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Biocytogen Pharmaceuticals Enters a Licensing Agreement with BeOne Medicines for Multiple Antibody Candidates
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…
July 10, 20250Comments
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Exactech Reports the US FDA 510(k) Clearance of Equinoxe Scapula Reconstruction System for Acromial Stress Fractures
Shots: 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…
July 10, 20250Comments
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Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML
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…
July 10, 20250Comments
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Merck to Acquire Verona Pharma for ~$10B
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…
July 10, 20250Comments
VIEWPOINTS
Unlocking Approval: Sofie Berg from AbbVie in a Riveting Conversation with PharmaShots 
Shots:  AbbVie adds an eighth indication to Rinvoq’s label with the European Commission’s approval for treating adult patients with giant cell arteritis (GCA)  Sofie Berg, Therapeutic Area Head of International Immunology at AbbVie, in a conversation with PharmaShots, shares insights from the SELECT-GCA trial evaluating Rinvoq in GCA, highlighting both primary and secondary endpoints  Rinvoq…
July 9, 20250Comments
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Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures
Shots: 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…
July 9, 20250Comments
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Lupin Joins Forces with Zentiva to Develop TNF-Alpha Inhibitor Biosimilar
Shots: 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…
July 9, 20250Comments