Pfizer Approves New Novel Coronavirus Treatment

Programming notes: We will be closed this Monday for Remembrance Day, but will be back in your inbox on Wednesday.

Pax Lovid Fully Approved — The FDA on Thursday approved paxlovid, a COVID-19 drug for adults at higher risk of severe illness, but access to the drug is limited as the government still has millions of doses of the vaccine on hand. No change in the short term.

“Pax Lovid will continue to be widely available at no cost and will be distributed by the U.S. government through all existing USG channels and retailers nationwide,” an HHS spokesperson said in an email.

HHS says about 9.3 million doses have been administered to patients since the antiviral treatment gained emergency use authorization from the FDA in December 2021. There are still 9.6 million doses of the vaccine on hand in the United States, and another 4 million doses at health care provider locations nationwide.

Clinical data: Walid Gerard, director of the University of Pittsburgh Center for Medicines Policy and Prescription, said there was no question that paxlovid would help people at high risk of developing severe COVID-19, but that health care providers would be more concerned with the UK’s Panorama clinical trial. He said he was waiting for data from trials. Check the efficacy of antiviral drugs in predominantly vaccinated populations.

The FDA said the approval was supported by a randomized clinical trial that resulted in symptoms of COVID-19 in people who had not been vaccinated or who had previously been infected with COVID-19. Paxlobid given within five days of treatment was found to reduce hospitalizations or deaths by 86 percent compared to placebo, it said.

“Price will influence how cautious insurers will be in deciding who gets this drug,” Gerard said. “Very few people are at high risk of progression. Literally almost nobody is now at four or five doses.”

Price range: Asked how much Paxlovid would cost, Pfizer did not give figures but said the drug is expected to be “marketed later this year.”

Angela Huang, President of Pfizer’s Global Biopharmaceuticals Division, told investors at the May 2 earnings call that the commercialized price will reflect the number of hospitalizations and deaths averted by Paxlovid treatment. rice field.

it’s friday Welcome to Prescription Pulse. Send your favorite Zelda discoveries and tips to David Lim ([email protected] again @Devidalim) or Catherine Ellen Foley ([email protected] again @katherineefoley).

today our pulse check podcast, Host Alice Miranda Allstein sits down with Carmen Pawn to explain why some Democrats say the HALT Fentanyl Act passed in the House yesterday is a nuisance.

negotiations continue — Momentum on some healthcare bills is slowing as Republicans and the president rush to reach a debt ceiling deal.

House Appropriations Committee Chairman Kay Granger (R-Texas) said the committee will postpone rate increases on four fiscal 2024 spending measures while debt ceiling negotiations continue. And there is little momentum for the Senate to take up bipartisan health policy any time soon.

Some laws are moving forward bit by bit. The House Energy and Commerce Committee had a full committee this week on six health-related bills, including a bill to improve value-based purchasing agreements between pharmaceutical companies and states.

And the House has advanced legislation to classify fentanyl as a Schedule 1 drug. The HALT Fentanyl Act, which classifies synthetic opioids as one of the most dangerous drugs in the country, was passed Thursday by a vote of 289 to 133, POLITICO’s Carmen Paun reported. Schedule 1 drugs are currently not approved for medical use, have a high potential for abuse, and are subject to the highest levels of federal regulation and enforcement.

Some Democratic lawmakers condemned the move, saying it could unduly harm communities of color. However, 74 Democrats joined the Republicans to pass the bill.

Tobacco litigation is ‘tired’ — FDA Commissioner Robert Calif lamented ongoing lawsuits from multiple branches of the tobacco industry as the FDA struggles to adequately regulate the spread of e-cigarettes. It has been hit with more than 40 lawsuits from companies whose marketing applications have been denied.

“We have legal battles every day, and the burden on government agencies is draining,” he said at the Reagan-Udall Foundation’s annual public meeting. “It had a big impact, much more impact than I thought it would.”

Caliph said he was overwhelmed by the millions of e-cigarette sales applications the agency received after Congress granted powers to regulate e-cigarettes. “Nobody expected 27 million e-cigarette applications,” he says. The agency has made decisions on more than 99 percent of them, but the fate of some major market players, including products from RJ Reynolds and NJOY, is yet to be decided.

Enforcement is also an issue. Khalif also said it would be difficult to keep illegal products off the shelves. “I found myself in the midst of a truly epic struggle when it comes to how to force an amazingly creative industry.”

A panel of experts at the Reagan Udall Foundation said in December that tobacco regulators need to improve law enforcement. This poses a challenge for authorities that must rely in part on the Department of Justice to enforce harsh penalties.

Caliph hinted that the FDA will soon meet with the Justice Department to discuss law enforcement, but declined to comment further. “Stay tuned for that.”

FDA Delays Gene Therapy Decisions — The FDA said it would take another three weeks to review Sarepta’s new gene therapy for Duchenne muscular dystrophy.

The agency had planned to make a decision by May 29, but plans to make a decision by June 22 after waiting for additional data and considering whether the drug is suitable for all ages. there is The agency’s independent advisers narrowly backed approval of the drug earlier this month.

Illumina chair banished — Shareholders on Thursday voted to remove Illumina board chairman John Thompson, with the DNA sequencing firm partly in a proxy fight with activist investor Carl Icahn, who was seeking three seats. won the

Mr. Icahn argued that by not focusing on Illumina’s core business and completing the acquisition of multi-cancer early-detection company Grail despite antitrust concerns, the company’s value was undermined.

But preliminary results show that the company continues to defend the deal, even though antitrust regulators in the U.S. and Europe continue to challenge his winning only one of the three seats in the shareholder vote. means that

Billionaires are waging unconventional influence campaigns against the influence of hospital lobbying, STAT’s Rachel Coles reports.

The FDA on Thursday issued warning letters to Shenzhen Innokin Technology and Breeze Smoke for unauthorized distribution of popular e-cigarettes Esco Bars and Breeze products. The warning letter calls on e-cigarette makers to stop selling, distributing and promoting their products immediately or face further enforcement action.

FDA is seeking feedback on factors to consider when considering proposed changes with third-party managers that may change the risk assessment and mitigation strategies required for a particular product. Pharmaceutical companies often hire vendors to help implement safety systems for specific medicines, and changing vendors can disrupt safety programs and adversely affect patient access to medicines.

The FDA issued final guidance on laboratory performance testing for certain medical devices on Thursday.

The EPA has extended the comment deadline from June 12 to June 27 on two proposals that would strengthen regulations on the use of ethylene oxide in the sterilization of millions of medical devices.

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