1. For Chinese biotechs, the out-licensing business is scorching hot. Could geopolitics rain on their parade?
The proposed BIOSECURE Act has become an “elephant in the room” between potential cross-border partners in the U.S. and China, an international lawyer familiar with global business development transactions told Fierce. Drugs originating from China often took a so-called “China discount” in negotiations due in part to the “transactional administrative burden” of executing these transactions, the lawyer said.
2. With wider approval, J&J and Legend's Carvykti quickly leaps ahead of BMS' rival myeloma CAR-T
AstraZeneca and Daiichi Sankyo’s Enhertu has become the first antibody-drug conjugate approved for a tumor-agnostic indication. The new nod allows the HER2agent to be used in patients with HER2-positive solid tumors after prior systemic treatment or in those who have no other alternatives. The accelerated approval is based on tumor shrinkage data from three phase 2 trials.
4. Fujifilm Diosynth blueprints another $1.2B expansion at NC plant where it aims to employ 1,400
Fujifilm Diosynth Biotechnologies unveiled a $1.2 billion investment in its biomanufacturing facility in Holly Springs, North Carolina. With the project, the company hopes to seize on the expanding antibody-drug conjugate and bispecific antibody marketplace. The site’s cell culture facility will grow by 425,500 square feet and add eight 20,000-liter mammalian cell culture bioreactors. The Japanese CDMO expects the expansion will create 680 new jobs, increasing the total at the site to 1,400 by 2031.
4. Boehringer teams up with Sino Biopharm in broad oncology partnership in China (disclosure, PDF)
5. FDA slams Jubilant Generics, Canada's Contract Pharmaceuticals with Form 483s
The FDA has sent a four-observation Form 483 to Jubilant Generics after an inspection of the company’s plant in Bhagwanpur, India. Inspectors found workers at the facility failed to investigate and identify the root cause of the presence of out-of-specification drugs in a batch distributed in the U.S. Other lapses in record-keeping, timely completion of production and control procedures were found.
6. China’s D3 Bio rases $62M in new financing round led by Medicxi (release)