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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…
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Quotient has entered into a multi-year research collaboration agreement with Merck to discover novel drug targets in inflammatory bowel disease leveraging Quotient’s somatic genomics platform tech
Through its somatic genomics platform, Quotient analyzes patient tissue to identify disease-causing or protective mutations, generating insights that inform novel therapeutic strategies across multiple conditions, including IBD
As…
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From AI-powered discovery to next-generation biologics and gene editing, 2025 was a blockbuster year for life sciences dealmaking. Pharma and biotech companies signed multibillion-dollar partnerships and acquisitions to accelerate innovation across oncology, cardiometabolic diseases, neurology, and rare disorders.
Platform technologies dominated the deal landscape, with big pharma securing access to cutting-edge modalities from bispecific…
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Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747 pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy
At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs…

