Shots:
Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EU
The study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…
NEWS
Shots:
AbbVie and IGI Therapeutics, a subsidiary of Ichnos Glenmark Innovation, have entered into an exclusive licensing deal for ISB 2001, a drug targeting oncology & autoimmune diseases developed using IGI's proprietary BEAT protein platform
As per the deal, AbbVie will obtain exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe,…
Shots:
The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy
Approval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC pts
Trial…
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LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received Adbry
Trial met its 1EP, with higher proportion of…
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…
Shots:
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…

