Drug Development
With new Alzheimer’s drugs receiving—and expected to receive—FDA approval, the market for diagnostic biomarker tests is set to expand.
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
AstraZeneca reported a pre-specified pooled analysis from its Phase III trial of the diabetes drug Farxiga in patients with heart failure.
Phase III data shows the potential of Bayer’s Kerendia to reduce the risk of all-cause and cardiovascular mortality in type 2 diabetes patients with chronic kidney disease.
Factor XIa inhibitors developed by Bayer and the duo of BMS and Janssen Pharmaceuticals missed Phase II endpoints in data presented at ESC.
89bio presented positive data for pegozafermin in SHTG, Tonix enrolled its first patient with Long COVID for TNX-102, Belite enrolled patients with STGD1 and more clinical trial news.
TG Therapeutics announced the publication of Phase III trials of relapsing/remitting multiple sclerosis (RMS) drug candidate in the NEJM.
Moderna announced it is filing lawsuits against Pfizer and BioNTech, alleging that the companies’ COVID-19 vaccine infringes patents covering its mRNA technology.
Pfizer’s RSV vaccine has produced promising data with an efficacy of 85.7% in adults over 60 with a more severe form of the disease. Data in hand, Pfizer plans to head to the FDA this Fall.
Erytech Pharma is abandoning plans to submit a Biologics License Application to the FDA for Graspa in hypersensitive acute lymphoblastic leukemia.
According to a recent study, Pfizer’s Paxlovid appeared to be far more effective at reducing deaths and hospitalizations in older adults than younger patients suffering from the Omicron variant of COVID-19.
AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.