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Regenxbio
NEWS

REGENXBIO Reports the US FDA’s BLA Acceptance and Priority Review of RGX-121 for Treating Mucopolysaccharidosis II

Shots: The US FDA has accepted BLA & granted priority review to RGX-121 (clemidsogene lanparvovec) for the treatment of Mucopolysaccharidosis II (MPS II or Hunter syndrome), with PDUFA action date of Nov 09, 2025 As per Jan 2025 partnership, NS Pharma (Nippon Shinyaku’s subsidiary) will commercialize RGX-121 in the US post approval while REGENXBIO will handle…
May 14, 2025

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Sarepta Therapeutics
NEWS

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

Shots: Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 Abs Approval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…
May 14, 2025

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mentice
NEWS

Mentice Reports US Launch of Ankyras 4.0 to Advance Patient-Specific Aneurysm Planning for Neuro Interventions

Shots: Following FDA 510(k) clearance, Mentice has launched Ankyras 4.0 for pts-specific flow diverter planning to treat intracranial aneurysms in the US Ankyras 4.0 introduces DICOM node integration, a redesigned user interface & broader accessibility via online platform & mobile apps, plus its integration with VIST simulation allows virtual case rehearsal to accelerate decision-making &…
May 13, 2025

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AbTherx
NEWS

Spice Biotechnologies Partners with AbTherx to Discover Antibodies in Immuno-Oncology

Shots: AbTherx has entered into a multi-program antibody discovery partnership with Spice Biotechnologies to identify antibodies against targets selected by Spice Bio, using AbTherx’s Atlas Mouse technologies As per the deal, Spice Bio will obtain rights to develop & commercialize antibodies from the collaboration in exchange for research payments, potential clinical & commercial milestones, plus…
May 13, 2025

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Genoox
NEWS

QIAGEN to Acquire Genoox for ~$80M

Shots: QIAGEN has entered into a definitive agreement to acquire Genoox, a provider of AI-driven software that allows clinical laboratories to scale & accelerate the analysis of complex genetic tests As per the deal, Genoox will receive $70M in cash & up to $10M in additional milestone payments Acquisition adds Franklin, Genoox’s cloud-based platform, to…
May 13, 2025

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Astrazeneca
NEWS

UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The UK’s MHRA has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) with HFO-1234ze(E), a next-generation, near-zero global warming potential (GWP) propellant for treating COPD in adults; regulatory review is ongoing in EU, China & other regions Approval was based on a next-generation propellant clinical development program assessing Trixeo + HFO-1234ze(E) vs Trixeo + HFA-134a,…
May 13, 2025

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