Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
Bright Peak Therapeutics Inc. has licensed rights to use Livzon Mabpharm Inc.’s anti-PD-1 candidate, LZM-009, to develop its own PD-1 targeted immunocytokines (PD-1 ICs). Bertolt Kreft, chief scientific officer for Bright Peak, told BioWorld that Livzon’s phase II anti-PD-1 “exhibits a promising initial safety and efficacy profile, making it well-suited to the task.
Immune system B cells secrete the neurotransmitter gamma amino-butyric acid (GABA), which promotes generation of anti-inflammatory macrophages and blunts the cytotoxic T cell-based response to tumors in mice.
Bristol Myers Squibb Co. has completed a $20 million equity investment in Compugen Ltd., part of an ongoing expansion a collaboration between the companies to combine their medicines for the potential benefit of patients with solid tumors.
Sotio Biotech AS has licensed Legochem Biosciences Inc.’s technology for five new antibody-drug conjugates (ADC) in a deal that could bring the latter over $1 billion. Prague, Czech Republic-based Sotio will have the rights to deploy Legochem’s Conjuall and potent linker-payload platform, including multiple different payloads, for five therapeutic programs targeting solid tumors and combine its proprietary antibodies with it.
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
Ono Pharma Korea Co. Ltd. has received approval in South Korea for Velexbru (tirabrutinib hydrochloride), its oral Bruton’s tyrosine kinase (BTK) inhibitor, as treatment of recurrent or refractory B-cell primary central nervous system lymphoma.
Continuing its downward trend, BioWorld’s Cancer Index (BCI) has fallen by 19.16% this year, a stark contrast with the broader Nasdaq Biopharmaceutical Index and the Dow Jones Industrial Average, both of which are tracking up by 4.49% and 19.03%, respectively. Two-thirds of the 21 stocks that make up BCI are showing losses so far this year, and everything from disappointing sales, strong competition, clinical holds and safety issues are to blame.
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