Shots:
Biocytogen & BeOne have entered into a global licensing agreement for multiple fully human antibodies discovered using Biocytogen’s RenMicefully human antibody platform
As per the deal, Biocytogen will receive an upfront payment, development, regulatory, & commercial milestones, with net sales-based tiered royalties on licensed products. Although, financial terms remain undisclosed
Collaboration builds on BeOne Medicines…
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Exactech has received the US FDA 510(k) clearance for the Equinoxe Scapula Reconstruction System to treat acromial & scapular spine fractures; limited US pilot launch is expected later this year
Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using single & dual plating techniques, which is compatible with any rTSA implant…
Shots:
The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026)
sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…
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Merck has entered into a definitive agreement to acquire Verona Pharma incl. its asset Ohtuvayre (ensifentrine), expanding its cardio-pulmonary pipeline & portfolio
As per the deal, Merck will acquire Verona Pharma for $107 per American Depository Share (ADS), each representing 8 ordinary Verona shares, for an aggregate of ~$10B; closing expected in Q4'25
Ohtuvayre…
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Mendaera has received the US FDA’s 510(k) clearance for Focalist robotic system for ultrasound-guided procedures
Mendaera will begin a limited launch of its Focalist system in 2025 to initially support urology procedures like PCNL, expanding to other specialties, with full commercialization expected in 2026
Focalist is designed to support precise & consistent needle placement…
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Zentiva has entered into a license & supply agreement with Lupin to commercialize Lupin's TNF-alpha inhibitor biosimilar across multiple global markets
Zentiva will lead commercialization outside the US & Canada, mainly in EU & CIS, while Lupin will handle development, manufacturing, & supply in agreed territories & commercialization in the remaining territories, incl. the…
Shots:
The EMA has received an application for a higher dose of Wegovy (semaglutide 7.2mg, SC) to treat obesity
Application was backed by the 72wk. STEP UP trial assessing Wegovy (7.2mg) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 adults without diabetes (BMI ≥30kg/m²), & the 72wk. STEP UP T2D trial assessing Wegovy…
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HealthBook+ has launched PaiGE, a personal health assistant that provides real-time, personalized health insights for both pts & clinicians
PaiGE offers consumers personalized lifestyle recommendations, shareable health records, mood & lifestyle-based insights, & a secure way to seek health information, while also guiding them to track progress between visits with clinician-backed instructions & PaiGE's…
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The US FDA has received sNDA of Caplyta (lumateperone) for the prevention of relapse in schizophrenia; sNDA of Caplyta as an adjunctive therapy for MDD is under FDA’s review
sNDA was supported by withdrawal P-III (Study 304) trial assessing Caplyta (42mg, QD) for 18wk. open-label phase followed by a double-blind phase, where pts received…
Shots:
JCR Pharmaceuticals & Alexion have entered into a license agreement for JCR’s JUST-AAV capsids to develop genomic medicines
As per the deal, Alexion may use licensed capsids from the JUST-AAV platform in up to 5 genomic medicine programs in exchange for an undisclosed upfront payment, ~$225M in R&D milestones, ~$600M in sales milestones (milestones…

