Big Pharma companies continued dealmaking with Asian biotechs.
The last few days of 2023 and the beginning of 2024 featured a flurry of dealmaking by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies. Big Pharma companies are also increasingly entrusting commercialization of some products in China to domestic firms. And more. AstraZeneca is paying $1 billion to acquire CAR-T specialist Gracell Biotechnologies in the first full buyout of an innovative Chinese biotech by a Big Pharma company. Gracell’s FasTCAR platform is designed to reduce manufacturing time and enhance T cell fitness. The company’s lead candidate, a BCMA and CD19 dual CAR-T coded GC012F has delivered some impressive early results in multiple myeloma. 2. A Christmas deal spree: See what J&J, Roche and more had in their stockings GSK heads back to Hansoh, paying $185M upfront for another ADC 3. Boehringer bets $2B in biobucks to unlock siRNA targets for MASH treatments
4. 2024 forecast: Big Pharma reworks China strategy, and job cuts are part of it
In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen tasked local companies to commercialize some of their products in China. Increased pricing pressure and competition, especially for mature products, makes in-house commercial buildup less cost-effective for foreign pharmas, L.E.K. Consulting’s China practice leader, Justin Wang, said. The moves also come amid companies’ global cost-cutting initiatives. The combination of Astellas and Pfizer’s Padcev and Merck’s Keytruda has won full FDA approval as a first-line treatment for bladder cancer. The go-ahead came way ahead of the FDA’s target decision date and was backed by impressive overall survival data that sparked a standing ovation when they were presented in October. The nod doubled the scope of a previous accelerated approval to now include patients who are eligible for cisplatin-based chemotherapy. 6. J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk With a $125 million payment, Daiichi Sankyo has settled a milestone dispute with Esperion Therapeutics around the latter’s bempedoic acid products. The two companies previously clashed over a $300 million milestone payment because of different views of a cardiovascular trial’s endpoints. With the new deal, the two companies will work together to develop a triple formulation product. 8. FDA slams trio of Indian drugmakers with Form 483 filings after December inspections
The FDA issued Form 483 letters to Dr. Reddy’s Labs, Torrent Pharma and Laurus Synthesis over lapses found at their plants in India. Dr. Reddy’s Bachupally R&D campus had deficient records-keeping or control procedures and lacked employee training, the FDA said. Torrent’s three-observation citation centered on its quality system. 9. Olympus lung scope recall details risks of fires, internal burns
10. Takeda’s gene therapy pivot leaves JCR behind after proof-of-concept preclinical test
12. After issuing Form 483, FDA classifies Aurobindo plant as only needing 'voluntary' action 13. Otsuka pays $65M cash for European rights to Ionis’ phase 3 rare disease med 15. Sciwind blows into GLP-1 contention with pivotal data on Chinese rival to Novo, Lilly 16. AGC extends CDMO expansion spree, plans second manufacturing facility in Japan