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is enrolling patients for its Phase 3 study at a slower clip than expected, according to FierceBiotech.
—Hammered by two study failures this month, Redwood City, CA, cancer drug developer OncoMed (NASDAQ: OMED) said it would lay off half its workforce and focus on earlier- stage compounds in its pipeline.
FDA: A WHOLE LOT OF YES
—The Senate Health, Environment, Labor & Pensions committee voted 14-9 to send Scott Gottlieb’s nomination for FDA commissioner to the full Senate for a final vote. The vote was along party lines save for two Democrats who supported Gottlieb.
—BioMarin Pharmaceutical (NASDAQ: BMRN) notched FDA approval for cerliponase alfa (Brineura), the first drug ever to treat the rare genetic Batten disease. BioMarin announced an annual list price of $702,000. European regulators have seemed favorable to the drug, as well, and will issue a final decision by the end of June.
—The FDA also approved the use of regorafenib (Stivarga) from Bayer HealthCare to treat advanced liver cancer. Regorafenib is already approved for stomach and colon cancer.
DEALS OF THE WEEK
—-Becton Dickinson (NYSE: [[ticker: BD]]), the Franklin Lakes, NJ-based medical technologies company, announced it would acquire Murray Hill, NJ-based medical device maker C.R. Bard in a $24 billion deal intended to diversify its portfolio and expand its international footprint.
—Cambridge, MA-based Akebia Therapeutics (NASDAQ: AKBA) expanded its partnership with Otsuka Pharmaceutical that was originally signed last year. Otsuka is paying $208 million for expanded rights to the experimental anemia pill vadadustat in Europe, China, and other countries. Akebia could receive $865 million more in downstream payments. Its shares were up more than 33 percent.
—Amgen (NASDAQ: AMGN) reworked its alliance with Novartis (NYSE: NVS) on erenumab, an experimental drug that could soon be the first of a wave of new therapies meant to prevent migraines. Novartis now shares U.S. rights to the drug with Amgen, which as FierceBiotech explains here, analysts took as a sign that Amgen is hedging its bet on the drug’s market potential.
—The Bill & Melinda Gates Foundation led a $45.5 million Series D round for Waltham, MA-based Arsanis, developer of antibodies for dangerous bacterial and viral infections co-founded by serial entrepreneur Tillman Gerngross.
—The Gates Foundation also said it was working on a nonprofit medical research institute, to be based in Seattle and Boston, to work on treatments for diseases in the developing world.
—San Diego-based Forge Therapeutics raised a $15 million Series A round to bring into clinical trials a drug that could treat drug-resistant infections.
—Sienna Biopharmaceuticals of Westlake Village, CA, raised a $40 million B round to apply to its pipeline of drugs for psoriasis and other skin conditions.
—Bay Area firm BridgeBio Pharma, which creates companies mainly around single drug assets, rolled out its latest, Eidos Therapeutics, with $27 million in funding. Eidos is built around a drug for the rare transthyretin amyloidosis, in which misfolded proteins build up in the heart and nerves.
—After steering Sarepta Therapeutics (NASDAQ: SRPT) towards the controversial first-ever approval for a Duchenne muscular dystrophy drug, president and CEO Ed Kaye will resign on Sept. 20 “or some other future date,” according to a regulatory filing. Kaye will stay on as a board member and advisor to Sarepta afterwards.
—For the first time, Cambridge-based Moderna Therapeutics published data, in humans, for one of its messenger RNA drug therapies—a new and unproven type of drugmaking. The study, published in the journal Molecular Therapy, tested an mRNA vaccine for the flu virus in 23 human subjects. The Wall Street Journal has more on the results here.