Tag Archives: FDA

Coronavirus Vaccine: Moderna and Pfizer Final Test Results Imminent

Moderna should have enough data from its late-stage trial to know whether its coronavirus vaccine works in November, CEO Stephane Bancel said Thursday. The company could have enough data by October, but that’s unlikely, Bancel said during an interview on CNBC’s “Squawk Box.

If the infection rate in the country were to slow down in the next weeks, it could potentially be pushed out in a worst-case scenario in December,” he added.

Moderna is one of three drugmakers backed by the U.S. in late-stage testing for a potential vaccine. The other two are companies Pfizer and AstraZeneca.

Moderna‘s experimental vaccine contains genetic material called messenger RNA, or mRNA, which scientists hope provokes the immune system to fight the virus. In July, the company released early-stage data that showed its potential vaccine generated a promising immune response in a small group of patients.

Bancel’s comment came four days after the CEO of Pfizer said its vaccine could be distributed to Americans before the end of the year. CEO Albert Bourla told CBS’ “Face the Nation” that the company should have key data from its late-stage trial for the Food and Drug Administration by the end of October. If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses,” he said.

Source: https://www.cnbc.com/

Biogen Nabs Speedy FDA Review For Alzheimer’s Drug

Biogen’s aducanumab is inching closer to an FDA decision. The Big Biotech, along with partner Eisai, announced  that the FDA accepted its regulatory submission for aducanumab, its once-failed Alzheimer’s drug—with priority review to boot. The agency expects to decide the fate of the treatment by March 7. Along the way, it will hold an advisory committee meeting. It has not set a date for the meeting, but Jefferies analyst Michael Yee expects it sometime in the first quarter of 2021.

The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Michel Vounatsos, Chief Executive Officer at Biogen.

How the FDA rules on aducanumab will show how far the FDA and its commissioner, Stephen Hahn, M.D., are willing to diverge from its established approval standards. Under U.S. law, companies need to show “substantial evidence of effectiveness to win approval.

Source: https://investors.biogen.com/

https://www.fiercebiotech.com/

Quick And Affordable Saliva-based COVID-19 Test

A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA).

The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA). SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing.

With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks, the researchers said. A key component of SalivaDirect, they note, is that the method has been validated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.

This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.”

Development of SalivaDirect as a means of rapidly expanding SARS-CoV-2 testing was spearheaded this spring by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health. After finding saliva to be a promising sample type for SARS-CoV-2 detection, they wanted to improve the method further.

The preprint on the development and validation of SalivaDirect was recently posted on medRxiv.

Source: https://news.yale.edu/

New Coronavirus Antibody Test Highly Accurate

Abbott Laboratories’ antibody test for the new coronavirus is highly likely to correctly determine whether people have ever been infected with the fast-spreading virus, the company said, citing a U.S. study.

Researchers at the University of Washington School of Medicine report in the Journal of Clinical Microbiology  that Abbott‘s test had a specificity of 99.9% and a sensitivity of 100%, suggesting very few false positives and no false negatives.

Antibody tests can tell whether a person has ever been infected and are considered crucial in efforts to get Americans back to work safely as the presence of antibodies to the virus indicates possible immunity to future infection.

Abbott’s test was launched last month under the U.S. Food and Drug Administration’s relaxed rules for some coronavirus tests, allowing their distribution before regulatory clearance. It has since received emergency use authorization from the FDA.

Abbott has already shipped more than 10 million antibody tests to hospitals and labs.

Source: bit.ly/2SKTVcQ
AND
https://www.reuters.com/

CRISPR-based Test For COVID-19

The Food and Drug Administration (FDA) has authorized a COVID-19 test that uses the gene-editing technology CRISPR and returns results in around one hour.

Though the test was only authorized for emergency use, this marks the first time the FDA has allowed a CRISPR-based tool to be used in patients. CRISPR technology can quickly find and link onto any genetic sequence in a specimen. The new test, created by the biotech company Sherlock Biosciences, uses one molecule to search for the virus gene in a patient sample. Then, if the molecule finds the gene, it releases a signal that the system can detect.

