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TOP STORIES
The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.
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.”
FDA
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.
UPCOMING EVENTS
PRESS RELEASES
• ASCO 2026: 2.5-Year Overall Survival Data • Jefferies Healthcare Conference: Partnering & Investor meetings • BIO International Convention: Panel Participation • MIB Agents Factor Osteosarcoma Conference: Data Presentation
The 6% naturally derived extract is set to be encapsulated for use in patients suffering from treatment-resistant depression under Australia’s Authorised Prescriber Scheme, where no serious adverse events have been reported as of December 2025
Live Presentation and Q&A: Thursday, May 28, 2026 12 PM EDT
• MustGrow has received approval from the agriculture departments of Texas, Utah, and Montana to commence sales of organic biofertility product TerraSanteTM. • Based on infield grower data, the mustard-derived TerraSanteTM biofertility product has been shown to improve crop yields, soil, and potentially the soil microbiome health for nutrient/water use efficiencies.
· Prof. Dr. med. Jürgen Braun joins the Scientific Advisory Board of MetrioPharm AG. · With more than 800 peer-reviewed publications and various prestigious awards, Prof. Braun is internationally recognized as a leading expert in the field of modern clinical and academic rheumatology.
Pharmaceutical service provider receives prestigious management award for the seventh year in a row · Family-owned company once again excels in all four key business areas · Site development and digitalization as strategic investment priorities · Focus on new sources for skilled workers and on lifelong learning
The upgraded platform offers a searchable database of over 300 risk-assessed HCPs, automated research scanning, and new flexible pricing options for mid-size drug developers.
New preprint by Jianghui Xiong, PhD, and the DeepoMe team introduces SteeraMed, a steerable biomedical world model for N-of-1 intervention reasoning across chronic diseases and aging
MARKET RESEARCH REPORTS