Covid-19 vaccine trials from AstraZeneca, Johnson & Johnson to restart

Two major studies of vaccines against Covid-19, both paused because of potential safety concerns, are set to restart, the companies running them said Friday.

Pharmalittle: Study says blood plasma did not help Covid-19 patients; FDA gives official blessing to remdesivir

Infusing hospitalized Covid-19 patients with blood plasma from people who recovered had no effect on whether patients got sicker or died, according to the first completed randomized trial of the therapy.

FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines

There are serious signs the FDA is getting cold feet over the notion of issuing emergency use authorizations to allow for the widespread early deployment of Covid-19 vaccines.

FDA pushes drug companies to include younger people in breast cancer drug trials 

New guidance from @US_FDA says those who are premenopausal should no longer be excluded from breast cancer drug trials, a move greeted as good news for younger patients.

As Trump misleadingly boasts of ‘rounding the turn’ on Covid-19, Biden warns of ‘dark winter’

On a day the U.S. reported more than 72,000 new Covid-19 cases and 1,000 new deaths, President Trump insisted the U.S. was “rounding the turn” on Covid-19. Joe Biden warned of a “dark winter.”

Watch this FDA hearing on Thursday. It’ll help ease your Covid-19 anxieties

The livestreamed discussion of the FDA's vaccine advisory committee's public deliberations can help ensure that science, expertise, and sound regulation will win out over politics and partisanship.

Pharmalittle: AstraZeneca Covid-19 trial may resume in U.S. this week; Trump is using HHS to boost re-election bid

The AstraZeneca Covid-19 vaccine trial in the U.S. is expected to resume as early as this week after the FDA completed its review of a serious illness in a study participant.

A pivotal FDA meeting on Biogen’s Alzheimer’s treatment is near. Here’s what you need to know

Apart from the possible approval of Covid-19 vaccines later this fall, there won’t be a bigger event in biotech this year than an FDA advisory panel meeting on Biogen's Alzheimer's drug.

Children and families need resources to address trauma at its roots

More than two-thirds of children experience at least one seriously traumatic event by age 16. These range from experiencing psychological, physical, or sexual abuse to witnessing domestic violence or experiencing neglect.

As election nears, Trump leans on health care agencies to aid his campaign

How the Trump administration is using federal health care agencies to bolster the president’s reelection odds.

Public health experts push vaccine makers, HHS to release Covid-19 trial protocols

"The stakes here are enormous and justify this step,” more than two dozen experts wrote to HHS and vaccine makers.

Why this week’s meeting of an FDA advisory panel on Covid-19 vaccines matters

It's dry. It's technical. But if you care about Covid-19 vaccines, you may want to tune in.

For Trump, Covid-19 therapeutics are the new vaccines

Trump has campaigned for months on a pledge that a Covid-19 vaccine will be available by Election Day. Now that it’s clear a vaccine will take longer, Trump is hyping experimental therapeutics instead.

STAT-Harris Poll: The share of Americans interested in getting Covid-19 vaccine as soon as possible is dropping

A new STAT and The Harris Poll survey finds the share of Americans who would get a Covid-19 vaccine once it’s available is falling — and the drop is steeper among Black Americans.

A defiant AMAG wants an FDA hearing rather than withdraw its premature birth drug

AMAG is refusing to voluntarily withdraw its controversial treatment for preventing premature births, despite an FDA request to do so.

Pharmalittle: Study finds remdesivir fails to prevent Covid-19 deaths; Trump’s $200 discount drug cards hit snags

A WHO study concluded that remdesivir appeared to have little or no effect on 28-day mortality or length of hospital stays for Covid-19 patients.

Pfizer won’t apply for Covid-19 vaccine authorization before mid-November, CEO confirms

Pfizer estimates it won't have the safety data that the FDA requires for emergency use authorization of a #Covid19 vaccine until the third week of November.

Health experts’ Thanksgiving advice in the time of Covid: plan, plan, plan

What to do about Uncle Frank, who dismisses Covid-19 as a “scamdemic” and won’t wear a mask?

Pharmalittle: NIH pauses Lilly Covid-19 drug trial; Trump team tries to rebrand FDA’s emergency use

A federal government-sponsored clinical trial that is testing an antibody treatment for Covid-19 developed by Eli Lilly has been paused because of a “potential safety concern.”

Covid-19 clinical trials pauses at J&J and Eli Lilly could be bumps on a hard road — or mere blips

Covid-19 clinical trials pauses at J&J and Eli Lilly could be bumps on a hard road — or mere blips.

Ezekiel Emanuel on vaccines, Trump’s Covid-19 treatment, and what went wrong on the U.S. response

Former White House adviser Ezekiel Emanuel on vaccines, Trump's Covid-19 treatment, and what went wrong in the U.S. response to the pandemic.

Pharmalittle: J&J pauses Covid-19 vaccine trial; Moderna exec has earned $50 million from stock sales during pandemic

Johnson & Johnson paused the study of its Covid-19 vaccine due to an unexplained illness in a participant.

When off-label may mean off-target: How would doctors and insurers navigate demand for a new, narrow Alzheimer’s drug?

“To put it mildly, this could be a major social dilemma,” warned Dana Goldman, a health policy expert who was on a panel of experts that Biogen convened privately in July to hash out questions around a potential approval.

What President Trump’s ‘compassionate use’ of a Covid-19 drug means — and doesn’t mean

Much has been made about the president's ability to get compassionate use of a drug while more than 210,000 Americans have died from Covid-19, many because of the inability to access treatment or even diagnostic tests.

FDA investigating whether Intercept Pharma drug is tied to potential liver injury risk

The FDA is evaluating a potential risk of liver injury in patients who take the Intercept Pharmaceuticals drug Ocaliva to treat a certain type of liver disease.

Harris and Pence square off on whether — and when — to trust a Covid-19 vaccine

In tonight's debate, Sen. Kamala Harris and Vice President Mike Pence squared off on whether — and when — to trust a Covid-19 vaccine.

FDA formally blasts a mask decontamination device maker once touted by Trump

The FDA formally chastised Battelle, which makes a mask decontamination system once touted by Trump, for skirting rules about safety monitoring.

Pharmalittle: White House relents on FDA vaccine standards; Lilly claims Covid-19 treatment is effective

Eli Lilly reported that an antibody treatment is effective in reducing levels of the virus that causes Covid-19 in patients, and also appears to reduce visits to the emergency room or hospital.

Race for Covid-19 vaccine slows as regulators, top Warp Speed official tap the brakes

The race for a Covid-19 vaccine slowed on Tuesday, as both U.S. regulators and the head of the Trump administration's Operation Warp Speed initiative tapped ever so softly on the brakes.

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