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).
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).
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 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).
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.
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 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.
US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group.
Ractigen Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for its new therapeutic siRNA, RAG-17, to treat Amyotrophic Lateral Sclerosis (ALS).
Ryne Biotechnology has received a $4m Clinical Stage Research Program (CLIN1) grant from the California Institute for Regenerative Medicine (CIRM) to advance its lead candidate RNDP-001.
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