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Merck partnered with Google Cloud in a multi-year deal worth up to $1B to deploy an AI-driven agentic platform across R&D, manufacturing, commercial, and corporate functions
The collaboration will integrate advanced AI tools, incl. Gemini Enterprise, to enhance productivity, digitize data, & support Merck’s global workforce of ~75,000 employees
The partnership aims to accelerate…
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The US FDA approved MSD's Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance
Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…
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FDA has accepted BLA for I-DXd under the RTOR & Project Orbis program, granting priority review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after Pt-based CT (PDUFA: Oct 10, 2026)
BLA was based on the P-II (IDeate-Lung01) study assessing I-DXd (IV, Q3W) in…
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The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
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AI is redefining compliance from reactive to predictive, as this April edition highlights how AI-powered systems are transforming regulatory oversight into a continuous, real-time, and data-driven function, enabling early risk detection, automated audits, and smarter regulatory collaboration across the pharma value chain.
Strategic dealmaking and AI partnerships shape industry momentum, with March witnessing high-value…
Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
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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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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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Infinimmune has partnered with Merck to discover & develop antibody candidates against multiple undisclosed targets selected by Merck using Infinimmune’s human-first antibody discovery platform
As per the deal, Infinimmune will use its Anthrobody discovery platform & Glimpse antibody language model to discover & optimize antibodies from human immune repertoires, enabling large-scale B-cell screening to…
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Trial assessed enlicitide (QD, PO) vs non-statin therapies (PO) added to background statins in adults with hypercholesterolemia & ASCVD risk or history, meeting its 1EP with a 64.6% LDL-C reduction at 8wks. & reductions of 56.7% vs bempedoic acid, 36% vs ezetimibe, & 28.1% vs their combination
Trial also showed 8wk. reductions in ApoB…
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Merck has entered into a definitive agreement to acquire Terns, incl. its asset TERN-701 asset, expanding its oncology pipeline
As per the deal, Merck will acquire Terns for $53/share in cash, representing a total equity value of ~$6.7B (~$5.7B net of acquired cash); closing is expected in Q2’26
TERN-701 is being evaluated in the…