The standard method for COVID-19 testing, called PCR, also looks for tiny bits of the virus gene. However, that method is slow and takes specialized equipment to run. The recently approved Abbott test gives results in minutes but can only run on that company’s platform. CRISPR-based techniques, on the other hand, are relatively fast and only need basic equipment found in most labs.

Experts say that the United States needs to run hundreds of thousands more tests each day to control the pandemic. Rapid, simple tests could help reach that scale.

Sherlock Biosciences said in a press release that it is working to produce and distribute testing kits. Two other groups, at Mammoth Biosciences and MIT, are also working on CRISPR-based tests.

Source: https://sherlock.bio/
AND
https://www.theverge.com/

US Needs To Conduct 20 Million Coronavirus Tests per day To Reopen Fully

The U.S. will need to administer 20 million tests for the novel coronavirus each day by mid-summer in order to fully remobilize the economy in a safe fashion, according to new report from a Harvard panel of more than 45 experts in health, science and economics. The figure far exceeds testing recommendations from other health experts. Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb has said that the country will need to initially conduct up to 3 million tests per week to reopen. A separate estimate from Harvard University researchers says the U.S. must conduct between 500,000 and 700,00 tests per day by mid-May to begin reopening.

The new report, released by Harvard University’s Edmond J. Safra Center for Ethics on Monday, emphasized the need for a massive scaling up of testing coupled with a robust contact-tracing program in order to reopen the U.S. in a way that avoids future shutdowns. Its top recommendations include a call for the nation to deliver 5 million tests per day by early June in order to ensure a safe reopening of portions of the economy.

This number will need to increase over time (ideally by late July) to 20 million a day to fully remobilize the economy,” the authors wrote, cautioning that even that figure may not be high enough to “protect public health.”

The value in dramatically increasing testing is it will “prevent cycles of opening up and shutting down,” the authors argued, adding that the testing output will allow the virus to be adequately managed until a vaccine is developed.

“This Roadmap is the only approach to BOTH contain the virus and ramp back up to vibrant economic life. And, in the long term, it allows us to build an infrastructure of pandemic resilience that will serve us well when the next health crisis or disaster hits, while improving community health,” Danielle Allen, director of Harvard University’s Edmond J. Safra Center for Ethics, said in a statement.

Source: https://ethics.harvard.edu/
AND
https://thehill.com/

Can Plasma From Recovered Covid-19 Patients Cure Infected Others?

US Food and Drug Administration (FDA) officials announced today they have approved plans for nationwide trials of two treatments for Covid-19, the global pandemic disease caused by the new coronavirus—and for their simultaneous use in perhaps hundreds of hospitals.

The therapeutic agents—convalescent plasma and hyperimmune globulin—are both derived from the blood of people who have recovered from the disease, decoctions of the antibodies that the human immune system makes to fight off germs.

 

This is an important area of research—the use of products made from a recovered patient’s blood to potentially treat Covid-19,” said FDA commissioner Stephen Hahn in a release announcing the trials. “The FDA had played a key role in organizing a partnership between industry, academic institutions, and government agencies to facilitate expanded access to convalescent plasma. This is certainly a great example of how we can all come together to take swift action to help the American people during a crisis.”

Physicians are already using a somewhat haphazard collection of antiviral and other drugs for people critically ill with Covid-19, because they don’t have any other options. Nothing—no drug, no vaccine—is approved for use specifically against Covid-19 in the United States, so any new possibility is a hopeful one. Convalescent plasma and hyperimmune globulin join the rarified group of therapeutics that scientists are testing, including a trial of the Ebola drug remdesivir and the much-hyped antimalarial/immune suppressants chloroquine and hydroxychloroquine.

