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Rx Drugs

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.

October 01, 2020 | Daily News

Sens. Michael Bennet (D-CO) and Todd Young (R-IN) on Wednesday (Sept. 30) introduced legislation that would establish a payment model under which antibiotic developers could get upfront payment for new antibiotics.

September 30, 2020 | Daily News

FDA biologics center director Peter Marks doubled down on the agency’s stance that its emergency use authorization guidance, hung up at the White House, simply lays out stricter criteria for potential COVID-19 vaccines that industry has been aware of for months, despite suggestions from the White House that the guidance is a political ploy.

September 30, 2020 | Daily News

FDA biologics center director Peter Marks thanked seven former FDA chiefs for their recent op-ed in which they voice concern about the negative effects that political interference from the White House could have on the public confidence in a COVID-19 vaccine, and in the FDA itself.

September 30, 2020 | Daily News

FDA has already shared its criteria for vaccine emergency use authorization directly with vaccine makers, even though the White House continues to stall publication of the guidance, former FDA chief Mark McClellan told House lawmakers Wednesday (Sept. 30).

September 30, 2020 | Daily News

FDA has already shared its criteria for vaccine emergency use authorization directly with vaccine makers, even though the White House continues to stall publication of the guidance, former FDA chief Mark McClellan told House lawmakers Wednesday (Sept. 30).

September 30, 2020 | Daily News

In the first presidential debate Tuesday, President Donald Trump contradicted Moncef Slaoui, the head of the administration’s Operation Warp Speed initiative, saying that a COVID-19 vaccine could be available as early as Nov. 1. Slaoui has said a vaccine could be available between April and June 2021.

September 30, 2020 | Daily News

Drug pricing policy came up briefly following the opening bell of the presidential debate, with the president touting administrative measures he announced last week that lobbyists had suspected were timed for the debate. However, President Donald Trump didn’t mention the $200 Medicare Part D gift cards he promised last week.

September 29, 2020 | Daily News

HHS strongly defends Operation Warp Speed chief Moncef Slaoui’s financial ties to drug companies in a letter sent to the House coronavirus select subcommittee the same day Sen. Elizabeth Warren (D-MA) said Slaoui should be fired from the role because of his investments in several biotech companies, including some making COVID-19 vaccines.

September 28, 2020 | Daily News

FDA’s latest clarification of the types of evidence it will use to determine whether companies intend for drugs and devices to be used off-label removes language that industry argued would have unfairly exposed companies to misbranding violations.

September 25, 2020 | Daily News

FDA cannot approve state plans to import Canadian drugs until 60 days after the final drug import rule is posted in the Federal Register, which hasn’t yet happened, and FDA officials don’t know whether they could begin reviewing state plans in the meantime.

September 25, 2020 | Daily News

Only some seniors will receive the president’s $200 Medicare Part D cards for copays before the election because it will take months to issue the cards, White House officials said Friday (Sept. 25).

September 25, 2020 | Daily News

Sen. Patty Murray (D-WA) said President Donald Trump and HHS Secretary Alex Azar need to “be quiet” and let FDA move forward on guidance that’s expected to strengthen the criteria for emergency use authorization of COVID-19 vaccines.

September 24, 2020 | Daily News

HHS on Thursday (Sept. 24) proposed a rule to implement the president’s recent executive order to lower insulin prices, which gives the administration about a week to turn around the final rule if the order is to take effect before the election.

September 24, 2020 | Daily News

The president promised to hand out $200 discount cards to help Medicare Part D beneficiaries cover their copays in the coming weeks, and a White House spokesperson said the administration plans to pay the $6.6 billion cost of those cards with savings from the most-favored-nation demonstration that does not yet exist and that relies on authority from the Affordable Care Act that the administration is trying to kill.

September 24, 2020 | Daily News

The Trump administration on Thursday (Sept. 24) finalized a rule laying out steps for states to create programs to import certain prescription drugs from Canada and will now allow states to import biologic products, such as insulin.

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