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Samsung this morning announced that the Galaxy Watch line has received FDA approval for sleep apnea detection. The move is a big one for the smartwatch category, where health and fitness now comprise a majority of new features. For the last several years, the industry has focused on heart monitoring and blood oxygen detection, as […]

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The FDA has cleared Merck’s new Covid-19 therapy molnupiravir, the latest antiviral that adults can take at home to avoid severe disease. WSJ’s Daniela Hernandez explains the science behind the new drug. Photo: Merck

An agency review of the available data determined that oral phenylephrine, a major component of popular products such as Benadryl, Advil and Tylenols was not effective against nasal congestion

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The agency announced approval for the diagnostic method on Saturday. Cheaper and easier to administer than genetic tests for the virus, it could potentially expand to daily testing of millions.

The U.S. Food and Drug Administration issued the first emergency use authorization for a new kind of coronavirus test this week.

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The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

The test can rapidly detect fragments of virus proteins in samples collected from swabs swiped inside the nasal cavity, the FDA said in a statement.

The test, which involves swabbing the inside of the nose, can produce results in minutes.

After the contact, FDA Commissioner Stephen Hahn immediately took a diagnostic test for COVID-19 and tested negative. He wrote a note to staff that he is in self-quaratine for the next 2 weeks.
Reuters Health Information

The agency announced approval for the diagnostic method on Saturday. Cheaper and easier to administer than genetic tests for the virus, it could potentially expand to daily testing of millions.

Coronavirus update: Quidel said that the test can provide an accurate, automated result in 15 minutes. The company said it specialises in testing for diseases and conditions including the flu and Lyme disease.

The Gefahrstoffdatenbank der Länder, a german database, is now linked to eChemPortal. 102545 substance records can be searched through the substance search. This includes German hazardous substances legislation as well as other sources reflecting the state of technology and occupational health and safety relating to activities involving hazardous substances. In addition, it contains links to various other German data bases.

The Food and Drug Administration on Saturday announced emergency authorization for antigen tests which rapidly detects fragments of virus proteins in samples from nasal swabs.

The FDA said the authorisation is for an antigen test, which is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19.

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Rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.; Credit: /AP

Updated at 4:59 p.m. ET

The Food and Drug Administration has given emergency use authorization to the antiviral drug remdesivir to treat hospitalized patients with the coronavirus, President Trump on Friday told reporters at the White House.

Gilead CEO Daniel O'Day said remdesivir maker Gilead Sciences is donating 1.5 million vials of the drug and will work with the federal government to distribute it to patients in need.

The news comes days after preliminary results from a study of the drug showed it can help patients recover faster. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, hailed the findings earlier this week as "quite good news."

The authorization means remdesivir can be distributed in the U.S. and given intravenously to treat COVID-19 patients — both adults and children — who are hospitalized with severe disease, the FDA says. The agency defines that category as "patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator."

Discussing the findings about the drug's ability to help COVID-19 patients, O'Day cautioned earlier Friday that remdesivir is used to treat advanced cases, in which people are already hospitalized. The recent positive findings, he said, are a starting point in the fight against the respiratory disease.

"We want to continue to see how we can expand remdesivir to more patient populations," O'Day said on NBC's Today show. "Clearly with other medicines and vaccines to come, this is part, I think — the beginning of our ability to make an impact on this devastating virus."

This content is from Southern California Public Radio. View the original story at SCPR.org.

Deputy Chief Patricia Cassidy of the Jersey City Police Department has blood drawn to test for coronavirus antibodies in Jersey City, N.J., on Monday.; Credit: Seth Wenig/AP

The Food and Drug Administration is stiffening its rules to counteract what some have called a Wild West of antibody testing for the coronavirus.

These tests are designed to identify people who have been previously exposed to the virus. The FDA said more than 250 developers have been bringing products to the market in the past few weeks.

In a rush to make antibody tests available as quickly as possible, the FDA had set a low standard for these tests. Manufacturers were supposed to submit their own information about the accuracy of their wares, but the agency had no standards for what would be acceptable. Companies weren't allowed to claim the tests were authorized by the FDA, under initial guidance issued in mid-March.

Now the FDA is telling manufacturers that if they want their tests to remain on the market, they must meet minimum quality standards and submit a request for emergency use authorization, a temporary route to market for unapproved products when others aren't available. The EUA involves a lower standard than the usual FDA clearance or approval.

