The cost of newly FDA approved Pepaxto (melphalan flufenamide) from Oncopeptides AB is designed to put the therapy in the middle of the range compared to other multiple myeloma therapies, CEO Marty Duvall told BioWorld. “There are products well entrenched in that space,” he added.
HONG KONG – Daejeon, South Korea-based Curocell Inc. has received the first IND approval for a CAR T therapy in South Korea from the Ministry of Food and Drug Safety (MFDS).
HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group International is aiming to get its most advanced candidate, HQP-1351, to market this year.
Bluebird Bio Inc. CEO Nick Leschly conceded that it’s “hard for folks on the outside looking in” to understand why the firm would cleave its severe genetic disease (SGD) and oncology efforts into two independently traded public companies, but said the Cambridge, Mass.-based firm is making the change by the end of this year in order “to make sure we can basically fall down and get back up and learn everything we can in the most disciplined manner,” he said.
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.
