GSK plc has announced it has stopped early two pivotal phase III trials of its urinary tract infection drug, gepotidacin, for efficacy and is preparing regulatory filings for what could be the first new oral antibiotic for the disease in more than 20 years.
Compass Pathways plc is poised to start the first ever phase III trial of the psychedelic drug psilocybin, after getting U.S. FDA backing for a study in treatment-resistant depression.
Shares in Affimed AG gained as much as 28% during trading on Nov. 3 as the company unveiled continued good news from a phase I/II combination trial in CD30-positive lymphoma of its CD30-directed innate cell engager, AFM-13, and allogeneic natural killer (NK) cell therapy, as well as a clinical development partnership with Artiva Biotherapeutics Inc., which will provide it with access to a commercially scalable source of NK cells as the program matures.
Abeona Therapeutics Inc. is on the road to filing a BLA with the U.S. FDA after posting positive top-line phase III data in wound healing and also to the bank with a new $35 million private placement financing. The data for EB-101, an autologous cell therapy, came from a pivotal study of treating recessive dystrophic epidermolysis bullosa, an ultra-rare connective tissue disorder. Results showed the study met its two co-primary endpoints in wound healing and for reducing pains in large, chronic wounds caused by the disorder.
Highly targeted light therapy delivered via a sleep mask has been shown to arrest the progress of diabetic retinopathy, and in some cases to improve visual acuity.
Pfizer Inc.’s bivalent prefusion vaccine for protecting newborns from severe respiratory syncytial virus (RSV) hit one of its two primary endpoints in its phase III study, which was good enough for the company to stop enrollment and plan to submit a BLA to the U.S. FDA by year-end. PF-06928316 is one of six RSV vaccines in active phase III development globally, which includes an Astrazeneca plc-Sanofi SA collaboration plus one from GSK plc. Pfizer’s is the only one developed for infants by way of maternal immunization and for older adults.
Heading into the readout of the phase III Mont Blanc study testing Nicox SA’s NCX-470, a nitric oxide-donating version of prostaglandin analogue bimatoprost, analysts were looking for a superior intraocular pressure-lowering profile vs. latanoprost, predicting such data could position the drug as a new standard of care in a crowded market.
In relapsed/refractory acute myeloid leukemia (AML), an indication that still needs adequate standard-of-care therapy, Actinium Pharmaceuticals Inc.’s topline pivotal phase III data shone brightly with radiotherapy lead candidate Iomab-B.
Biogen Inc. presented new data showing how applying artificial intelligence (AI), machine learning (ML) and radiomics can produce actionable insights on multiple sclerosis (MS) disease progression. The results, released at this week’s European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, could help to advance new digital health tools to improve monitoring and quality of life of MS patients.
Word from Talaris Therapeutics Inc. of a patient death in its phase III study called Freedom-1 with allogeneic cell therapy FCR-001 renewed speculation about the company’s odds in living donor kidney transplant patients, where Medeor Therapeutics Inc. also is advancing a late-stage candidate.
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