China green-lighted Bristol-Myers Squibb's Opdivo as a second-line non-small cell lung cancer treatment, making it the country's first immuno-oncology approval. Indivior seeks a U.S. court injunction to Dr. Reddy's just-approved Suboxone Film generic. Offering higher pay and an less-layered entrepreneurial environment, Chinese biopharma startups have recently attracted many Big Pharma executives. And more.
1. Bristol-Myers’ Opdivo ushers in a new era as the first I-O therapy approved in China
Bristol-Myers Squibb’s Opdivo just became the first immuno-oncology therapy approved in China. The approval, for second-line non-small cell lung cancer, is based on a phase 3 done predominantly on Chinese people. While BMS sets Opdivo’s price with authorities, applications from Merck’s rival Keytruda, along with a few local PD-1/L1 players, are also under review by China’s Drug Administration.
2. Dr. Reddy's forced to stop Suboxone generic rollout amid Indivior patent dispute
A patent dispute with Indivior has forced Dr. Reddy’s to halt its Suboxone Film generic rollout. Late last week, Dr. Reddy’s and Mylan both won U.S. nods for their copycats, but Mylan had made a confidential deal with Indivior on its launch timing. A U.S. court issued a temporary restraining order against Dr. Reddy’s. Indivior, knowing generics were coming, has crafted a plan in place to deal with substantial loss of market share when generics hit.
3. Big Pharma executives jump to China startups for higher pay and more say: report
Many former Chinese executives from multinational pharma companies have recently either jumped to domestic firms or started their own shops. The drivers behind their decisions: higher salary supported by handsome venture capital investments and more room for growth in an entrepreneurial environment, according to the Financial Times.
4. FDA pressured to revoke Takeda’s popular gout drug Uloric due to death concerns
Nonprofit consumer advocacy group Public Citizen is asking the FDA to remove Takeda’s gout drug Uloric from the U.S. market. The petition came after a postmarket study required by the FDA showed higher heart-related death risks for people on Uloric compared to an older drug. The FDA twice rejected the drug over cardiovascular risks before approving it in 2009.
Soon after resubmitting its Rituxan biosimilar for FDA approval, Celltrion has done the same for its Herceptin copycat. Both had been sidelined by the agency because of manufacturing problems. Celltrion said it expects approval within this year, and after that, its partner Teva will be responsible for commercial activities in the U.S. and Canada.
6. Sirtex accepts $1.4B buyout bid from Chinese consortium, expects to gain regulatory approval
Sirtex Medical accepted a $1.4 billion buyout offer from China’s CDH Investments and China Grand Pharmaceutical. The Australian biotech focuses on liver cancer, with its lead product SIR-Spheres, which are radioactive beads that target high doses of radiation to liver tumors.
7. FDA gives Indian drugmaker Glenmark its first approval for generics produced at U.S. plant
The FDA gave Indian generic drugmaker Glenmark its first supplemental Abbreviated New Drug Application approval for its manufacturing facility in Monroe, North Carolina, for the production of a generic version of GlaxoSmithKline's Malarone used to treat malaria.