Pharmaceutical and biotech news covering drug approvals, clinical trials, FDA decisions, and pharmaceutical industry developments.
New Zealand's pharmaceutical regulator Medsafe approved two psychiatrists to prescribe pharmaceutical-grade MDMA for severe PTSD treatment on Friday. The approval relies on Phase 3 trials showing significant improvement in PTSD patients, despite the U.S. FDA rejecting similar applications in 2024 due to safety concerns.
The US FDA approved Ionis Pharmaceuticals' zanvestro as the first disease-modifying treatment for Alexander disease, showing stabilization in gait speed during phase III trials. Ionis received a priority review voucher alongside the approval, though commercial potential remains limited by the ultra-rare nature of the condition affecting one in three million people.
Merck shares traded at $151.07 as investors reacted to news that Cipla secured exclusive U.S. commercialization rights for a Keytruda biosimilar ahead of the drug's 2028 patent expiration. Cipla subsidiary Invagen partnered with China's Qilu Pharmaceutical, which will handle development and supply, while Cipla manages U.S. commercialization.
The US Food and Drug Administration has approved daraxonrasib for pancreatic cancer, making it available to qualifying patients within two weeks. Clinical trials showed the treatment doubles median survival from 6.7 to 13.2 months, though it costs approximately $480,000 annually.
Johnson & Johnson shares rose roughly 1% to $277.955 on Thursday as investors viewed AbbVie's positive myeloma trial data as category expansion rather than a direct threat to J&J's Carvykti franchise. Reuters reported that AbbVie's experimental drug appears most differentiated after CAR-T therapy, suggesting it is not an immediate substitute for J&J's leading treatment.
The FDA is collaborating with all six manufacturers to increase the production of estradiol transdermal patches following a surge in demand. This increased usage followed the removal of a boxed warning regarding health risks, leading to shortages from major suppliers like Sandoz and Viatris despite no official shortage designation.
Summit Therapeutics announced that partner Akeso achieved positive overall survival results for the lung cancer drug ivonescimab in the Phase III HARMONi-2 study. The treatment demonstrated a statistically significant improvement in overall survival compared with pembrolizumab in patients with PD-L1-positive lung cancer, reversing previous investor concerns.
Novartis disclosed three patient deaths in a clinical trial for an autoimmune disease treatment using CAR-T cell therapy, triggering industry-wide safety concerns. Bristol Myers Squibb also paused its autoimmune drug research due to life-threatening side effects, with both companies delaying public disclosure of the halts for weeks or months.
Artificial intelligence rapidly generates thousands of potential drug candidates, accelerating the ideation phase. However, this speed has created a significant bottleneck in physical testing, which is expensive and slow to keep pace with digital generation.
HUTCHMED announced an exclusive licensing agreement with GSK for its first-in-class KRAS-EGFR antibody-targeted therapy conjugate, HMPL-A830. The deal includes an $110 million upfront payment and potential milestone payments totaling up to $1.295 billion, granting GSK worldwide rights outside of Greater China. HUTCHMED shares rose 15% following the announcement.