Login

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

Rx Drugs

September 03, 2020 | Daily News

In an open letter published Thursday (Sept. 3), the Biotechnology Innovation Organization urges FDA to maintain its independence as the “gold-standard” regulatory body, and for politics to stay out of the development and approval of new medicines so the public can rest assured any vaccine or therapy that comes to market has undergone a rigorous review process and has been upheld to the “highest standards of scientific and medical integrity.”

September 03, 2020 | Daily News

House Energy & Commerce Committee leaders say HHS needs to stop drug manufacturers from limiting 340B discounts via contract pharmacies -- which they say HHS has the authority and obligation to do -- or 340B participants might stop following any of the program’s requirements.

September 03, 2020 | Daily News

There is still a chance the government will fund additional coronavirus vaccines, but they would need to offer a significant potential advantage or difference from the vaccines already in the government’s portfolio, HHS Deputy Chief of Staff for Policy Paul Mango said Friday (Aug. 28).

September 02, 2020 | Daily News

CMS on Wednesday (Sept. 2) increased Medicare pay to hospitals that administer chimeric antigen receptor T-cell treatments for cancer by creating a national unadjusted pay rate for CAR T that excludes clinical trial cases and unusually low hospital charges from the pay rate calculation.

September 02, 2020 | Daily News

Two days after House Energy & Commerce Democrats asked the administration to let FDA chief Stephen Hahn testify before the panel this month, the GOP-led Senate health committee announced it will hear from key HHS officials, including Hahn and National Institutes of Allergy and Infectious Diseases Director Anthony Fauci, at hearings slated for Sept. 9 and 23.

September 01, 2020 | Daily News

The National Academies of Sciences, Engineering and Medicine, in its Tuesday (Sept. 1) vaccine allocation discussion draft, calls for the federal government to fully compensate anyone who takes a COVID-19 vaccine and experiences vaccine-related injuries.

September 01, 2020 | Daily News

Lilly will stop providing 340B discounts on almost all drugs purchased through contract pharmacies, with the exception of insulin, a major expansion of its July policy that affected only three formulations of Cialis.

September 01, 2020 | Daily News

The United States will not participate in a World Health Organization-led effort to develop and distribute COVID-19 vaccines globally because the Trump administration says working with other countries on vaccines would slow America’s recovery.

September 01, 2020 | Daily News

President Donald Trump again said Tuesday (Sept. 1) he signed a most-favored-nation executive order, and he added drug companies are meeting with White House officials this week to discuss alternatives to that order.

September 01, 2020 | Daily News

President Donald Trump said Tuesday (Sept. 1) that drug companies are meeting with White House officials this week to discuss alternatives to his favored-nation executive order, but a spokesperson for the Pharmaceutical Research and Manufacturers of America said she is not aware of a meeting with PhRMA.

September 01, 2020 | Daily News

President Donald Trump said Tuesday (Sept. 1) that drug companies are meeting with White House officials this week to discuss alternatives to his favored-nation executive order, but a spokesperson for the Pharmaceutical Research and Manufacturers of America said she is not aware of a meeting with PhRMA.

September 01, 2020 | Daily News

Leading World Health Organization officials cautioned that any decision to grant emergency use authorization to a COVID-19 vaccine should not be taken lightly and should be accompanied by strict postmarket safety and adverse event monitoring.

September 01, 2020 | Daily News

Former FDA chief Scott Gottlieb highly doubts that FDA will make a regulatory decision on a COVID-19 vaccine before data from phase 3 trials are made public, he said in reaction to FDA chief Stephen Hahn’s suggestion over the weekend that a vaccine could be authorized or approved before such trials are done.

August 31, 2020 | Daily News

The House Energy & Commerce Committee announced Monday (Aug. 31) that it will hold a public hearing with FDA chief Stephen Hahn in September, coming after committee heads held a phone briefing with Hahn and other top agency officials to address the agency’s response to the COVID-19 pandemic and FDA’s reputation as an independent agency.

August 31, 2020 | Daily News

Drug and device industry lawyers are surprised that FDA’s latest inspection guidance fails to expand on whether and how the agency will use remote technologies to conduct facility inspections during the COVID-19 pandemic.

August 31, 2020 | Daily News

Groups representing insurers, doctors and consumers are discouraging the administration from accepting pharma-backed alternatives to the president’s executive order that ties Medicare reimbursement to the lowest prices among developed countries.

August 28, 2020 | Daily News

Operation Warp Speed officials are confident they’ll have millions of doses of COVID-19 vaccine ready for distribution by the year-end or early 2021 timeline that’s been touted by HHS and Trump administration officials.

August 28, 2020 | Daily News

FDA on Friday (Aug. 28) expanded the emergency use of remdesivir to all hospitalized patients suspected of coronavirus infection, though it’s not clear that there is a clinical benefit to patients.

August 28, 2020 | Daily News

FDA and the Centers for Disease Control and Prevention will conduct “heightened safety monitoring” for any COVID-19 vaccine that comes to market either through emergency use authorization or full licensure, CDC Director Robert Redfield said during a press call Friday (Aug. 28).

August 28, 2020 | Daily News

A group of Democratic senators wrote to FDA Thursday (Aug. 27) requesting whether the agency is tracking adverse events and monitoring the use of hydroxychloroquine in COVID-19 patients after state reports revealed some nursing home residents were given the investigational therapy without proper authorization or consent.

Pages