Curated news and analysis on clinical trials, drug approvals, and medical research.
Researchers are developing gene therapy approaches for neurological disorders and head and neck conditions, using viral vectors and advanced delivery methods to treat brain tumors, Alzheimer's, and Parkinson's disease.
Ocugen has completed enrollment of 140 patients in its Phase 3 liMeliGhT trial for OCU400, a gene therapy for retinitis pigmentosa. Topline data expected in Q1 2027 could support potential approval later that year.
Phase III trial of 196 patients shows stereotactic radiation targeting individual tumors significantly improved symptom burden and daily functioning compared with hippocampal-avoidance whole-brain radiation, without compromising survival.
Multiple organizations submitted comments opposing CMS's proposed GLOBE and GUARD models, which would tie Medicare drug reimbursement to international reference prices. Critics argue the models function as price controls that could undermine pharmaceutical innovation.
Canada's Drug Agency issued a draft recommendation against public drug plan coverage for lecanemab, an Alzheimer's treatment conditionally approved by Health Canada in October 2025, citing cost concerns despite the drug's ability to slow cognitive decline.
AbbVie announced positive topline results from the Phase 3 AFFIRM study showing risankizumab subcutaneous induction achieved superior clinical remission and endoscopic response rates versus placebo in adults with moderately to severely active Crohn's disease.
The pharmaceutical industry is experiencing recovery driven by innovation in drug development, aggressive M&A activity, and expansion of drug development services. The sector faces both opportunities and headwinds including pipeline setbacks and regulatory pressures.
Two major partnerships in India's diagnostics sector aim to strengthen precision medicine capabilities. MedGenome acquires majority stake in Medcare Management Services, while SRMIST partners with CORE Diagnostics to train future oncology professionals.
Recent studies examine biological factors affecting sleep in older adults, finding connections between inflammatory markers, antioxidant capacity, and sleep quality in aging populations.
The FDA has accepted New Drug Applications for rusfertide in polycythemia vera with Priority Review and tirabrutinib for relapsed/refractory primary CNS lymphoma under Accelerated Approval, with PDUFA dates set for Q3 2026 and December 2026 respectively.
The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
Merck is diversifying its oncology pipeline beyond Keytruda as the blockbuster approaches patent cliffs, focusing on immune modulating therapies, antibody-drug conjugates, and tumor intrinsic treatments through strategic acquisitions and partnerships.
The FDA removed the clinical hold on Intellia Therapeutics' Phase 3 trial of nexiguran ziclumeran for transthyretin amyloidosis with cardiomyopathy. The hold was imposed in October following liver safety concerns in one patient.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
The global drug discovery services market is valued at $22.04 billion in 2025 and is forecast to reach $75.13 billion by 2034, growing at a 14.6% CAGR from 2026-2034, driven by rising industry demand and technological advancements.
A CNIC study demonstrates that remote ischemic conditioning can protect the heart during anthracycline chemotherapy without compromising antitumor efficacy, while researchers explore additional methods to manage chemotherapy side effects.
Researchers in China developed DeepRare, an AI-based diagnostic tool that achieved 69% accuracy in diagnosing rare diseases by combining patient symptoms, genetic data, and clinical notes, outperforming existing methods and expert opinion.
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
