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Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.

Sarah Silbiger | Getty Images

A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

Shares of Biogen surged 38% Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.

This is a developing story. Please check back for updates.

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Health

Dementia skilled says proof ‘wasn’t enough’ for approval

Dementia expert says evidence 'wasn’t sufficient' for approval

Dementia expert Dr. Jason Karlawish told CNBC he’s skeptical of the Food and Drug Administration’s approval of Biogen’s Alzheimer’s disease drug, Aduhelm, saying “the evidence to approve the drug wasn’t sufficient.”

“Another study is needed to establish whether this drug, in fact, is effective. Unfortunately, the FDA approved the drug for marketing, although they also do want another study,” the co-director of the Penn Memory Center at the University of Pennsylvania said on Monday following the agency’s formal OK.

The FDA’s approval marks the first new treatment for Alzheimer’s in nearly two decades. Alzheimer’s is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. More than 6 million Americans live with the disease, according to estimates by the Alzheimer’s Association. 

Karlawish told “The News with Shepard Smith” that there are a lot of promising Alzheimer’s drugs in the pipeline.  

“I’m optimistic about the coming future here, so I have hope. I just think this is not the drug upon which to pin our hopes,” he said. “Desperation should drive funding for Alzheimer’s research, it should not drive the interpretation of scientific evidence.”

Clinical trials found some patients who got the approved dose of Aduhelm experienced painful brain swelling.

“What you’re asking someone to do, is to take a chance at uncertain benefit, but known risk,” Karlawish said of prescribing the drug to patients.

The FDA said it will continue to monitor the drug as it reaches the U.S. market. The agency granted approval on the condition that Biogen conduct another clinical trial. 

Karlawish told host Shepard Smith that Biogen will face a challenge in “how to do that study when the drug is also available for clinical prescribing.” 

Representatives for Biogen and for the FDA did not immediately return requests for comment on Karlawish’s statements.

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Health

Moderna Seeks Full F.D.A. Approval for Covid Vaccine

Moderna Seeks Full F.D.A. Approval for Covid Vaccine

Moderna was the next pharmaceutical company to file with the U.S. Food and Drug Administration on Tuesday for full approval of its coronavirus vaccine for use in people aged 18 and over.

Last month Pfizer and BioNTech filed with the agency for full approval of their vaccines for use in people 16 years and older.

“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the ongoing filing,” said Stéphane Bancel, CEO of Moderna, in a statement.

Moderna’s emergency vaccine was approved in December, and by Sunday more than 151 million doses had been administered in the United States, according to the Centers for Disease Control and Prevention.

“I think there are a lot of people on the fence who are worried that things are moving too fast and about possible side effects,” said Dr. William Schaffner, National Foundation for Infectious Diseases medical director and vaccine expert. “But those concerns are allayed as they see more of their friends and acquaintances celebrating their vaccination.”

Jan Hoffman contributed to the coverage.

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Health

Moderna applies for full FDA approval

Moderna applies for full FDA approval

A medical worker from Parrish Medical Center holds a vial of the Moderna COVID-19 vaccine at a drive through vaccination clinic for employees of Port Canaveral, workers at local hotels and restaurants, and residents of the Port Canaveral community.

Paul Hennessy | LightRocket | Getty Images

Moderna on Tuesday asked the Food and Drug Administration for full U.S. approval of its Covid-19 vaccine — the second drugmaker in the U.S. to seek a biologics license that will allow it to market the shots directly to consumers.

The mRNA vaccine is currently on the U.S. market under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval based on two months of safety data. It’s not the same as a biologics license application, or a request for full approval, which requires at least six months of data. Over 100 million of the shots have already been administered, according to data compiled by the Centers for Disease Control and Prevention.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

The FDA approval process is likely to take months.

Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks, the company said Tuesday.

Once companies submit applications to the FDA, agency scientists painstakingly look through the clinical trial data, including for any discrepancies or safety concerns, said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee. “They want to make sure that the company has fairly and accurately displayed all those data,” he said.

Full U.S. approval will allow Moderna’s vaccine to stay on the market once the pandemic is over and the U.S. is no longer in a public health emergency, said former FDA commissioner Dr. Robert Califf. It also sets the stage for the company to begin advertising the shots on TV and other media platforms, he said, which is not permitted under an EUA.

Moderna is the second company to seek full U.S. approval of its Covid vaccine. On May 7, Pfizer and partner BioNTech said they started the process of seeking full approval for their vaccine for use in people 16 and older in the U.S.

