ImmunologyDrug DiscoveryInflammation March 26, 2024 Q32 Bio concludes merger deal with Homology Medicines By PBR Staff Writer With the deal closing, the merged business will now function under the name Q32 Bio. Concurrent with the merger’s closure, Q32 Bio also finalised a $42m private placement.
RegulationDrug DiscoveryHaematology March 25, 2024 EMA CHMP recommends marketing authorisation for Novartis’ PNH treatment By PBR Staff Writer This endorsement is a significant step towards the availability of Fabhalta for PNH patients in Europe. The positive opinion is based on data from two Phase III clinical
ApprovalsNeurology March 22, 2024 FDA approves Italfarmaco’s Duvyzat for DMD treatment By PBR Staff Writer This development marks the first nonsteroidal medication authorised to treat DMD patients with all genetic variants of a rare neurological disorder. A histone deacetylase (HDAC) inhibitor, Duvyzat can
ApprovalsHaematology March 20, 2024 Takeda gets approval for acute lymphoblastic leukemia treatment sNDA By PBR Staff Writer This kinase inhibitor is indicated to be used in combination with chemotherapy in adult patients with newly diagnosed Ph+ ALL. The approval was based on the treatment regimen
Oncology March 19, 2024 AstraZeneca signs agreement to acquire Fusion Pharmaceuticals By PBR Staff Writer The acquisition is a significant step in AstraZeneca’s strategy to transform cancer treatment by offering more targeted therapies as alternatives to traditional treatments like chemotherapy and radiotherapy. RCs,
RegulationDrug DiscoveryHaematology March 18, 2024 FDA committee recommends BMS-2seventy’s Abecma By PBR Staff Writer Abecma is a B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR)-T cell immunotherapy. The ODAC validated the favourable benefit/risk profile of the therapy based on findings from the Phase
OncologyDrug Discovery March 15, 2024 Tubulis secures $138.8m to develop ADCs for solid tumours By PBR Staff Writer EQT Life Sciences and Nextech Invest jointly led the financing round with contributions from new US-based investors, Frazier Life Sciences and Deep Track Capital. Existing investors including Andera
Oncology March 14, 2024 FDA grants orphan drug status to Poseida’s multiple myeloma therapy By PBR Staff Writer The allogeneic CAR-T product candidate is being developed in partnership with Roche for relapsed/refractory multiple myeloma (RRMM). P-BCMA-ALLO1 targets the B-cell maturation antigen (BCMA) and is enriched with
Neurology March 13, 2024 Prilenia Therapeutics plans MAA submission to CHMP for pridopidine By PBR Staff Writer The submission is scheduled for mid-2024, following constructive pre-submission meetings with EU regulatory authorities. The company also plans to engage with the US Food and Drug Administration (FDA)
RegulationGastrointestinal March 12, 2024 Johnson & Johnson files sBLA for ulcerative colitis treatment By PBR Staff Writer A dual-acting IL-23 inhibitor, TREMFYA acts on both IL-23 and CD64 to potentially provide relief for patients. The sBLA is based on the data from the Phase III