Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.
A medicine Stealth Biotherapeutics Inc. has been developing for the potential treatment of primary mitochondrial myopathy (PMM) missed the co-primary endpoints of a key phase III trial, sending company shares (NASDAQ:MITO) down 65.9% to close at $4.75 on Friday.
Roche Holding AG took an interest in immunometabolism specialist Rheos Medicines Inc. even before its March 2018 launch. Now, less than two years later, it has tapped Cambridge, Mass.-based company, founded by Third Rock Ventures, to identify and develop an undisclosed number of new therapies for autoimmune and inflammatory disease.
The therapeutic value of LSD, the psychedelic muse behind countless books, music and works of visual art, has hit an altogether more prosaic milestone, albeit toward a still far-out end: A phase I study, sponsored by U.K.-based Eleusis Pharmaceuticals Ltd., found low doses safe and well-tolerated, setting the stage for new tests of the approach as a disease-modifying therapy for Alzheimer’s disease (AD).
Little more than a month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously supported approval of Amarin Corp. plc's fish oil-based Vascepa (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adults with elevated triglyceride levels, the agency has greenlighted a label expansion for the already-approved medicine, allowing for its adjunctive use in that indication.
Transgene SA is quitting development of one of its lead therapeutic vaccines after a combination of the candidate, TG-4010, with chemotherapy and Opdivo missed its primary endpoint in a phase II trial evaluating the combination as a first-line treatment for certain advanced non-squamous non-small-cell lung cancers.
New commitments by investors in Boston-based Omega Funds have put the firm on track to deploy $438 million into new and existing life sciences companies during what Managing Director Otello Stampacchia called "the most exciting time to be investing in life sciences in a generation." The final close adds to what's becoming a busy season for fund rollouts, punctuated so far this month by announcements of closing for a new series A-focused $210 million fund from Perceptive Advisors and a new $115 million med-tech-focused fund from Israel's Peregrine Ventures.
ORLANDO, Fla. – New research on sutimlimab, an investigational complement pathway inhibitor under development by Sanofi SA's Bioverativ unit, showed substantial benefits for people with the rare autoimmune disorder cold agglutinin disease (CAD).
