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
In 2017, Sanofi partnered with the Lebanon, New Hampshire-based ImmuNext to develop an antibody for autoimmune diseases like lupus and multiple sclerosis, which included giving Sanofi a worldwide license to develop frexalimab. The agreement involved milestone payments upto $500 million.
Global manufacturer for the pharmaceutical, biotech and nutraceutical markets, Lonza has announced that it has acquired Synaffix, a biotech company focused on the commercialisation of its clinical stage technology platform for the development of antibody-drug conjugates (ADCs).
In its hunt for the new head of its pharmaceutical systems business—which makes syringes, self-injection systems and other drug delivery devices for 70% of the top 100 drugmakers in the world, according to the company—BD landed on a candidate with plenty of experience among that customer group.