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FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

Abbott Wins U.S. Emergency Use Authorization for New COVID-19 Antibody Test | Top News

(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.

The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.

Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.

The FDA’s emergency use authorization allows the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases with no adequate or approved alternatives.

IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201012:nPn8KFxtXa.

Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.

However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Shares of Abbott were up 0.5% at $110.21 in early trading.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)

Copyright 2020 Thomson Reuters.

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Dentist Campbelltown, A Plus Dental Offers Preventative, General, Cosmetic, Restorative and Dental Emergency Services – Press Release

Dentist Campbelltown, A Plus Dental Offers Preventative, General, Cosmetic, Restorative and Dental Emergency Services

Campbelltown, NSW – Residents in and around Campbelltown, NSW who are interested in 5-star and premium dental care and treatment solutions can now save more money by remaining in the area and choosing A Plus Dental, a top dental facility in the area. The dental team at A Plus Dental focuses on delivering the very best dental solution and dental experience to all patients. By using the latest dental technologies, the best dental specialists, and creating a welcoming environment for patients, A Plus Dental has been able to achieve this goal.

Focused on creating the very best dental experience for all patients, A Plus Dental is proud to announce that the clinic now offers general, cosmetic, restorative, and emergency dental services.

Making the announcement, the top dentist Campbelltown at the clinic said: “At A Plus Dental, we strive to provide all patients with caring and gentle treatments in a relaxed and welcoming environment. A Plus Dental has been servicing families in Campbelltown and surrounding areas since 1997. Our goal is to help you and your family achieve optimal oral health through comprehensive and modern dentistry. We cover a wide range of dental services – preventative dentistry, general dentistry, cosmetic dentistry, restorative dentistry, and a dental emergency. We cover simple regular dental check-ups to complicated procedures such as Periodontics and bone grafting.”

Reiterating the dental clinic’s commitment to addressing the needs of the members of the community, irrespective of how small or complex those dental needs may appear, the dentist Campbelltown noted that patients will have access to free consultations as well as modern dental facility and surgery designed to boost their overall oral health and wellness.

Focused on delivering reasonably-priced dental treatments, members of the Campbelltown, NSW community will have access to preventative dentistry procedures like oral hygiene service, dental check-ups, dental X-Rays, white fillings which are designed to strengthen and improve the appearance of the teeth, dental sealants which prevent intrusion of bacteria into the teeth, as well as dental scaling and cleaning. Those who need mouthguards and splints, as well as children who need the best children’s dentistry experience, will find A Plus Dental to be the best dental facility for their dental care and treatment needs.

Far more than preventative dentistry solutions, A Plus Dental offers general dentistry services like family dentistry, oral surgery, bad breath treatment, dry mouth treatment, treatment for sensitive teeth, periodontal treatment, gum disease treatment, wisdom tooth extractions, sedation dentistry, TMJ, and TMD treatment, as well as treatment for tooth decay, root canal therapy, and more.

Patients can also visit A Plus Dental for top cosmetic dentistry solutions, restorative dentistry procedures, as well as dental emergency services.

A Plus Dental is located at Suite 3/300 Queen Street, Campbelltown, NSW 2560, AU, and can be reached on phone at (02) 4627 3833. For more information, send an email to Dr. Anthony Kong via [email protected]plusdental.net.au or visit the website.

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‘It is literally horrific’: World Food Programme, Nobel Peace Prize winner, fights growing hunger emergency

“We’ve got a vaccine against starvation. It’s called food,” said David Beasley.

David Beasley, the executive director of the World Food Programme, knows the existence of his organization is both a blessing and a curse: it helps so many, but that means many are suffering.

On Friday, that World Food Programme’s fight against hunger and work to prevent the use of hunger as “a weapon of war and conflict” was honored with the Nobel Peace Prize.

Beasley, also the former governor of South Carolina, said the award came as a surprise, but is ultimately a testament to the organization’s much-needed work amid the pandemic.

PHOTO: Linsey Davis interviews the executive director of the World Food Programme, David Beasley on ABC News Prime after the organization won the Nobel Peace Prize Oct. 9, 2020.

Linsey Davis interviews the executive director of the World Food Programme, David Beasley after winning the Nobel Peace Prize Oct. 9, 2020.

