Drug Development
The company’s treatment for IgA nephropathy, sparsentan, failed to meet statistical significance by a measure of kidney function in a head-to-head confirmatory study versus irbesartan.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Research on Alzheimer’s, specifically in neuroscience, continues with the Alzheimer’s Drug Discovery Foundation, Critical Path Institute, Abbvie, AlzeCure Pharma and more.
The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies.
Intellia Therapeutics reported early, positive signs from its in vivo gene therapies for both transthyretin (ATTR) amyloidosis and hereditary angioedema Friday.
AstraZeneca’s rare disease subsidiary Alexion posted positive late-stage results from a potential complementary treatment for paroxysmal nocturnal hemoglobinuria.
The U.S. FDA approved Mallinckrodt’s Terlivaz in adults with hepatorenal syndrome and is the only FDA-approved drug for that indication.
The Lancet Commission published a lengthy criticism of the WHO’s COVID-19 pandemic response. In turn, the WHO offered a reply to a number of the complaints.
BrainStorm Cell Therapeutics announced the publication of peer-reviewed data from a Phase II trial in progressive multiple sclerosis Thursday showing “preliminary evidence of efficacy.”
There’s a new collaboration in the Parkinson’s disease development space, Cardiff Oncology kicks off a mid-phase study in colorectal cancer and Ocugen published a new review of COVAXIN.
After reporting a failed clinical trial of ELX-02 for cystic fibrosis (CF), Eloxx Pharmaceuticals plans to shift its focus and use the drug to treat Alport syndrome, a rare kidney disease.
Pfizer is leveraging its funding and experience with vaccines, developing its meningococcal, flu, and RSV vaccines. It also announced its venture investment in Nimbus Therapeutics.