Neurological
Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
The pact could be worth more than $2.6bn and adds to growing big pharma investment in the technology.
By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
The study’s failure in the overall MDD population was not a surprise, but solriamfetol’s efficacy in MDD with EDS provided a rationale for testing it in that subpopulation.
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
The Texas-based firm is giving up on the investigational Alzheimer’s therapy after a second Phase III failure left it with nowhere to go in the disease.
The FOCUS study met its primary and key secondary endpoints, but lack of statistical significance on the higher dose and a crowded market raised questions.
A decision from the FDA is due by 28 September.
A new “quasi-experimental” study using UK National Health Service data might confirm that GSK’s shingles vaccine helps cut dementia cases.
The Belgian firm banks nearly €77.7m to push its Charcot-Marie-Tooth to proof-of-concept.
Encouraging results in younger children with Duchenne is keeping Regenxbio on track for a potential mid-2026 filing for its gene therapy, RGX-202.
Move to acquire profitable Tokyo-based venture part of Japanese major's strategy of building a broader ecosystem for dementia detection and care.
The potential first-in-class antibody oligonucleotide conjugate could treat a form of the muscle wasting disease, and could be the first of Avidity’s trio of rare disease drugs to gain approval.
A joint venture with AI specialist Hologen will bring in much-needed cash for the ambitious gene therapy firm.
The future of kappa opioid receptor antagonism as a therapeutic strategy in major depressive disorder is looking increasingly bleak after J&J dropped aticaprant from development, but rival Neumora is pressing on with navacaprant.
Alzheimer’s Drug Discovery Foundation CFO Karen Harris talked to Scrip about the non-profit group’s investment strategy and biopharma interest in Alzheimer’s disease.
While Lexicon’s non-opioid pain candidate missed the primary endpoint in a diabetic peripheral neuropathic pain study, the company insisted the data revealed a path forward with a 10mg daily dose.
Leqembi is finally on track for approval by the summer, though safety precautions mean fewer patients will be eligible for treatment than in the US, and its uptake is not expected to be strong.
The Essential3 program’s data monitoring committee recommended stopping one of the essential tremor studies for futility, but the company said it will continue the trials anyway.
Results from the Phase III EMERGE study showed that Axsome’s recently approved Symbravo is effective in patients dissatisfied with oral CGRP inhibitors.