“[COVID-19] comes on top of what you already thought was a worst-case scenario and it’s compounded, exacerbated problems around the world. … It is literally horrific,” Beasley told ABC News Prime host Linsey Davis.

At the beginning of this year, 135 million people already faced starvation from manmade conflict and climate extremes, Beasley said. Now, 270 million people are on the brink of starvation.

The award comes with the equivalent of a $1.1 million U.S. cash prize and a gold medal to be handed out at a ceremony in Oslo, Norway, on Dec. 10, the anniversary of prize founder Alfred Nobel’s death.

Beasley told ABC News Prime that the award money and government funding is critical in sustaining the program’s global effort in 2021.

“The economies of the world’s strongest nations on Earth are struggling. We are not going to have the money we need next year. And not only are the resources going to go down, but the needs are going to be going up,” said Beasley.

“We have 18,000 men and women that are out there in the field putting their lives on the line, every day, in war, conflict zones. You name it,” Beasley told ABC News.

He is currently working with the organization in Nigeria, a country that faces a threat from extremist terrorist groups and climate change.

“The good news and the bad news is the fact that we are winning [the award]. But that means

Overnight Health Care: Regeneron asks for emergency authorization of coronavirus treatment Trump received | McConnell says he hasn’t visited White House in two months due to coronavirus

Welcome to Thursday’s Overnight Health Care.



Donald Trump wearing a suit and tie: Overnight Health Care: Regeneron asks for emergency authorization of coronavirus treatment Trump received | McConnell says he hasn't visited White House in two months due to coronavirus | Employer-sponsored health insurance premiums rise 4 percent


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Overnight Health Care: Regeneron asks for emergency authorization of coronavirus treatment Trump received | McConnell says he hasn’t visited White House in two months due to coronavirus | Employer-sponsored health insurance premiums rise 4 percent

Regeneron filed for emergency authorization of its antibody COVID-19 treatment drug, just hours after President Trump claimed it basically cured him. Mitch McConnell hasn’t been to the White House in months, and a new analysis shows Americans’ job-based health care is continually getting more expensive.

We’ll start with Regeneron:

Regeneron asks for emergency authorization of coronavirus treatment Trump received

Biotech company Regeneron late Wednesday applied for emergency authorization for an experimental antibody treatment praised by President Trump.

“Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for our REGN-COV2 investigational antibody combination for COVID-19,” the company said in a news release.

The move came just hours after the president praised the efficacy of the treatment in a short video message posted on Twitter.

“They gave me Regeneron, it’s called Regeneron,” Trump said in the five-minute video Wednesday afternoon. “It was unbelievable. I felt good immediately. I felt as good three days ago as I do now.”

Why it matters: Trump was taking several drugs for his illness, so it’s not clear which helped him feel better. He claimed he has the “emergency use authorization all set,” but the FDA is supposed to make decisions based on science and not demands from the president. Regeneron’s drug is still undergoing clinical trials, and while early results seem promising, the company has not released data to back up its claims.

Read more here.

McConnell says he hasn’t visited White House in two months due to coronavirus

Senate Majority Leader Mitch McConnell (R-Ky.) said on Thursday that he hasn’t visited the White House in two months because of how it has responded to the coronavirus.

Speaking in Kentucky, McConnell said that while he talks to President Trump frequently, he hasn’t been to the White House in person since Aug. 6.

“Because my impression was their approach to how to handle this was different from mine and what I insisted we do in the Senate, which was to wear a mask and practice social distancing,” he told reporters.

McConnell’s comments come in the week after President Trump and roughly two dozen people in his orbit have tested positive for the coronavirus.

The Senate doesn’t have a mask mandate, though most senators wear masks around the Capitol and there are also signs to remind people to socially distance.

Unlike the Senate, the White House has rapid testing for those in contact with the president. But there have also been several events where the White House did not require social distancing and most people at the event did not wear masks.

McConnell on Thursday appeared to take a veiled jab at the White

Regeneron asks for emergency FDA approval for COVID-19 antibody treatment

Oct. 8 (UPI) — Biotechnology company Regeneron has requested emergency use authorization from federal regulators for a COVID-19 antibody treatment.

The REGN-COV2 treatment is a combination of two antibodies that’s designed to “block infectivity” of the SARS-CoV-2 virus that causes COVID-19.

“The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population,” the company said in a statement.

