Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nanjing Leads, Sanofi, Regeneron.
Researchers at Harvard Medical School have found that blocking the neuron-released peptide CGRP decreases pain sensitivity and reduces lesion size in endometriosis. Endometriosis is a painful, steroid-dependent inflammatory condition in which tissue similar to that of the endometrial lining grows and establishes outside the uterine mucosa.
In a pipeline shakeup, Tango Therapeutics Inc. has halted enrollment in a phase I/II study in order to push two other brain cancer drugs into development. TNG-908 had success in treating non-CNS solid tumors such as non-small-cell lung cancer and pancreatic cancer but missed the minimum pharmacokinetic exposure in clinical efficacy for treating glioblastoma.
While uncertainty often casts a shadow on the Street, U.S. investors welcomed the presidential and congressional election results with a late-night surge that carried into the morning Nov. 6. The Dow Jones peaked at 1,380.47 points early the day after, up 3.27% from Election Day itself and hitting its highest point of the year so far. The celebration extended to the biotech sector, with the BioWorld Index, which covers more than 500 companies, up 17.06% for the year, compared with a 12.28% increase for the year on Nov. 1.
“I think elections are like pregnancy. … Everyone puts all of the energy into D-day – the birth. We’ve had the gender reveal, but what really, really matters is what happens now and the path ahead.” That was the instant response of Emma Walmsley, CEO of GSK plc, reacting to breaking news from the U.S. that Donald Trump has won a second term in office.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
Celltrion Inc. posted preclinical study results of two new antibody-drug conjugate (ADC) candidates – CT-P70 and CT-P71 – at the World ADC 2024 conference in San Diego Nov. 6, with plans to move the assets into clinical trials. Poster presentations of both ADC candidates “drew significant attention from the attendees” at the oncology meeting, Incheon, South Korea-based Celltrion said, while highlighting its efforts to transition from a biosimilar maker to a novel therapy developer.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ionis, Insignis, Neuropace, Organon.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avet, Biofactura, Biovaxys., Emcure, Probiogen, Transgene.
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