Regulation

China’s NMPA approves CStone’s sugemalimab for NSCLC treatment

China’s National Medical Products Administration (NMPA) has approved CStone Pharmaceuticals’ sugemalimab (Cejemly) for unresectable stage III non-small cell lung cancer (NSCLC) treatment.

VBI Vaccines’ hepatitis B vaccine gets UK MHRA marketing authorisation

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to VBI Vaccines’ PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)].

US FDA grants Breakthrough Therapy designation to haemophilia A treatment

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Swedish Orphan Biovitrum (Sobi) and Sanofi’s efanesoctocog alfa (BIVV001) to treat haemophilia A.

FDA grants fast track designation for Priothera’s AML therapy

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Priothera’s mocravimod and allogeneic Hematopoietic Stem Cell Transplant (HSCT) combination for post remission therapy of Acute Myeloid Leukemia (AML) patients.

FDA accepts for priority review Sanofi and Regeneron’s Dupixent sBLA

The US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) for priority review in adults with prurigo nodularis.

US FDA approves Amneal’s application for biosimilar

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ biologics license application (BLA) for a biosimilar to Neulasta, pegfilgrastim-pbbk.

Novartis receives EC approval for Jakavi to treat GvHD

Novartis has received approval from the European Commission (EC) for its oral therapy Jakavi (ruxolitinib) to treat patients aged 12 years and above with acute or chronic graft-versus-host disease (GvHD).

Kite’s cell therapy facility gets FDA approval for commercial production

Gilead Company’s subsidiary Kite has received the US Food and Drug Administration (FDA) approval for the commercial production at its new CAR T-cell therapy manufacturing facility in Maryland.

NICE recommends Merck’s tepmetko to treat non-small cell lung cancer

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Merck’s tepmetko (tepotinib) to treat adult patients with advanced non-small cell lung cancer (NSCLC).