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Rx Drugs

September 14, 2020 | Daily News

Any COVID-19 vaccine that becomes available in 2020 likely will be administered in a stepwise manner and be used more like a therapeutic to lower the risk in certain populations, rather than to develop herd immunity and end the pandemic, former FDA chief Scott Gottlieb told a group of public health experts and fellow former FDA chiefs last week.

September 13, 2020 | Daily News

The White House released an executive order Sunday evening (Sept. 13) that extends the president’s controversial most-favored nation policy to include Medicare Part D in addition to Part B, a move that could eventually drastically lower seniors’ drug costs but that policy experts view as a Hail Mary before the election and expect to be challenged in court.

September 11, 2020 | Daily News

FDA and CMS are in talks about implementing a no-cost medical health care claim to help gather postmarket safety data on COVID-19 vaccines that are administered to the public under an emergency use authorization, an FDA official said Thursday (Sept. 10).

September 11, 2020 | Daily News

The president’s executive order aimed at making insulin affordable for low-income diabetics would do the opposite in some circumstances, and the order violates the law that governs community health centers, health center representatives told White House officials in a private meeting Wednesday (Sept. 9).

September 11, 2020 | Daily News

HHS submitted for White House review on Thursday (Sept. 10) a final rule to let states import prescription drugs from Canada.

September 11, 2020 | Daily News

FDA will apply a so-called emergency use authorization-plus standard to COVID-19 vaccine review that leans closer to requirements for a full biologics license application, agency biologics center chief Peter Marks said Thursday (Sept. 10).

September 10, 2020 | Daily News

Eight high-level FDA officials, including drug center director Janet Woodcock who is currently playing an integral role in Operation Warp Speed, penned an op-ed on Thursday (Sept. 10) in a bid to reaffirm that FDA is an independent agency and reassure the public that agency reviewers will be guided by science in their COVID-19 therapy and vaccine decisions.

September 10, 2020 | Daily News

More than 1,100 hospitals across the country are stepping up pressure on HHS Secretary Alex Azar to stop drug makers from limiting 340B discounts via contract pharmacies or tying those discounts to claims data submissions, telling Azar in a letter Thursday (Sept. 10) that the manufacturers are taking away discounts on some of the costliest cancer and diabetes drugs.

September 10, 2020 | Daily News

The White House budget office wouldn’t object if Congress includes in an upcoming continuing resolution a provision to extend funding for FDA’s rare pediatric disease priority review voucher program, according to a document obtained by sister news site Inside Defense.

September 10, 2020 | Daily News

The House Energy & Commerce Committee on Wednesday (Sept. 9) sent to the House floor 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 researchers for medical purposes.

September 09, 2020 | Daily News

National Institutes of Health Director Francis Collins told senators on Wednesday (Sept. 9) that AstraZeneca’s decision to pause its COVID-19 vaccine trial after a participant experienced a serious adverse effect is not out of the ordinary for large-scale vaccine trials, and he tried to assuage lawmakers’ concerns that there won’t be enough COVID-19 vaccines if AstraZeneca’s doesn’t pan out.

September 09, 2020 | Daily News

Pharmacists will be allowed to administer COVID-19 vaccines to anyone three years or older without a prescription, according to guidance HHS issued Wednesday (Sept. 9).

September 09, 2020 | Daily News

Democratic presidential nominee Joe Biden and his vice-presidential pick Kamala Harris ask the administration to let FDA’s biologics center staff, the agency’s outside panel of advisors, and National Institute of Allergy and Infectious Diseases Director Anthony Fauci publicly state whether they support any future COVID-19 approval or authorization decision by FDA.

September 09, 2020 | Daily News

The United States Pharmacopeia (USP) and FDA last week published guidances that address how drug makers and suppliers can check drug products for the presence of nitrosamines, and reduce or prevent the level of nitrosamines in finished products.

September 09, 2020 | Daily News

One quarter of brand drugs with copay assistance face generic competition, and drug companies often make it difficult to get financial assistance for drugs without generic alternatives, according to a report by drug pricing watchdog GoodRx.

September 08, 2020 | Daily News

Community health centers are prepping legal action in a bid to avert drug manufacturers’ limitations on 340B discounts accessed via contract pharmacies, as two hospital groups also consider their legal options and the Health Resources and Services Administration weighs whether manufacturers’ policies violate the 340B statute and sanctions should apply.

September 08, 2020 | Daily News

The CEOs of nine leading vaccine makers, all of which are developing COVID-19 vaccines, signed a pledge Tuesday (Sept. 8) to uphold “high ethical standards and sound scientific principles” in their testing and development processes, but they left it unclear whether they might seek to market a vaccine before finishing phase 3 trials.

September 08, 2020 | Daily News

Former FDA chief Margaret Hamburg expressed confidence that FDA and other global regulators will follow the science when deciding whether to approve a COVID-19 vaccine, and she joined other current and former public health officials in calling for increased reliance on international regulators to make sure coronavirus vaccines are distributed equally around the globe.

September 04, 2020 | Daily News

FDA is giving blood centers that collected investigational convalescent plasma prior to the administration’s Aug. 23 emergency use authorization, 90 days to meet the EUA’s new requirements.

September 04, 2020 | Daily News

Peter Stein, director of FDA’s Office of New Drugs, said the agency wants to expeditiously move forward on its long-awaited proposal to allow certain prescription drugs to be sold over-the-counter, but he added it is unclear whether FDA will meet its goal to propose the rule in December.

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