Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
Candel Therapeutics announced a $100 million royalty funding agreement with RTW Investments, contingent on FDA approval of aglatimagene besadenovec for intermediate- to high-risk localized prostate cancer, with tiered royalties on U.S. net sales.
NEXT Life Sciences has advanced two male birth control options into Phase II clinical trials: Plan A™, a long-acting reversible system, and NLS-133, a non-hormonal pill designed for on-demand or daily use.
Swiss pharmaceutical major Novartis AG has signed a definitive agreement to sell its entire 70.68% stake in Novartis India to a ChrysCapital-led consortium for Rs 1,446 crore, with a mandatory open offer for an additional 26% from public shareholders.
Johnson & Johnson announced a more than $1 billion investment to build a new cell therapy manufacturing facility in Lower Gwynedd, Pennsylvania, creating 500 skilled biomanufacturing jobs and 4,000 construction jobs as part of its $55 billion U.S. investment strategy through early 2029.
Scientists in Shanghai have developed DeepRare, an AI system that diagnoses rare diseases with 79% accuracy, outperforming experienced doctors in head-to-head testing. The system is now being used by clinicians at over 600 institutions worldwide.
Novartis AG agreed to sell its entire 70.68% stake in Novartis India to a consortium led by WaveRise Investments, ChrysCapital, and Two Infinity Partners for approximately ₹1,446 crore, triggering a mandatory open offer at ₹860.64 per share.
Swiss drugmaker Novartis will sell its entire 70.68% stake in its listed Indian unit to a private equity consortium for $159 million as part of broader global restructuring. Shares of Novartis India surged nearly 20% following the announcement.
Ontario has designated Kinross Gold's $5 billion Great Bear gold project for fast-track approval under its One Project, One Process framework, making it the first major miner to receive the designation. The mine near Red Lake faces opposition from Grassy Narrows over mercury contamination risks.
PureTech Health announced that deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for idiopathic pulmonary fibrosis, with a Phase 3 trial planned for the first half of 2026.
A Phase II trial led by WVU Cancer Institute reports the first-ever use of subcutaneous blinatumomab in CD19-positive mixed phenotype acute leukemia, with the first patient achieving complete remission after one cycle.
PureTech Health's deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for treating idiopathic pulmonary fibrosis, a rare and fatal lung disease. Phase 2b trial results showed superior efficacy compared to existing therapies.
AbbVie reported progress on two clinical studies: a Phase 2a trial of ABBV-142 for idiopathic pulmonary fibrosis now recruiting patients, and completion of a JUVÉDERM VOLITE study for facial skin quality improvement.
Precision oncology has transformed brain metastases treatment from lung cancer, extending survival from 6-12 months to 3-5 years through targeted therapies, immunotherapy, and radiosurgery. With 100,000-200,000 annual cases in the US, multidisciplinary approaches now manage this once-terminal condition as a chronic disease.
Eli Lilly's Omvoh demonstrated durable efficacy in Crohn's disease, with over 90% of patients maintaining steroid-free clinical remission through three years of monthly treatment in the Phase III VIVID-2 extension study.
Researchers develop a nanoplatform that co-induces cuproptosis and disulfidptosis to upregulate PD-L1 expression and sensitize tumors to immune checkpoint blockade therapy, addressing resistance in PD-L1-low malignancies.
The FDA will now require a single pivotal clinical trial as the default for novel medicine approvals, replacing its decades-old two-trial standard. The policy aims to reduce development costs and accelerate innovation.
Scientists at Gladstone Institutes have discovered why living at high altitude reduces diabetes risk: red blood cells absorb large amounts of glucose in low oxygen environments. A drug mimicking this effect reversed diabetes in mice.
Boehringer Ingelheim India and NIPER Raebareli have signed an MoU to strengthen pharmaceutical education and research collaboration, including access to the company's open science portal and joint initiatives in drug delivery systems.
The U.S. Court of Appeals for the Federal Circuit ruled that Teva Pharmaceuticals did not infringe Corcept Therapeutics' patents for methods of safely co-administering Korlym with CYP3A4 inhibitors, affirming a 2023 district court verdict.
