CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

Get the full story at our sister site, Medical Design & Outsourcing.

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CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar on Wednesday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

CMS created the MCIT pathway in the last days of the Trump Administration, and it was among a host of regulations the Biden Administration immediately put on hold for further consideration.

“While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population…

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A closer look at Urovant’s vibegron blood pressure study

In recent years, regulators including FDA have increased their focus on the potential of drugs to cause blood pressure increases. To that end, the agency asked Urovant (Irvine, California) to study the impact of the beta-3 adrenergic receptor agonist vibegron on blood pressure.

The study, recently published in the Journal of Urology, found no significant change in blood pressure among either vibegron or placebo recipients. There were 96 patients in the vibegron group. Another 101 received placebo. “The good news was that the changes in blood pressure were trivial — on average less than one millimeter of mercury,” said Dr. Michael A. Weber, a professor of medicine at SUNY Downstate College of Medicine in New York, who was involved in the study. 

Weber recently summarized the results at the Annual Meeting of the American Urological Association. 

FDA approved vibegron in late 2020. In addition, the agency approved another beta-3 adrenergic receptor agonist…

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COVID-19 vaccine booster tensions mount between White House, CDC and FDA

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Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. 

But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. 

Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an uptick in adverse events, according to The Lancet art…

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COVID-19 vaccine booster tensions mount between White House, CDC and FDA

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Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. 

But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. 

Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an…

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Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic

[Image from Cepheid]Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.

Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV).

Nearly one year ago, the company received EUA for the Xpert Xpress testing platform. According to a news release, the “plus” version of the test offers a third gene target for SARS-CoV-2 detection to meet the challenge of future viral mutations.

The company touts the test as capable of delivering results in approximately 36 minutes. It expects to begin shipping to U.S. customers in the next few weeks.

“This respiratory season, healthcare providers may encounter a range of viral infections with symptoms that overlap with COVID-19, including Flu A, Flu B, and respirator…

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Why the pandemic is a crucible for clinical trial innovation

Image from Sam Moqadam on Unsplash

The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations.

To get a clearer sense of what the ramifications of this accelerated development will be for the industry at large, we spoke with Neta Bendelac, senior director of strategy at 4G Clinical, which offers software and services for clinical drug trials.

Drug Discovery & Development: What impact has the pandemic had on trials for COVID-19 therapies?

Neta Bendelac: Speed was the most important factor for the early COVID-19 studies as many sponsors raced to get promising therapies and potential vaccines into the clinic. We all felt the urgency, all day, every day. It made sense for the FDA to sti…

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FDA clears NeuroOne’s Evo sEEG electrode

NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology.

Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release.

The Evo sEEG electrode represents the second FDA-cleared product from NeuroOne its Evo cortical electrode technology in November 2019. The company develops surgical care options for patients suffering from neurological disorders.

NeuroOne’s sEEG electrodes, contrary to cortical electrodes, provide a similar function at the subsurface level of the brain while using a much less invasive process as it does not require the removal of the top portion of the patient’s skull.

The company anticipates a la…

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FDA outlines COVID-19 vaccine review plan for children

[Photo by Eugene Chystiakov]

FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children.

The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation.

Get the full story at our sister site, Drug Discovery & Development.

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FDA outlines plan to ‘follow the science’ as it mulls over COVID-19 vaccines for children

[Photo by Eugene Chystiakov]FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children.

In a news release attributed to acting commissioner Dr. Janet Woodcock and director of the FDA’s Center for Biologics Research and Evaluation Dr. Peter Marks, the FDA said it plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country.

Get the full story at our sister site, Drug Discovery & Development.

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FDA outlines plan to ‘follow the science’ as it mulls over COVID-19 vaccines for children

Photo from Pexels

FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children.

In a news release attributed to acting commissioner Dr. Janet Woodcock and director of the FDA’s Center for Biologics Research and Evaluation Dr. Peter Marks, the FDA said it plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country.

The FDA leaders noted that they are “eager to see COVID-19 vaccines available for young children,” while safety remains a top priority in allowing for that to happen.

“As regulators, we recognize we have an important task ahead of us that will require us to act expeditiously while undertaking an extremely meticulous and thoughtful review once we receive requests to authorize a COV…

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FDA rejects EUA for Humanigen’s monoclonal antibody for COVID-19 

FDA determined it couldn’t conclude that the benefits of lenzilumab from Humanigen (NSDQ:HGEN) outweigh the risks for patients hospitalized with COVID-19. 

Lenzilumab is the company’s lead product candidate. 

The drug works by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF), which is implicated in the so-called cytokine storm. 

The drug is the subject of 16 clinical trials spanning a range of diseases. 

The Burlingame, California–based company had submitted EUA paperwork to the agency in May. Included in the filing were data from the LIVE-AIR Phase 3 clinical trial that evaluated the drug’s role in improving survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.

The company’s shares dropped 47.25% apiece to $7.97 following the announcement.  

Analysts at H.C. Wainwright wrote in a brief note that the stock drop was an “overreaction,” but reduced their price target for the compa…

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