Today's Rundown ASH18: Amgen’s anti-BCMA bispecific shines again, but CAR-T threat remains ASH18: J&J, Legend CAR-T treatment posts 88% ORR in multiple myeloma With Gilead and rivals deep in phase 3, FDA unveils draft guidance on NASH drug development Boehringer inks pact with Domain for GPCR neurology drugs RedHill’s H. pylori antibiotic flies through phase 3, on track for 2019 launch SmartZyme spins off protein tech company for a metabolic disease partnership with Hemoshear Featured Story | | | Tuesday, December 4, 2018 Amgen has posted early clinical data on anti-BCMA T cell engager AMG 420 in patients with relapsed or refractory multiple myeloma. The 70% objective response rate and lasting efficacy at the optimum dose show the drug has promise, but time-consuming administration via continuous infusion and the presence of CAR-T competitors cast a shadow over its prospects. |
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Top Stories Tuesday, December 4, 2018 Janssen and Legend Biotech reported updated data from a phase 1/2 study of their BCMA-targeted CAR-T therapy in patients with relapsed or refractory multiple myeloma. In the 57 patients who received the treatment, the overall response rate was 88%, with 74% having a complete response. Tuesday, December 4, 2018 The FDA has published draft guidance on developing NASH drugs that has implications for Gilead and the host of other companies targeting the indication. In the draft, the FDA sets out the endpoints and patient populations it wants companies to look at in phases 2 and 3. Tuesday, December 4, 2018 French-Canadian biotech Domain Therapeutics has another big pharma partner, signing a deal with Germany’s Boehringer Ingelheim to develop new drugs for central nervous system disorders. Monday, December 3, 2018 RedHill Biopharma’s lead asset, antibiotic cocktail RHB-105, bested an amoxicillin combination in patients with H. pylori infection, topline phase 3 data show. The results set RedHill up for an FDA filing in the first half of 2019 and, assuming all goes well, a launch by the end of the year. Tuesday, December 4, 2018 SmartZyme BioPharma is spinning off its protein-based therapeutic platform into a new company—dubbed Carnot BioSciences—as part of a collaboration with Hemoshear Therapeutics aimed at rare metabolic diseases. Enrollment Showcase | | | Sponsored by: Biotech Primer BioBasics is an intensive two-day course starting with a review of the healthcare sectors and the scientific concepts required for understanding the biopharma industry, then delves into the cause of genetic and infectious disease, diagnostics and strategies used to mitigate disease and finally the latest innovations in biopharma are explained. Register today! |
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