Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors.
LONDON – After 17 years of patient toil, Lytix Biopharma AS has landed the first commercial endorsement of its oncolytic peptide platform, agreeing to a potential $113.5 million deal in which Verrica Pharmaceuticals Inc. will develop the lead product, LTX-315, as a transdermal treatment for skin cancer.
LONDON – A breakthrough technology for generating fully human T-cell receptors (TCR) is set to deliver next-generation T-cell therapies for treating solid tumors, following the €66 million (US$78.3 million) series A funding of T-knife GmbH.
Matterhorn Bioscience AG has launched to develop T-cell receptor therapies based on the power of MR1T cells that have been found to find and kill a range of tumors in various tissue organs.
PERTH, Australia – Patients with relapsed or refractory acute myeloid leukemia (r/r AML) who have received three or more lines of therapy are often too sick to get much-needed bone marrow transplants and often run out of options. Melbourne-based Race Oncology Ltd. hopes to change those outcomes with a new take on an old drug that slipped through the cracks in the 1980s.
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest.
Nanjing, China-based Simcere Pharmaceutical Co. Ltd. became the second Chinese player to seek assets from G1 Therapeutics Inc., of Research Park Triangle, N.C., this year. On Tuesday, it licensed trilaciclib, an intravenous CDK4/6 inhibitor, from G1 Therapeutics in a $170 million deal for Greater China rights.
LONDON – Morphosys AG finally has some heft to put behind its U.S. commercialization ambitions following FDA approval for its long-nurtured anti-CD19 antibody, Monjuvi (tafasitamab-cxix) in relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL).
Chinese biosimilar maker Shanghai Henlius Biotech Inc. won EMA approval for its Zercepac, a biosimilar to Roche Holding AG’s Herceptin (trastuzumab) on July 28. Henlius CEO Scott Liu told BioWorld that Zercepac will be the first Chinese monoclonal antibody biosimilar to enter the EU market, setting a precedent for Chinese drugmakers seeking to join the global race in biosimilars.
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