The FDA said 12 manufacturers have already opted to request EUA's for their products. More than 100 other producers have been talking to the agency about using this process, said FDA Commissioner Stephen Hahn. He spoke on a press call Monday. Companies have 10 days to submit that request.

"Our expectation is that those who can't [meet the new standard] will withdraw their products from the market and we will be working with them to help them do that," he said.

These tests are now so widespread that people can order them from lab giants Quest or LabCorp. The tests can cost more than $100. Though the FDA's original guidance calls for these tests to be run by a certified lab, the kits themselves are simple to use and have been readily available.

Despite the enthusiasm surrounding these tests, they have substantial limitations. Though people who test positive for antibodies have in most cases been exposed to the coronavirus, scientists don't know whether that means those people are actually immune from the coronavirus, and if so for how long.

"Whether this is the ticket for someone to go back to work [based solely on an antibody test result], my opinion on that would be no," Hahn said.

The tests may be more useful when combined with information from a standard coronavirus diagnostic test, or in someone who has symptoms, or if the results have been confirmed with a different antibody test. That "would dramatically increase the accuracy of those tests," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health

Antibodies are a potentially valuable research tool, and can be used to determine the prevalence of a disease in a population. In that circumstance, individual false results are less important. New York State used antibody tests to determine that about 20 percent of people in New York City have already been exposed to the coronavirus.

In California, researchers have attempted to measure the prevalence of the coronavirus in Los Angeles County and Santa Clara County in the Bay Area. Those unpublished results have garnered criticism because even a test that's more than 99 percent accurate can produce many false positive results when used to survey hundreds or thousands of people.

In the face of this criticism, the authors of the Santa Clara study have posted revised results acknowledging the high degree of uncertainty in their findings. Those findings haven't been peer-reviewed.

The emergency use authorization is only valid during the time of the national emergency. "Once the national emergency ends, the EUA authorizations end as well," Shuren said. Companies that want to keep marketing these tests will need to get them approved through the regular, more stringent FDA process.

FDA officials say they will continue to crack down on companies that falsely claim their tests are approved by the FDA, or that market them for home use, which isn't currently allowed.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.

Source: Streetwise Reports   04/29/2020

Biopharmaceutical company Chimerix Inc. (CMRX:NASDAQ), which focuses on developing medicines to treat cancer and other serious diseases, today announced that it will initiate a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients suffering from acute lung injury (ALI).

The firm explained that "DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.^"

Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School commented, "Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19...Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection."

The company's CEO Mike Sherman remarked, " DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications...We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection."

The company outlined its plans for the study indicating that it will be a randomized, double-blind Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at a high risk of respiratory failure. The study subjects will be confirmed COVID-19 patients who require hospitalization and supplemental oxygen therapy. The primary endpoint established in the study is the percentage of subjects who survive and do not require mechanical ventilation through 28 days. Several secondary endpoints listed include time needed for showing improvement, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality and changes in several key biomarkers.

The study will begin by enrolling 24 subjects in Phase 2 to first establish dosage levels and then expand to 74 total patients. The firm advised that if Phase 2 results are positive, it would enroll approximately 450 subjects in the Phase 3 portion of the study.

The company reported that "the clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation." The firm indicated that the mechanisms of action of DSTAT may address overactive inflammatory response including underlying causes of blood coagulation disorders associated with COVID-19.

Chimerix is a development-stage biopharmaceutical company based in Durham, N.C. which is engaged in advancing medicines in the areas of cancer and other serious diseases. The company listed that it presently has two active clinical-stage development programs. The first is dociparstat sodium (DSTAT) which is a glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity. The second pipeline candidate is brincidofovir (BCV) which is an antiviral drug being developed as a medical countermeasure for smallpox.

Chimerix began the day with a market capitalization of around $93.2 million with approximately 61.74 million shares outstanding. CMRX shares opened 30% higher today at $1.97 (+$0.46, +30.46%) over yesterday's $1.51 closing price. The stock has traded today between $1.82 to $2.62 per share and is currently trading at $2.27 (+$0.76, +50.33%).

Disclosure:
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( Companies Mentioned: CMRX:NASDAQ, )

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