Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Astrazeneca, Capricor, GSK, Lundbeck, Novo Nordisk, OS Therapies, Quoin, Zambon.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amarin, Bend, Kineta, Recordati, Sarepta, Starton, Thermo Fisher, Tuhura, Xcell.
The U.S. FDA said June 25 it has required updates to the prescribing labels of COVID-19 mRNA vaccines Comirnaty and Spikevax to include new safety information on the risks of myocarditis and pericarditis.
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
Kymera Therapeutics Inc. found itself juggling partnerships by bringing one on board while going to the development bench in another. Kymera and Gilead Sciences Inc. will collaborate on a molecular glue degrader program that targets cyclin-dependent kinase 2 in solid tumors, including breast cancer.
Although the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) was scheduled to vote June 25 on recommendations for maternal and pediatric respiratory syncytial virus vaccines, it adjourned by pushing that vote to the second day of the meeting. But before leaving for the day, it got an earful of comments from pediatricians, nurses and even a retired FDA scientist urging the CDC to reinstate the 17 committee members Health and Human Services Secretary Robert Kennedy dismissed two weeks earlier and replaced with eight new members.
Abion Inc. signed a potential $1.315 billion deal with an anonymous partner June 22, granting the counterparty exclusive global rights to a preclinical claudin 3-targeting monoclonal antibody, ABN-501, and the potential to license four more protein targeting antibodies.
RSS
