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Rx Drugs

November 19, 2020 | Daily News

Pharmacists plan to use their success in getting HHS to let them administer coronavirus vaccines to lobby for recognition as providers so they may administer all vaccines, regardless of whether there is a pandemic.

November 18, 2020 | Daily News

With news that Pfizer has completed the final analysis of its phase 3 COVID-19 vaccine trial, and Moderna expected to reach its study objectives soon, Operation Warp Speed officials and FDA are having conversations about how and when to move trial participants who are in the placebo arm over to the active vaccine arm, Operation Warp Speed chief Moncef Slaoui said on a Wednesday (Nov. 18) press call.

November 18, 2020 | Daily News

The White House Office of Management and Budget on Tuesday (Nov. 17) started reviewing a final rule laying out a 340B administrative dispute resolution process, surprising stakeholders because the proposed version of the rule was issued by the Obama administration back in 2016 and was withdrawn by the Trump administration in August 2017.

November 18, 2020 | Daily News

It took three business days for White House budget officials to review the final version of a drug-rebate-ban rule that HHS and White House officials said they withdrew in the summer of 2019.

November 18, 2020 | Daily News

If the Trump administration uses an interim final rule to put in place the president’s plan to base Medicare reimbursement on international drug prices, drug makers will surely sue, drug lobbyists say.

November 17, 2020 | Daily News

White House Coronavirus Task Force Lead Anthony Fauci said Tuesday (Nov. 17) he hasn’t spoken with President-elect Joe Biden since Biden was the vice president, highlighting the barriers the incoming administration faces due to President Donald Trump’s continued refusal to begin the presidential transition.

November 17, 2020 | Daily News

FDA will publicly post its reviews of data and information supporting emergency use authorization decisions for drugs and biologics, including vaccines, as part of the agency’s COVID-19 response, FDA chief Stephen Hahn announced Tuesday (Nov. 17), just a few hours before the Government Accountability Office issued a report calling for FDA to be more transparent about its sometimes inconsistent EUA reviews and decisions.

November 17, 2020 | Daily News

When the president revived an effort to ban drug rebates, most lobbyists assumed HHS would have to restart rulemaking since the department had withdrawn a rebate-ban proposed rule last year, but HHS is ignoring that withdrawal, and a former adviser to the Trump White House said the proposed rule was not officially terminated.

November 17, 2020 | Daily News

Bipartisan bills calling for generic drug labeling updates, an end to gaming of certain orphan drug exclusivity provisions and an updated list of major allergens are among 10 health care measures that were passed by the House on Tuesday (Nov. 17).

November 16, 2020 | Daily News

Moderna announced on Monday (Nov. 16) that its investigational COVID-19 vaccine can be stored for up to 30 days in temperatures ranging from 36 to 46 degrees Fahrenheit -- the same temperature setting as a standard home or medical refrigerator.

November 16, 2020 | Daily News

Moderna on Monday (Nov. 16) said that in the coming weeks, it will submit an emergency use authorization request to FDA for the company’s investigational COVID-19 vaccine, which demonstrated 94.5% efficacy in an early analysis of trial data.

November 13, 2020 | Daily News

President Donald Trump and HHS Secretary Alex Azar on Friday (Nov. 13) blasted state leaders, especially New York Gov. Andrew Cuomo (D), for setting up expert panels to review the safety and efficacy of COVID-19 vaccines after the vaccines get FDA clearance.

November 12, 2020 | Daily News

The Institute for Clinical and Economic Review, which analyzes drug prices, lowered its recommended price for Gilead’s remdesivir after accounting for results from the World Health Organization-funded Solidarity trial.

November 12, 2020 | Daily News

Although taxpayers helped fund the development of Regeneron’s coronavirus antibody cocktail, the U.S. government is prohibited from licensing third parties to make cheaper versions of the product due to its price, according to the government’s $450 million contract with the drug maker, though the contract allows for compulsory licensing if the company cannot or will not make the drug.

November 10, 2020 | Daily News

Eli Lilly indicated in a letter to the Health Resources and Services Administration that its co-pay coupons are more helpful for patients than the 340B program, shortly after CMS finalized a proposal to let Obamacare plans exclude brand drug makers’ coupons from out-of-pocket calculations even when there are no generics available.

November 10, 2020 | Daily News

FDA advisers cautioned FDA that approving Biogen’s Alzheimer’s drug aducanumab based on what the advisers saw as little evidence of effectiveness could stifle research on more effective drugs for years, a view shared by a clinical analyst in FDA’s neurology review division.

November 10, 2020 | Daily News

FDA advisers on Friday (Nov. 6) butted heads with agency staff over Biogen’s Alzheimer’s drug candidate, which if approved would likely spark a debate over the price of the first drug for a tragic condition that is expensive to care for.

November 09, 2020 | Daily News

FDA on Monday (Nov. 9) granted emergency use authorization for Eli Lilly’s investigational monoclonal antibody therapy, bamlanivimab, for treatment of mild-to-moderate COVID-19 in adults and pediatric patients who have not been hospitalized, coming as the company’s trial of the drug in hospitalized patients remains on hold.

November 09, 2020 | Daily News

When the Supreme Court hears the challenge to the Affordable Care Act on Tuesday (Nov. 10), prescription drug policies are at stake in addition to the future of the insurance exchanges.

November 09, 2020 | Daily News

In a final compounding guidance released Friday (Nov. 6), FDA maintains that it will not take regulatory action against physicians who compound products in a physician’s office for in-office administration, despite previous pushback from a key pharmacy organization that had argued safe compounding practices should not differ based on the setting in which the drugs are compounded.

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