Neurology

TGA grants provisional approval to Hansa’s Idefirix as desensitisation treatment

The Australian Therapeutic Goods Administration (TGA) has granted provisional approval to Hansa Biopharma’s Idefirix (imlifidase) as desensitisation treatment for highly sensitised patients before kidney transplantation either from living or deceased donors.

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.

Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension.

Tetra Pharm Technologies debuts first drug in Germany

Denmark-based biotech firm Tetra Pharm Technologies has introduced its first product in Germany.

QurAlis raises funds to develop neurodegenerative disease medicines

Clinical-stage biotechnology company QurAlis has closed $88m in oversubscribed Series B financing round to advance precision medicines for neurodegenerative diseases.

Avenue signs license agreement with AnnJi Pharmaceutical for AJ201

Avenue Therapeutics has signed an exclusive license agreement with Taiwanese clinical-stage drug company AnnJi Pharmaceutical to develop and commercialise the first-in-class clinical asset, AJ201.

Coya and ARScience expand global licensing agreement for COYA 301

Coya Therapeutics has expanded its exclusive global licensing agreement with ARScience Biotherapeutics for low-dose IL-2 subcutaneous administration product candidate COYA 301.

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.