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Rx Drugs

February 26, 2021 | Daily News

Johnson & Johnson will unblind participants in its COVID-19 vaccine clinical trial, if the shot gets emergency use authorization from FDA, even though the agency remains adamant that there’s no need for vaccine makers to offer vaccines to all placebo recipients once an EUA is granted.

February 25, 2021 | Daily News

Johnson & Johnson will need to monitor its COVID-19 vaccine for any potential link to thromboembolic events if it gets emergency use authorization from FDA and the vaccine is distributed to a larger population beyond those included in the clinical trials, FDA says in briefing materials released ahead of its Friday (Feb. 26) vaccine advisory committee meeting.

February 25, 2021 | Daily News

FDA will let undiluted, frozen vials of Pfizer’s COVID-19 vaccine be transported and stored at higher temperatures more commonly found in pharmaceutical freezers for a period of two weeks, the agency announced Thursday (Feb. 25).

February 25, 2021 | Daily News

Pfizer and BioNTech have begun studying whether adding a third shot, or a booster shot, to their two-dose COVID-19 vaccine could increase the vaccine’s effectiveness against new mutant strains of the virus, the companies announced Thursday (Feb. 25), just days after top FDA officials encouraged vaccine developers to begin testing booster shots as soon as possible to prepare for potentially resistant strains.

February 25, 2021 | Daily News

HHS Secretary-nominee Xavier Becerra promised senators Wednesday that if confirmed he will work with FDA and other agencies to address drug shortages and increase manufacturing of drugs that are inexpensive to make but not seen as profitable by drug makers.

February 25, 2021 | Daily News

HHS Secretary-nominee Xavier Becerra sidestepped a question about whether he thinks the government can seize patents on government-funded drugs to help spur generic competition, coming months after he called on the federal government to use so-called march-in rights to help develop lower-cost generic versions of Gilead’s COVID-19 therapy remdesivir.

February 24, 2021 | Daily News

With former Senate Majority Leader Mitch McConnell (R-KY) out of the way, Sen. Chuck Grassley (R-IA) said it’s possible to pass the bipartisan drug pricing bill he helped negotiate in 2019, and he asked HHS Secretary-nominee Xavier Becerra whether the Biden administration would support that bill, but the California attorney general didn’t answer.

February 24, 2021 | Daily News

The Biden administration is prepared to allocate 3 to 4 million doses of Johnson & Johnson’s one-shot COVID-9 vaccine as early as next week, if the vaccine gets emergency use authorization from FDA, White House COVID-19 Response Team Coordinator Jeff Zients said Wednesday (Feb. 24).

February 24, 2021 | Daily News

While World Trade Organization members remain deadlocked over the question of whether to waive some intellectual property obligations in response to the pandemic, they largely share a common sense that countries must explore how intellectual property flexibilities can be part of a pandemic response framework, according to a Geneva-based trade official familiar with the discussions.

February 24, 2021 | Daily News

Leading vaccine makers are using real-world evidence from across the globe, including from Israel and the United Kingdom, to further assess the safety and effectiveness of their COVID-19 vaccines outside of randomized controlled clinical trials.

February 24, 2021 | Daily News

President Joe Biden will sign an executive order Wednesday (Feb. 24) afternoon calling for a 100-day review of the U.S. pharmaceutical supply chain in a bid to protect finished drug products and active pharmaceutical ingredients against a range of vulnerabilities, including overreliance on foreign competitors and diminished capacity.

February 23, 2021 | Daily News

At a Senate confirmation hearing Tuesday, HHS Secretary-nominee Xavier Becerra said the Trump administration “took sides” with its last-minute pharma-backed rule to ban drug rebates, and he said he would build on the 340B advisory opinion on contract pharmacies, also issued near the end of the Trump administration, that favors hospitals.

February 23, 2021 | Daily News

Xavier Becerra told the Senate health committee Tuesday (Feb. 23) that if confirmed as HHS secretary he will aim to collect more comprehensive data and enhance community health efforts to ensure disadvantaged populations receive their share of COVID-19 shots and that all Americans get vaccinated.

February 23, 2021 | Daily News

Acting FDA Commissioner Janet Woodcock and biologics center director Peter Marks want COVID-19 vaccine makers to begin working on booster shots as soon as possible so that the United States is prepared if new strains of the SARS-CoV-2 virus end up being resistant to currently authorized vaccines.

February 23, 2021 | Daily News

A COVID-19 vaccine research activist is pressing FDA to be transparent about the differences between Johnson & Johnson’s COVID-19 vaccine and other already-authorized vaccines and the impacts those differences might have on underserved communities.

February 22, 2021 | Daily News

FDA on Monday (Feb. 22) issued two new guidances and updated two existing guidances to guide COVID-19 test, vaccine and therapeutics developers on how to update their products to account for COVID-19 variants.

February 22, 2021 | Daily News

The White House, HHS and the Centers for Disease Control and Prevention kicked off a series of listening sessions with key stakeholder groups as part of the second phase of the Biden administration’s vaccine education and outreach to underserved and vaccine-hesitant communities, White House COVID-19 Response Team Senior Adviser Andy Slavitt said Monday (Feb. 22).

February 19, 2021 | Daily News

National Institute of Allergy and Infectious Diseases Director Anthony Fauci said that the messaging around Johnson & Johnson’s one-shot COVID-19 vaccine needs to change so that underserved and disadvantaged communities don’t mistakenly perceive the vaccine, which FDA is reviewing for potential emergency use authorization, as being inferior to the FDA-authorized Pfizer and Moderna vaccines.

February 19, 2021 | Daily News

The Centers for Disease Control and Prevention released a report Friday (Feb. 19) stating it found no significant serious safety problems after its first month of monitoring those who received the two FDA-authorized COVID-19 vaccines, consistent with data from earlier vaccine clinical trials.

February 19, 2021 | Daily News

Pfizer and BioNTech have submitted new data to FDA that show their COVID-19 vaccine can be stored at temperatures more commonly found in pharmaceutical freezers and refrigerators as opposed to the ultra-cold freezers that have been used so far, the companies announced Friday (Feb. 19).

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