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.
1. China slaps monstrous $1.3B penalty on vaccine scandal culprit Changsheng
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.
2. Merck ditches biosimilar Lantus, but will that ease the path for Mylan’s rival insulin product?
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.
3. Seeking global deals, Taiho swells its U.S.-based VC fund to $300M
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.
4. EU expands look at Zhejiang Huahai as impurities show up in other 'sartans'
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.
5. Neopharma JV snatches Dr. Reddy's API business as it continues global expansion
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.
6. After putting £35M into MiNA Therapeutics, Sosei passes on buyout option
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.
7. FDA spanks South Korea's Hanlim Pharm with warning letter
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.