Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Biogen, Eisai, Hemex, Krystal, Median Technologies, Peijia, Sanofi.
Clinical updates for biopharma and med tech, including data readouts and publications: Anixa, Atraverse, Biofrontera, Breye, Cala, Clearmind, Estrella, Johnson & Johnson, Lumosa, Rapid, Roche, Zenas.
New hires and promotions in the biopharma and med-tech industries, including: Conexeu, Bioaffinity, Entera, Evogene, Human Longevity, Nervgen, Ocugen, Trained Therapeutix.
Novo Nordisk A/S’ television ad introducing the tablet form of its weight-loss drug, Wegovy (semaglutide), to American consumers didn’t pass regulatory muster.
Sava Technologies Ltd. reported positive clinical data showing that its multi-molecule biosensor technology can reliably monitor glucose levels beneath the skin in real time.
As many had predicted following news of a clinical hold on the gene therapy last month, Regenxbio Inc. disclosed receipt of a complete response letter (CRL) regarding its BLA for RGX-121 (clemidsogene lanparvovec) in mucopolysaccharidosis II, an ultrarare neurodegenerative disease in dire need of new therapies.
Genentech Inc. is covering more bases in multiple sclerosis, with its latest swing on fenebrutinib hitting a rare phase III noninferiority win against Ocrevus (ocrelizumab) in primary progressive multiple sclerosis.
Wall Street pushback against relaxin player Tectonic Therapeutic Inc. was sharp, but a trial design that differs could save the drug from the fate of Astrazeneca plc’s long-acting relaxin-2 analogue, AZD-3427, which the pharma giant has “removed from phase II,” where it was being tested in a trial called Re-phire, because of less than ideal efficacy.
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