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Rx Drugs

December 16, 2020 | Daily News

HHS Secretary Alex Azar on Wednesday (Dec. 16) said the federal government will use “any power” it has to ensure Pfizer supplies the United States with the number of vaccine doses stipulated in the company’s contract as well as extra supply when the United States needs it.

December 16, 2020 | Daily News

The Trump administration on Tuesday (Dec. 15) asked a federal judge to reject the drug industry’s request for a temporary restraining order and preliminary injunction against the most-favored nation drug pricing demonstration.

December 16, 2020 | Daily News

The Trump administration on Tuesday (Dec. 15) asked a federal judge to reject the drug industry’s request for a temporary restraining order and preliminary injunction against the most-favored nation drug pricing demonstration.

December 16, 2020 | Daily News

Health policy experts, including former FDA Commissioner Scott Gottlieb, are blasting Operation Warp Speed officials’ decision to hold back distribution of nearly 3 million doses of Pfizer’s COVID-19 vaccine until it’s time to ship out second doses next month, saying that more lives could be saved by sending out additional initial doses now and getting more people vaccinated with the first dose upfront.

December 15, 2020 | Daily News

Moderna will conduct a real-world study to assess the effectiveness of its COVID-19 vaccine once it’s on the market under emergency use authorization, FDA and Moderna say in briefing materials posted on the agency’s website Tuesday (Dec. 15).

December 14, 2020 | Daily News

Xavier Becerra, California attorney general and President-elect Joe Biden’s pick for HHS secretary, is spearheading an effort by 29 AGs to get the Health Resources and Services Administration to stop drug makers from limiting 340B discounts accessed via contract pharmacies, saying the drug makers are unjustifiably flouting 340B requirements and their actions cannot be ignored -- especially in the middle of the COVID-19 pandemic.

December 14, 2020 | Daily News

Pfizer will move forward with administering its COVID-19 vaccine to placebo recipients -- and thus unblinding its study -- on a rolling basis once the vaccine is available to trial participants’ demographic groups based on federal and state prioritization plans, company officials said, despite FDA’s repeated objections to unblinding vaccine studies immediately after emergency use authorization.

December 14, 2020 | Daily News

World Trade Organization members decided Thursday (Dec. 10) to continue discussing a proposal to waive certain intellectual property protections for COVID-19 vaccines and medical products after a 90-day deadline passes, though consensus on the waiver remains unlikely as many of the largest developed members remain against it.

December 14, 2020 | Daily News

Pfizer and the U.S. government will send out another 581 shipments of the company’s COVID-19 vaccine on Thursday (Dec. 17), in addition to the 636 shipments that began shipping out Sunday (Dec. 13), Operation Warp Speed Chief Operating Officer Gen. Gustave Perna said.

December 14, 2020 | Daily News

Hospitals and pharmacists on Friday (Dec. 11) asked the U.S. District Court for the Northern District of California to force HHS to stop drug makers from limiting 340B discounts that providers access via contract pharmacies and to make the drug makers refund the discounts providers were unable to access.

December 12, 2020 |

The U.S. government plans to complete delivery of the initial doses of Pfizer and BioNTech’s COVID-19 vaccine to states by Wednesday (Dec. 16), Operation Warp Speed officials said Saturday (Dec. 12), less than 24 hours after FDA granted emergency use authorization for the vaccine to be administered to people ages 16 and up.

December 12, 2020 | Daily News

The U.S. government plans to complete delivery of the initial doses of Pfizer and BioNTech’s COVID-19 vaccine to states by Wednesday (Dec. 16), Operation Warp Speed officials said Saturday (Dec. 12), less than 24 hours after FDA granted emergency use authorization for the vaccine to be administered to people ages 16 and up.

December 12, 2020 |

Officials from the Centers for Disease Control and Prevention are working to revise allergy warnings for Pfizer’s COVID-19 vaccine to make clear that not everyone with allergies should avoid getting the vaccine, as some CDC advisers worry the language in Pfizer’s fact sheets, which were cleared by FDA, and in proposed CDC guidance will deter the public and health care providers from taking and administering the shot.

December 12, 2020 | Daily News

Officials from the Centers for Disease Control and Prevention are working to revise allergy warnings for Pfizer’s COVID-19 vaccine to make clear that not everyone with allergies should avoid getting the vaccine, as some CDC advisers worry the language in Pfizer’s fact sheets, which were cleared by FDA, and in proposed CDC guidance will deter the public and health care providers from taking and administering the shot.

December 12, 2020 | Daily News

The Centers for Disease Control and Prevention’s vaccine advisers on Saturday (Dec. 12) unanimously agreed with FDA that Pfizer and BioNTech’s COVID-19 vaccine should be administered to people aged 16 years and older, following FDA’s emergency use authorization for the vaccine late Friday (Dec. 11).

December 11, 2020 | Daily News

FDA Friday evening (Dec. 11) granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine for people ages 16 and up, just one day after the agency’s vaccine advisory committee voted in favor of authorizing the two-dose mRNA vaccine.

December 11, 2020 | Daily News

The Trump administration doubled its purchase of Moderna Therapeutics’ coronavirus vaccine candidate to 200 million, and the government has committed to paying the company a total of $4.1 billion for the vaccine, HHS announced Friday (Dec. 11).

December 11, 2020 | Daily News

The Centers for Disease Control and Prevention is preparing its Advisory Committee on Immunization Practices for a potential Saturday morning emergency meeting to discuss the immunization schedule for Pfizer’s COVID-19 vaccine, should it get emergency use authorization from FDA Friday evening (Dec. 11), ACIP officials said, coming amid reports that the White House has ordered agency chief Stephen Hahn to issue the EUA Friday or submit his resignation.

December 11, 2020 | Daily News

FDA on Tuesday (Dec. 8) published a draft guidance that details how sponsors should select and screen proprietary names for nonprescription drugs, after stakeholders complained the agency’s more general naming guidance published in 2014 did not adequately address nonprescription drugs.

December 11, 2020 | Daily News

FDA has notified the Centers for Disease Control and Prevention, Operation Warp Speed and Pfizer that it’s working to quickly finalize and issue an emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine, Peter Marks, director of the agency’s biologics center, said in a statement Friday morning (Dec. 11), less than 24 hours after the agency’s vaccine advisers threw their support behind the vaccine.

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