Login

Forgot password?
Sign up today and your first download is free.
REGISTER

Rx Drugs

December 10, 2020 | Daily News

An overwhelming majority of FDA’s vaccine advisers on Thursday (Dec. 10) agreed that Pfizer’s vaccine is safe to authorize for emergency use, with 17 committee members voting that the benefits outweigh the risks. Of the four who voted “no” and the one member who abstained from voting, it seemed the main concern was that the emergency use authorization might apply to 16- and 17-year-olds, even though there are no data on use of the vaccine in teens.

December 10, 2020 | Daily News

HHS on Thursday (Dec. 10) finalized a 340B administrative dispute resolution rule -- more than 10 years after the Affordable Care Act called for the dispute resolution process to be set up and years after the Trump administration froze the Obama administration's proposal.

December 10, 2020 | Daily News

The Supreme Court unanimously ruled Thursday (Dec. 10) in favor of an Arkansas law that regulates how much pharmacy benefit managers can pay pharmacies, clearing the way for the more than 40 states with similar laws that aim to use PBM regulation to control drug prices.

December 10, 2020 | Daily News

House lawmakers on Wednesday (Dec. 9) introduced a bipartisan bill that would establish a subscription-style reimbursement model for antimicrobial drugs to incentivize drug makers to create new, innovative antibiotics by removing volume sales as the payment driver.

December 10, 2020 | Daily News

Sanofi Pasteur may not charge the U.S. government more than other G7 countries for its coronavirus vaccine candidate, according to a redacted contract posted on HHS’ website.

December 09, 2020 | Daily News

The White House Office of Management and Budget on Monday (Dec. 7) finished reviewing a final rule to put in place a 340B administrative dispute resolution process, after having previously withdrawn a proposed rule on the issue, raising questions about how the Trump administration can legally move forward with a final rule.

December 09, 2020 | Daily News

The House on Wednesday (Dec. 9) passed by voice vote a bipartisan bill that would require FDA and the National Institute on Drug Abuse to issue guidelines on the production of marijuana, as part of the legislation’s larger goal to make marijuana accessible to be studied for medical purposes.

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.

Pages