Regeneron, which asked the Food and Drug Administration for the emergency authorization, said it has doses available for 50,000 patients and will have enough for another 300,000 in the coming months.

“If [emergency use authorization] is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the company added.

President Donald Trump took a dose of the Regeneron cocktail last week after he tested positive for COVID-19, even though it hasn’t been approved by the FDA.

Regeneron said if its request is approved, it will distribute the treatment in the United States and partner Roche will distribute overseas.

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Maker of Antibody Cocktail Trump Took Seeks Emergency Use OK | Health News

By Robin Foster and E.J. Mundell
HealthDay Reporters

(HealthDay)

THURSDAY, Oct. 8, 2020 (HealthDay News) — Regeneron Pharmaceuticals Inc. said Wednesday that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to President Donald Trump shortly after he was diagnosed with COVID-19.

Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an “unbelievable” effect on his recovery from coronavirus infection, the Washington Post reported.

“I think this was the key,” Trump said, after acknowledging that the antibody cocktail was one of several drugs he was prescribed by his medical team. While there is no hard evidence yet proving the drug’s effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.

In his video, Trump said, “I have emergency-use authorization all set, and we’ve got to get it signed now.” However, an FDA spokeswoman told The New York Times Wednesday that the agency does not confirm or deny product applications.

Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.

The antibody cocktail is now in late-stage testing. The company has granted fewer than 10 “compassionate use” requests allowing people not enrolled in its trials to use the drug, the Associated Press reported.

The U.S. government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported.

Regeneron isn’t the only company developing an antibody cocktail to battle COVID-19 infection: Eli Lilly and Co. announced earlier on Wednesday that it was seeking emergency-use authorization from the FDA for a similar cocktail. Both treatments use lab-made antibodies to give patients’ immune systems a boost. In both cases, scaling up production to meet demand is expected to be a major challenge, the Post reported.

White House approves tougher vaccine development rules

Following weeks of delay, the White House on Tuesday approved tough new rules for coronavirus vaccine developers that will make it unlikely that a vaccine will be approved before Election Day.

The approval came only after the U.S. Food and Drug Administration published the updated guidelines on its website as part of briefing materials for outside vaccine advisers, the Post reported.

The standards, which would be applied to an emergency-use authorization for a vaccine, are similar to the standards for a traditional approval. But the White House has worried that the criteria would delay authorization of a vaccine beyond Nov. 3 and sat on the guidance, the Post reported.

The delayed clearance by the White House came only after White House Chief of Staff Mark Meadows demanded detailed justification from the agency about the tougher criteria, the Post reported. The FDA provided the White House with additional data,

Regeneron Asks FDA for Emergency Use Authorization of Coronavirus Therapy Used to Treat President Trump | Health News

Regeneron announced Wednesday night that it has asked the Food and Drug Administration for emergency use authorization for the experimental coronavirus antibody therapy used to treat President Donald Trump after he tested positive for the virus.

The biotechnology company said in a statement that it made that emergency use request for its REGN-COV2 investigational antibody combination for COVID-19. If the emergency authorization is granted, the government has committed to making it available to Americans at no cost and would be responsible for its distribution, the statement said.

Enough doses are currently available for 50,000 coronavirus patients, and the company expects to have 300,000 doses within the next several months.

Cartoons on the Coronavirus

The experimental treatment is still in large-scale clinical trials but has been available for compassionate use, something the FDA approves on a case-by-case basis, such as the case with the president.

REGN-COV2 is a combination of two monoclonal antibodies designed specially to block SARS-CoV-2, the virus that causes COVID-19. Regeneron scientists sorted through thousands of human antibodies, including from people who recovered from COVID-19, to choose ones that fought the virus most effectively.

Scientists chose two virus-neutralizing antibodies, scaled them up and put them into a medication in hopes that it could treat virus symptoms and possibly be used as a preventative measure.

The president received an 8 gram dose of the treatment on Friday at Walter Reed National Military Medical Center following his coronavirus diagnosis. Trump called the treatment “unbelievable” and said he “felt good immediately.”

Early data from the company’s clinical trials have shown that the treatment is effective and safe, with few side effects.

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Regeneron asks FDA for emergency authorization of its Covid-19 antibody therapy that was given to Trump last week

Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus.



a woman preparing food in a kitchen: New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.