Using blood products from people who’ve already beaten a disease is a century-old approach, predating vaccines and antibiotics. Inspired by its use against polio, two physicians at a Naval hospital in Massachusetts tried it on people who had pneumonia as a result of influenza in 1918, with enough success to warrant more tests. The quality of actual studies of efficacy has varied over the decades, but health care workers used convalescent plasma against SARS, MERS, and Ebola. And a couple of studies—small and preliminary—have shown convalescent plasma having some promise against SARS-CoV-2 as well.

It was all promising enough that the FDA wanted to make sure current patients could have access to the plasma at the same time that researchers were starting a more rigorous investigation. “This seems like ancient history, but maybe it isn’t. There have been niche uses of it for a while,” says Michael Joyner, a physiologist at the Mayo Clinic who in March spearheaded the creation of an ad hoc coalition of researchers interested in pursuing the therapy. Joyner is facilitating the 40-center trial of the new therapies approved today by the FDA, with researchers at Johns Hopkins leading the science. (Joyner himself received gamma globulin, a variant of the treatment, as a preventative against hepatitis B in the 1980s, when he was a medical student.)

At Houston Methodist Hospital, James Musser, the chair of Pathology and Genome Medicine, is a friend of Arturo Casadevall, the Johns Hopkins University immunologist who proposed using convalescent serum early in the pandemic. Musser pushed to get his hospital involved, putting out a call for donors—people who had confirmed positive tests for the virus and had gone at least 14 days without symptoms. His hospital is already doing compassionate-use transfusions. “So far, as of yesterday, we’ve transfused four patients,” Musser said on Thursday. He expected a fifth to receive plasma today. And how’d it work?The truth is, it’s far too early,” Musser says. “We, nationally, need to do controlled trials and understand, first and foremost, is this a safe therapeutic? There’s lots of reasons to think it will be, but you never know.”

Source: https://www.wired.com/

Breakthrough In The Fight Against Alzheimer’s

In a shocking reversal, Biogen (BIIB) said that it would resurrect an Alzheimer’s drug that the company previously said had failed and will ask the Food and Drug Administration (FDA) to approve it. The company said a “new analysis of a larger dataset” showed that the drug, aducanumab, reduced clinical decline in patients with early Alzheimer’s disease on multiple measures of the drug’s effectiveness. That directly contradicts a decision in March to halt studies of the therapy based on the recommendations of an independent monitoring board that was charged with protecting patients in the study. Aducanumab’s failure sent shock waves far beyond Biogen. It was thought to be the last of a series of drugs—the previous ones, from many different drug companies, all failed—that targeted a protein in the brain called beta amyloid. After Biogen’s announcement in March, most researchers and biotechnology executives saw little hope for a drug that would help patients with Alzheimer’s disease even as cases mount.

Biogen said that it conducted a new analysis in consultation with the FDA of a larger data set from the discontinued studies. The new analysis includes additional data that became available after the previous analysis showed the studies were “futile”—that it had no chance of succeeding. Biogen said that the new data show aducanumab is “pharmacologically and clinically active” and that it reduced patients’ clinical decline based on the results of a survey called Clinical Dementia Rating-Sum of Boxes (CDR-SB), which was the main goal of both studies.

With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,” Michel Vounatsos, Biogen’s chief executive, said in a statement. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”

Al Sandrock, Biogen’s head of research and development and chief medical officer, said in his first interview about the new results that his team could only find one previous instance where a trial was stopped for futility and then it turned out to be positive. “I have to pinch myself because I almost don’t believe it yet,” Sandrock said. “It’s so amazing to have this change from March. But I’m also very, very happy because… I know people with mild cognitive impairment and I felt like I had let them all down.

By June, as Biogen analyzed the full data set, researchers started to realize that a different picture was emerging of aducanumab, Sandrock said. The reason was because of changes that Biogen had made to the study late in the game. Initially, the company worried about a potential side effectbrain swelling—and limited the dosage of the drug. But later patients were allowed to receive higher doses of the medicine.

Source: https://www.biogen.com/
A
ND
https://www.scientificamerican.com/