Curated news and analysis on clinical trials, drug approvals, and medical research.
India Pharma 2026 will be held April 13-14 in New Delhi with the theme "Discover in India: Leapfrogging Life-Sciences Innovation." The event will focus on R&D, regulation, AI, CRDMO and financing.
Psyence Biomedical Ltd. completes a $5 million share-for-share equity investment in PsyLabs through put option exercise, strengthening their strategic supply relationship. The transaction involves no cash exchange but gives PsyLabs approximately 50% ownership of PBM. The deal aims to secure pharmaceutical-grade psychedelic compound supply for clinical programs.
Oncotelic Therapeutics announced expanded international intellectual property coverage for OT-101 across neurology, oncology and CNS drug-delivery technologies. The company also highlighted biotech valuation trends tied to clinical progress and its 45% stake in GMP Bio.
Kansas City, Missouri, approved a 13-0 ordinance banning synthetic 7-OH and limiting natural kratom sales to adults 21 and older. The law adds sales restrictions, licensing requirements and fines as scrutiny of 7-OH products increases.
LENZ Therapeutics submitted a UK marketing authorization application for VIZZ for presbyopia on April 20, 2026. The filing follows FDA approval in July 2025 and EMA validation in March 2026.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Nektar said extended rezpeg treatment promoted greater hair growth in severe alopecia areata and reported durable 52-week efficacy for rezpegaldesleukin in atopic dermatitis. The company said it has FDA alignment on Phase 3 design and is targeting a BLA submission by 2029.
Asahi Kasei has started a Phase I clinical trial in Japan for AK1940, a peptide-based investigational compound for autoimmune diseases. The study will assess pharmacokinetics, safety and tolerability in healthy volunteers.
Phase 3 OCEANIC-STROKE data showed asundexian plus antiplatelet therapy reduced recurrent ischemic stroke versus placebo. Major bleeding rates were similar between groups.
New data from the American Cancer Society shows the U.S. cancer death rate has dropped 34% since 1991, preventing nearly five million deaths. More than 18 million Americans are living after a cancer diagnosis, with that number expected to surpass 22 million by 2030.
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Galux completed a $29 million Series B financing and entered an MOU with OliX Pharmaceuticals to jointly develop a next-generation AI-based siRNA delivery platform. The funding will support GaluxDesign, R&D expansion and preclinical validation.
Genflow Biosciences has entered a technology collaboration with Acuitas Therapeutics to formulate Genflow's SIRT6 mRNA payload using Acuitas' lipid nanoparticle platform for preclinical evaluation. The collaboration is fully funded by Acuitas, with no cash payable by Genflow and no dilution to existing shareholders.
GLP-1 drugs are still being studied for Alzheimer’s and addiction after semaglutide failed to slow cognitive decline in Alzheimer’s. A 2025 abstract reported semaglutide slowed cognitive impairment in an Alzheimer’s model.
The global cancer monoclonal antibodies market was valued at USD 66.7 billion in 2025 and is expected to reach USD 135.2 billion by 2033. Growth is being driven by targeted therapies, bispecific antibodies, ADCs and checkpoint inhibitors.
A pan-cancer study identified 56 local cellular programs and 13 spatial niches across 12 cancer types. Multiple niches were linked to prognosis, immunotherapy response, and macrophage spatial distribution.
Phase III data showed dirozalkib improved progression-free survival and intracranial efficacy versus crizotinib in first-line ALK-positive advanced NSCLC. The drug received NMPA approval in August 2025.
Updated phase I data showed zoldonrasib produced a 52% confirmed objective response rate and 93% disease control rate in previously treated KRAS G12D-mutant NSCLC. No grade 4 or higher treatment-related adverse events were observed at the recommended phase II dose.
UAB researchers are advancing cancer prevention, tumor targeting and precision ablation, while AdvanCell is developing targeted alpha therapy and a prostate cancer drug in Phase 1 trials. Both efforts focus on new treatment approaches and research infrastructure.
Pfizer and Valneva said their investigational Lyme disease vaccine candidate showed more than 70% efficacy in the phase 3 VALOR trial. Pfizer plans regulatory submissions after the study, which reported no safety concerns at the time of analysis.
