This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Biosimilar. Check out our full report below:
Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)
Read More: Gilead
Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Read More: Genentech
Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025
Read More: Merck
GSK & Spero Therapeutics Reports Early Conclusion of P-III (PIVOT-PO) Trial of Tebipenem HBr for Complicated Urinary Tract Infections (cUTIs)
Read More: GSK and Spero Therapeutics
Regeneron and Sanofi Report P-III (AERIFY-1 & AERIFY-2) Trials Data of Itepekimab for Chronic Obstructive Pulmonary Disease (COPD)
Read More: Regeneron and Sanofi
Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)
Read More: Genentech
Rezolute Reports Enrollment Completion in P-III (sunRIZE) Trial of Ersodetug for Congenital Hyperinsulinism
Read More: Rezolute
GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma
Read More: GSK
The CHMP Adopts Positive Opinion for SpringWorks Therapeutics’ Mirdametinib to Treat NF1-PN
Read More: SpringWorks Therapeutics
Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer
Read More: Roche
Read More: Autolus Therapeutics
GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
Read More: GSK
RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)
Read More: RemeGen
AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)
Read More: AstraZeneca
The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC
Read More: Bayer
Alcon Reports the US FDA’s Approval of Tryptyr to Treat Dry Eye Disease
Read More: Alcon
Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer
Read More: Zymeworks
GRIN Therapeutics Collaborates with Angelini Pharma to Co-Develop and Commercialize Radiprodil for Neurological Disorders
Read More: GRIN Therapeutics and Angelini Pharma
Biogen Joins Forces with City Therapeutics to Develop Novel RNAi Therapies
Read More: Biogen and City Therapeutics
SNAP Biosciences Licenses Monarch Therapeutics’ Technology to Advance Snap-Car NK Cell Therapy for Cancer Targets
Read More: SNAP Biosciences and Monarch Therapeutics
Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011
Read More: Astellas and Evopoint Biosciences
AI Medical Technology’s Dermalyser Receives European CE Mark Approval for Melanoma Detection
Read More: AI Medical Technology
Read More: AnX Robotica
Read More: Reflow Medical
CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study
Read More: CoreMap
Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline
Read More: Eli Lilly and SiteOne Therapeutics
Lupin Collaborates with SteinCares to Commercialize Ranibizumab Biosimilar in Latin America
Read More: Lupin and SteinCares
Read More: Bio-Thera Solutions and Hikma Pharmaceuticals
Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations
Read More: Samsung Bioepis and Organon
Alvotech Expands its Partnership with Advanz Pharma to Commercialize Three Additional Biosimilars in the EU
Read More: Alvotech and Advanz Pharma
Related Post: PharmaShots Weekly Snapshots (April 19, 2025 – May 23, 2025)