The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee and the company, one of Japan’s biggest pharmas, will discuss this during July 18’s adcom hearing regarding the efficacy of Rexulti in combination with sertraline.
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies, primarily due to its dense, desmoplastic and immunosuppressive tumor microenvironment (TME) that hinders the efficacy of immune checkpoint inhibitors such as anti-programmed cell death 1 (PD-1).
It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.
Harbour Biomed is out-licensing its B-cell maturation antigen and CD3 bispecific T-cell engager HBM-7020 for autoimmune diseases to Otsuka Pharmaceutical Co. Ltd. in a deal worth up to $670 million.
Harbour Biomed is out-licensing its B-cell maturation antigen and CD3 bispecific T-cell engager HBM-7020 for autoimmune diseases to Otsuka Pharmaceutical Co. Ltd. in a deal worth up to $670 million.
Harbour Biomed Ltd. has established a global strategic collaboration with Otsuka Pharmaceutical Co. Ltd. to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases.
Diagonal Therapeutics Inc.’s DIAG-723 has been awarded orphan drug designation by the FDA for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the EMA has provided a positive opinion for orphan drug designation, confirming that DIAG-723 meets the criteria for designation as an orphan drug in the E.U.
An 85% remissions rate was found in updated results from Aptevo Therapeutics Inc.’s ongoing phase Ib/II Ranier study of mipletamig in one of the toughest blood cancers to treat.
Cullinan Therapeutics Inc. swept up ex-China rights to a multiple myeloma (MM)-targeting BCMAxCD3 bispecific T-cell engager (TCE) velinotamig from Chongqing Genrix Biopharmaceutical Co. Ltd. via a potential $712 million deal June 4. The plan is to repurpose the cancer drug to autoimmune disease.
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