Ocean Biomedical Inc. has demonstrated the effectiveness of its anti-chitinase 3-like-1 (CHI3L1) antibody in suppressing and reversing tumor growth in studies of epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) cells.
Takeda Pharmaceutical Co. Ltd. said it will work with U.S. regulators on the market withdrawal of Exkivity (mobocertinib), only two years after the oral tyrosine kinase inhibitor gained the FDA’s accelerated approval for use in locally advanced or metastatic non-small-cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed after chemotherapy.
For the second time in two weeks, the extent of regulatory flexibility will be at the heart of a U.S. FDA advisory committee meeting. The Oct. 4 meeting of the Oncologic Drugs Advisory Committee (ODAC) comes exactly a week after the Cellular, Tissue and Gene Therapies Advisory Committee voted overwhelmingly that the evidence presented for Brainstorm Cell Therapeutics Inc.’s amyotrophic lateral sclerosis drug, Nurown (debamestrocel), didn’t meet the agency’s flexibility standard. If the FDA’s briefing document for the ODAC meeting is anything to go by, the outcome for US Worldmeds LLC’s eflornithine, also known as DFMO, could be more positive, even though once again the agency is asking if the evidence from a single trial, along with supportive data, is sufficient.
Indianapolis-based Eli Lilly and Co. agreed to acquire Point Biopharma Global Inc. for $12.50 per share in cash, or about $1.4 billion, in a deal that would bring the pharma company a pipeline of preclinical and clinical radioligand therapies for cancer. The purchase price is an 87% premium to Point’s closing stock price on Oct. 2, and a 68% premium to the 30-day volume-weighted average price. Shares (NASDAQ:PNT) of Point, also of Indianapolis, rose 84.9%, or $5.67, to close at $12.36 on Oct. 3.
Patients with metastatic brain tumors are among the most desperate of patients for at least a modestly effective treatment let alone a cure, and GT Medical Technologies Inc., of Tempe, Ariz., reported the interim findings from a study of 48 patients suffering from a total of 51 brain metastases. Four-month data from this study demonstrate that implant of the Gammatile device is safe as demonstrated by the lack of adverse events, and these results combined with other data suggest that this device can offer this patient population real hope of surviving one of the deadliest series of afflictions known to humankind.
The receipt of a reimbursement code for the Episwitch Prostate Screening (PSE) test developed by Oxford Biodynamics plc, following its recent launch, is good news for men frustrated with the inaccuracies in prostate-specific antigen (PSA) tests and the lack of alternatives, Jon Burrows, CEO of Oxford Biodynamics told BioWorld.
Sorrento Therapeutics Inc. has divulged antibody-drug conjugates comprising antibodies targeting HER2 covalently linked to exatecan through a linker. They are reported to be useful for the treatment of cancer.
Researchers at Shanghai Institute of Materia Medica of the Chinese Academy of Sciences have synthesized cucurbitacin B derivatives acting as NF-κB activation inhibitors reported to be useful for the treatment of cancer and inflammatory disorders.
Chengdu Scimount Pharmatech Co. Ltd. has disclosed non-receptor tyrosine-protein kinase TYK2 inhibitors reported to be useful for the treatment of cancer, autoimmune, inflammatory, bone, cardiovascular, metabolic, neurological and respiratory disorders.
Researchers from Fudan University and affiliated organizations have reported the discovery of dual inhibitors of histone deacetylase (HDAC) and tubulin polymerization as potential anticancer agents.
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