HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group Corp. Ltd. is aiming to get its most advanced candidate, HQP-1351 (olverembatinib dimesylate) to market this year for patients with TKI-resistant chronic myeloid leukemia.
A U.S. study has shown for the first time that enhancing signals from the nociceptive nervous system could provide new approaches to improve the collection of hematopoietic stem cells (HSCs) for treating cancers of the blood and bone marrow.
The latest global regulatory news, changes and updates affecting biopharma, including: Convalescent plasma trials expand; CBD public meeting, generics; ICER updates in CF in MM.
About two weeks after European regulators gave their go-ahead for Blenrep (belantamab mafodotin-blmf), the B cell maturation antigen (BCMA)-targeting therapy from Glaxosmithkline plc (GSK) for relapsed/refractory multiple myeloma (MM), the FDA did likewise.
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.
Patients with triple-refractory multiple myeloma who are running out of options may soon have a new lifeline. That’s if the FDA follows the unanimous vote of its Oncologic Drugs Advisory Committee (ODAC) and grants accelerated approval to Glaxosmithkline plc’s (GSK) belantamab mafodotin as a fifth-line therapy for adults with relapsed or refractory multiple myeloma.
Kiadis Pharma NV’s takeover last year of Cytosen Therapeutics Inc. to get a natural killer (NK) platform paid off in a potentially huge way, with Sanofi SA paying €17.5 million (US$19.7 million) up front in a licensing deal with as much as €857.5 million more if preclinical, clinical, regulatory and commercial goals are reached, as well as up to double-digit royalties.
Cellectis SA said the FDA has placed a clinical hold on a phase I study of UCART-CS1A, an allogenic CAR T-cell therapy it has been testing in patients with relapsed or refractory multiple myeloma, after one person enrolled in the study died from a case of treatment-emergent cardiac arrest. Cellectis' chief medical officer, Carrie Brownstein, told BioWorld she supported the move, which formalized a decision she'd already taken with her team.
Nearly a week after filing for a $115 million IPO that it had put off for more than a year, and two months after dosing the first patient in its phase I trial in metastatic castration-resistant prostate cancer, Poseida Therapeutics Inc. has closed on a $110 million series D to continue its CAR T-cell therapy programs.
Oncopeptides AB remains on track for an NDA filing in the second quarter for its peptide-drug conjugate, melflufen, in relapsed refractory multiple myeloma (RRMM).
