Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.
As Sanofi SA gets ready to welcome a new CEO, the company along with partner Regeneron Pharmaceuticals Inc. said a happy hello as well to robust sales of Dupixent (dupilumab, dupi) and gained U.S. FDA clearance for the IL-4 receptor alpha antagonist to treat children, ages 2 to 11, with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment.
Researchers from Sanofi SA have detailed the development of a next-generation HER2-targeting T-cell engager (TCE) to increase selectivity for HER2-low tumor cells, while minimizing its effects on normal tissues expressing physiologic levels of HER2.
Introduced last year as a pilot program, the U.S. FDA Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV last June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway,” one to two months instead of the standard 10 to 12 months, for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency.
To overcome the limitations regarding conventional immunotherapy for treating tauopathies, researchers from Sanofi SA aimed to improve brain exposure and targeting pathological tau species by optimizing antibody design.
T-cell engager company Kali Therapeutics Inc. licensed its lead product, CD19/BCMA/CD3 trispecific antibody KT-501, to Sanofi SA in a global deal that could be worth more than $1.2 billion. The San Mateo, Calif.-based biotech first emerged in 2024 and moved KT-501 into a phase Ia trial last week to treat adults with rheumatoid arthritis.
Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.
On the heels of China’s approval of Sino Biopharmaceutical Ltd.’s rovadicitinib, Sanofi SA is now inlicensing the first-in-class dual JAK/ROCK inhibitor in a deal worth more than $1.4 billion.
On the heels of China’s approval of Sino Biopharmaceutical Ltd.’s rovadicitinib, Sanofi SA is now inlicensing the first-in-class dual JAK/ROCK inhibitor in a deal worth more than $1.4 billion.
The BioWorld Biopharmaceutical Index finished 2025 up 24.07%, building slightly on its 23% gain recorded at the end of November. While the increase trailed the Nasdaq Biotechnology Index’s 32.4% rise for the year, it outperformed the broader Dow Jones Industrial Average, which advanced 12.97%.
