Immunogen Inc. said the FDA wants yet another phase III, randomized trial for mirvetuximab soravtansine in patients with high folate receptor alpha-positive, platinum-resistant ovarian cancer, so the company is prepping a redesigned study for a launch later this year. Read More
DUBLIN – Symphogen A/S's main shareholders are putting together a rescue package for the privately held antibody developer comprising DKK390 million (US$58.5 million) in new equity funding, combined with a DKK182 million debt-to-equity conversion. The move would involve a complete write-off of the company's existing share capital, which would cover accrued losses. All warrants would also be canceled. Read More
Rather than develop vonoprazan in the U.S., Europe and Canada on its own, Takeda Pharmaceutical Co. Ltd. decided to spin the drug out into a new company, Phathom Pharmaceuticals Inc., with the help of venture capitalists at Frazier Healthcare Partners. Read More
The congressional bipartisan commitment to tame U.S. drug prices is being put to the test Thursday when the House is scheduled to vote on a legislative package combining bipartisan bills aimed at increasing prescription drug competition with definitively partisan measures intended to reinvigorate the exchange provisions of the Affordable Care Act (ACA). Read More
Rostock, Germany-based Centogene AG has unveiled a 24-month global study to look at the genetic factors in Parkinson's disease (PD), which affects about 1% of individuals older than 60. Read More
TEL AVIV, Israel – It's long been known that academia and industry, two key actors in the development of new products for the medical technology and biotechnology sectors, have very different priorities and approaches to research and products. The ongoing effort to bridge the gap between those differences to eliminate waste in the system and develop more new and efficient products was a key focus of the MIXiii Biomed conference this week. Read More
Overturning a ruling from a district court judge, the U.S. Court of Appeals for the Federal Circuit Wednesday invalidated two patents protecting Mississauga, Ontario-based Nuvo Pharmaceuticals Inc.'s Vimovo (naproxen/esomeprazole magnesium), clearing the way for generics of the gastric-friendly nonsteroidal inflammatory drug. Read More
Principia Biopharma Inc., of South San Francisco, said it is expecting a $30 million milestone payment, triggered by partner Sanofi SA, of Paris, dosing the first patient in a phase IIb trial of SAR-442168 in relapsing multiple sclerosis. Read More
Ideaya Biosciences Inc., of South San Francisco, disclosed plans to raise $70 million in an IPO by offering 5 million shares at a price range of $13 to $15. The company plans to list on Nasdaq under the symbol IDYA. J.P. Morgan, Citi and Jefferies are the joint bookrunners on the deal, expected to price next week. Read More
Beam Therapeutics Inc., of Cambridge, Mass., appointed Christine Bellon senior vice president, chief legal officer, Susan O'Connor chief human resources officer, Suzanne Fleming senior vice president, finance and Courtney Wallace senior vice president, head of business development and strategy. Read More
