Tag: FDA

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BREAKING: Moderna to apply for Emergency use Authorization for COVID-19 Vaccine Candidate Today

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the staff of the Ridgewood blog

CAMBRIDGE  Mass ,  Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). The Company also announced that today, Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

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FDA to Convene on Pfizer and BioNTech COVID Vaccine December 10th

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the staff of the Ridgewood blog
Ridgewood NJ, according to Johns Hopkins Center for Health Security , the US FDA announced that its Vaccines and Related Biological Products Advisory Committee will convene on December 10 to review the Emergency Use Authorization (EUA) requests submitted by Pfizer and BioNTech for their candidate SARS-CoV-2 vaccine. FDA Commissioner Dr. Stephen Hahn emphasized that while the advisory board “will review the request as expeditiously as possible,” it is unclear how long the review process will take. That being said, this represents another major step toward authorization for a SARS-CoV-2 vaccine. The FDA intends to livestream the meeting via its YouTube, Facebook, and Twitter accounts as well as from the FDA website.

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FDA Approves Home Test Kits for COVID

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the staff of the Ridgewood blog

Ridgewood NJ, according to Johns Hopkins Center for Health Security the US FDA granted Emergency Use Authorization to the first fully at-home SARS-CoV-2 diagnostic test kit. The Lucira COVID-19 All-In-One Test Kit must be prescribed by a healthcare provider, but it can be performed by individuals at home. The manufacturer recommends that children under 14 years old should have the test performed by a healthcare provider in order to maximize the chances of obtaining a valid result. The kit comes with a nasal swab, a test tube with detection reagents, and a small test machine. Once the used nasal swab is swirled around the test tube for the requisite amount of time, the user inserts the tube into the machine, which will automatically process the sample and provide visual indication of the results. The test kit will light up as positive, negative, or inconclusive results in around 30 minutes.

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U.S. Food and Drug Administration Grants Emergency Use Authorization for Eli Lilly COVID Antibody Drug

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the staff of the Ridgewood blog

INDIANAPOLIS  IN, The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.

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Phase 2 clinical trial indicated Eli Lilly’s monoclonal antibodies reduced viral load in COVID-19 patients mitigated symptoms and resulted in fewer hospitalizations

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the staff of the Ridgewood blog

Ridgewood NJ, according to Johns Hopkins Center for Health Security ,Pharmaceutical manufacturer Eli Lilly submitted an EUA request to the FDA for its monoclonal antibody cocktail as a COVID-19 treatment after clinical trials for the drugs met the target clinical endpoints. Results from a Phase 2 clinical trial indicate that a combination of two of Eli Lilly’s monoclonal antibodies reduced viral load in COVID-19 patients mitigated symptoms and resulted in fewer hospitalizations and emergency department visits. The study included 268 total participants with mild-to-moderate COVID-19 symptoms, 112 of whom received the treatment and 156 who received a placebo. Additionally, a press release issued by the company indicates that no serious adverse events were reported. The company stated that it aims to make 100,000 doses of a single antibody available by the end of October and 1 million by the end of 2020. For the combination therapy, the company hopes to produce 50,000 doses by the end of 2020, and it is collaborating with various external partners to ensure availability for lower-income countries.

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Is COVID-19 Over in New Jersey?

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Kenneth Sable, M.D. contributes to topics such as Emergency Medicine.

 

Hackensack NJ, The sun is shining, the number of people in New Jersey who are getting sick from the novel coronavirus (COVID-19) is declining and the beaches are open. Does this mean that the COVID-19 pandemic is over? Unfortunately, the answer is no: Nothing has caused an end to the pandemic, despite the nice weather and the lifting of certain restrictions, so it’s still necessary to take precautions.

“We are still very much in this fight against COVID-19, so now more than ever it’s important to continue to wear face masks, practice social distancing and wash hands regularly to minimize the spread of this novel coronavirus,” says Ken Sable, M.D., southern region president at Hackensack Meridian Health.

