Central Nervous System

Cycle expands MS treatment portfolio with Banner Life Sciences acquisition

Cycle Pharmaceuticals has completed the acquisition of Banner Life Sciences, including BAFIERTAM (monomethyl fumarate) product, a US Food and Drug Administration (FDA)-approved treatment for relapsing forms of multiple sclerosis (MS) in the adult population.

Sanofi’s multiple sclerosis therapy gains breakthrough therapy status from FDA

Sanofi’s oral bioactive Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib has gained breakthrough therapy designation from the US Food and Drug Administration (FDA) for treating the adult population with non-relapsing secondary progressive multiple sclerosis (nrSPMS).

MindMed receives innovation passport for GAD therapy from UK MHRA

Mind Medicine (MindMed) has received the innovation passport designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its MM120 Orally Disintegrating Tablet (ODT) as a potential treatment for generalised anxiety disorder (GAD).

FDA issues CRL to PharmaTher’s ketamine ANDA

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher concerning its ketamine abbreviated new drug application (ANDA).

Acumen Pharmaceuticals extends collaboration with Lonza for sabirnetug

Acumen Pharmaceuticals has announced the extension of its collaboration with Lonza to facilitate the anticipated commercial launch of sabirnetug, a new therapeutic for early Alzheimer's disease (AD).

Cipla enters deal to distribute Sanofi’s CNS products in India

Sanofi India Limited and Sanofi Healthcare India (together called “Sanofi India”) have entered into an exclusive partnership with Cipla, focusing on the expansion of its central nervous system (CNS) product portfolio in the Indian market.

Fermion receives IND approval in China for pain relief drug FZ008-145

Guangzhou Fermion Technology (Fermion) has received approval from China’s National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for FZ008-145.

CuraSen Therapeutics secures funding to advance CST-3056 for Alzheimer’s disease

CuraSen Therapeutics has secured up to $5.8m from the Alzheimer’s Drug Discovery Foundation (ADDF) to progress CST-3056 for the treatment of Alzheimer’s disease.

Biotech AltPep scores around $53m in Series B funding round

US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group.