The recent licensing agreement that Alzpath Inc. signed with Roche AG for use of its pTau217 antibody to develop and commercialize an Alzheimer's disease diagnostic blood test will not only transform the company but also allow patients access to a more cost-effective test, Venkat Shastri, CEO of Alzpath told BioWorld.
Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.
The U.S. FDA cleared Basel, Switzerland-based Roche Holding AG’s whole-slide imaging system, the Roche Digital Pathology Dx, for use as an aid in clinical diagnosis. The system helps pathologists review and interpret digital images of scanned pathology slides.
Siemens Healthineers AG has received CE mark for a neurofilament light chain assay to help with the early diagnosis of multiple sclerosis and aid in predicting the risk of relapse in patients suffering from the disease. The test developed in collaboration with Novartis Pharma AG will be launched in Europe later this year.
Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago.
In lieu of pending guidance, the U.S. FDA’s approval May 20 of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic.
Positive data from Novo Nordisk A/S’s pivotal phase IIIa study of once-weekly and once-monthly doses of its hemophilia treatment, Mim8, are prompting the company to say it will submit the first regulatory approval request toward the end of this year. It could challenge Roche Holding AG’s Hemlibra (emicizumab), a bispecific factor IXa- and factor X-directed antibody for hemophilia A, that was approved in 2017 by the U.S. FDA.
Hookipa Pharma Inc. has received clearance from the U.S. FDA for its IND application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers. The HB-700 program is a replicating 2-vector therapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers by targeting the five most prevalent KRAS mutations in these disease indications.
Synox Therapeutics Ltd. has raised $75 million in a series B round to fund phase III development of emactuzumab, an antibody in-licensed from Roche Holdings AG. The product, a colony stimulating factor 1 receptor inhibitor, was tested by Roche in a number of indications. Synox is taking it into a phase III registrational trial in tenosynovial giant cell tumor on the basis of phase II data showing an overall objective response rate of 71%.
The U.S. FDA granted Roche Holding AG breakthrough device designation for the Elecsys pTau217 assay that it is developing with Eli Lilly and Co. The test will help with the earlier diagnosis of Alzheimer's disease as it will be able to identify pTau217, a phosphorylated fragment of the protein tau, which is a biomarker that can distinguish the disease from other neurodegenerative disorders.
