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Merck new

Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration

Shots: Merck initiates the P-IIb/III (MALBEC) trial assessing MK-8748 (Tiespectus/EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD) The trial will assess the safety & efficacy of two intravitreal dose levels of MK-8748 vs aflibercept (2mg), with Q4W dosing initially for 3mos., then Q8W through Wk. 48, followed by individualized dosing intervals, with…

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Merck new

Merck Receives the EC Approval for Keytruda, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The EC has approved Keytruda/Keytruda SC + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapies, in all 30 EEA member states Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda…

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Biocytogen and Sihuan Pharmaceutical Partner to Discover Novel Therapeutics in Multiple Indications

Shots: Biocytogen has partnered with Sihuan Pharmaceutical to discover innovative therapies across multiple areas, incl. weight loss As per the deal, Biocytogen and Sihuan will combine Biocytogen’s fully human antibody discovery platform with Sihuan’s development, manufacturing, & commercialization capabilities In this collaboration, Biocytogen will leverage its integrated platforms, incl. target-humanized mouse models, in vivo efficacy…

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Astrazeneca

AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma

Shots: The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…

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JenaValve Launches Trilogy Transcatheter Heart Valve System in the US to Treat Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: JenaValve Technology has launched Trilogy THV System to treat ssAR in pts at high or greater surgical risk & reported successful first cases across the US The System uses radiopaque locators to attach directly to native aortic leaflets without calcification, allowing stable implantation, precise alignment, reduced paravalvular regurgitation, & preserving future coronary access with…

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PharmaShots Quarterly Outlook: The Forces Reshaping Biopharma in Q1 2026 

Headlines, Trends, and the Signals Shaping the Future of Biopharma  A Quarter That Reset the Biopharma Narrative  The first quarter of 2026 did not simply continue the momentum of the global biopharmaceutical industry; it redefined its direction.  From multi-billion-dollar acquisitions and accelerating rare disease breakthroughs to AI-powered discovery collaborations and gene therapy approvals, the industry demonstrated a clear shift toward precision innovation, strategic consolidation, and next-generation…

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GSK New

GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma

Shots: The Chinese NMPA has approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) characterised by an eosinophilic phenotype based on P-III (SWIFT-1: n=382) & (SWIFT-2: n=380) trials  Exdensur reduced asthma exacerbations by 58% (SWIFT-1) & 48% (SWIFT-2) over 52wks., with results in Chinese pts (n=58, SWIFT-1) consistent with the overall population. Pooled data…

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