The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance therapy in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
After expanding development of DM-199 (rinvecalinase alfa) into preeclampsia last year, Diamedica Inc. rolled out early phase II results showing the recombinant form of human tissue kallikrein-1 reduced the mother’s blood pressure, did not cross the placental barrier, and potentially improves blood flow to the fetus.
Sarepta Therapeutics Inc. made known a third gene therapy death, this time with SRP-9004 for limb-girdle muscular dystrophy. The patient was a late-stage, non-ambulatory 51-year-old man participating in the phase I Discovery trial, who expired about a month ago of acute liver failure, as did the two previous subjects who passed away after they were treated with Elevidys (delandistrogene moxeparvovec), Cambridge, Mass.-based Sarepta’s gene product for Duchenne muscular dystrophy.
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.
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.
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.
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