Skip to content Skip to footer
Subscribe Now

NEWS

Merck new
Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA
Shots: The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026 DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 study The…
July 11, 2025
AbbVie Enters a Licensing Deal with IGI Therapeutics for ISB 2001
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,…
July 11, 2025
BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma
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…
July 10, 2025
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, 2025
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, 2025
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, 2025
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, 2025
Load more