First Anti-PD-1 Regimen Approved in China for First-Line Treatment of Advanced Esophageal or GEJ Cancer, Regardless of Histology or PD-L1 Expression
KEYTRUDA Is Now Approved for Eight Indications Across Five Different Types of Cancer in China
https://finance.yahoo.com/news/merck-keytruda-pembrolizumab-approved-china-104500852.html
Moderna (MRNA) - Get Moderna, Inc. Report shares edged lower Tuesday after White House chief medical advisor Anthony Fauci cautioned that the rollout of the drugmaker's COVID-19 booster shots could be delayed.
Fauci told CBS’ “Face the Nation” Sunday that only the Pfizer (PFE) - Get Pfizer Inc. Report vaccine booster may get Food & Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) approval in time for a rollout the week of Sept. 20. Moderna asked for formal authorization of its booster shot last week, but has not completed its data submissions, Facui noted.
“Looks like Pfizer has their data in, likely would meet the deadline ... We hope that Moderna would also be able to do it, so we could do it simultaneously," he said on the show," Fauci said. "But if not, we’ll do it sequentially. So the bottom line is, very likely, at least part of the plan will be implemented, but ultimately the entire plan will be."
Moderna shares were marked 1.1% lower in pre-market trading Tuesday to indicate an opening bell price of $412.00 each. Pfizer shares edged 0.45% higher to $47.05 each while Johnson & Johnson slipped 0.38% to $174.37 each.
The U.S. plans to begin distributing COVID booster shots around the third week of September, with those protected by imessenger RNA vaccines made by Moderna and Pfizer receiving a third dose, while those protected by the Johnson & Johnson (JNJ) - Get Johnson & Johnson (JNJ) Report vaccine receiving a second.
Coronavirus cases in the country have surpassed 40 million on Tuesday as a surge in the highly infectious delta variant races through the unvaccinated population.
A third dose of the Moderna vaccine -- given six months after the initial two doses -- significantly boosts immunity, according to data the company submitted to the FDA last Wednesday.
The FDA and the CDC have already recommended a third dose of both the Pfizer and Moderna vaccines for some immunocompromised people.
https://www.thestreet.com/investing/moderna-stock-slips-as-fauci-cautions-on-booster-shot-deadline
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided an update with respect to its resubmission timeline for the DefenCath New Drug Application (“NDA”). CorMedix has encountered delays at its third-party contract manufacturer (“CMO”). The Company was informed by the CMO that there are issues that are unrelated to DefenCath manufacturing activities. The timeline for CorMedix and the CMO to address deficiencies at the facility that are required for resubmission of the DefenCath NDA is uncertain at this time. We will provide an update when more information becomes available.
https://finance.yahoo.com/news/cormedix-inc-announces-regulatory-123000959.html
