Positive top-line data from Eyepoint Pharmaceuticals Inc.’s phase II study of EYP-1901 and the selective tyrosine kinase inhibitor vorolanib for treating wet age-related macular degeneration (AMD) is challenging Regeneron Pharmaceuticals Inc.’s recently approved Eylea (aflibercept).
Altimmune Inc.’s peptide-based glucagon-like peptide-1/glucagon dual receptor agonist pemvidutide hiccupped in a phase I study earlier this year but has bounced back with top-line results from its phase II study in obesity. Results showed robust reductions in body mass index and serum lipids, along with improvements in blood pressure with no imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate. The data showed liver-fat loss similar to Novo Nordisk A/S’ GLP-1 drug Wegovy (semaglutide).
Companies have invested billions for decades to crack the problem of treating the deep complexities involving stromal cancers, Phenomic AI CEO Girish Aakalu told BioWorld. Now he and his company are on the receiving end as they enter a new collaboration with Boehringer Ingelheim GmbH.
Acelyrin Inc. said a vendor used by Fortrea Inc., a CRO the company used for its phase IIb/III study testing interleukin-17A inhibitor izokibep in psoriatic arthritis, incorrectly programmed the study’s protocol and created a dose sequencing error, resulting in some patients in two of the four dosing arms to randomly receive placebo and active treatment instead of the intended alternating pattern. The discovery has prompted a review of other studies involving the CRO, including a study that failed to reach statistical significance in September.
GSK plc is looking at a comeback for Blenrep (belantamab mafodotin) as an interim efficacy analysis brought the company good news. Almost exactly a year ago, phase III confirmatory study data for the already-approved multiple myeloma drug fell short of the U.S. FDA’s accelerated approval requirements, so the agency asked GSK to take the drug off the market for the indication.
Morphosys AG’s rare blood cancer treatment hit its phase III primary endpoint but missed statistical significance on a secondary endpoint, sinking the stock for the day. Top-line data from the study treating JAK inhibitor-naïve patients who have the rare blood cancer myelofibrosis showed the combination of pelabresib, a BET inhibitor, and the JAK inhibitor ruxolitinib produced a statistically significant improvement in spleen volume reduction, which was the primary endpoint.
Bayer AG’s asundexian, considered one of the next generation class of anticoagulants and a potential blockbuster, has failed a phase III clinical trial in atrial fibrillation. The factor XIa inhibitor is one of three with a similar mechanism of action in late stage development by big companies.
Along with Enhertu, Astrazeneca plc now has another breast cancer treatment in its portfolio and it may also become a blockbuster. Truqap (capivasertib), combined with the company’s Faslodex (fulvestrant), is now U.S. FDA-approved for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure.
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure.
