Phase III
Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.
Immunic released favorable updated results for the Phase II EMPhASIS clinical trial investigating the safety and efficacy of vidofludimus calcium to treat relapsing-remitting multiple sclerosis.
Black/African American hematological cancer patients tend to have the worst outcomes. This is partly driven by a lack of access to allogeneic hematopoietic stem cell transplant and available donors.
Day One Biopharmaceuticals announced positive early data assessing tovorafenib as a once-a-week treatment in people aged six months to 25 years with relapsed or progressive pediatric low-grade glioma.
The FDA has approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults.
Soleno announced promising results of its diazoxide choline extended-release tablets in patients with Prader-Willi syndrome at ENDO 2022.
Eli Lilly’s Olumiant (baricitinib) received approval from the FDA for the treatment of severe alopecia areata, making it the first systemic treatment for adults living with the disease.
Treatments for overactive bladder are not one size fits all, which is why Urovant is advancing URO-902, an injectable gene therapy that is currently being investigated in Phase IIa clinical trials.
OptiNose announced positive top-line results from its Phase III ReOpen2 clinical trial testing OptiNose’s XHANCE, a fluticasone propionate nasal spray for chronic sinusitis.
BioSpace looks at several companies developing new gene therapies in the wake of the FDA recommending two of bluebird bio’s lentiviral vector gene therapies.
PRESS RELEASES