Celltrion is buying an Eli Lilly drug substance plant in the U.S. for $330 million. The FDA has declined to approve Lundbeck and Otsuka's Rexulti in PTSD. Hengrui Pharma has out-licensed certain rights to its HER2 antibody-drug conjugate to Glenmark. And more.
Celltrion is paying 460 billion Korean won (about $330 million) to buy Eli Lilly’s drug substance plant in Branchburg, New Jersey. Once the deal is closed by the end of the year, Celltrion plans to retain all employees and start operations immediately with existing CDMO contracts at the site. The purchase is meant to protect the company from tariffs, the company said.
2. FDA turns down Lundbeck, Otsuka's Rexulti in PTSD on lack of efficacy data
The FDA has declined to approve Lundbeck and Otsuka’s application for Rexulti as part of a combination with Viatris’ Zoloft in post-traumatic stress disorder. The FDA cited a lack of substantial evidence of effectiveness and asked the partners to run additional trials should they wish to pursue an approval again, according to the companies.
3. In potential $1.1B deal, Glenmark grabs certain rights to Hengrui's ADC rival to Enhertu
Hengrui Pharma is licensing certain rights in emerging markets around its HER2 antibody-drug conjugate, trastuzumab rezetecan, to Glenmark. The deal features $18 million in upfront payment and up to $1.09 billion in milestones. The drug was approved in China in May in second-line non-small cell lung cancer with HER2-activating mutations.
4. Generics makers to sell Gilead's Yeztugo at $40 a year under deals with Gates Foundation, others
India's Dr. Reddy’s Laboratories and Hetero Lab have signed deals with charity organizations to provide generic versions of Gilead Sciences' long-acting HIV PrEP injection Yeztugo at $40 a year in 120 low- and middle-income countries starting in 2027. The deals were enabled by licensing agreements with Gilead.
5. FDA hands warning letter to J&J subsidiary over stopper issues, spotty reporting at Korean plant
Johnson & Johnson's Janssen Vaccines in South Korea was hit with an FDA warning letter. The regulator criticized the company’s manufacturing site in Incheon, South Korea, for inconsistent quality control procedures and failure to follow up thoroughly on product complaints. The site no longer performs any vaccine development, a spokesperson said.
Other News of Note:
6. Fujifilm Biotechnologies cuts ribbon on $3.2B antibody facility in N.C.
7. Fujifilm, argenx expand partnership to bring Vyvgart production to the US
8. Italy's Angelini inks $550M-plus pact for preclinical brain condition asset
9. Takeda scientists tackle Mount Fuji to advocate for patients in need of plasma-derived therapies
10. Japan biotech inks research pact in effort to develop new RNA meds
11. Lantheus hands GE HealthCare the rights to its blockbuster prostate cancer PET tracer in Japan