3rd December 2020 Johnson & Johnson’s pharmaceuticals division Janssen has purchased rights to acquire an investigational gene therapy asset for geographic atrophy from Hemera Biosciences. Geographic atrophy is an advance and severe form of age-related macular degeneration (AMD) which affects five million people globally. Hemera’s investigational gene therapy, HMR59, is administered as a one-time intravitreal injection to aid vision preservation in patients with geographic atrophy. HMR59 is designed to increase the ability of retina cells to produce a soluble form of CD59, a protein that protects the retina from damage. Patients with wet AMD often have low levels of this protein, which is an essential component of the body’s natural immune response. “Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday tasks, such as reading, driving, cooking, or even seeing faces,” said James List, global therapeutic area head, cardiovascular & metabolism, Janssen Research & ...
Vaccines must be stored in specific conditions to avoid degradation, usually defined specifically by the manufacturer. Across the stages of manufacture, distribution, storage, and ultimately administration, these conditions must be adhered to, and this process is known as the cold chain. Should the cold chain be broken at any point during transport or storage, via exposure to temperate extremes, then the potency of the vaccine risks being reduced, or the vaccine is even rendered completely ineffective. The vast majority of vaccines must be refrigerated at between 2-8⁰C, with a preferred average of 5⁰C with minimal fluctuations. Specially designed lab refrigerators are usually used for this purpose, which has comparatively minimal temperature fluctuation across days and seasons, do not present any temperature extremes on any interior surface, and may bear an external temperature display that automatically logs the internal temperature at particular time intervals. Many live vaccines tolerate freezing, and depending on the ...
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 ...
Understanding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the virus that causes the coronavirus disease 2019 (COVID-19) – is crucial for both vaccine and treatment development. Since the pandemic started in December 2019, many studies have explored the virus’s origins and how it infects humans. This way, scientists and clinicians have an idea of how to combat the infection. A team of researchers from Germany, Taiwan, and the United States has identified and characterized a new hidden gene in SARS-CoV-2 that is also present in Guangxi pangolin coronaviruses – though, curiously, absent in closely related pangolin and bat coronaviruses. What are overlapping genes? The coronavirus pandemic raises urgent questions about the properties that allow viruses in animals to jump to humans. Called zoonosis, these types of diseases have impacted human life for years, including the AH1N1 virus, bovine tuberculosis, glanders, and bubonic plague, among others. To further understand zoonotic diseases, ...
Predicting the course of a COVID-19 patient’s disease after hospital admission is essential to improving treatment. Brigham and Women’s Hospital researchers analyzed patients’ levels of inflammation, known to be associated with severity of illness, by looking at C-reactive protein (CRP) trends in 100 COVID-19 patients admitted to the hospital. They found that a rapid rise in CRP levels during the first 48-to-72 hours of hospitalization was predictive of subsequent respiratory deterioration and intubation, while steadier CRP levels were observed in patients whose condition remained stable. Findings were published in Cell Reports Medicine. We realized that whereas a single CRP lab value from hospital admission wasn’t very practical as a predictor of who might get sicker, tracking the rate of change from Day 1 to Day 2 or 3 was a very powerful and very clinically predictive test. Even though all of these patients looked clinically similar upon admission, as early as ...
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 ...
by Institute of Cancer Research Scientists have revealed details of the discovery of a new cancer drug that could be used to treat a range of cancer types, including some blood cancers and solid tumors. The drug, called fadraciclib, was jointly discovered by scientists at The Institute of Cancer Research, London, in collaboration with the company Cyclacel. It is already being tested in early clinical trials targeting select hematological malignancies and solid tumors. In a new publication in the journal PLOS One, a team of scientists from Cyclacel and the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research (ICR) describe the discovery of fadraciclib, formerly known as CYC065, and describe its mechanism of action and therapeutic properties. Fadraciclib is a leading dual inhibitor of two cancer-driving proteins from the cyclin-dependent kinase (CDK) family, CDK2 and CDK9. CDK2/9 inhibitor It was designed by improving the chemical ...
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 University of South Florida Children with multiple islet autoantibodies—biological markers of autoimmunity—are more likely to progress to symptomatic type 1 diabetes (T1D) than those who remain positive for a single autoantibody. Now, new findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study in the U.S. and Europe show that detailed information about the order, timing and type of autoantibodies appearing after the first autoantibody can significantly improve prediction of which children are most likely to progress to type 1 diabetes more rapidly. The TEDDY analysis was published in the September 2020 issue of Diabetes Care. “A better understanding of distinct autoantibody spreading is important, because it will allow us to identify at-risk children earlier in the disease process,” said the study’s lead author Kendra Vehik, Ph.D., a professor of epidemiology at the University of South Florida Health (USF Health) Morsani College of Medicine’s Health Informatics ...
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 ...
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