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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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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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…
Shots:
The US FDA has received NDA of bezuclastinib under the RTOR program for the treatment of pts with GIST who were previously treated with imatinib, backed by the P-III (PEAK) trial of bezuclastinib + sunitinib vs sunitinib monotx.
Trial met its 1EP of improved PFS by 50% (mPFS: 16.5 vs 9.2mos.) & showed ORR of…
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…
Shots:
FDA has approved Foundayo along with lifestyle intervention for obese/overweight adults with weight-related medical problems; Foundayo will be available via LillyDirect beginning Apr 6, 2026
Approval was backed by the ATTAIN program, incl. ATTAIN-1, where Foundayo showed weight loss of 27.3 lbs (12.4%) vs 2.2 lbs (0.9%) with PBO at the highest dose, with…
Shots:
Axsome has entered into an asset purchase agreement with Takeda for TAK-063 (balipodect), with an intention to develop it for treating schizophrenia & Tourette syndrome (P-III trial-enabling activities for schizophrenia to begin in 2026)
As per the deal, Axsome gains global rights to develop, manufacture, & commercialize TAK-063, while Takeda receives an upfront payment,…
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…
Shots:
Frontier has granted LG Chem an exclusive global license to develop & commercialize FMC-220 outside of Greater China, with Frontier retaining full rights in Greater China
As per the deal, LG will handle regulatory filings, global clinical development, & commercialization in licensed regions, while Frontier may partially fund confirmatory trials & receive upfront, clinical,…
Shots:
Biogen to acquire Apellis, incl. its assets Empaveli, Syfovre & felzartamab, for $41/share plus a non-transferable CVR, representing an upfront equity consideration of ~$5.6B, with remaining shares acquired later via a second-step merger
CVR holders will receive $2/CVR if Syfovre achieves $1.5B sales (2027-2030), an additional $2 if it reaches $2B in the same…

