding Principia common stock shares for $100 each at a $3.36 billion enterprise value. Sanofi will get SAR-442168 (PRN-2246), the brain-penetrant candidate at the heart of the deal. The agreement now gives Sanofi full control of the program, bringing a three-year partnership between the two companies to an end
In deals worth billions, Sanofi SA and Glaxosmithkline plc (GSK) have made new agreements this week to supply the U.S. and U.K. governments with a COVID-19 vaccine. The two companies also are in advanced discussions with the European Union to supply up to 300 million doses of a vaccine.
The industry's expanding quest for protein degraders grew a little larger on July 9 with Sanofi SA tapping Kymera Therapeutics Inc. to advance two new protein degrader programs, one of which will target IRAK4 in patients with immune-inflammatory diseases and another for an undisclosed target. Each program could yield multiple therapies.