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Americans to Receive Vaccine for Free in Trump Administration COVID Deal with Pfizer

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the staff of the Ridgewood blog

The US government has finalized an agreement with Pfizer and BioNTech to acquire 100 million doses of their candidate SARS-CoV-2 vaccines, worth US$1.95 billion. Additionally, the US government could purchase an additional 500 million doses under the agreement. Pfizer and BioNTech currently have several candidate vaccines in the development pipeline, including various stages of clinical trials. According to a press release issued by Pfizer, the companies aim to begin Phase 2b/3 clinical trials later this month with the goal of securing US FDA authorization for at least one vaccine by October and delivering the vaccine doses by the end of 2020. The companies also hope to expand production to a total of 1.3 billion doses by the end of 2021. The agreement was signed as part of Operation Warp Speed, which has resulted in similar agreements—to support research and development, scale up manufacturing capacity, and purchase vaccine doses—with other pharmaceutical companies pursuing their own candidate vaccines.

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FDA Sends Warning on False Positive COVID Test Results

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the staff of the Ridgewood blog

Franklin Lakes NJ, The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.  A Letter to Clinical Laboratory Staff and Health Care Providers alerting them of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.

In one study, the manufacturer found approximately three percent (3%) of results were false positive results. The FDA is working with Becton, Dickinson and Company (BD) to resolve this issue and will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed for new or additional information.

 

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Cognizin: Is Cognizin Safe For Use in Bulgaria?

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Cognizin is the latest drug launched by Ciba of America, the makers of brand-name Asprin and such other drugs. They claim that Cognizin will help people fight the effects of mental anxiety as well as manage pain and increase the memory power in general.

First of all, let’s take a look at Cognizin and try to understand how it works. So, as you can see Cognizin is quite an interesting drug and not just because it can treat memory impairment.

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Chinese Manufacturer Charged with Exporting Defective N95 Masks

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the staff of the Ridgewood blog

NEWARK NJ, A Chinese manufacturer was charged today with producing and exporting to the United States in the midst of the COVID-19 pandemic nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, U.S. Attorneys Craig Carpenito, District of New Jersey, and Richard P. Donoghue, Eastern District of New York, announced.

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FDA Approves First At-Home Saliva Collection Test for Coronavirus

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the staff of the Ridgewood blog

New Brunswick NJ, Rutgers’ RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.

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NJ Hospital Virtua Health Contributes to New, Promising National Study on Coronavirus Treatment Option

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the staff of the Ridgewood blog

Voorhees NJ, Two patients at Virtua Voorhees Hospital are steadily recuperating from critical cases of COVID-19 after receiving convalescent plasma transfusions in the first week of April. The pair – a 61-year-old man and a 63-year-old woman – are expected to return home to their families in May. They are the first two New Jersey residents to receive the ground-breaking plasma therapy.

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FDA Authorizes First COVID 19 Test for Patient At-Home Sample Collection

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Washington DC, The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

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New Rutgers Saliva Test for Coronavirus Gets FDA Approval

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the staff of the Ridgewood blog

New Brunswick NJ,

The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency.

The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for broader population screening than the current method of nose and throat swabs.

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Hackensack Meridian Health Recruiting Recovering COVID-19 Patients

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the staff of the Ridgewood blog
Hackensack NJ, As of late last night, HMH has been approved by the FDA to recruit recovered and recovering COVID-19 patients to assess their blood and test it for antibodies in response to the virus. These antibodies may help other patients who are infected with COVID-19. Patients with promising antibodies will be asked to come back to donate an additional blood sample which may be helpful for sick COVID-19 patients. This convalescent plasma therapy is still pending approval from the FDA which we hope to receive soon.
If you, or someone you know, have recovered or are recovering from COVID-19, you may be eligible to donate. If you are interested, please contact our coordinator [email protected].