Central Nervous System

Takeda’s Orzeyful secured Japan MHLW approval for narcolepsy type 1

Takeda has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orzeyful (oveporexton) to treat narcolepsy type 1 in adults.

Andelyn Biosciences to develop GM2 gangliosidosis therapy

Andelyn Biosciences is set to develop and manufacture a gene therapy known as AAV9-GM2, for Queen’s University to treat GM2 gangliosidoses, including Tay-Sachs and Sandhoff diseases.

Remepy secures $36m funding for hybrid drug pipeline expansion

Remepy has closed a $36m Series A financing round to accelerate its pharmaceutical co-development partnerships and expand its hybrid drug pipeline.

Jazz Pharmaceuticals to acquire Actio Biosciences for $820m upfront

Jazz Pharmaceuticals has signed a definitive agreement to purchase Actio Biosciences in a deal that includes an upfront payment of $820m and up to $500m in additional contingent payments.

Kenvue’s Tylenol with Naproxen gains FDA approval

The US Food and Drug Administration (FDA) has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter (OTC) fixed-dose combination of acetaminophen (650mg) and naproxen sodium (220mg).

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.