© Regeneron
New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.

The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night.

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“Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the statement said. “At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.

Regeneron’s experimental antibody treatment is still in large-scale clinical trials, but has been available for compassionate use, something the FDA has to approve on an individual basis, like it did for the President.

The antibody therapy is a combination of two monoclonal antibodies that is designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19, according to the company’s statement.

A cocktail antibody therapy uses two or more lab-engineered antibodies. Regeneron’s cocktail includes a monoclonal antibody that targets the spike protein the virus uses to drill into healthy cells, and another antibody that targets a different part of the novel coronavirus. With two, the hope is to trap and shut down viral replication.

“When you weigh the potential benefit versus the risks, the downsides are very low here because we have not seen any safety concerns,” Regeneron CEO Dr. Leonard Schleifer told CNN in an interview after Trump received an 8 gram dose of the treatment.

Early data from the company’s antibody trials released recently showed it worked fairly safely with few side effects.

“This class of drugs is an extremely safe class,” Schleifer said.

Dr. Richard Besser, a former acting director of the US Centers for Disease Control and Prevention who now heads the Robert Wood Johnson Foundation, said it makes sense that a treatment that gives a patient antibodies would help the immune system, but he said peer review will find any holes or pitfalls.

“I would withhold judgment on this until we see the data,” Besser said. “You know these early results that keep coming out from companies in press releases strike me as being … much more about the stock price than they are about science.”

But Dr. Thomas Frieden, also a former CDC director, disagreed with Besser.

Although Regeneron’s antibody therapy is unproven, it is “a promising treatment,” Frieden told CNN.

“There’s a report that only fewer than 300 patients have received it,” he said. “It seems to be most effective early in the disease, especially before patients make antibodies of their own.”

“We don’t know if it’ll be

Eli Lilly Applies For Emergency Approval For Covid-19 Antibodies

The US biotech firm Eli Lilly on Wednesday announced it was seeking an emergency use authorization (EUA) for its lab-produced antibody treatments against Covid-19, after early trial results showed they reduced viral load, symptoms and hospitalization rates.

“Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments,” said Daniel Skovronsky, Lilly’s chief scientific officer.

“Lilly is diligently working with regulators around the world to make these treatments available,” he added.

The company said in a statement that its “combination therapy” of two antibodies working together was shown to be effective in a placebo-controlled study of 268 patients with mild to moderate Covid-19.

Their analysis showed the proportion of patients with high viral load at day 7 of their illness was 3.0 percent on the therapy, compared to 20.8 percent on the placebo arm.

Improvement in symptoms was seen as early as three days after dosing.

The rate of Covid-related hospitalization and emergency visits was 0.9 percent for patients treated with combination therapy versus placebo 5.8 percent on placebo, a relative risk reduction of 84.5 percent.

The company is also studying a “monotherapy” of just one of the two antibodies, and said that parallel research showed that this was similarly effective.

The trial is ongoing and Lilly wants to recruit a total of 800 people.

Aa transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient,captured and color-enhanced Aa transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient,captured and color-enhanced Photo: National Institute of Allergy and Infectious Diseases / Handout

Lilly said it expects to have 100,000 doses of the monotherapy available this month, and a million by the end of the year. It also expects to have 50,000 doses of the combination therapy by the end of 2020.

The findings have not yet been published in a peer-reviewed journal.

Both antibodies work by binding to different parts of spike proteins on the surface of the SARS-CoV-2 virus, distorting their structure so the virus can’t invade living cells.

Antibodies are infection-fighting proteins made by the immune system and can also be harvested from recovered patients, but it is not possible to make so-called “convalescent plasma” a mass treatment.

Researchers can also comb through the antibodies produced by recovered patients and select the most effective out of thousands, and then manufacture them at scale.

US President Donald Trump, who has Covid-19, received a dose of synthetic antibodies produced by the firm Regeneron last week.

Regeneron has also reported encouraging results from its early trials, but hasn’t yet applied for emergency approval and so remains an experimental treatment.

The US Food and Drug Administration has previously granted an EUA for the antiviral remdesivir, for convalescent plasma, and for hydroxychloroquine, which was subsequently revoked over safety fears.

In addition, US health authority’s guidelines recommend the use of the steroid dexamethasone to control a damaging inflammatory response seen in later stages of Covid-19.

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