Taking a strong stance against drug production violations, China fined Changchun Changsheng Life Sciences $1.3 billion. As pricing pressure mounts on the insulin market, Merck & Co. and Samsung Bioepis have jettisoned a Lantus biosimilar project. Looking to further take advantage of booming cancer research in the U.S., Taiho swelled its VC fund sixfold to $300 million.
China's drug regulator handed Changchun Changsheng Life Sciences a whopping 9.1 billion Chinese yuan ($1.32 billion) penalty over a high-profile vaccine scandal that provoked nationwide anger. Changsheng had seriously violated vaccine manufacturing rules and falsified data to cover its tracks. Separately, the country’s stock regulator slapped a maximum fine of 0.6 million yuan on the company for faulty disclosure.
Citing “anticipated pricing and cost of production,” Merck & Co. has ditched a partnership with Samsung Bioepis to develop a Lantus biosimilar. Merck will pay the Korean company about $155 million to end the deal. That leaves Mylan and partner Biocon in a position to challenge Sanofi’s brand and an already-launched biosim, Basaglar, from Eli Lilly and Boehringer Ingelheim.
Hoping to become a global oncology company, Japan’s Taiho Pharma has decided to multiply its VC fund sixfold to $300 million. Taiho Ventures, set up in 2016 with $50 million, has already backed such cancer biotechs as Arcus Biosciences, Harpoon Therapeutics and Quentis Therapeutics, a 2018 Fierce 15 winner. Taiho just reached a $130 million deal to license certain Asian rights to an Arcus dual adenosine receptor antagonist.
As a global recall linked to a possible carcinogen rocks the valsartan world, European regulators have found the same N-nitrosodimethylamine (NDMA) impurity in losartan made by Hetero Labs and irbesartan by Aurobindo Pharma. EU authorities have yet to say where the impurity originated.
Just weeks after announcing a deal to sell its antibiotics manufacturing in the U.S. to Abu Dhabi-based Neopharma, India’s Dr. Reddy’s has agreed to sell its API manufacturing business in Hyderabad to Therapiva, a joint venture of Neopharma and Indian generics maker Laxai Life Sciences. The two sales are steps Dr. Reddy’s made to streamline its operations and optimize cost structures.
About a year and a half after it invested £35 million ($45.2 million) in MiNA Therapeutics, Japan’s Sosei has decided not to exercise its option to buy out the RNA biotech but maintained its current 25% stake. MiNA said the decision doesn’t affect its development plan for lead candidate MTL-CEBPA, the centerpiece of the buyout option.
After placing Hanlim Pharm—a South Korean company specializing in sterile ophthalmic drugs—on import alert, the FDA has dealt the company a warning letter. It cited a plant for aseptic practices and data integrity problems, some of which were also cited in 2014.