Neurological
US priority review for Japanese firm's first-in-class ADHD drug could result in approval of a new option this year.
Fund IV exclusively targets company creation and early-stage investing across the UK and the US.
The company plans to take Aqneursa to regulators in the US, Europe and elsewhere for ataxia-telangiectasia (A-T), which currently lacks any approved therapy.
Two months after adding major depressive disorder to Caplyta’s US label, Johnson & Johnson reported pooled data showing the drug can offer durable remission of symptoms.
Management says it is prepared to sacrifice early volume if pricing fails to reflect the drug’s role in moderate to severe schizophrenia.
Servier has deepened its AI-enabled collaborations with a deal potentially worth over €1bn with Iktos to accelerate small-molecule drug discovery for undisclosed targets in oncology and neurology.
Bright Minds Biosciences is preparing to advance BMB-101 toward registrational trials and present additional analyses later this year.
The Paris-headquartered firm has been hit with a complete response letter for its oral BTK inhibitor, quite a shock given that it was not expecting to hear from the US agency on its application for the multiple sclerosis drug until early next year.
The Japan-headquartered group is seeking a new partner for a Phase II-ready GPR52 agonist.
Despite recent setbacks in the field, big pharma still appears to have faith in the tau approach to Alzheimer's, as evidenced by Sanofi's new $1bn-plus deal with Korean venture ADEL for an early stage candidate.
The French firm has been hit with a double whammy for its oral BTK inhibitor for multiple sclerosis but analysts at Jefferies say it is premature to write the drug off.
The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.
The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.
Dyne’s data from a larger Phase I/II trial cohort showed much greater dystrophin production with z-rostudirsen (DYNE-251) than seen with Sarepta’s Exondys 51 and some functional gains.
A submission to the FDA in the coming months for essential tremor drug ulixacaltamide could be swiftly followed by a filing of relutrigine for two rare forms of epilepsy.
Doctors and biopharma executives discussed the opportunities and challenges for researching and administering combination therapy at the Clinical Trials on Alzheimer’s Disease meeting.
Novo Nordisk presented topline results from its Phase III semaglutide studies at the Clinical Trials on Alzheimer’s Disease meeting, Lilly SVP Ronald DeMattos advocated for anti-amyloid brain shuttles to reduce ARIA and Eisai presented subcutaneous Leqembi data.
The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.
If approved, VER-01 would be the first cannabinoid-based therapy for chronic low back pain.
At the Clinical Trials On Alzheimer’s Disease meeting, Novo explained why it tested semaglutide in AD a day before the company’s Phase III EVOKE/EVOKE+ presentation, Roche updated Phase Ib/IIa results for its anti-amyloid trontinemab and UCB’s bepranemab remains in limbo.