Neurology

FDA accepts NDA filing by Biogen and Sage for zuranolone

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) filing by Biogen and Sage Therapeutics for their investigational drug zuranolone to treat major depressive disorder (MDD) and postpartum depression (PPD).

Rewind Therapeutics raises funding to further lead programme into clinical development

Rewind Therapeutics has raised further funding that has seen Sunstone Life Science Ventures joining as a new investor.

Forge Biologics receives EMA PRIME designation for Krabbe disease drug

Forge Biologics has received priority medicines (PRIME) designation from the European Medicines Agency (EMA) for its drug candidate FBX-101 to treat patients with Krabbe disease.

Myrtelle, rAAVen Therapeutics announce partnership to develop novel gene therapy vectors

Myrtelle and rAAVen Therapeutics have announced a partnership to develop novel recombinant adeno-associated virus (rAAV) vectors to progress gene therapy treatments for diseases of the central nervous system (CNS) in which myelin is impacted.

Vistagen agrees to acquire Pherin Pharmaceuticals

Vistagen has signed a definitive agreement for the acquisition of clinical-stage drug development firm Pherin Pharmaceuticals.

KemPharm receives Orphan Drug Designation for idiopathic hypersomnia prodrug

KemPharm has received the Orphan Drug Designation from the US Food and Drug Administration (FDA) for serdexmethylphenidate (SDX) to treat rare neurological sleep disorder, idiopathic hypersomnia (IH).

Marinus Pharmaceuticals signs collaboration agreement with Tenacia Biotechnology

Marinus Pharmaceuticals has signed a collaboration and supply agreement with Tenacia Biotechnology (Shanghai), a China-based biotechnology company focused on the development of innovative treatments for central nervous system (CNS) disorders.

FDA approves Axsome Therapeutics’ oral antidepressant Auvelity

The US Food and Drug Administration (FDA) has approved Axsome Therapeutics’ Auvelity (dextromethorphan HBr -bupropion HCl) to treat adult patients with major depressive disorder (MDD).

Acadia Pharmaceuticals receives CRL for sNDA for NUPLAZID to treat ADP

Acadia Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on its supplemental New Drug Application (sNDA) for NUPLAZID (pimavanserin).