Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the FDA’s frequent use of accelerated pathways.
Eisai’s request for an accelerated assessment of its Alzheimer’s disease candidate lecanemab has been rejected by the European Medicines Agency, a blow to hopes of fast access to the treatment in the EU.
The drug has been tipped as a potential blockbuster for Eisai and its partner Biogen, but gaining full regulatory approval, then reimbursement and acceptance by physicians and patients in...
In a study intended to show similar benefit in western patients, PD-1/VEGF-targeting ivonescimab met a progression-free survival endpoint, but missed on OS.
One Phase III trial hits but a second study misses by a mile.
Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.
The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.
The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.
Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.
Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.
