After welcoming the political agreement on the EU pharmaceutical legislation in December 2025, the EMA says it will be devoting 2026 to “intense preparation” for its implementation.
Securing a second major partnership with Sanofi SA – this time worth a potential $2.56 billion – Earendil Labs will provide its AI-driven discovery platform to find new therapeutics for autoimmune and inflammatory diseases.
After raising $292 million in its Hong Kong IPO, AI discovery and development biotech, Insilico Medicine, signed an R&D collaboration with French pharma Servier SA valued at $888 million to discover and develop innovative oncology therapies by combining Insilico's AI-driven drug discovery platforms with Servier's global expertise in cancer drug development.
With plans in place to launch global pivotal testing of GH-001, its inhaled version of psychedelic mebufotenin (5-MeO-DMT), in treatment-resistant depression in 2026, GH Research plc reported the lifting of a U.S. FDA clinical hold, enabling U.S. subject enrollment. The firm now will seek a meeting with the agency to discuss trial design.
Zenas Biopharma Inc.’s positive data from the phase III Indigo trial with obexelimab in immunoglobulin G4-related disease (IgG4-RD) set investigators to speculating about the bifunctional antibody’s odds in the marketplace, as the Waltham, Mass.-based firm plans a BLA submission the U.S. FDA in the second quarter of this year.
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