The European Union’s drug regulator has recommended approval of AstraZeneca and Sanofi’s Beyfortus to prevent respiratory syncytial virus infection in newborns and babies, the companies said Friday. The antibody drug would be the first to be used broadly in those children.
Beyfortus is recommended as a preventive treatment for babies in their first RSV season, which like for colds and influenza runs from late autumn through spring. The drug is given as a single injection and, the companies report, reduced RSV infections requiring medical attention by 75% compared to a placebo in a Phase 3 trial.
The recommendation from the European Medicines Agency’s human drugs committee needs to be confirmed by the European Commission, which has two months to do so. READ MORE
By Jonathan Gardner
Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals in a deal valued at $576m. Under the deal, the company will buy all shares of Concert common stock through a tender offer for $8.00 per share in cash upfront payment.
The Food and Drug Administration on Thursday approved Novo Nordisk’s diabetes pill Rybelsus as an initial treatment to lower blood sugar levels, a label expansion that will allow it to compete more directly with other oral drugs from Merck & Co. and Eli Lilly.
Since making an ill-advised $63 billion buy of Monsanto in 2018, Bayer has faced heaps of pressure from investors that have called for the company to oust its leadership and to restructure. Now comes new pressure from a familiar source. Bluebell Capital Partners has bought an undisclosed stake in the company and is agitating for a breakup, sources told Reuters.