Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Daiichi Sankyo, Hikma, Sumitomo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Achilles, Astrazeneca, Bionomics, Bio-Thera, City of Hope, Enanta, Fuse-AI, Heron, Johnson & Johnson, Neuphoria, Pfizer, Tabuk, Xlife.
2024 was another banner year for GLP-1 receptor agonists (GLP-1RAs) on multiple fronts. They continued to expand into new indications, and provide their developers with both rich remuneration and scientific acclamation. There are now seven approved GLP-1RAs. Commercially, the most successful one so far is semaglutide, sold under the brand name Wegovy or Ozempic depending on the indication.
The first round of the U.S.’ Medicare negotiations accounted for a lot of digital ink and headlines in 2024. Next year is sure to bring more of the same as Medicare is to announce up to 15 Part D drugs to be negotiated in the second round by Feb. 1, even as several constitutional challenges to the process continue in federal appeals courts across the country.
Even though pharmacy benefit manager (PBM) reforms were dropped from the continuing resolution that was signed into law Dec. 21 to keep the U.S. government fully functional through March 14, the incoming administration and Congress likely will continue to try to rein in the PBMs, which serve as middlemen in the nation’s drug supply chain.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied, Astrazeneca, Bristol Myers, Eli Lilly, Glaukos, Keymed, Novo Nordisk, Nuvation, Pfizer, Rhythm, Tonix, Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Corxel, Ikena, Inmagene, Jemincare, Neurosense, Rapt, Vicentage.