Novartis AG is making good on its plan to streamline the company so it can save $1 billion by 2024. The Basel, Switzerland-based company told BioWorld the restructuring that’s underway could impact 8,000 positions around the world, with 1,400 of them in Switzerland.
Priovant Therapeutics Inc. is the newest of the Vants, a creature of Roivant Sciences Ltd., of Basel, Switzerland and Pfizer Inc. Established in September 2021, Priovant is developing brepocitinib, a tyrosine kinase 2 and JAK1 inhibitor for treating multiple highly inflammatory autoimmune diseases.
Axsome Therapeutics Inc. and the U.S. FDA appear to be working out their differences. The company said it received the proposed labeling from the agency for AXS-05 (dextromethorphan + bupropion), an oral NMDA receptor antagonist with multimodal activity, for treating major depressive disorder.
The only way to avoid food allergies right now is to stay away from whatever triggers them and, at best, grab some rescue epinephrine in case there’s trouble. Peanut allergies have an FDA-approved treatment, but the remainder of the troublemakers don’t have any therapies. Hoping to change that, Alladapt Immunotherapeutics Inc. closed a $119 million financing to develop its food allergy treatments. The Menlo Park, Calif.-based company’s lead candidate is ADP-101, an oral immunotherapy that is in a phase I/II trial and an open-label extension study of children and adults.
Sanofi SA and GSK plc said new phase III data show their adjuvanted bivalent D614 and beta (B.1.351) COVID-19 vaccine candidate responded well against omicron despite it being designed to fight the original SARS-CoV-2 virus and the beta variant.
Despite a huge amount of progress in the hot space CD47, there’s a large space beyond it to explore, according to DEM Biopharma Inc.’s CEO David Donabedian. The new company just raised $70 million to develop therapies targeting don’t eat me, hence DEM, and eat me signals on cancer cells and macrophages.
In this case, more is just too much. The number of participants needed to determine a significant clinical outcome in 9 Meters Biopharma Inc.’s phase III of larazotide in treating celiac disease has grown too large to support the study. The company said an independent statistician’s interim analysis convinced it to take a step back and re-evaluate its options for developing the zonulin inhibitor in the indication.
New data from the phase I study of Ultimovacs ASA’s lead candidate showed positive two-year overall survival data for the cancer vaccine. UV-1, combined with the checkpoint inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.) for treating malignant melanoma, demonstrated a 24-month survival rate of 73% in all 30 patients in the study.
A day after announcing it would pump $120 million into a Michigan manufacturing facility for Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. produced new data it plans to use in an U.S. NDA submission for treating COVID-19. While some data for the oral antiviral fell short of statistical significance, other companies are not far behind Pfizer in their drive for FDA acceptance using similar approaches.
Eli Lilly and Co. crossed the line in front of three strong competitors with the U.S. FDA’s approval of Olumiant (baricitinib) as a first-in-disease systemic treatment for severe alopecia areata. Two of those three are, like Olumiant, JAK inhibitors and have recent phase III data to run by the FDA.
