After more than two years of efforts, Sun Pharma finally got its key plant for the U.S. market up to the FDA's standard. Eisai will open up a new genetics-driven drug discovery unit in Cambridge, Massachusetts, focused on Alzheimer's disease and other dementias. Opponents to Takeda's $62 billion deal for Shire are rallying support to reach the 33% shares threshold needed to call off the transaction.
1. Sun Pharma finally free of FDA restrictions on its key plant in India
Sun Pharma’s key Halol facility has finally been freed of FDA restrictions tied all the way back to a 2015 warning letter. Halol is the plant from which Sun supplies most of its products for the U.S., its largest market. The plant’s problems have kept Sun from launching new products in the U.S., forced it to look for contractors to produce some important generics, and taken a toll on its finances.
2. Eisai to close Andover site, move to new Alzheimer’s drug discovery center in Cambridge
Eisai will commit over $100 million to build a new discovery center to develop human genetics-guided medicines for Alzheimer’s disease and other dementias. It will close its site in Andover, Massachusetts, and move operations a few miles away to the new 50,000-square-foot Cambridge facility, which will be organized around data sciences, immuno-dementia, discovery technologies and precision chemistry.
3. Opponents to Takeda’s $62B buyout of Shire gain support but need much more
Opponents to Takeda’s $62 billion buyout of Shire has grown to a group of 130 people. It includes members of the founding Takeda family, which hold 10% of the company’s shares, Reuters reported. It is still far from the 33% needed to derail the deal, and the dissenters are looking for support from retail customers in Japan, which hold about 25% of shares.
4. WuXi Biologics to build U.S. plant as it rapidly moves beyond its China base
After announcing plans to build new plants in Ireland and Singapore, WuXi Biologics says it will invest $60 million to build a plant in the U.S. The new plant in Worcester, Massachusetts, will have about 4,500 L bioreactor capacity and will handle both clinical and small volume commercial production.
5. WuXi AppTec to test AI-generated compounds from Insilico Medicine
WuXi AppTec’s venture capital arm is leading an investment in artificial intelligence drug discovery company Insilico Medicine. The investment entails a collaboration where WuXi will test novel molecules discovered at Insilico to validate the latter’s pipeline, preparing for a closer integration of Insilico’s technology with WuXi’s own drug discovery capabilities.
6. Taiwan Biotech gets FDA warning letter over quality-control issues
Taiwan Biotech was dealt an FDA warning letter. Among a few citations, the FDA found that the Taiwanese company didn’t have an adequate system for monitoring environmental conditions in aseptic processing areas, and that it didn’t have a standard written testing program to assess the stability of drug products.
7. FDA hits CDMO Kolmar Korea with warning letter over manufacturing issues
The FDA issued a warning letter to CDMO Kolmar Korea. FDA inspectors found the company didn’t investigate out-of-specification results for certain lots of an over-the-counter cream, but instead retested and invalidated the results without justification.