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Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Shots: The US FDA has cleared Novaliq’s IND application for NOV05, enabling initiation of the EYETAC P-II clinical study in pts with non-infectious anterior uveitis (NIAU) The EYETAC P-II study will be conducted in the US and is expected to begin in Q1’26, evaluating the safety, tolerability, and dose-dependent anti-inflammatory effects of NOV05 NOV05 is…

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BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

Shots: The US FDA has granted 510(k) clearance to BlueOcean Global’s Excelsior External Fixation System, a circular external fixation platform designed to support both bone reconstruction and soft tissue management The system is cleared for commercial distribution in the US and will be rolled out initially through select centers, with broader availability planned in the…

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J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2025 (Part 02)  

Shots:  Novartis led biopharma dealmaking in 2025, executing 23 transactions worth $37.92B with a disciplined, high-impact strategy that balanced scale, science, and strategic fit    Dealmaking was spread across high-conviction areas; neuroscience, cardiovascular disease, immunology, and RNA platforms, combining transformational acquisitions with flexible licensing partnerships to build a future-ready pipeline    Standout transactions (Avidity, Monte…

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Genethon Signs Worldwide Licensing Agreement with AskBio (Bayer AG) to Advance Gene Therapy for Pompe Disease

Shots: Genethon has entered into an exclusive, worldwide licensing agreement with AskBio for the use of a patented component of AskBio’s investigational gene therapy AB-1009 for the treatment of Pompe disease The licensed component is based on a transgene encoding a truncated form of GAA, developed by Genethon, which demonstrated preclinical efficacy in correcting glycogen…

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Ipsen Pharmaceuticals

Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Shots: The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML) The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…

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J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2025 (Part 01) 

Shots:    Lilly leads with precision and purpose with 45 deals totaling $21.22B in 2025, focusing on platform-driven, science-led partnerships across oncology, gene therapy, RNA editing, and AI-enabled discovery while building durable innovation engines rather than chasing short-term wins  Strategic dealmaking over sheer volume is evident in partnerships like precision oncology with Scorpion Therapeutics and CNS delivery with Sangamo, structured to…

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Know Your Investor: ARCH Venture Partners (December’25 Edition) 

Shots:  ARCH Venture Partners is a leading US-based venture capital firm recognized for backing bold science and building category-defining companies across biotechnology, life sciences, and transformational healthcare, with a strong focus on company creation  In 2024, ARCH completed 31 investments from Seed to Series A–F and beyond, including late-stage and private rounds. The firm backed innovators such…

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Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M

Shots: Repare Therapeutics has entered into a definitive asset purchase agreement with Gilead Sciences for the acquisition of Repare's RP-3467, a polymerase theta (Polθ) ATPase inhibitor, strengthening Gilead’s precision oncology pipeline Under the Agreement, Repare will receive up to $30M in total consideration, including $25M upfront (subject to customary adjustments) and an additional $5M upon…

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Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia

Shots: The US FDA has approved Agios’ Aqvesme (mitapivat) for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies (n=452), which met all 1EPs and 2EPs, demonstrating significant improvements in hemoglobin, fatigue, and reductions in transfusion burden vs PBO Aqvesme…

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