Moderna’s vaccine, which requires two doses given four weeks apart, has been found to be more than 90% effective at protecting against Covid and more than 95% effective against severe disease up to six months after the second dose. The company said in an earnings report on May 6 that it planned to begin the process of seeking full FDA approval soon.

In addition to seeking full approval, the company is also expected to ask the FDA to expand the emergency use of its Covid vaccine for adolescents as young as 17. The company said last week its shots were found to be 100% effective in a study of kids ages 12 to 17.

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Health

‘It’s a giant deal’ for America’s push to reopen, says NIH Director on Pfizer vaccine approval for adolescents

Pfizer and BioNTech begin the process of seeking full U.S. approval for their Covid vaccine

The director of the National Institutes of Health, Dr. Francis Collins, called the Food and Drug Administration approval for emergency use of Pfizer and BioNTech’s Covid vaccine for children ages 12-15 as “a big deal” in America’s drive to reopen.

“This is exciting news,” said Collins. “We know that since this pandemic started, one and a half million teenagers have been infected with Covid-19, and not all have been as good as most. And some of them have ended up where they have been with this long Covid We are not doing any better , even weeks or months after the illness, so we really want to protect young people. “

The Centers for Disease Control and Prevention’s Vaccine Advisory Board has scheduled a meeting on Wednesday to review recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

More than 44% of all adults in the US are fully vaccinated, and according to the CDC, around 58% have now received at least one dose of the Covid vaccine. The White House aims to increase that number to 70% by July 4th.

Collins told CNBC’s “The News with Shepard Smith” that the US is “on a pretty good path” and that the nation should be able to see CDC regulations to relax indoor masks.

“It’s just about finding the right way to balance the desire not to create another wave. This is the last thing we need right now with the fact that people are really fed up with masks to wear, “said Collins.

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Health

Pfizer and BioNTech start the method of searching for full U.S. approval for his or her Covid vaccine

Pfizer and BioNTech begin the process of seeking full U.S. approval for their Covid vaccine

Vials containing the Pfizer-BioNTech Covid-19 vaccine on Thursday, February 11, 2021 at the vaccination site of the Sun City Anthem Community Center in Henderson, Nevada, USA.

Roger Kisby | Bloomberg | Getty Images

Pfizer and German drug maker BioNTech announced that they have begun filing for full approval of their Covid-19 vaccine for people aged 16 and over in the United States. This makes the companies the first in the nation to apply for full regulatory approval.

The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed 170 million doses in the US, with the goal of having 300 million doses by the end of July.

“We are proud of the tremendous progress we have made in working with the US government to deliver vaccines to millions of Americans since December,” said Albert Bourla, Pfizer CEO, in a statement. “We look forward to working with the FDA to complete this ongoing filing and support its review with the aim of ensuring full regulatory approval for the vaccine in the months ahead.”

Pfizer needs to demonstrate that it can reliably manufacture the vaccines in order to get full clearance. If approved, companies could market their shots directly to consumers and potentially change the pricing of the cans. It also allows the shot to stay in the market once the pandemic is over and the US is no longer considered an “emergency”.

It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the once in a century pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.

The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.

“The BLA filing is an important cornerstone in achieving long-term herd immunity and future COVID-19 containment,” said Dr. Ugur Sahin, CEO and Co-Founder of BioNTech, in a statement. “We are excited to be working with US regulators to apply for approval of our COVID-19 vaccine based on our key Phase 3 study and follow-up data.”

Early data from 12,000 vaccinated people aged 16 and over in this Phase 3 study showed that the shots were 91.3% effective at getting the disease up for up to six months after the second dose and 95.3% effective against severe Covid as defined by the FDA. The companies said on April 1st. The data also showed “a favorable safety and tolerability profile,” they said at the time.

The companies are awaiting FDA emergency approval to use their vaccine in children ages 12-15 and intend to apply for a full license once they have six months of data.

They said in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

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Health

Pfizer Will Search Approval to Give Covid Vaccine to Youngsters

Pfizer Will Seek Approval to Give Covid Vaccine to Children

Pfizer is expected to apply to the Food and Drug Administration for emergency clearance to administer its coronavirus vaccine to children ages 2-11 in September, the company told Wall Street analysts and reporters on Tuesday during its quarterly call for profits.

The company also plans to file for full approval of the vaccine this month for people ages 16 to 85. Clinical study data on the safety of his vaccine in pregnant women should be available by early August.

