Pharmaceutical News
-
Daiichi Sankyo Names Ex-Syncona, Ex-Novartis Leader John Tsai Global Head of R&D
Daiichi Sankyo has appointed Dr. John Tsai as the new Global Head of Research & Development, effective April 1, 2026, succeeding Dr. Ken Takeshita. Dr. Tsai brings over 25 years of experience in drug development and leadership, supporting the company’s strategic focus on scientific innovation in high-need therapeutic areas. Read more
-
Novartis to Divest India Listed Unit, Continue Commercial and R&D Presence
Novartis AG has agreed to sell its entire 70.68% stake in Novartis India Limited to ChrysCapital. This transaction will initiate a mandatory open offer for up to 26% of the company’s voting shares from public shareholders. Novartis will retain its presence in India through other entities as the deal awaits regulatory approvals. Read more
-
FDA Approves Fixed-Duration Calquence Combo for First-Line CLL and SLL
AstraZeneca’s Calquence® (acalabrutinib) has received FDA approval as the first all-oral, fixed-duration treatment for adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In the Phase III AMPLIFY trial, this regimen demonstrated significant improvements in progression-free survival compared to standard therapies, offering a more convenient treatment option. Read more
-
NHS-Galleri Trial Shows Early Detection Gains, Reduced Late-Stage Cancer Diagnoses
GRAIL, Inc. reported results from the NHS-Galleri trial, which involved about 142,000 adults. While it didn’t meet its primary endpoint, the addition of the Galleri blood test significantly improved early cancer detection, reducing Stage IV diagnoses and increasing Stage I and II cases. These findings support enhanced multi-cancer screening strategies. Read more
-
NHS-Galleri Trial Reveals Clinically Meaningful Cancer Detection Improvements, Despite Mixed Primary Results
By VETTAPHARMA reporter: GRAIL, Inc. (Nasdaq: GRAL) announced topline results from the landmark NHS-Galleri trial, a large, randomized study assessing annual multi-cancer screening with the Galleri® blood test in England’s National Health Service among ~142,000 asymptomatic adults aged 50–77. While the trial did not meet its primary endpoint of a statistically significant reduction in combined Stage III-IV cancers, it showed substantial reduction in Stage IV diagnoses, increased detection of early-stage cancers, and a four-fold higher overall cancer detection rate compared to standard screening alone. Key findings from the three-year trial include: Screening also led to a notable reduction in cancers… Read more
-
Insmed Reports 2025 Financial Results; Guides Strong 2026 Revenues With Growth
Insmed Incorporated reported $606.4 million in total revenues for 2025, driven by strong sales of BRINSUPRI and ARIKAYCE. Despite significant revenue growth, the company faced a net loss of $1.28 billion. For 2026, Insmed anticipates revenue growth and plans to advance clinical trials and regulatory submissions for multiple products. Read more
-
Takeda Reports Sustained Pediatric ENTYVIO Efficacy With Strong One-Year Remission Rates
Takeda Pharmaceutical revealed positive Phase III results from its KEPLER trial of ENTYVIO® (vedolizumab) in children with active ulcerative colitis. Nearly half of the participants achieved clinical remission after one year. The findings, presented at the ECCO Congress, support possible label expansion for pediatric use, with no new safety concerns identified. Read more
-
Merck’s ENFLONSIA™ Shows Promising RSV Protection for Kids
Merck & Co. announced positive findings from the Phase 3 SMART trial of ENFLONSIA™ (clesrovimab) for infants under 2 at risk for severe RSV disease. Results indicated consistent safety and effectiveness across two RSV seasons. Merck plans to submit data to regulators to expand use for high-risk children. Read more
-
Omvoh Delivers Durable 3-Year Steroid-Free Remission in Crohn’s Disease Patients with >90% Maintaining Durable Control in Phase 3 VIVID-2 Study
Eli Lilly’s Omvoh (mirikizumab-mrkz) has shown long-term efficacy in maintaining steroid-free remission in patients with moderately to severely active Crohn’s disease over three years. Data presented at ECCO revealed over 90% of patients who achieved remission at one year sustained it, highlighting its potential to improve disease outcomes significantly. Read more
-
US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated ER-Positive Advanced Breast Cancer
Roche’s NDA for giredestrant with everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer has been accepted by the FDA. The Phase III evERA study demonstrated significant improvements in progression-free survival compared to traditional therapies. The target decision date is December 18, 2026, indicating a promising treatment avenue. Read more
-
Regeneron’s Garetosmab: FDA Priority Review for FOP Treatment
Regeneron Pharmaceuticals has announced that the FDA has accepted its Biologics License Application for garetosmab, granting it Priority Review for treating adults with fibrodysplasia ossificans progressiva (FOP). If approved, garetosmab would be the first therapy to significantly reduce new lesions in this ultra-rare genetic disorder, impacting about 900 individuals globally. Read more
-
Eli Lilly’s Retevmo: Game-Changer in Early-stage Lung Cancer
Eli Lilly’s Retevmo (selpercatinib) shows significant improvement in event-free survival for early-stage RET fusion-positive non-small cell lung cancer, according to the LIBRETTO-432 trial. This Phase 3 study highlights the importance of genomic testing and demonstrates Retevmo’s potential in reducing disease recurrence risk post-surgery. Further data will be presented soon. Read more