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Rx Drugs

February 10, 2021 | Daily News

Brand drug makers are targeted for up to $20 billion in offsets in the House Energy & Commerce Committee bill to increase federal government funding of state Medicaid programs: The bill would penalize companies that quickly raise prices by eliminating the cap on Medicaid inflation rebates.

February 09, 2021 | Daily News

FDA on Tuesday night (Feb. 9) granted emergency use authorization for a combination of monoclonal antibodies from Eli Lilly, bamlanivimab and etesevimab, to treat patients who experience mild to moderate COVID-19 symptoms and are at risk of severe adverse health effects or hospitalization.

February 05, 2021 | Daily News

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.

February 05, 2021 | Daily News

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).

February 05, 2021 | Daily News

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.

February 04, 2021 | Daily News

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.

February 04, 2021 | Daily News

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.

February 04, 2021 | Daily News

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

February 04, 2021 | Daily News

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.

February 04, 2021 | Daily News

In less than 24 hours, Johnson & Johnson and Novavax published clinical trial results for their vaccine candidates that are likely to impact the bargaining position of government officials who are negotiating prices for vaccines made by Pfizer and Moderna.

February 03, 2021 | Daily News

President Joe Biden is seeking $4 billion to build and equip two state-of-the-art manufacturing facilities with the capacity to produce and fill 100 million COVID-19 vaccine doses per month, according to a breakdown of the president's broader $160 billion direct pandemic relief request shared by Protect Our Care.

February 03, 2021 | Daily News

The federal government is partnering with California to launch community vaccination centers in two areas of the state that have been hit hardest by the pandemic, Oakland and Los Angeles, and there are plans to work with other states to stand up new sites over the coming weeks, the Biden administration announced Wednesday (Feb. 3).

February 02, 2021 | Daily News

State health officials told lawmakers Tuesday (Feb. 2) they need better predictability around how many COVID-19 vaccine doses they’ll receive each week, and some said until they know for sure there’s ample supply, they will continue holding back doses to make sure everyone who got their first dose is able to get their second shot.

February 02, 2021 | Daily News

The Biden administration announced that it will begin delivering COVID-19 vaccines directly to pharmacies in addition to the vaccines that have been allotted to states, territories and tribes to further the United States’ vaccination efforts as part of President Joe Biden’s national COVID-19 response strategy.

January 29, 2021 | Daily News

Novartis will support production of Pfizer and BioNTech’s COVID-19 vaccine by filling vials with bulk mRNA active ingredient and shipping it back to BioNTech for distribution to health care system customers “around the world,” Novartis announced Friday (Jan. 29).

January 28, 2021 | Daily News

The Biden administration on Tuesday (Jan. 26) requested an extra 60 days to respond to the drug industry’s lawsuit against the Trump administration’s drug import rule.

January 28, 2021 | Daily News

The Pharmaceutical Research and Manufacturers of America recently sued HHS over what it alleges is a rushed 340B administrative dispute resolution process that doesn’t allow fair access for manufacturers due to impermissible audit requirements.

January 28, 2021 | Daily News

Congressional Medicare advisers said they are leaning toward recommending that Medicare Part B cover all vaccines, without cost sharing for preventive vaccines, at a meeting Friday (Jan. 15) on potential changes to the reimbursement formula for vaccines.

January 28, 2021 | Daily News

When Trump’s CMS finalized its policy to immediately cover breakthrough medical devices following FDA approvals, the agency decided against expanding the new rule to drugs.

January 27, 2021 | Daily News

The Biden administration is eyeing all possible options for ramping up vaccine supply using the Defense Production Act, including retrofitting competing drug makers’ facilities to manufacture already-authorized COVID-19 vaccines from Pfizer and Moderna, the White House COVID-19 Response Team told reporters Wednesday (Jan. 27).

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