Drug Manufacturing

EMA validates X4’s mavorixafor application for WHIM syndrome treatment

The European Medicines Agency (EMA) has validated X4 Pharmaceuticals’ marketing authorisation application (MAA) submitted for mavorixafor, aimed at treating WHIM syndrome, a rare primary immunodeficiency.

FDA approves Amneal Pharmaceuticals’ Alzheimer’s and oncology treatments

The US Food and Drug Administration (FDA) has granted approval for Amneal Pharmaceuticals’ three medications, memantine/donepezil extended-release capsules and everolimus tablets for oral suspension, with tentative approval for rifaximin oral tablets.

Kamada to supply immune globulin products in Latin America

Kamada has secured a three-year contract with an international organisation to supply its KAMRAB and VARIZIG immune globulin products in Latin America from 2025 to 2027.

Health Canada authorises Roche’s Vabysmo for certain eye conditions

Health Canada has granted authorisation to Roche Canada's Vabysmo (faricimab injection) to be used in a 6.0 mg single-use pre-filled syringe (PFS) for treating diabetic macular oedema, wet or neovascular, age-related macular degeneration (AMD), and macular oedema secondary to retinal vein occlusion (RVO).

Fermion and Simcere to partner on development of pain treatment drug

Guangzhou Fermion Technology and Simcere Pharmaceutical Group have announced a collaboration aiming to develop FZ002-037 for pain treatment.

Micron Biomedical secures funds for needle-free vaccine development

Micron Biomedical has secured over $16m in a Series A3 financing round to expand the commercial manufacturing of its needle-free vaccines.

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.

RheumaGen secures $15m in Series A funding to advance RA therapies

RheumaGen has secured $15m in Series A financing round to advance the development of a class of human leukocyte antigen (HLA) gene-editing therapies for autoimmune ailments including rheumatoid arthritis.

Star Therapeutics’ von Willebrand disease therapy gains FDA fast track status

Star Therapeutics' investigational monoclonal antibody, VGA039, has gained fast track designation from the US Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD).