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Daily News

February 05, 2021

FDA Thursday evening (Feb. 4) revoked its emergency use authorization for convalescent plasma that contains low concentrations of antibodies, known as low-titer plasma, based on data from randomized, controlled trials that show the use of low-titer plasma in hospitalized COVID-19 patients no longer meets the “may be effective” standard for an EUA.

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Employees who lost job-based coverage due to lay-offs or furloughs could get fully subsidized COBRA coverage under legislation introduced Thursday (Jan. 28) by a group of 11 Democratic senators led by Majority Whip Dick Durbin (IL) and Catherine Cortez Masto (NV).

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While the Senate “vote-a-rama” held Thursday night featured mostly a slew of messaging bills, the Senate did add several health-related non-binding amendments to the resolution, including a deficit-neutral fund for legislation that would expand the use of health savings accounts (HSAs), new commissions tasked with improving the solvency of the federal trust funds and more.

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The health insurance lobby leading the lawsuit over the Trump administration’s rule that expands the duration of short-term health plans is deliberating its next steps now that a federal appeals court has declined to rehear their case en banc and that the Biden administration is expected to reverse the rule as part of its regulatory review.

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The Biden administration is leveraging the Defense Production Act to give Pfizer priority access to critical supplies needed to make its COVID-19 vaccine, namely filling pumps and tangential flow filtration units, the White House announced Friday (Feb. 5).

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The federal government has directed six different manufactures to ramp up domestic production of non-prescription, at-home COVID-19 tests under the Defense Production Act, the White House’s COVID-19 Response Team revealed Friday (Feb. 5).

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The federal government will use the Defense Production Act to build U.S.-based factories that will produce more than a billion surgical gloves every month, the White House COVID-19 Response Team told reporters Friday (Feb. 5).

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Acting FDA Commissioner Janet Woodcock said COVID-19 vaccine makers testing vaccines against new variants and developing booster shots likely will need to provide the agency with new safety and immunity data, but more limited data might be permitted depending on how quickly new strains emerge and how effective current vaccines remain against them.

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The Senate late Thursday (Feb. 4) agreed to add to the budget resolution a bipartisan amendment sponsored by Sens. Susan Collins (R-ME) and Joe Manchin (D-WV) that aims to replenish the Provider Relief Fund by $35 billion, with 20% set aside for rural hospitals. Only one senator, Mike Lee (R-UT), voted against the language, which now could be included as congressional committees write legislation for Democrats’ $1.9 trillion COVID-19 package.

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February 04, 2021

The Supreme Court will hear oral arguments in the case over the validity of Trump-era 1115 Medicaid work requirement waivers on March 29, the court said Feb. 1.

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Immigrant advocates suing over the former Trump administration’s controversial public charge rule plan to pow wow with Biden’s Department of Justice on next steps in their suits, given the new administration is considering revoking the rule.

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Johnson & Johnson has submitted an emergency use authorization application to FDA for its single-shot COVID-19 vaccine, the company announced Thursday (Feb. 4), less than a week after its subsidiary, Janssen, announced the company’s phase 3 ENSEMBLE trial showed the vaccine prevented moderate to severe COVID-19 in 66% of patients in clinical trials around the world and was 72% effective in U.S. trials.

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A group of GOP lawmakers are backing providers’ push for relief funding to be included in the next COVID-19 stimulus package, with the Republicans asking President Joe Biden to add $35 billion for providers to his American Rescue Plan.

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States are not in as bad shape as some experts first feared but they're still facing an uncertain road to financial recovery, sparking concerns from health advocates that governors and lawmakers might resort to reducing Medicaid benefits like dental coverage if states don’t get federal relief.

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Democratic Sen. Edward Markey (MA) on Thursday (Feb. 4) reintroduced legislation that would give $1 billion over a period of four fiscal years to the National Institutes of Allergy and Infectious Diseases to research a universal coronavirus vaccine.

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Medicare Advantage grew to almost 26 million enrollees last month, and while plans and MA advocates are pleased, other beneficiary advocates say Congress and CMS need to do a better job about treating the private plans and fee-for-service coverage equally.

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Roger Severino, former director of HHS’ Office of Civil Rights (OCR), late Wednesday, sued President Biden and other officials for asking him to resign from an independent federal advisory committee that focuses on administrative procedure only weeks after being reappointed by former President Trump and significantly short of his expected three- year tenure.

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Former FDA and HHS officials told lawmakers during a Wednesday (Feb. 3) hearing that the United States needs to invest in reforming key components of the U.S. health care system to better respond to COVID-19 by, among other things, implementing a national COVID-19 testing strategy that establishes standards for testing and contact tracing and provides Americans with digital access to their test information, and using emerging technology to better coordinate vaccination records between states and jurisdictions.

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The U.S. government signed a contract with Pfizer worth up to $10.5 billion for an undisclosed number of coronavirus vaccines.

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With 2021 state legislative sessions barely underway, lawmakers in five states have already introduced legislation to tie prices of drugs sold in those states to Canadian prices.

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