Drug Discovery March 28, 2024 Santhera’s vamorolone NDA receives priority review in China By PBR Staff Writer Sperogenix Therapeutics, the company’s rare disease partner in China, filed the application with the NMPA. The Center for Drug Evaluation (CDE) of the NMPA accepted the filing after
Central Nervous SystemProduction & Sales March 27, 2024 Cipla enters deal to distribute Sanofi’s CNS products in India By PBR Staff Writer This collaboration is expected to leverage Cipla’s extensive distribution network to enhance the reach of Sanofi India’s CNS products. Under the agreement, Cipla will handle the distribution and
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
Drug Discovery March 21, 2024 Evommune expands EVO756 collaboration with Maruho in Asia By PBR Staff Writer EVO756 is a highly selective small molecule antagonist targeting mas-related G-protein coupled receptor X2 (MRGPRX2), a receptor implicated in various inflammatory conditions. This partnership builds on a previous
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