Search Results for “FDA” – Page 158 – media

Moderna’s Phase 3 COVE study for its COVID-19 vaccine

30 November 2020 The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has ...
- Source: drugdu
- 155
- December 1, 2020
Covid-19 vaccine
How do Coronavirus Antibody Tests Work?

The coronavirus antibody test is performed to determine the blood level of antibodies that are developed against the virus. This test determines if a person was infected by a coronavirus in the past. Image Credit: joel bubble ben/Shutterstock.com What is coronavirus? Coronaviruses are a group of viruses that cause respiratory infections in humans. The infections can range from mild (common cold) to severe (Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS)). Importantly, coronavirus disease 2019 (COVID-19) is a severe, highly infectious disease caused by very recently identified coronavirus namely severe acute respiratory syndrome coronavirus 2 (SARS-CoV 2). How coronavirus is detected in COVID-19 patients? Presently, two types of viral tests are approved by the U.S Food and Drug Administration (FDA): molecular test and antigen test. In molecular tests, the viral genetic material is detected using polymerase chain reaction (PCR). The test is done using biological fluid collected from ...
- Source: drugdu
- 166
- November 25, 2020
Covid-19
‘We will be ready to distribute within hours of authorization’

The companies announced the conclusion of the vaccine’s Phase 3 trial earlier this week: reporting 95% efficacy. They also announced that they had gathered the two months of safety data required by the US’ Food and Drug Administration (FDA) for a Emergency Use Authorization (EUA) submission. Dr. Albert Bourla, Pfizer Chairman and CEO, said: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” Other regulatory submissions will follow ‘immediately’ Pfizer and BioNTech have already started rolling reviews of the ...
- Source: drugdu
- 396
- November 23, 2020
Covid-19 vaccine
PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY

Monday, November 09, 2020 – 06:45am Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201109005539/en/ NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE)– Pfizer Inc. (NYSE: ...
- Source: drugdu
- 1,236
- November 10, 2020
Covid-19 Pfizer
Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer

Only HER2-directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy for previously treated patients in this setting AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, will be during the first quarter of 2021. There are more than 27,000 new cases of gastric cancer in the US each year, of which approximately one in five are HER2 positive.1,2 For patients with metastatic gastric cancer who progress ...
- Source: drugdu
- 312
- November 4, 2020
gastric cancer
Bayer to acquire Asklepios Bio in foray into gene therapy worth up to $4 billion

By Ludwig Burger FRANKFURT (Reuters) – Bayer <BAYGn.DE> agreed to acquire unlisted U.S. biotech firm Asklepios BioPharmaceutical Inc for as much as $4 billion in a bet on gene therapy with the help of modified viruses. Germany’s Bayer will pay $2 billion upfront and up to an additional $2 billion in milestone payments contingent on development achievements, it said on Monday. The North Carolina-based takeover target, also known as AskBio, is trying to use the harmless adeno-associated virus as a delivery device to bring genetic repair kits against a range of diseases into the body.Drugs and farming pesticides maker Bayer needs to upgrade its drug development pipeline amid a weaker outlook for agricultural sales and as it seeks to finalise an $11 billion settlement over claims its Roundup weedkiller causes cancer. Among AskBio’s most advanced projects are early tests on volunteers of prospective treatments against Pompe disease – a ...
- Source: drugdu
- 280
- November 2, 2020
Gene therapy
Will COVID-19 Get Worse in the Winter?

BY ELIZABETH HANES, BSN, RN OCTOBER 19, 2020 As you stock up your medicine cabinet for the traditional winter “cold and flu season,” you may find yourself wondering if COVID-19 will get worse this winter, too. Probably, yes. As I keep saying, there’s a lot we don’t know about how this virus behaves. But we do know a combination of factors — including human behavior — could lead to a spike of COVID-19 cases throughout the winter months. First, thanks to cold weather, people will get pushed indoors. We know the virus spreads more easily indoors than outdoors, where wind can disperse and blow away the viral particles. So if people decide to beat “quarantine fatigue” by engaging in more indoor activities — like entertaining friends at home or dining out or gathering for the holidays — then we could see a surge of COVID-19 cases. Second, the onset of cold and flu season means more people will ...
- Source: drugdu
- 604
- October 21, 2020
Covid-19 SARS-CoV-2
New Antiviral COVID-19 Treatment to Be Used as Nasal Spray Could Be Made Available Over the Counter

By HospiMedica International staff writers Posted on 08 Sep 2020 An antiviral treatment to be used as a topical nasal spray as prophylaxis against COVID-19 promises to be easy to use, low-cost and quickly made available over-the-counter for consumers. The Nomovid Nasal Spray developed by Parnell Pharmaceuticals (San Rafael, CA, USA) is based upon a substance licensed by the company from New Mexico Tech University to treat drug-resistant bacteria and fungi such as MRSA and Candida auris. Since it breaks down lipids in the viral envelope, Parnell tested it against the novel coronavirus. “An independent, outside laboratory has confirmed our findings and found it to be greater than 99.9% effective in vitro against the SARS-CoV-2 virus,” said Dr. Francis Parnell, Chairman and CEO of Parnell Pharmaceuticals. “Our product is based upon existing FDA approvals of the active ingredients for use in intravenous and inhalation formulations for other indications. Since the ...
- Source: https://www.hospimedica.com/covid-19/articles/294784405/new-antiviral-covid-19-treatment-to-be-used-as-nasal-spray-could-be-made-available-over-the-counter.html
- 147
- September 9, 2020
Significant Approvals, Diabetes And NASH In India, Japan M&A

Take a look at some of the most significant regional pharma stories of the past few weeks.
- Source: https://scrip.pharmaintelligence.informa.com/SC141368/APAC-Podcast-Significant-Approvals-Diabetes-And-NASH-In-India-Japan-MA
- 1,310
- January 8, 2020
Alzheimer's disease SK Biopharm，
Fasenra Granted US Orphan Drug Designation for Eosinophilic Oesophagitis

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE). EoE is a rare, chronic, inflammatory disease that occurs when eosinophils, a type of white blood cell, accumulate in the oesophagus causing injury and inflammation. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. About Fasenra Fasenra (benralizumab) is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death). Fasenra is AstraZeneca’s first respiratory biologic, now approved as an add-on maintenance treatment in severe eosinophilic asthma in the US, EU, Japan and other countries, with further regulatory reviews ongoing. In June 2019, the European Medicines ...
- Source: drugdu
- 750
- October 8, 2019
AstraZeneca Orphan Drug

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