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Rx Drugs

August 18, 2020 | Daily News

AstraZeneca is the latest drug maker to tell providers it plans to end 340B pricing for contract pharmacies, with few exceptions, a move that 340B Health called a serious escalation of an ongoing trend and said, if HHS doesn’t step in, the group will turn to Congress for help or take the drug manufacturers to court.

August 18, 2020 | Daily News

Sen. Bernie Sanders (I-VT) and Rep. Pramila Jayapal (D-WA), lead advocates of Medicare for All, told progressives who are not excited about the moderate 2020 Democratic ticket to support former Vice President Joe Biden and Sen. Kamala Harris (D-CA) because it would make progressive health care priorities more achievable.

August 17, 2020 | Daily News

House Energy & Commerce Democratic leaders Monday (Aug. 17) launched an investigation into whether the Trump administration’s changes to the U.S. Postal Service are delaying delivery of prescription drugs during the COVID-19 pandemic.

August 17, 2020 | Daily News

Of the $1.5 billion Moderna would be paid for its experimental coronavirus vaccine, $300 million depends on getting the vaccine either approved or authorized for emergency use by the end of January, according to a company financial statement.

August 17, 2020 | Daily News

The administration says it will only use march-in rights to lower the cost of COVID-19 drugs if all a product’s patents are owned by the federal government, which is not the case for remdesivir.

August 17, 2020 | Daily News

FDA is using real-world data to better understand and answer questions about potential COVID-19 therapies, and remdesivir is the next therapy in the spotlight.

August 17, 2020 | Daily News

Catalyst Pharmaceuticals is pushing back on a federal magistrate judge’s recommendation to throw out the company’s lawsuit against FDA, which alleges the agency violated Catalyst’s orphan drug exclusivity for its Lambert-Eaton myasthenic syndrome drug, Firdapse.

August 13, 2020 | Daily News

National Institutes of Health Director Francis Collins on Thursday (Aug. 13) shot down estimates that a COVID-19 vaccine could be out for distribution earlier than November or December, as an Operation Warp Speed official reiterated that the goal is to get a vaccine distributed by January 2021.

August 13, 2020 | Daily News

If the president insists that federal agencies buy domestically made essential drugs, those agencies should guarantee higher prices and sales volume in long-term contracts with drug makers, and the government should give generic drug makers tax breaks and grants because other countries lured away production with similar incentives, Association for Accessible Medicines Interim CEO Jeff Francer said Thursday (Aug. 6).

August 13, 2020 | Daily News

Hospital pharmacies worry the president’s buy-American executive order could disrupt the very supply chain that it intends to secure by giving the federal government first dibs on domestically made drugs and ingredients that are part of existing private supply chains, American Society of Health-System Pharmacists Vice President of Government Relations Tom Kraus said.

August 12, 2020 | Daily News

FDA this week finalized a guidance that provides additional clarity on when the agency will change a drug’s marketing status in the Orange Book -- information insurers had told the agency was essential to companies’ efforts to bring new generics to market.

August 12, 2020 | Daily News

The per dose price for Moderna’s coronavirus vaccine candidate is $15.52, not the $32 to $37 price that some thought the company might charge the U.S. government for its messenger RNA vaccine.

August 12, 2020 | Daily News

Generic drug makers are pleased the president is again saying he’ll eliminate rebates because it would fix an aspect of Medicare Part D that encourages plans to use brands over generics.

August 11, 2020 | Daily News

The Democratic presidential ticket now includes two moderates who support aggressive measures to rein in drug prices and reform health insurance markets.

August 11, 2020 | Daily News

The Democratic presidential ticket now includes two moderates who support aggressive measures to rein in drug prices and reform health insurance markets.

August 11, 2020 | Daily News

The White House is reviewing an FDA guidance on controlling the levels of nitrosamine impurities found in drugs, according to the Office of Management and Budget’s regulatory dashboard.

August 11, 2020 | Daily News

FDA is launching a Pandemic Recovery and Preparedness Plan (PREPP) that will apply best practices and lessons learned from the COVID-19 response so far to chart the agency’s response efforts going forward, FDA Commissioner Stephen Hahn said Monday (Aug. 10) during a webinar hosted by the Reagan-Udall Foundation for the FDA.

August 10, 2020 | Daily News

Top FDA officials say the traditional biologics license application process and emergency use authorization, including possible subpopulation EUAs, are the most likely avenues for COVID-19 vaccine approvals, and they suggest vaccine makers veer away from the agency’s Accelerated Approval program.

August 10, 2020 | Daily News

FDA Commissioner Stephen Hahn and biologics center director Peter Marks say they plan to convene the agency’s vaccines advisory committee to review any COVID-19 vaccine, whether it be for emergency use authorization or licensure.

August 10, 2020 | Daily News

Seven major drug companies have launched an initiative to seek regulatory and legislative reforms that allow for expanded electronic drug labeling.

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