Browsing Tag
European Medicines Agency
86 posts
REGN rises 3.8% as Pasatru opens a new rare-disease franchise for Regeneron
Pasatru wins FDA approval after cutting new FOP lesions 90%, expanding Regeneron’s rare-disease portfolio as pediatric development approaches.
RESTORE trial could turn NVG-291 into NervGen’s defining spinal cord injury asset
NVG-291 heads into Phase 3 as NervGen deploys its $61m cash runway behind a 150-patient test of hand-function recovery in chronic tetraplegia.
Theriva targets Phase 2/3 VCN-01 trial after early eye-preservation signal
Theriva plans a VCN-01 Phase 2/3 retinoblastoma trial after early eye-preservation signals, but its $11.3m cash runway raises the stakes.
Sutacimig Phase 3 path puts Hemab’s $457.5m post-IPO cash base to work
Sutacimig gets an FDA-backed Phase 3 path as Hemab deploys its $457.5m post-IPO cash base. See what the pivotal trial means for growth.
Neuren Pharmaceuticals (ASX: NEU) lifts 2026 royalty outlook after record DAYBUE quarter
Record DAYBUE sales and rapid adoption of its STIX formulation have strengthened Neuren Pharmaceuticals’ royalty outlook, while Europe and Japan offer the next major tests of the franchise’s global potential.
Susvimo EU recommendation gives Roche a new weapon in the battle for longer-lasting eye treatments
Roche moves Susvimo toward EU approval as its refillable eye implant targets injection burden and strengthens a CHF 2.1 billion retinal franchise.
Can Elisabeth Svanberg help Medincell turn clinical progress into durable value?
Medincell wants pharmaceutical executive Elisabeth Svanberg to join its board and lead its remuneration and nomination committee. The proposal comes as the French biotechnology company moves from platform development towards recurring royalty growth and potential multi-product commercialisation.
Neuraxpharm Group’s leriglitazone bet advances as European regulators back a narrow pediatric label
Minoryx Therapeutics revives its €258 million Neuraxpharm deal as leriglitazone moves closer to a narrow European rare-disease launch.
Can Portela’s once-quarterly dosing unlock the next phase of Zoetis’ feline pain franchise?
Zoetis launches Portela in Canada and Europe, offering cats three months of osteoarthritis pain relief while testing veterinary uptake.
Orchid Pharma (NSE: ORCHPHARMA) signs $178m Russia deal to commercialise Exblifep
Orchid Pharma signs a $178 million Russia deal for Exblifep. Read how the Pharmasyntez pact could reshape ORCHPHARMA’s global antibiotic strategy.