Central Nervous System

FDA grants fast track designation for Lundbeck’s Lu AH69593

Lundbeck has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational treatment, Lu AH69593, to treat narcolepsy.

Teva and Polpharma Biologics sign global deal for ocrelizumab biosimilar

Teva Pharmaceuticals International and Polpharma Biologics have signed a global licensing agreement for a proposed biosimilar to Ocrevus (ocrelizumab) to treat multiple sclerosis (MS).

FDA approves Eisai and Biogen’s Leqembi Iqlik BLA for early Alzheimer’s

The US Food and Drug Administration (FDA) has granted approval for Eisai and Biogen’s biologics licence application (BLA) for Leqembi Iqlik, a once-weekly subcutaneous injection maintenance dosing to treat early Alzheimer's disease (AD).

Secarna, Vect-Horus partner to develop RNA-targeted therapeutics

Secarna Pharmaceuticals and Vect-Horus have entered a research collaboration for developing RNA-targeted therapeutics capable of crossing the blood-brain barrier (BBB) for treating central nervous system (CNS) diseases.

EC grants orphan drug status to JR-446 for MPS IIIB

The European Commission (EC) has granted orphan drug designation (ODD) to Medipal and JCR Pharmaceuticals' investigational drug, JR-446, to treat mucopolysaccharidosis type IIIB (MPS IIIB), also known as Sanfilippo syndrome type B.

GRIN Therapeutics and Angelini Pharma collaborate on radiprodil development

GRIN Therapeutics has announced a collaboration with Angelini Pharma to develop and commercialise radiprodil outside of North America.

Canadian research initiative secures grant for paediatric brain cancer

The University of Calgary and Alberta Children’s Hospital have secured C$68,000 ($48,694) from Brain Cancer Canada for a research initiative spearhead by Dr Patrick Sipila and Dr Aru Narendran, aimed at improving outcomes for children with aggressive brain cancers.

FDA grants RMAT to BrainChild Bio’s CAR T-cell therapy for DIPG

BrainChild Bio's B7 homolog 3 (B7-H3) targeting autologous chimeric antigen receptor (CAR) T-cell therapy, BCB-276, has received the regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for treating diffuse intrinsic pontine glioma (DIPG).

MIRA secures board approval to buy SKNY Pharmaceuticals

US-based firm MIRA Pharmaceuticals has secured approval from its board of directors to acquire SKNY Pharmaceuticals, a company engaged in the development of SKNY-1 oral drug candidate for weight loss and smoking cessation.