Jazz Pharmaceuticals plc and Werewolf Therapeutics Inc. signed a licensing pact that could be worth more than $1.26 billion, assigning Jazz exclusive global development and commercialization rights to Werewolf's preclinical cancer prospect, WTX-613, a conditionally activated interferon (IFN)-alpha molecule known as an Indukine that emerged from Werewolf’s Predator protein engineering platform. Read More
Pfizer Inc., with pockets bulging from COVID-19 vaccine money, is taking another step in respiratory syncytial virus (RSV) development with its acquisition of Reviral Ltd. Read More
After a difficult start, there’s been more progress in PIK3 drug class, with FDA approval of Novartis AG’s Vijoice (alpelisib) for the rare condition PIK3CA-related overgrowth spectrum (PROS). Read More
Shares in Gensight Biologics SA dropped by as much as 41% April 7 on news that the Paris-based gene therapy firm failed to complete a second manufacturing campaign within five months, a setback that could delay a commercial launch of its lead product, Lumevoq, by at least a year. Read More
The China Securities Regulatory Commission (CSRC) has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC. Read More
When the U.S. FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) April 6 to advise on a path forward to the next generation of COVID-19 vaccines and boosters, there was a lot of talk about all the unknowns. Read More
Citing the lack of clear evidence that vaccine protection against severe COVID-19 disease is substantially waning in the EU in people younger than 80, the European Centre for Disease Prevention and Control and the EMA’s COVID-19 task force concluded that it’s too early to consider using a fourth dose, or second booster, of mRNA COVID-19 vaccines in the general population. Read More
New hires and promotions in the biopharma industry, including: Anocca, Aptose, Black Diamond, Cormedix, Enochian, Lianbio, Navidea, Onxeo, Urovant. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Arcutis, Astrazeneca, Avadel, Direct, Eucure, Everest, Intrommune, Kintor, Lutris, Pepgen, Rhythm, Sanbio, United Biomedical, United Therapeutics. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Beigene, Bionecure, Bioxcel, Dialectic, GSK, Innovent, Iovance, Merck, Novartis, Sellas, Tonix, UCB, Vir. Read More
