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At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.
Alicia Jackson formerly served as deputy director of the Biological Technologies Office at the Defense Advanced Research Projects Agency.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Johnson & Johnson will discontinue the Phase II Auτonomy study of posdinemab after a scheduled review found the anti-tau antibody failed to slow clinical decline in patients with early Alzheimer’s disease.
Analysts agree that the failure of Novo Nordisk’s semaglutide to reduce Alzheimer’s disease progression removes a “modest” or “perceived” overhang on Biogen and the anti-amyloid antibody class in general, clearing the way for increased uptake of Leqembi and Eli Lilly’s Kisunla.
“We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, Novo’s R&D chief, said on Monday.
NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord injury.
Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.
PRESS RELEASES
Patent strengthens Company’s global intellectual property portfolio and reinforces the Company’s commitment to establishing and protecting competitive advantages
• Vial’s INHBE siRNA is a first‑in‑class, liver‑targeted (GalNAc‑conjugated) siRNA therapy that silences INHBE and its gene product, Activin E • Leading key opinion leaders (KOLs) Drs. Jason Fung, Scott Kahan, Lawrence Cheskin, and Lee Kaplan from leading institutions such as Johns Hopkins, GMU, and Dartmouth University respectively shared their insights on challenges with current GLP-1 treatments as well as the potential benefits of INHBE siRNA therapies like Vial’s • INHBE siRNAs are designed to deliver fat-selective weight loss while preserving lean muscle mass • Vial’s INHBE siRNA will be investigated for its potential as both a mono-therapy and in combination with GLP-1s to offer patients flexibility on their weight loss journey
Recognized for Excellence in Drug Discovery Research Services on Global R&D Sourcing Platform in 2025.