Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bpgbio, Clinuvel, Daiichi, Formycon, Fresenius, Invivyd, Ionis, J&J, Oryzon, Papillon, PTC, Sagimet, Thryv.
A collaboration led by the Flywire Consortium and comprising hundreds of scientists has completed a whole map of the adult fruit fly brain after several decades of collaborative work. By using electron microscopy and three-dimensional reconstruction supported by AI tools, the researchers have revealed the neural wiring of the Drosophila melanogaster brain, a connectome of 140,000 neurons with 50 million synaptic connections. In the future, researchers could possibly use this map as an artificial in silico model to study the brain as a simulator through its connections, though a lot of work remains to be done for this.
In one of the top series A financings in biopharma history, new company Kailera Therapeutics Inc. emerged with $400 million raised and a pipeline of next-generation assets to treat obesity and type 2 diabetes.
Gritstone Bio Inc. has had a tough year and new interim phase II data of Granite haven’t helped. The company called the progression-free survival results “encouraging” in the ongoing phase II/III trial of its personalized neoantigen-targeting immunotherapy for treating front-line microsatellite stable colorectal cancer.
Shattuck Labs Inc. opted, as one analyst put the matter, to do “the right thing early” by ending the clinical program with phase I-stage SL-172154 and shift resources to SL-325, a death receptor 3 antagonist, initially for inflammatory bowel disease, where TL1A/DR3-blocking antibodies have shown compelling monotherapy efficacy.
Depending on how long it lasts, the dockworkers strike that hit all 14 ports on the U.S. East Coast and along the Gulf Oct. 1 could literally unload a world of hurt to patients and the biopharma/med-tech industries, as it will impact both U.S. imports and exports of life-saving drugs and technologies.
The spread of drug-resistant bacteria is a global health concern and could once again become a leading cause of mortality. The World Health Organization has flagged carbapenem-resistant Acinetobacter baumannii as a top priority pathogen requiring innovative therapies for its management, which has a mortality rate of 25%-60% and caused more than 100,000 deaths worldwide in 2019. Therapy based on the use of bacteriophages (phages) to fight antibiotic-resistant bacteria is one such innovative strategy.
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Formycon, GE Healthcare, J&J, Kalvista, Modalis.
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