Frequent FDA citation-getters Aurobindo and Glenmark have once again caught the attention of U.S. regulators in a Form 483 and a warning letter, respectively. Looking for novel inflammatory drug disease targets, Takeda has penned a deal with Prometheus Biosciences, committing up to $420 million in milestones. Ascletis, the first biotech to have listed under the Hong Kong Stock Exchange's revamped rule, has lured a Novartis veteran as its chief scientific officer. And more.
An FDA Form 483 sent to Glenmark’s Baddi facility in India has been upgraded to a warning letter. The company didn’t say what the issues were, but, in August, it recalled more than 31,000 tubes of clotrimazole and betamethasone dipropionate cream because of consumer complaints the fungal fighter had a liquid texture. The facility accounts for about 7% of Glenmark’s U.S. sales.
Aurobindo has had its own FDA headaches. Its Unit 7 was dealt with a Form 483 with seven observations, none of which are related to data integrity, the Indian drugmaker said, adding it believes it can resolve the issues quickly. The letter adds to several other manufacturing citations the company’s plants have gotten this year.
Gastroenterology is one of Takeda’s key focus areas, led by its fast-growing inflammatory bowel disease (IBD) therapy Entyvio. Now, the Japanese has tapped Prometheus Biosciences to identify and validate three IBD drug targets for an undisclosed upfront payment and up to $420 million in milestones. Prometheus garners drug discovery insights from a repository of samples from IBD patients.
Chinese biotech Ascletis has poached Novartis veteran Handan He as its new chief scientific officer. He was most recently Novartis’ global head of computational, biopharmaceutics and translational PK/PD. The liver disease-focused biotech previously attracted former MSD China R&D leader Zhengqing Li to be its CMO, only to lose him to his old employer in just a few months.
Bayer has become the first pharma company to publicly sign up to work with Japan’s Riken Innovation in a drug discovery deal. Riken Innovation, a wholly owned subsidiary of Japanese research institute Riken, just began operating last month. The institute employs more than 3,000 researchers and has an annual budget of close to $900 million.
Insilico Medicine is on a roll. Shortly after a landmark Nature Biotechnology paper that showed it could quickly generate and screen out promising drug compounds in less than 50 days, it has partnered up with Jiangsu Chia Tai Fenghai Pharmaceutical in a drug discovery pact worth up to $200 million.
AI Medical Service, a Tokyo-based developer of artificial intelligence programs that analyze endoscopy images for potential diagnosis in real time, has raised about $43 million in a series B round. The money will go toward funding clinical trials, hiring and investment in equipment and global expansion, the company said.
After a New York short seller questioned BeiGene’s operations in Guangzhou, China, the Chinese biotech has opened the 100,000-square-meter phase one of its CNY 2.3 billion ($320 million) Guangzhou Bio-manufacturing Base, which it will use for commercial manufacturing of the oncology drugs it’s developing.
Cambridge, Massachusetts-based biotech incubator LabCentral is building new biomanufacturing capabilities to support startups. Dubbed LabCentral 238, the project has got nearly $13 million in investments from Astellas, and it’s slated to open in fall 2021.