Ongoing improvements at Biocon's Malaysian facilities have delayed the U.S. approval of its Mylan-partnered Lantus copycat for the second time. CStone Pharmaceuticals has yet to start generating sales, but that didn't stop its CEO from collecting nearly $20 million in pay last year. As potential buyers line up for Novartis' Grimsby, U.K. site, the Swiss drugmaker has penned a deal to sell its Suzhou, China, site to a local company for $111 million. And more.
Biocon’s manufacturing problems have once again interfered with partner Mylan’s winning approval for a Lantus copy. The FDA issued a second complete response letter for the drug “pending completion” of improvements at Biocon’s Malaysian facilities, where the FDA had previously found a dozen problems in need of fixing. Biocon said it does not anticipate the CRL will delay the commercial launch.
Hong Kong-listed Chinese biotech CStone Pharmaceuticals hasn’t even started making money yet, but its CEO, Jiang Ningjun, is already racking up top U.S. Big Pharma-level pay. Jiang’s total compensation reached 141.25 million yuan (just under $20 million) last year, on par with the $20.9 million Merck & Co. CEO Ken Frazier collected during the same period.
Just weeks after GlaxoSmithKline sold its Suzhou, China factory to Fosun Pharma, Novartis has decided to hive off its ingredients operation in the same city to China’s Zhejiang Jiuzhou Pharma for 790 million yuan ($111 million). The two go way back in their collaboration, and the new deal will allow the Chinese firm to continue supplying Novartis with ingredients while beefing up its own CDMO business, it says.
Insilico Medicine’s computer networks could potentially speed up drug discovery hit-to-lead timelines, the Hong Kong-headquartered company showed in a paper published in Nature Biotechnology. In less than 50 days, the company and its partners used AI programs to generate and select promising drugs against fibrosis and had the lead candidate go on to show favorable activity in mouse models.
Indian drugmakers, better known as generics and API suppliers, are pivoting to more lucrative innovative therapies. Lupin is one of them. The Indian firm’s lead MEK inhibitor, LNP3794, has attracted Boehringer Ingelheim, which is shelling out $20 million up front and committing more than $700 million for rights to pair it with its in-house KRAS inhibitor in KRAS-driven gastrointestinal and lung cancers.
At Dr. Reddy’s oncology plant in Duvvada, India, someone tried to fix a water tube connecting equipment in the fill-and-finish area with three zip ties, causing sterility problems. That’s one example of problematic operations the FDA laid out in an eight-observation Form 483 for the facility. It was the plant’s second citation in less than a year.
WuXi AppTec launched its DELight service aimed at making “cost-effective and efficient hit finding services” to speed up early drug discovery. DELight, or DNA Encoded Library, is a self-serve product that gives researchers direct access to a collection of more than 8 billion compounds.
South Korean conglomerate SK Holdings is merging its SK Bioteck operations in Korea and Ireland with Ampac Fine Chemicals in the U.S. to form SK Pharmteco. The new CDMO will be headed by Ampac CEO Aslam Malik and headquartered in Sacramento, California.
South Korea’s JW Pharmaceutical has acquired Euvipharma, getting a 35,000-square-meter manufacturing facility in Vietnam that once belonged to Valeant. The plant, reportedly the largest in Vietnam, can produce up to 1.9 billion units a year. JW intends to use it as a base to export to other Asian countries and for contract manufacturing.