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Category Archives: Federal News

Senate Republicans Release HEALS Act – COVID-19 Stimulus Package

By Denise Bell | Published July 31, 2020

Earlier this week, Senate Majority Leader Mitch McConnell released the Republican version of a fourth COVID-19 package (or as some say, a second round of a CARES Act stimulus bill). The bill, titled the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act is actually a collection of bills. Highlights include another round of $1200 […]

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President Trump Signs Drug Pricing Executive Orders, Touts “Most Favored Nation” Pricing

By Denise Bell | Published July 31, 2020

Last Friday, President Trump signed four executive orders aimed at lowering drug prices, including an order that would set up a “most favored nation” (MFN) pricing model for Medicare Part B drugs, effectively imposing foreign price controls on critical medicines for seniors. The goal, Trump said, is to “end global freeloading on the backs of […]

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Pfizer and BionTech Announce Agreement with U.S. Government for Up to 600 million doses of COVID-19 Vaccine Candidate

By Denise Bell | Published July 24, 2020

On July 22, Pfizer and BioNTech announced the execution of an agreement with the HHS and DOD to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 […]

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White House, GOP Deal on $1T COVID-19 Relief Package Takes Shape

By Denise Bell | Published July 24, 2020

As reported by The Hill, “White House and Senate Republicans on Thursday reached a “fundamental agreement” on a coronavirus package…” Among other items, the agreement includes: Another round of $1200 in direct payments to individuals making up to $75,000 Replacing the current $600 in federal unemployment benefits with a 70% match of a worker’s wages […]

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President Trump to Sign Executive Orders to Lower Drug Prices

By Denise Bell | Published July 24, 2020

While the drug pricing issue has been sidelined amid the COVID-19 pandemic, President Trump is now returning to the issue with several executive orders that he is expected to sign today. According to a report by The Hill, Republican lawmakers have been invited to a presidential event on drug pricing today at 3 p.m. at […]

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Sens. Warren, Sanders Slam Gilead Deal with Government while New Research Says Americans Don’t Pay Twice for Drugs

By Denise Bell | Published July 23, 2020

This week Sens. Elizabeth Warren and Bernie Sanders sent a letter to HHS Secretary Alex Azar seeking an explanation for why the deal with the administration to acquire a large supply of remdesivir in their words “forces U.S. purchasers to pay the highest prices in the world for the drug” The letter requests a response […]

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Initial Data for Moderna COVID-19 Vaccine Shows Promise

By Denise Bell | Published July 17, 2020

On Tuesday, Moderna announced promising results from the Phase 1 study of its vaccine candidate, called mRNA-1273. The study, published in The New England Journal of Medicine  showed that all 45 volunteers who received two vaccine doses developed immune responses that were stronger than in patients who have recovered from COVID-19. “These positive Phase 1 […]

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BioFire Respiratory Panel with COVID Target Scores CE Mark

By Denise Bell | Published July 17, 2020

BioMerieux announced that Utah-based BioFire’s Respiratory Panel 2.1 plus, which tests for SARS-CoV-2 and 23 pathogens encompassing 19 viruses, and four bacteria that cause the most frequent respiratory tract infections, has received CE marking.  “It’s exciting to see the advances that BioFire is making in COVID-19 and infectious disease diagnostics,” said Kelvyn Cullimore, president and […]

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PhotoPharmics Stay-At-Home Trial for People with Parkinson’s

By Denise Bell | Published July 17, 2020

This week, PhotoPharmics announced a collaboration with the Center for Health + Technology (CHeT) at the University of Rochester Medical Center to conduct an at home, telemedicine, phase 3 trial for the company’s Celeste® – a non-invasive, specialized light therapy device for Parkinson’s. The trial follows an FDA Breakthrough Device Designation for the device in […]

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Johnson & Johnson to Begin COVID-19 Vaccine Clinical Trials in Humans Next Week

By Denise Bell | Published July 17, 2020

Last month, Johnson & Johnson (J&J) announced that its Phase 1/2a in-human clinical trial of its potential COVID-19 vaccine was expected to begin in July – instead of September as initially scheduled. On Thursday, as reported by Fierce Pharma, J&J chief scientific officer Paul Stoffels confirmed the accelerated timeline, saying that the company has seen […]

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Pfizer, BioNTech Get FDA Fast Track Status for COVID-19 Vaccines

By Denise Bell | Published July 17, 2020

U.S. Pfizer and Germany’s BioNTech announced Monday that they have received Fast Track designation from the FDA for two COVID-19 vaccine candidates – BNT162b1 and BNT162b2 – part of the companies’ “Project Lightspeed” program. The designation was issued based on promising preliminary data from Phase 1/2 clinical studies. The FDA’s Fast Track designation is intended […]

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Changes to PPP Rules Set After Senate Passes Paycheck Protection Flexibility Act of 2020

By Denise Bell | Published June 5, 2020

By Brandon Allfrey, Partner, Squire, Brandona@squire.com Late Wednesday evening, the U.S Senate passed by unanimous consent the Paycheck Protection Program Flexibility Act of 2020 to ease some of the original rules of the PPP application and forgiveness rules from the CARES Act and the subsequent guidance from the Treasury Department.  The details of the Act did not change from the […]

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