All Clarivate Analytics websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.
While the FDA’s Oncologic Drugs Advisory Committee (ODAC) shared some of the agency’s concerns about uncertainties surrounding Mesoblast Ltd.’s Ryoncil (remestemcel-L), it voted 8-2 Aug. 13 that the mesenchymal stromal cell (MSC) product showed evidence of efficacy as a treatment for steroid-refractory acute graft-vs.-host disease (GVHD) in children.
The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular Therapeutics, Bayer, Hyperfine, Inmode, Osprey Medical, Quidel, RapidAI, Spectronrx.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Akeso, Antengene, Biomarin, Enzychem, Genentech, Hoth, Micurx, NS, Passage, Scholar Rock, TG.
The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors.
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.”
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
RSS
