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 ...
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 ...
President Alberto Fernández confirms Argentina and Mexico will co-produce millions of doses of a coronavirus vaccine developed by scientists at the University of Oxford and Swedish-British pharma firm AstraZeneca. President Alberto Fernández has announced that Argentina and Mexico will co-produce millions of doses of a coronavirus vaccine developed by the AstraZeneca pharmaceutical firm and scientists at the University of Oxford, with it potentially reaching citizens across Latin America in the first quarter of next year. The Peronist leader, speaking at a press conference at the Olivos presidential residence on Wednesday, said that the two countries would be in charge of the “Latin American production” and distribution of a vaccine created by the prestigious British university and Swedish-British pharmaceutical group. Argentina will be in charge of producing “the active substance,” said Fernández, with Mexico finishing “production and packaging.” He said that the country “could be in a position to vaccinate” by the ...
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 ...
By MedImaging International staff writers Posted on 14 Oct 2020 Image: Novel AI algorithms power the Voluson SWIFT OB/GYN ultrasound scanner (Photo courtesy of GE Healthcare) A new OB/GYN ultrasound scanner includes artificial intelligence (AI) algorithms that support auto-recognition, high image quality, and efficiency features. The GE Healthcare (GE; Little Chalfont, United Kingdom) Voluson SWIFT ultrasound system includes an embedded AI platform that features SonoLyst, a fully integrated AI tool with a suite of image recognition tools that automatically identify fetal anatomy in over 20 standard views. A scan assistant tool reduces patient scan times by 45% through simplified workflow and personal protocol customization. SonoBiometry measurements, which are 38% faster than in previous platforms, add three measurements that increase system automation by 60%; Additional features include SonoCNS, part of GE’s Edison intelligence platform, that reduces keystrokes for capturing fetal central nervous system (CNS) planes and measurements by 78%; Tricefy, ...
(CNN)A Covid-19 vaccine developed by the biotechnology company Moderna in partnership with the National Institutes of Health has been found to induce immune responses in all of the volunteers who received it in a Phase 1 study.
Source:https://www.medicalnewstoday.com/articles/327296.php Using a new type of genetic engineering tool called epigenome editing in mice, scientists have restored irregularities in the developing brain that arise from a gene mutation. New research in mice suggests that gene editing could prevent brain developmental disorders.Epigenome editing is a way of altering the expression, or reading, of genes without altering their underlying DNA code. A team from Johns Hopkins University in Baltimore, MD, led the Nature Communications study that focuses on the protein C11orf46. One of the study’s corresponding authors is Dr. Atsushi Kamiya, who is an associate professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine. In humans, mutations in the section of DNA that contains the C11orf46 gene can lead to WAGR syndrome, a genetic condition that can cause intellectual disability and impair many systems of the body. The researchers found that C11orf46 directs the development of the corpus ...
A recent study reviewed evidence from 23 controlled scientific studies which investigated the health effects of WiFi on animals, human cell lines, and humans to determine once and for all, whether WiFi has a detrimental effect on human health.
Researchers at SLAC and Stanford are developing new accelerator-based technology that aims to speed up cancer radiation therapy by hundreds of times and make related medical devices more compact. The approach could reduce side effects in patients and possibly make radiation therapy more accessible around the world.
Henan Mecare Trading Co., Ltd. is a professional disposable medical consumables supplier of surgical packs, surgical gown, surgical drape, c-arm cover, ultrasound probe cover, shoe cover, face mask, cap, and underpads. This reputed trader from China supplies its products on Ddu (Drugdu.com), the leading global pharmaceutical and medical devices online B2B platform. One of its high demand products is the surgical gown which is manufactured from SMS/ smms/ pp material. These surgical gowns are available with a warranty of 3 years. These gowns can be ordered in different variants. They provide gowns with long sleeves, short sleeves, and nonsleeves. They can either have an elastic cuff or a knitted cuff. They are available in sterilized or non-sterilized packaging. They have neck and waist ties. They also provide personalized printed logos on the gowns. These gowns can be ordered in various sizes, weight, colors, and styles. They are manufactured under strict ...
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