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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

CVS Health is planning to double the number of its drive-thru testing sites by mid-October, the healthcare giant announced...CVS intends to add more than 2,000 sites at its pharmacies in the next several weeks, bringing its total to more than 4,000 nationwide. The new locations will be opened in waves, beginning with 400 new sites opening on Friday...READ MORE

Shortages of vital generic drugs—particularly since the start of the coronavirus disease 2019 pandemic in the US—are well known by pharmacy teams in both health systems and community settings...although pharmacy associations appreciate the Trump administration’s efforts to move more pharmaceutical and active pharmaceutical ingredient manufacturing to the United States...they say government initiatives must include an overall plan for drug pricing, payment model, and supply chain transparency...READ MORE

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

Any way you look at it, the numbers related to coronavirus vaccine candidates in development are impressive. In less than nine months, researchers have advanced 180 experimental coronavirus vaccines at least into preclinical testing. Thirty-five of those candidates are now in clinical studies...The field narrows considerably, though, when we look only at vaccine candidates that have made it to late-stage testing. Currently, only three experimental coronavirus vaccines are in phase 3 clinical trials being conducted in the U.S.:

-AstraZeneca
-Pfizer
-Moderna

Here's how these three coronavirus vaccines in phase 3 testing stack up against each other...READ MORE

Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, testified...before the U.S. Senate...He noted that although a vaccine against COVID-19 will likely be available and to begin dosing in November or December of this year, it will be limited. Getting the entire U.S. population vaccinated will likely take “six to nine months.”...He also said that face masks are “the most important, powerful public health tool we have.” He added, “I might even go so far as to say that this face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine.”...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

Computer vision company Gauss teamed up with biotechnology company Cellex to develop a rapid, at-home and point-of-care COVID-19 antigen test...While there are other at-home COVID-19 diagnostic tests available, at least two companies are working on rapid antigen tests that can be performed by people at home without involving a laboratory...The Gauss and Cellex test has not yet gained Food and Drug Administration approval. The companies are pushing for FDA Emergency Use Authorization some time this fall...READ MORE

Safe and effective vaccines represent the most effective way to restore the health and economic security disrupted by the Covid-19 pandemic. To help achieve that goal, the U.S. government launched Operation Warp Speed...to accelerate development and manufacturing of several Covid-19 vaccines, with a goal of having 300 million doses available to the U.S. population by January 2021...Operation Warp Speed is expediting vaccine development primarily by moving clinical trials forward without pauses between phases, and by scaling up manufacturing capacity before knowing if a candidate works...Covid-19 vaccines can help stop the pandemic only if people trust them and want to be vaccinated. To earn and keep the trust of the American people, our government needs to ensure three key needs are met before launching any immunization campaign...READ MORE

• Ensure transparency and confidence in FDA decisions
• Ensure robust active safety monitoring as Covid-19 vaccines are rolled out
• Ensure the distribution and administration of Covid-19 vaccines are equitable and well-executed