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 ...
Abstract Resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), such as gefitinib, has greatly affected clinical outcomes in non-small cell lung cancer (NSCLC) patients. The long noncoding RNAs (lncRNAs) are known to regulate tumorigenesis and cancer progression, but their contributions to NSCLC gefitinib resistance remain poorly understood. In this study, by analyzing the differentially expressed lncRNAs in gefitinib-resistant cells and gefitinib-sensitive cells in the National Institute of Health GEO dataset, we found that lncRNA CASC9 expression was upregulated, and this was also verified in resistant tissues. Gain and loss of function studies showed that CASC9 inhibition restored gefitinib sensitivity both in vitro and in vivo, whereas CASC9 overexpression promoted gefitinib resistance. Mechanistically, CASC9 repressed the tumor suppressor DUSP1 by recruiting histone methyltransferase EZH2, thereby increasing the resistance to gefitinib. Furthermore, ectopic expression of DUSP1 increased gefitinib sensitivity by inactivating the ERK pathway. Our results highlight the essential role ...
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 ...
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 ...
Beginning or growing a peritoneal dialysis program requires knowledgeable staff who can reach as many potential patient candidates as possible, according to a speaker at ASN Kidney Week. “A successful PD program is a program that can offer PD to the widest possible range of patients and not only can a successful program offer PD to these patients, but it can maintain these patients on PD to maximally realize their goals of care,” Brendan McCormick, MD, FRCPC, associate professor at the University of Ottawa and medical director of home dialysis at the Ottawa Hospital, said during the meeting, which was held as a virtual event. Nephrologists, nurses and other health care team members can most easily identify potential candidates in chronic kidney disease programs, but it is important to avoid overlooking patients in the hospital, McCormick said. Educating potential candidates is a key component. Effective education requires knowledgeable staff and ...
Source: Potsdam Institute for Climate Impact Research (PIK) Summary: While the ongoing coronavirus pandemic continues to threaten millions of lives around the world, the first half of 2020 saw an unprecedented decline in carbon dioxide emissions — larger than during the financial crisis of 2008, the oil crisis of the 1979, or even World War II. Masked Earth photo concept (stock image; elements furnished by NASA). While the ongoing coronavirus pandemic continues to threaten millions of lives around the world, the first half of 2020 saw an unprecedented decline in CO2 emissions — larger than during the financial crisis of 2008, the oil crisis of the 1979, or even World War II. An international team of researchers has found that in the first six months of this year, 8.8 percent less carbon dioxide was emitted than in the same period in 2019 — a total decrease of 1551 million tonnes. The ...
US expert Dr Anthony Fauci says it should be known by early December if vaccine is safe to roll out Nurses on a Covid-19 ward in Merseyside, north-west England. Healthcare workers and people most at risk will be prioritised for first doses of a vaccine. Photograph: Peter Byrne/PA Hopes are rising that a coronavirus vaccine will be approved by the end of the year, with healthcare workers receiving their first dose in early 2021. Dr Anthony Fauci, the US’s leading expert in infectious diseases, said on Sunday it should be known by the end of November or early December if a vaccine was safe and effective. The Irish government added to the growing optimism that a vaccine would soon be available. “I’m increasingly optimistic, as is government, that we will see a vaccine approved in the next couple of months and that in the first half or first quarter of next ...
For Immediate Release: October 22, 2020 Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to ...
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