Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.
Scientists at Newcastle University U.K., have reported the births of eight healthy babies following mitochondrial transfer, in which the fertilized egg of a woman carrying mutations in their mitochondrial DNA was placed in the enucleated egg of a non-carrier.
The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.
After a 10-year project and a £60 million (US$80 million) investment, the UK Biobank has completed the whole body scans of 100,000 volunteers and is making the 1 billion images available for researchers worldwide.
After a 10-year project and a £60 million (US$80 million) investment, the UK Biobank has completed the whole body scans of 100,000 volunteers and is making the 1 billion images available for researchers worldwide.
China has proved to be a fertile ground for innovation as evidenced by some big deals in the antibody-drug conjugate (ADC) space, and the number of candidates entering clinical trials in China or being advanced in the U.S. by Chinese companies.
Takeda Pharmaceutical Co. Ltd.’s dual phase III victories in narcolepsy type 1 (NT1) with oral orexin receptor 2 (OX2R)-selective agonist oveporexton (also known as TAK-861) had Wall Street mulling what the outcome might mean for others trying the mechanism of action, and questions linger about side effects on eyesight.
Immuno-oncology company Imugene Ltd.’s allogeneic, off-the-shelf CD19 CAR T, azercabtagene zapreleucel (azer-cel), has resulted in seven complete responses and three partial responses in a phase Ib trial in relapsed diffuse large B-cell lymphoma patients, according to an interim analysis. The responses to date show a 75% overall response rate.
A glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor dual agonist developed by Jiangsu Hengrui Pharmaceuticals Co. Ltd. and licensed by Kailera Therapeutics Inc. has shown a mean weight loss of 19.2% at the 6-mg dose with no plateau over 48 weeks in a phase III trial conducted in China.
The complete remission of a testicular cancer patient receiving Mink Therapeutics Inc.’s allogeneic, off-the-shelf invariant natural killer T-cell therapy Agent-797 with nivolumab drove the company’s shares up by 730% July 11. The results, published in Nature’s Oncogene, described the complete, durable remission of a 49-year-old man with a germ cell neoplasm, showing no evidence of disease two years after receiving a single infusion.
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