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Rx Drugs

October 08, 2020 | Daily News

A U.S. appeals court ruling in a case between GlaxoSmithKline and Teva Pharmaceuticals could discourage the use of so-called “skinny labels” to speed generic competition, according to the dissenting judge in the case.

October 07, 2020 | Daily News

President Donald Trump on Wednesday (Oct. 7) conceded that a vaccine likely won’t be available until after the November presidential election, but he blamed it on so-called political games.

October 07, 2020 | Daily News

President Donald Trump announced in a video posted on Twitter Wednesday (Oct. 7) that he has authorized FDA to grant emergency use authorization to experimental COVID-19 antibody cocktails developed by Regeneron and Eli Lilly, adding that they’ll be distributed to patients at no cost.

October 07, 2020 | Daily News

FDA is open to using data from other countries to approve a COVID-19 vaccine, biologics center director Peter Marks told physicians during a Wednesday (Oct. 7) webinar.

October 07, 2020 | Daily News

Eli Lilly plans to price its coronavirus antibody candidates based on how much money they save by avoiding hospitalizations, emergency room visits “or other problems associated with COVID-19," and the company will tier pricing among countries so rich countries pay more than poor countries, Eli Lilly Chairman and CEO Dave Ricks said Wednesday (Oct. 7).

October 06, 2020 | Daily News

In a Tuesday (Oct. 6) letter, a group of more than 60 medical academics and scientists, including former Obama-era health officials, urge FDA Commissioner Stephen Hahn and biologics center director Peter Marks to strengthen the agency’s guidance on safety criteria for COVID-19 vaccines brought to market under an emergency use authorization.

October 06, 2020 | Daily News

Connecticut Attorney General William Tong told drug makers Eli Lilly, Novartis, Sanofi, AstraZeneca and Merck to stop policies that could limit 340B discounts available through contract pharmacies, though some following the issue say it’s unclear what a state attorney general could do to halt the practices as 340B is a federal program.

October 06, 2020 | Daily News

Supreme Court justices heard arguments Tuesday (Oct. 6) in a case that could determine whether states may regulate pharmacy benefit managers to lower drug prices, and many justices sounded skeptical states have that authority.

October 06, 2020 | Daily News

Despite prior opposition from the White House, FDA on Tuesday (Oct. 6) published guidance that lays out the criteria for any COVID-19 vaccine maker seeking emergency use authorization.

October 06, 2020 | Daily News

The European Medicines Agency on Tuesday (Oct. 6) began its rolling review of Pfizer and BioNTech’s COVID-19 vaccine, marking EMA’s second rolling review of a vaccine in the past week; the agency began reviewing AstraZeneca’s vaccine on Oct. 1.

October 05, 2020 | Daily News

Over the weekend, President Donald Trump’s doctors revealed the president was put on a five-day course of remdesivir, hours after he was given a dose of Regeneron Pharmaceutical’s investigational COVID-19 antibody cocktail, REGN-COV2, though the company told Inside Health Policy there are currently no data on combined use of the drugs.

October 05, 2020 | Daily News

FDA’s risk mitigation programs for fentanyl and extended-release opioids are not suited to quickly address the opioid crisis, according to the HHS Office of Inspector General, which released a report Tuesday (Sept. 29) recommending the agency improve the programs.

October 02, 2020 | Daily News

President Donald Trump’s physician Sean Conley announced that the president took a single dose of an experimental antibody cocktail, along with vitamin supplements, after being diagnosed with COVID-19 early Friday (Oct. 2) morning, and the president is now heading to Walter Reed hospital where the White House says he will stay for a few days out of an abundance of caution.

October 02, 2020 | Daily News

Pfizer CEO Albert Bourla on Thursday (Oct. 1) urged people to stop talking about potential COVID-19 vaccines in political terms and instead focus on the science, echoing similar pleas from former FDA chiefs, doctors and public health experts, some of whom recently criticized politicians and company CEOs, including Bourla, for talking about vaccine timelines.

October 01, 2020 | Daily News

The European Medicines Agency announced Thursday (Oct. 1) that its human medicines committee has begun reviewing the first batch of data from AstraZeneca’s COVID-19 vaccine clinical trial, coming as reports reveal that the U.S. trial of the vaccine remains on hold while FDA expands its safety investigation into a serious adverse event experienced by a trial participant in the United Kingdom.

October 01, 2020 | Daily News

AstraZeneca and Sanofi moved forward Thursday (Oct. 1) with their highly contentious plans to limit the availability of 340B pricing for drugs at certain contract pharmacies -- and were promptly slammed by 340B hospitals -- but it appears Novartis has yet to put its contract pharmacy policy into effect as the company’s CEO told House lawmakers the drug maker is still collecting data from hospitals.

October 01, 2020 | Daily News

HHS will no longer distribute remdesivir so hospitals must now buy the drug directly from Gilead Sciences, the company announced Thursday (Oct. 1).

October 01, 2020 | Daily News

Celgene hiked the price of Revlimid to meet sales goals that determine executive compensation and to make it difficult for other companies to research competing cancer drugs, according to a report by the House Oversight Committee.

October 01, 2020 | Daily News

On day two of the House Oversight Committee’s drug pricing hearing, Democrats released details on three more drug makers’ pricing practices, including Amgen’s use of shadow pricing for Enbrel.

October 01, 2020 | Daily News

The Defense Department awarded a $20 million contract to On Demand Pharmaceuticals for domestic manufacturing of prescription drugs and ingredients as part of the government’s effort to avert drug shortages and price gouging during the pandemic.

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