Roche's Genentech is pairing up with Novartis to split the ex-U.S. rights to an Ophthotech eye drug, opting into an agreement that could be worth more than $1 billion.
Japan's Daiichi Sankyo and its associated company Plexxikon said the U.S. Food and Drug Administration (FDA) has approved cobimetinib for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib), the company said in a statement.
Just weeks after announcing a fresh batch of promising Phase III data, the FDA has handed Genentech and its biotech partner Exelixis an approval to market cobimetinib in combination with Zelboraf among a genetically defined group of melanoma patients.
This year is shaping up to be a pivotal one for Nimbus Therapeutics. Having pocketed $43 million from a clutch of big-name backers in March, the computational chemistry specialist has persuaded Roche's Genentech to license an interleukin-1 receptor-associated kinase 4 inhibitor program.
New Haven, CT-based Arvinas has hit a biotech trifecta. Over the past month the biotech grabbed recognition as a Fierce 15 company, signed up Genentech as its second marquee collaborator and now has garnered a $41.6 million B round to continue its pipeline development work.
Roche's Genentech is buying into Nimbus Therapeutics and its computer-driven approach to designing new drugs, partnering up on one of the company's programs in oncology and inflammation.
Genentech has added another piece of the trial puzzle for its MEK inhibitor cobimetinib. The big Roche subsidiary's partner Exelixis announced early Tuesday that the drug combined with Zelboraf hit the mark in a Phase III study, offering a statistically significant overall survival benefit among advanced melanoma patients carrying a BRAF V600 mutation.
Fresh on the heels of its inclusion in this year's Fierce 15, New Haven, CT-based Arvinas has pulled the wraps off a new partnership with Genentech that comes with a $300 million package of milestones.
Japan's Chugai Pharmaceutical and Switzerland's Roche's and its Genentech unit received U.S. FDA acceptance for a new drug application of alectinib for ALK positive advanced non-small cell lung cancer in patients for whom crizotinib is no longer an option.
Japan's Chugai Pharmaceutical said the U.S. FDA has granted a breakthrough therapy designation to candidate ACE910 to prevent bleeding episodes in hemophilia A patients aged 12 and older.