Haematology

ImmunoACT and Caring Cross sign TriCAR-T cell therapy development deal

India-based ImmunoAdoptive Cell Therapy (ImmunoACT) has entered into a partnership with Caring Cross to advance the development and commercialisation of a Tri-functional chimeric antigen receptor (TriCAR)-T cell immunotherapy aimed at treating leukaemia and lymphoma.

NICE recommends Novartis’ CAR-T therapy for leukaemia

The UK National Institute for Health and Care Excellence (NICE) has recommended the routine use of Novartis' tisagenlecleucel (Kymriah), a chimeric antigen receptor T-cell (CAR-T) therapy, for children and young adults aged up to 25 years with B-cell acute lymphoblastic leukaemia (ALL).

EMA CHMP recommends marketing authorisation for Novartis’ PNH treatment

Novartis has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for Fabhalta (iptacopan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from haemolytic anaemia.

Takeda gets approval for acute lymphoblastic leukemia treatment sNDA

Takeda has received accelerated approval for a supplemental new drug application (sNDA) from the US Food and Drug Administration (FDA) for ICLUSIG (ponatinib) to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

FDA committee recommends BMS-2seventy’s Abecma

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.

Juventas receives NMPA market approval for cell therapy

CASI Pharmaceuticals’ partner Juventas Cell Therapy has received market approval from the China National Medical Products Administration (NMPA) for Inaticabtagene Autoleucel (CNCT 19).

FDA accepts BLA for Pfizer’s haemophilia B gene therapy

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.

EC grants marketing authorisation for Kapruvia to treat pruritus in hemodialysis patients

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced the receipt of marketing authorisation from European Commission for Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus linked with chronic kidney disease (CKD) in adult hemodialysis patients.

Sobi agrees $8bn takeover offer from Advent and GIC

Swedish Orphan Biovitrum (Sobi) has agreed a $8bn (SEK69.4bn) takeover offer from Advent International and Singapore’s wealth fund GIC.