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Annexon Seeks European Approval of Tanruprubart for Guillain-Barré Syndrome
Shots: The EMA has received MAA of tanruprubart for the treatment of Guillain-Barré syndrome (GBS) The MAA dossier demonstrated rapid neuroinflammation control & improved recovery, supported by a PoC study & a P-III trial against PBO, favorable risk/benefit, robust US & Southeast Asian biomarker data, PK (US/EU/SE Asia), & RWE matching P-III outcomes to IVIg…
January 9, 2026
Fondazione Telethon’s Waskyra Receives the EC Approval for Wiskott-Aldrich Syndrome 
Shots:  The EC has approved Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy for Wiskott-Aldrich Syndrome (WAS)    Waskyra is a single-administration therapy that uses a patient’s CD34+ hematopoietic stem and progenitor cells, modified with a lentiviral vector carrying the WAS gene  The EC’s decision follows a CHMP opinion issued in November 2025 recommending marketing authorization, with the same therapy also approved by…
January 9, 2026
BioNet’s VacPertagen Receives the EC Approval for Pertussis Disease 
Shots:  The EC has approved VacPertagen as a booster aganist Pertussis for pts (age≥12) and for passive infant protection via maternal immunization during pregnancy     CHMP recommendation was supported by data from three clinical trials and nine supportive studies, all consistently demonstrating that VacPertagen is safe for use in teenagers, adults, and pregnant women across populations  VacPertagen is an acellular pertussis vaccine with two components, including recombinant…
January 9, 2026
CuraTeQ
CuraTeQ Biologics Reports the Health Canada’s NOC for Dyrupeg (Biosimilar, Neulasta) 
Shots:  CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received NOC from the BRDD for Dyrupeg, a biosimilar to Neulasta (pegfilgrastim)  Dyrupeg (pegfilgrastim) is a long-acting form of filgrastim that mimics human G-CSF, stimulating bone marrow to increase white blood cell production and treat neutropenia  In 2025, Dyrupeg received marketing authorization from the EC and the UK MHRA, with three additional CuraTeQ biosimilar…
January 9, 2026
Pierre Fabre Partners with Iktos for AI-Driven Drug Discovery in Oncology
Shots: Pierre Fabre Laboratories has entered into an integrated drug discovery collaboration with Iktos to identify & develop novel small-molecule drug candidates in oncology As per the deal, Iktos will apply its AI-driven generative design platform to rapidly identify optimized small-molecule candidates for an undisclosed oncology target, while Pierre Fabre will contribute oncology & preclinical expertise…
January 9, 2026
Roche Signs an Exclusive Licensing Deal with MediLink Therapeutics for YL201
Shots: MediLink has entered into an additional collaboration & exclusive licensing agreement with Roche for the development & commercialization of YL201 (B7H3 ADC) across numerous solid tumor types Under the deal, Roche will obtain an exclusive license to develop, manufacture, & commercialize YL201 worldwide, excl. Mainland China, Hong Kong SAR, & Macau SAR In return,…
January 9, 2026
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals Receives the NMPA Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)
Shots: The Chinese NMPA has approved Redemplo to reduce triglycerides (TGs) in adults with FCS; regulatory review is ongoing in other regions Redemplo will be commercialized by Sanofi in Greater China under an agreement with Arrowhead, with NMPA approval triggering a $10M milestone payment from Sanofi to Arrowhead’s subsidiary Visirna Therapeutics Redemplo is an siRNA…
January 8, 2026
Foresee Pharmaceuticals Licenses MMP-12 Inhibitor Programs to Primevera Therapeutics in a ~$584.5M Deal
Shots: Foresee has entered into an exclusive global licensing agreement with Primevera for its MMP-12 inhibitor programs, which incl. FP-025, FP-020 & third-generation MMP-12 inhibitors in discovery stage As per the deal, Foresee USA will receive a $10M upfront, ~$574.5M in milestones, & tiered single-digit royalties, or alternatively a tiered share of sublicense proceeds in lieu…
January 8, 2026
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