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The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies - Hutchmed Ltd - needs to test its drug for the U.S. population in a diverse multi-regional trial...This is the second time the U.S. regulator has declined to approve a drug that was tested mainly in China. In March, it declined to approve Eli Lilly and partner Innovent Biologics Inc's lung cancer drug that had been studied only in China...Coherus BioSciences Inc and Chinese partner Shanghai Junshi Biosciences Co Ltd said the FDA indicated their China-only trial may be sufficient for its cancer drug, toripalimab, but declined to approve it over quality processes...READ MORE

Doctors and hospital leaders are pushing back against a package of Republican bills that seek to bar health care providers from withholding unproven treatments for COVID-19...The three bills released this week would prevent health systems and medical credentialing boards from disciplining doctors for ordering or advocating for therapies or medicine for patients that go against medical opinions held by their employers or regulators...
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With Nevada hospitals reporting a staffing “crisis” and health officials reporting COVID-19 patient tallies at pandemic highs, Nevada Gov. Steve Sisolak highlighted a program...to enlist nursing students to help meet the demand for medical providers...“The state continues to work with all of our partners to leverage existing resources and break down barriers so Nevadans in need can access care,” the governor...said on a day that health officials reported what Dr. John Hess, a University of Nevada School of Medicine associate faculty member, called a “challenging time” with case counts “incredibly high right now.”...READ MORE

Ex-GlaxoSmithKline researcher Lucy Xi has pled guilty to conspiracy to steal trade secrets from her former company to help a rival firm launch a business in China. She is the fourth person to plead guilty to the offense...Xi and co-defendants Yan Mei, Yu Xue, Yan Mei, and Tao Li created Renopharma in the guise of conducting research and development of anti-cancer therapies. However, it was found that Renopharma had been operating as a repository of stolen GSK information and was receiving compensation and subsidies from the People's Republic of China to do so...READ MORE

As Nevada’s COVID-19 case rates plummet to their lowest levels since last summer, state health officials are turning more attention to therapeutic treatments for those who can’t get vaccinated or are most at risk of severe illness or death...It’s the latest step in the evolution of a nearly two-year effort to combat the virus after the omicron variant pushed caseloads to new highs in January, said Julia Peek, deputy administrator for Nevada’s Division of Public and Behavioral Health. It comes as governments across the country lift restrictions and move away from emergency measures...READ MORE

Florida has been forced to shut down sites administering monoclonal antibodies, which have been widely used as supplemental treatment for Covid-19, after the FDA revoked authorization for distribution...“This evening, without any advanced notice, the U.S. Food and Drug Administration revised the Emergency Use Authorization for bamlanivimab/etesevimab and REGEN-COV. The revised EUAs do not allow providers to administer these treatments within the United States,” a press release from the Florida Department of Health read...“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” it continued...READ MORE

GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they're the only companies with an antibody that appears to be truly effective against omicron...The FDA...cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab)...Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year...READ MORE

Pfizer projects it will generate record-high revenue in 2022, saying...it expects to sell $32 billion of its Covid-19 shots and $22 billion of its antiviral coronavirus treatment pill Paxlovid this year...Pfizer CEO Albert Bourla said sales of Paxlovid could be higher than the company’s guidance, but the expectations are based on deals signed or close to being signed...However, Pfizer’s fourth-quarter revenue more than doubled overall to $23.84 billion year-over-year, driven by $12.5 billion in sales of its Covid vaccine. The company’s antiviral pill that fights Covid, Paxlovid, contributed $76 million in U.S. sales during the fourth quarter...READ MORE

Nearly 4,000 people may have received a slightly less than recommended dose of the Pfizer COVID-19 vaccine at a Kaiser Permanente location in California last year. The health system is offering repeat vaccinations to anyone affected...The vaccinations were given at the Kaiser Permanente Walnut Creek Medical Center...Individuals may have received between 0.01 and 0.04 milliliters less than the correct 0.3-ml dose. The health system reportedly said the incident was a misunderstanding among staff, which it has retrained, and is contacting patients about the error...READ MORE

...federal judge in Texas has denied attempts by the U.S. Food and Drug Administration to conceal data on Pfizer’s COVID-19 vaccine. The judicial rule overturned the regulatory agency’s plan to withhold data for up to 55 years...The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit...the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed...The judge’s ruling demands that the FDA make the data publicly available within a span of eight months...READ MORE