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Today's Rundown

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Gilead scored a full FDA approval for COVID-19 drug Veklury, but experts aren't convinced

As new COVID-19 cases spike in the U.S., and ahead of an expected winter surge, the FDA just issued its first full approval for a drug to treat the disease—Gilead Sciences’ Veklury, formerly known as remdesivir. But the approval closely follows a large trial that showed no benefit for the therapy, and experts quickly questioned the FDA's move.

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AstraZeneca’s U.S. COVID-19 trial is back on track after 45-day hold

It’s been a minute, but AstraZeneca has gotten the FDA’s all-clear to restart the U.S. study of its COVID-19 vaccine. The British pharma slammed the brakes on the program in early September, when a patient in the U.K. developed an inflammatory side effect. The pause came just one week after the 30,000-patient U.S. trial kicked off.

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Demand for virtual mental healthcare is soaring. Here are key trends on who is using it and why

The COVID-19 pandemic is driving enormous demand for virtual mental health care services. Here is how mental health diagnoses have shifted during COVID-19 and other notable tele-therapy trends, based on data from leading telehealth companies.

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CDC's distribution road map, safety monitoring plans plus other takeaways from FDA's big COVID-19 vaccine meeting

In less than a year, scientists around the world have rallied against COVID-19 and developed promising vaccines that could stem the pandemic. Concerns remain, though, and, amid that backdrop, top government expert took a chance Thursday to discuss safety and efficacy requirements, distribution plans and vaccine confidence—plus more.

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Convalescent plasma fails phase 2 in moderate COVID-19 patients

A randomized phase 2 clinical trial has found convalescent plasma has no effect on progression to severe disease or all-cause mortality in COVID-19 patients. The data raise significant doubts about the efficacy of an intervention that has been given to more than 100,000 people in the U.S.

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Biopharma roundup: AstraZeneca gets OK to unpause U.S. trial; Merck's slow and steady vaccine approach sparked internal debates: report

AstraZeneca's trial can resume in the U.S., WSJ reports. Plus, Merck's slow entry into the vaccine race was controversial among employees, the Journal wrote. HHS Secretary Azar has discussed firing FDA chief Hahn, Politico reports. Some experts want more than two months vaccine safety data. And plasma missed the mark in a mid-stage trial.

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Gen Zers, millennials feeling impacts of COVID-19 on health coverage, costs: TransUnion

Millennials and Generation Zers are particularly feeling the impacts of COVID-19 on their health coverage, according to a new survey.

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Merck, Pfizer pneumonia vaccines running low in EU as researchers fight COVID-19: report

As COVID-19 continues to rage worldwide, health authorities worry that a perfect storm of the novel coronavirus, pneumonia and seasonal flu could overtake hospital systems. Two major pneumococcal vaccines are already seeing shortages in the EU, which could be an ill omen for the coming months.

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Deaths rattle South Korea's seasonal flu vaccination, but authority presses ahead with free scheme

South Korea is preparing to fight two infectious diseases this winter: the novel coronavirus and the flu. But reports of deaths after flu shot vaccination may jeopardize the second effort. Despite 36 deaths linked to at least seven companies, including Sanofi, local health authorities still decide to continue with the national vaccination scheme.

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Novartis launches metastatic breast cancer Instagram series to address new patient concerns during COVID-19

Novartis is taking its metastatic breast cancer campaign to Instagram with a newly launched video series. It's part of the long-running “Make Your Dialogue Count” effort that's now shifted focus to patients’ changed needs during the COVID-19 crisis. The first video focuses on mindfulness, with two MBC patients talking about the practice and demonstrating actual techniques.

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Avalere: 1 in 3 Medicare Advantage plans to offer supplemental benefits linked to COVID-19 next year

A new analysis found that 34% of Medicare Advantage plans are offering some form of supplemental benefit related to COVID-19, including relief packages.

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