OMEN Pharma Hutchmed (China) Limited has announced a significant development in the regulatory pathway of tazemetostat for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in China. The company disclosed that the New Drug Application (NDA) for tazemetostat has been accepted for review by the China National Medical Products Administration (NMPA), which has … Read more
Johnson & Johnson Reports Significant Survival Benefit in Phase 3 Study of Carvykti for Multiple Myeloma Johnson & Johnson has announced promising findings from the phase 3 CARTITUDE-4 trial, showing that Carvykti (ciltacabtagene autoleucel; cilta-cel) provides a statistically significant improvement in overall survival compared to standard therapies for patients with relapsed or lenalidomide-refractory multiple myeloma … Read more
Boehringer Ingelheim and Gubra Launch Phase 1 Study of BI 3034701, a Promising Triple Agonist Peptide for Obesity Treatment Boehringer Ingelheim, a renowned biopharmaceutical firm committed to research, and Gubra have initiated a phase 1 clinical trial (NCT06352437) for BI 3034701, a novel long-acting triple agonist peptide aimed at revolutionizing obesity treatment. Obesity affects over … Read more
AstraZeneca’s application for sipavibart has been accepted by the European Medicines Agency (EMA) through an accelerated assessment procedure. This application is specifically for using sipavibart as a preventive treatment (pre-exposure prophylaxis) against Covid-19 in immunocompromised patients. Sipavibart is an experimental long-acting antibody designed to protect immunocompromised patients from Covid-19. These patients often do not respond … Read more
WHO Issues Landmark Guideline to Boost Global Tobacco Cessation Efforts The World Health Organization (WHO) has released its inaugural guideline on tobacco cessation, urging comprehensive strategies that include behavioral support by healthcare professionals, digital interventions, and pharmacological treatments. Addressing the needs of over 750 million tobacco users worldwide who desire to quit various forms of … Read more
Samsung Bioepis Receives FDA Approval for Pyzchiva, a Biosimilar to Stelara, for Multiple Inflammatory Conditions Samsung Bioepis Co., Ltd. has achieved a significant milestone with the US Food and Drug Administration (FDA) granting approval to its Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe). Pyzchiva is now approved for both subcutaneous injection and intravenous infusion, serving … Read more
The US Food and Drug Administration has granted approval for donanemab, a new treatment for Alzheimer’s disease developed by Eli Lilly. This approval follows extensive clinical studies demonstrating that the drug can significantly slow cognitive decline, marking a milestone after years of regulatory delays. Donanemab, branded as Kisunla, will be administered as a monthly injection. … Read more
TauRx Pharmaceuticals Ltd, a global leader in Alzheimer’s disease research focusing on tau proteins, has applied for permission to sell a new drug in the UK. The drug, hydromethylthionine mesylate (HMTM), aims to treat mild cognitive impairment and early to moderate stages of Alzheimer’s dementia. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has … Read more
A federal judge has dealt a blow to a group of cancer victims aiming to block Johnson & Johnson’s proposed bankruptcy settlement over claims that its talc products contain cancer-causing asbestos. The decision, made by U.S. District Judge Michael Shipp on Friday, rejected the plaintiffs’ bid for a preliminary order to prevent J&J from pursuing … Read more
Altimmune, a biotech company relatively unknown until now, is aiming to disrupt the weight loss medication market dominated by giants like Novo Nordisk. Their lead program, pemvidutide, is showing promising results in clinical trials, posing a potential challenge to Novo Nordisk’s Wegovy, a popular weight loss drug. In trials, patients treated with pemvidutide showed significant … Read more