Browsing Tag
European Medicines Agency
81 posts
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.
Neuren Pharmaceuticals (ASX: NEU) jumped 45% in two sessions, but how much DAYBUE upside remains?
DAYBUE’s EU breakthrough sent NEU up 45% in two sessions. The harder test is whether royalties and NNZ-2591 justify A$2.25 billion.
Could Datroway become AstraZeneca and Daiichi Sankyo’s next major oncology franchise after Enhertu?
atroway has received a positive European regulatory recommendation for first-line treatment of metastatic triple-negative breast cancer in patients unable to receive immunotherapy. The decision moves AstraZeneca PLC and Daiichi Sankyo Company, Limited closer to opening a commercially important market while increasing the strategic value of their antibody drug conjugate partnership.
Could elsunersen become the asset that steadies Praxis Precision Medicines’ CNS pipeline?
Find out how Praxis’ FDA Breakthrough Therapy Designation for elsunersen could affect PRAX stock, rare epilepsy strategy and precision neuroscience today!
Is the gMG treatment race entering a lower-burden dosing phase?
Find out how Regeneron’s cemdisiran review could reshape generalized myasthenia gravis treatment, REGN stock sentiment and siRNA competition today!
Wockhardt wins FDA approval for Zaynich as #WOCKPHARMA nears 52-week high
Wockhardt Limited’s Zaynich FDA approval could reshape its antibiotic pipeline story. Find out what it means for investors and Indian pharma.