Curated news and analysis on clinical trials, drug approvals, and medical research.
Phase III KALOS and LOGOS trial results published in The Lancet Respiratory Medicine show Breztri Aerosphere improved lung function and reduced severe asthma exacerbations compared to dual-combination therapies in patients with uncontrolled asthma.
Novo Nordisk plans to expand its Athlone facility in Ireland to produce Wegovy for non-US markets and will launch lower-cost vials in the US in 2026, responding to aggressive pricing from Eli Lilly as the company forecasts a 5-13% decline in revenue and operating profit.
Ultragenyx will lay off 130 employees as part of restructuring aimed at profitability by 2027. The FDA rejected the company's gene therapy application for Sanfilippo syndrome due to manufacturing concerns.
Major pharmaceutical companies are highlighting their drug pipelines to offset upcoming patent losses, while Moderna confronts FDA rejection of its flu vaccine. The industry faces significant revenue challenges from patent cliffs in 2026.
The Emirates Drug Establishment unveiled the InSilico Medicine project at World Health Expo 2026, using AI and digital models to reduce drug development costs and accelerate pharmaceutical research. EDE signed an MoU with InSilico Medicine AI Limited to formalize the collaboration.
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
F3 Tech will lead Maryland's proposal for a $40 million multi-user biomanufacturing facility under the federal BioMADE program, developed with the Maryland Department of Commerce to strengthen the state's biotechnology economy.
PTC Therapeutics has withdrawn its New Drug Application resubmission for ataluren (Translarna) for nonsense mutation Duchenne muscular dystrophy after the FDA indicated the submission lacked substantial evidence of effectiveness.
The U.S. Pharmacopeia announces development of digital reference standards and digitally structured methods for pharmaceutical workflows, with formal recognition in USP–NF effective December 2025.
Novartis US shares traded at all-time highs in early February 2026 despite expected generic competition, driven by sales above expectations and positive Phase 3 kidney drug data. The company's market capitalization reached $265.2 billion.
Real-world study finds SGLT2 inhibitors reduce chronic kidney disease and acute kidney injury risk more effectively than GLP-1 receptor agonists in patients with type 2 diabetes, with greatest benefits in those without preexisting kidney disease.
GLP-1 drugs for weight loss and diabetes are driving up health insurance premiums by about 30 percent, while consumer advocates petition for generic authorization citing unjustifiably high prices and strained federal budgets.
The FDA removed black box warnings related to breast cancer, cardiovascular disease and dementia from six hormone replacement therapies for menopausal women, following a comprehensive review of scientific literature.
Global pharmaceutical companies are accelerating licensing deals for China-developed experimental medicines, with deal values reaching unprecedented levels in 2026 as firms cut costs ahead of patent expirations.
Novartis debuted its "Relax, it's a blood test" prostate cancer awareness initiative at Super Bowl LX with an experiential booth and commercial featuring NFL tight ends, ranking seventh among all ads.
The FDA announced a new policy making one robust pivotal trial plus confirmatory evidence the default approval requirement, ending the two-trial standard. Separately, the agency finalized guidance on enhancing clinical trial participation to improve enrollment diversity.
U.S. regulators have received more than 1,400 reports since 2021 involving AI-enabled surgical devices, including allegations of botched surgeries and misidentified body parts. The FDA has authorized over 1,300 AI-integrated medical devices.
Natco Pharma has received approval from India's CDSCO to manufacture and market generic semaglutide injection, with a March 2026 launch planned. The approval comes amid patent litigation and intense competition in India's rapidly expanding diabetes and obesity drug market.
AbbVie projects 43-45% earnings growth in 2026 as newer immunology drugs Skyrizi and Rinvoq offset declining Humira sales, while maintaining its 54-year dividend increase streak as a Dividend King.
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
