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Sisolak, his staff, officials from various state agencies met with representatives of the Southern Nevada and Washoe County health districts...to address the concerns the local health officials had raised in a letter last week about being shut out of the governor’s decision making process for COVID-19 directives, according to a joint statement from Sisolak and the local health officials...In their original letter, health officials said they received less than a day’s notice that the governor would increase the state’s gathering limit from 50 to 250, and allow for even larger crowds for sporting events and other live entertainment, with approval from local authorities. The health districts added that their resources are already strained from responding to the pandemic, and expressed frustration with the state adding more responsibility to their plate without discussing the issue with them...READ MORE

Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc...Medical experts said more data is needed to assess the treatment’s efficacy before wider use should be allowed...The company said...that it has submitted a request to the U.S. Food and Drug Administration for an emergency use authorization for its antibody combination...READ MORE

Medical specialists have elected to start Remdesivir therapy for President Donald Trump...Trump has completed his first dose of the drug and is resting comfortably...He is not requiring any supplemental oxygen...Later in the day he was also transported to Walter Reed military hospital for a few days' of treatment as a precautionary measure, though officials said he is expected to remain on the job...READ MORE

The US Food and Drug Administration... is expected to issue new, tougher requirements for its approval of a coronavirus vaccine, a move that could obliterate the chances of a shot getting emergency use authorization before Election Day...Regulators could publish the new approval standards as early as this week, and will do so publicly in an effort to bolster Americans' eroded trust in the US to ensure the safety a COVID-19 vaccine...President Trump and his Operation Warp Speed initiative have been pushing for months to have a coronavirus vaccine approved ahead of the November 3...READ MORE

Nevada health officials said they would resume the use of rapid “point of care” tests after federal health officials chided them for banning their use and accused them of violating federal law...Dr. Ihsan Azzam, Nevada’s chief medical officer, doubled down on his insistence that too many questions remained about the accuracy of rapid antigen tests. He said his team was “disappointed” in the U.S. Department of Health and Human Services...“We are not saying the tests have no use, we are just saying pause for further review and additional training,”... Admiral Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, told reporters that federal law prohibits states from imposing a ban like the one that Nevada health officials ordered Oct. 2. He said Nevada is the only state to do so...READ MORE

As one of few COVID-19 therapeutics with global regulators on board, Gilead Sciences' remdesivir saw immediate U.S. demand that has somewhat tapered off in recent months. But in the EU, some nations have seen spot shortages, and Gilead is stepping in with more supply...Gilead has shipped enough doses of its antiviral Veklury (remdesivir) to the EU to treat 3,400 patients—or 20,300 doses—after countries reported rationing and shortages of the COVID-19 therapy, a Gilead spokeswoman confirmed Wednesday. That $8.2 million order would be enough to meet roughly one to two weeks of treatment supply...READ MOVE

Enabling tens of millions of Americans to get themselves speedily vaccinated against COVID-19 will be a huge logistics challenge. A new policy brief from the Mercatus Center, a think tank at George Mason University, argues that we could greatly accelerate the process by removing the complex state regulations that prevent pharmacists from administering vaccines...The...report recommends that state regulators relax age restrictions on pharmacist-administered vaccinations; issue statewide standing orders authorizing pharmacists to administer vaccines without requiring a physician-written prescription for each patient; and revise regulations, as Oregon has, to permit pharmacists to administer all of the vaccines recommended by the CDC's Advisory Committee on Immunization Practices. The latter recommendation "prevents lag in vaccine administration due to boards or legislatures having to approve individually named vaccines for pharmacist administration."...READ MORE

The head of Centers for Medicare & Medicaid Services reiterated support for Medicaid work requirements as enrollment in the program swells this year...CMS Administrator Seema Verma spoke about work requirements...Her remarks come less than a month after a study in Health Affairs found that work requirements in Arkansas did not lead to more employment...“I am supportive of states making decisions about their programs and deciding what has worked best,” Verma said...She added that 20 states have been interested in the work requirements program...CMS has approved waivers for 10 states but currently no states are running a work requirement program. Arkansas, Indiana, Michigan and New Hampshire all started work requirement programs, but court rulings struck them down. Utah implemented its work requirement program in January, but it was suspended in April due to COVID-19...Verma said that the goal of the programs were to help improve the health of able-bodied Medicaid beneficiaries...READ MORE

After a somewhat chaotic initial rollout by the U.S. government, Gilead Sciences is now taking distribution of COVID-19 drug remdesivir into its own hands...Starting Thursday, Gilead will directly sell remdesivir, branded as Veklury, to American hospitals, ending a five-month phase when the U.S. Department of Health and Human services was responsible for allocating it...AmerisourceBergen will remain the sole U.S. distributor through the end of the year...READ MORE

U.S. President Donald Trump said...he may or may not approve any new, more stringent FDA standards for an emergency authorization of a COVID-19 vaccine, saying such a proposal would appear political...The Washington Post reported on Tuesday the U.S. Food and Drug Administration would issue the guidance to boost transparency and public trust as health experts have become increasingly concerned the Trump administration might be interfering in the approval process to rush out a vaccine...READ MORE