The Pfizer BioNTech vaccine will be given to adults as part of an emergency clearance the companies received in December. Obtaining full FDA approval would, among other things, enable the companies to commercialize the vaccine directly to consumers. The approval process is expected to take months.

“Full approval is a welcome indicator of the continued safety and effectiveness of the Pfizer vaccine,” said Saskia Popescu, an infectious disease epidemiologist at George Mason University, in an email. It could also “build further confidence in the importance of vaccination,” she said.

The Pfizer BioNTech coronavirus vaccine was the first to receive emergency approval in the United States. Emergency permits are temporary and can be revoked once a public health emergency has ended.

Full approval would allow the vaccine to stay in the market when the pandemic wears off. This can also make it easier for businesses, government agencies, schools, and other institutions to request a vaccination. For example, the University of California and California State University school systems have announced that after coronavirus vaccines are fully FDA approved, students, faculties, and staff will need to be vaccinated. The U.S. military, where many troops have turned down coronavirus vaccines, has said it wouldn’t make them mandatory as long as they only have an emergency permit.

The FDA is expected to issue emergency approval early next week to allow the vaccine to be used in children ages 12-15.

White House press secretary Jen Psaki said at a news conference Tuesday that she does not want to be ahead of the FDA but that the government is preparing to “make this available to additional, younger populations.”

Dr. Popescu said the opportunity to allow children in the United States to use the vaccine was both exciting and frustrating. “We have key people around the world who cannot get vaccines and countries that may not have access for a year or more, so we need to add global access to this conversation,” she said.

As of Tuesday, more than 131 million doses of the Pfizer BioNTech vaccine had been administered in the US, according to the Centers for Disease Control and Prevention. They make up just over half of all doses administered in the country to date.

Pfizer’s managing director, Dr. Albert Bourla said the company reached out to the FDA on Friday with new data to convince the agency that the vaccine can be stored at refrigerator temperatures and not frozen for up to four weeks. Currently the limit is five days. He said the company was working on an updated version of the vaccine that could potentially be refrigerated for up to 10 weeks and hoped to have supportive data for that by August.

Rebecca Robbins contributed to the coverage.

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Health

MDMA Reaches Subsequent Step Towards Approval for Therapy

MDMA Reaches Next Step Toward Approval for Treatment

However, in the early 1980s, MDMA fled the clinic to the dance floor, where it became known as ecstasy. In 1985 the Drug Enforcement Administration criminalized MDMA as a List I substance, defined as “currently unaccepted medical use and high potential for abuse”.

Some mental health workers continued to administer MDMA-based therapies underground, but most stopped. The number of scientists completing studies with MDMA also decreased. Some people, including Dr. Doblin, who formed his association in 1986 to focus on developing MDMA and other psychedelics into FDA-approved drugs, continued to be heavily involved in MDMA research. It took nearly two decades to overcome alarmist claims about Ecstasy’s dangers, including the fact that it had eaten holes in users’ brains, to finally get approval to start college. Animal and human studies confirm that MDMA does not cause neurotoxic effects at the doses used in clinical studies.

Ecstasy or molly, on the other hand, can be adulterated with other potentially dangerous substances, and users can take doses far higher than is safe. According to a database maintained by the Drug Abuse and Mental Health Administration up to this year, MDMA accounted for 1.8 percent of all visits to the US emergency room in 2011. In Europe, MDMA was responsible for 8 percent of drug-related emergency visits to 16 major hospitals in 10 countries from 2013 to 2014.

Scientists still do not fully understand the source of MDMA’s therapeutic effects. The substance binds to proteins that regulate serotonin, a neurotransmitter that can, among other things, improve mood. Antidepressants like Prozac bind to the same proteins and block their reabsorption of serotonin. However, MDMA continues this process and causes the proteins to pump serotonin into synapses and strengthen their chemical signal.

MDMA also increases levels of oxytocin, dopamine, and other chemical messengers and creates feelings of empathy, trust, and compassion.

The primary therapeutic effect, however, may be due to the apparent ability to reopen what neuroscientists refer to as “critical phase”, the window in childhood when the brain has the superior ability to create and recreate new memories to save. A mouse study published in Nature in 2019 found that MDMA may restore the adult brain to this earlier state of malleability.

An estimated 7 percent of the US population will suffer from PTSD at some point in their life, and up to 13 percent of combat veterans will have the disease. In 2018, the U.S. Department of Veterans Affairs spent $ 17 billion on disability payments for over one million veterans with PTSD.

