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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
8 hours ago

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NEWS

UCB to Acquire Neurona Therapeutics for ~$1.15B, Expanding into Regenerative Epilepsy Therapies

Shots: UCB has entered into a definitive agreement to acquire Neurona Therapeutics for up to $1.15B, including $650M upfront and up to $500M in potential milestones expected to close by end of Q2’26 The acquisition adds NRTX-1001, an investigational neuronal cell therapy currently in P-I/II study for drug-resistant mesial temporal lobe epilepsy, strengthening UCB’s neuroscience…
2 days ago

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NEWS

UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d) 

Shots:  The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age  Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.) …
March 26, 2026

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NEWS

Antengene and UCB Strike ~$1.18B Deal to Advance ATG-201 for B-Cell–Related Autoimmune Diseases

Shots: Antengene has granted UCB a global exclusive license to develop, manufacture, & commercialize ATG-201 for B-cell–related autoimmune diseases, plus access to Antengene’s associated manufacturing tech supporting the therapy As per the deal, Antengene will receive $80M in upfront & near-term milestones & ~$1.1B in development & commercial milestones, as well as net sales-based tiered…
March 5, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in January 2026    

Shots:  The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka.  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock.  Decisions were backed by strong Phase II/III data…
February 17, 2026

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NEWS

UCB Reports the CHMP Positive Opinion of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: The CHMP has recommended Kygevvi (PO) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age, supported through EMA's PRIME scheme. EC decision is expected by Q2’26 Supportive evidence came from pooled data from 2 studies of Kygevvi in 39 pts with genetically confirmed TK2d & symptom…
February 2, 2026

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Top 20 immunology companies of 2025
TOP 20

Top 20 Immunology Companies of 2025

Shots:  Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes  In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…
July 24, 2025

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