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Rx Drugs

December 09, 2020 | Daily News

FDA biologics center director Peter Marks said the agency is working with its colleagues in the United Kingdom to understand why two U.K. health care workers experienced severe allergic reactions to Pfizer’s COVID-19 vaccine, and he said the agency will discuss the issue with its advisers during the agency’s Thursday (Dec. 10) advisory committee meeting.

December 09, 2020 | Daily News

Xavier Becerra, President-elect Joe Biden’s nominee for HHS secretary, recently asked the federal government to use a controversial monopoly-busting mechanism to lower the cost of the COVID-19 drug remdesivir, and there are several COVID-19 drugs and vaccines that are susceptible to the government’s so-called march-in rights.

December 08, 2020 | Daily News

FDA and Pfizer are clashing again over whether COVID-19 vaccine trials should be unblinded once a vaccine has emergency use authorization.

December 08, 2020 | Daily News

President Donald Trump on Tuesday (Dec. 8) said his administration will consider invoking the Defense Production Act if there are any problems with manufacturing enough COVID-19 vaccines for U.S. citizens, coming amid reports that the U.S. government did not take the opportunity to buy more doses from Pfizer over the summer and that the drug makers’ remaining doses through next June have been allocated to other countries.

December 08, 2020 | Daily News

Senior White House administration officials denied a recent New York Times report that alleged the Trump administration passed up the opportunity to purchase more doses of Pfizer’s COVID-19 vaccine and as a result Pfizer now might be unable to provide more of its vaccine to the United States until next June because of its commitments to other countries.

December 08, 2020 | Daily News

A pharmaceutical economics professor says the federal government should consider creating an agency, separate from FDA, of which the sole purpose would be to track drug use, create multiple drug shortage lists and develop shortage mitigation strategies.

December 07, 2020 | Daily News

President Donald Trump will sign an executive order Tuesday (Dec. 8) that affirms Americans will be first to get U.S. COVID-19 vaccines once authorized and that provides instructions for providing leftover doses to other countries, White House and HHS officials said Monday (Dec. 7).

December 07, 2020 | Daily News

FDA biologics center director Peter Marks and Operation Warp Speed chief Moncef Slaoui say it remains unclear whether people who have recently experienced severe COVID-19 infection and likely have higher levels of antibody protection will need to get the vaccine when it’s available.

December 07, 2020 | Daily News

Though FDA is reviewing the same Pfizer COVID-19 vaccine data upon which the United Kingdom based its temporary authorization decision last week, FDA’s review is taking longer because the agency is looking at every line item in the data package, including adverse event reports and physician notes, FDA’s biologics chief Peter Marks said.

December 04, 2020 | Daily News

The Pharmaceutical Research and Manufacturers of America and three groups representing doctors and patients filed suit Friday (Dec. 4) against the Trump administration’s demonstration that ties Medicare doctor reimbursement to foreign drug prices, and at press time the Biotechnology Innovation Organization was poised to file a separate suit in a federal court in California.

December 04, 2020 | Daily News

The House on Friday (Dec. 4) passed by a vote of 228 to 164 legislation that removes marijuana from the Controlled Substances Act.

December 04, 2020 | Daily News

FBI cyber official Tonya Ugoretz and CISOs from Johnson & Johnson and Eli Lilly discussed extensive collaboration efforts underway to protect development and distribution of COVID-19 vaccines and therapies, at an event sponsored by the Aspen Institute.

December 03, 2020 | Daily News

Operation Warp Speed chief Moncef Slaoui said on Wednesday (Dec. 2) that data from AstraZeneca’s COVID-19 vaccine trials in the United Kingdom and Brazil, which resulted in two separate efficacy results of 90% in one cohort and 62% in another, likely will not be sufficient to support an emergency use authorization application in the United States.

December 03, 2020 | Daily News

In the months leading up to COVID-19 vaccine sponsors’ newly submitted applications for emergency use authorization, FDA and its advisers, as well as advisers for the Centers for Disease Control and Prevention, discussed whether to push expanded access as a way to initially deliver experimental vaccines to narrow segments of the population in advance of broader EUAs and full approvals.

December 03, 2020 | Daily News

The United States will have enough of Pfizer’s and Moderna’s COVID-19 vaccines to immunize 100 million people by the end of February, if the two-shot vaccines get emergency use authorization, Operation Warp Speed chief Moncef Slaoui said during a press call Wednesday (Dec. 2).

December 03, 2020 | Daily News

The most-favored-nation demonstration, which aims to lower drug prices, undermines price-competing biosimilars by subjecting them to international reference pricing, according to Coherus BioSciences, the maker of the biosimilar covered by the demonstration.

December 03, 2020 | Daily News

The Canadian government halted bulk exports of prescription drugs when exporting drugs would create shortages domestically, a move that effectively blocks President Donald Trump’s drug imports rule from having any effect.

December 02, 2020 | Daily News

CMS backed away from its proposal to increase cuts to Part B pay for 340B drugs by an additional 6% in 2021, citing the COVID-19 public health emergency, and instead finalized its alternative proposal to continue paying hospitals for those drugs at the Average Sales Price minus 22.5% as part of the final 2021 hospital outpatient pay rule.

December 02, 2020 | Daily News

Novo Nordisk on Tuesday (Dec. 1) became the latest drug manufacturer to take steps to stop certain providers from accessing 340B discounts through contract pharmacies -- though Novo Nordisk’s policy will only affect 340B hospitals, and grantees like Ryan White Clinics and community health centers will still be able access the discounts via contract pharmacies.

December 02, 2020 | Daily News

The United Kingdom temporarily authorized Pfizer and BioNTech’s COVID-19 vaccine on Wednesday (Dec. 2), which makes the U.K. the first Western country to authorize a vaccine for the novel coronavirus, coming as the White House and HHS reportedly are pressuring FDA to move more quickly to authorize the vaccine in the United States.

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