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Politics

Biden job approval hits 53%, majority assist infrastructure plan: NBC Information ballot

Biden job approval hits 53%, majority support infrastructure plan: NBC News poll

United States President Joe Biden speaks about his $ 2 trillion infrastructure plan during an event at Carpenters Pittsburgh Training Center in Pittsburgh, Pennsylvania on March 31, 2021.

Jonathan Ernst | Reuters

More than half of Americans say they support President Joe Biden’s performance to date and agree with his sweeping proposal for an infrastructure, according to a new NBC News poll.

Poll results, released on Sunday, showed that 53% of respondents approve of Biden’s inauguration, including 90% Democrats, 61% of Independents and 9% of Republicans, while 39% of respondents disapprove of Biden’s performance.

The president also received support for his coronavirus bailout package, approved in March, and his $ 2 trillion infrastructure proposal, which is designed to help boost the post-pandemic economy.

The poll found that 46% of Americans thought the president’s $ 1.9 trillion Covid relief bill, which included direct payments to Americans and expanded unemployment insurance, was a good idea. while 25% thought it was a bad idea and 26% had no opinion.

Additionally, 61% of respondents said the worst of the U.S. pandemic is over, while only 19% think the worst is yet to come.

Biden’s infrastructure plan, which aims to revitalize U.S. transportation infrastructure, water systems, broadband, manufacturing, and combat climate change, was also popular with respondents. 59% said the plan was a good idea, 21% disagreed, and 19% disagreed.

Reactions varied across party lines: 87% of Democrats, 68% of Independents and 21% of Republicans said they supported the infrastructure plan.

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“What we don’t know is whether this is part of a 100-day honeymoon or something that is more permanent and permanent for the Biden-Harris administration,” said Democratic pollster Jeff Horwitt of Hart Research Associates, who conducted the poll with the Republican pollster Bill McInturff conducted by Public Opinion Strategies, NBC News told.

“What we do know is that Joe Biden’s presidency is timely,” said Horwitt.

The president also received high marks for his handling of the coronavirus pandemic, which received 69% approval, as well as his handling of the economy, which received 52% approval.

Regarding the unification of the country and dealing with racial relations, 52% and 49% of respondents agreed.

Participants were less satisfied with Biden’s handling of relations with China, arms issues, and border security and immigration. The poll also found that 80% of people still believe the US is largely divided, despite Biden’s promises to unite the country.

The survey polled 1,000 adults across the country from April 17th to 20th. The error rate is plus or minus 3.1 percentage points.

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Health

Covid vaccine maker CureVac hopes shot will get EU approval in June

Covid vaccine maker CureVac hopes shot will get EU approval in June

Coronavirus vaccine maker CureVac is hoping its Covid shot will get European approval in the second quarter.

Franz-Werner Haas, CEO of CureVac, told CNBC on Thursday that the vaccine maker was close to finalizing recruitment for the vaccine’s Phase 3 clinical trial. In view of the urgent need for additional effective coronavirus vaccines and the accelerated regulatory approval process, approval cannot take place long afterwards.

“According to our calculations, we expect to have the data by late April or early May,” Haas told CNBC’s Squawk Box Europe.

“We therefore assume that, depending on the dates, we will receive the approval in early June.”

As soon as the study is running, the German biotechnology company CureVac will wait for safety data and then carry out an interim analysis of the results of the late study. It is also crucial that a certain number of study participants have to wait for Covid-19 to develop to determine how effective the vaccine is in preventing the virus.

The data is then sent to regulatory authorities such as the European Medicines Agency for so-called “ongoing review”. This is where the data is analyzed by regulators to expedite the evaluation of new, potentially life-saving vaccines or drugs in public health emergencies.

The UK and EU have pre-ordered up to 455 million doses of CureVac’s mRNA vaccine, pending regulatory approval. The company is already making its vaccine, even though it hasn’t been approved, pending approval of the shot.

Haas, CEO of CureVac, said the company is trying to avoid manufacturing pitfalls that have been hit by other vaccine manufacturers. This issue was perhaps most noticeable at AstraZeneca, and has significantly relieved the vulnerability of global supply chains.

“Manufacturing is certainly a struggle right now,” he said.

“It’s not just that we manufacture ourselves, we have a whole network in Europe, with other companies that also support us in manufacturing, but it is sometimes very difficult to get the equipment to set up the plants, however also the material for the production of the mRNA. “

“But we are doing everything we can to produce as many cans as possible,” added Haas.