The progressive neurodegenerative disease affects more than 55 million people globally Innovate UK has awarded £4m through its Contracts for Innovation to four UK companies for research into dementia diagnosis. As part of the Bio-Hermes-002 study led by the US-based Global Alzheimer’s Platform Foundation (GAP) in partnership with Novo Nordisk, the organisations will evaluate blood-based and digital innovative biomarkers for the neurological condition. Affecting more than 55 million people globally, which is expected to triple by 2050, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. The study aims to explore whether these biomarkers can predict the extent of tau and amyloid brain pathology and potentially provide more efficient and less invasive alternatives to the current gold standard for dementia diagnoses: positron emission tomography brain imaging. The project will involve 1,000 participants who are cognitively normal, have mild cognitive impairment or ...
The serious, rare condition is responsible for up to 7% of all neonatal deaths globally Researchers from the University of Birmingham are developing a new blood-free test to help identify children across the Global South missing immunity to tetanus and other essential vaccines. Supported by £1.1m of funding by the Medical Research Council, the low-cost, non-invasive saliva lateral flow test can potentially reveal whether a person has protection against tetanus within just 15 minutes. Estimated to be responsible for up to 293,000 deaths worldwide every year, according to the European Centre for Disease Prevention and Control, tetanus is a serious disease of the nervous system caused by a toxin-producing bacterium, Clostridium tetani, and is responsible for up to 7% of all neonatal deaths globally. Newborn tetanus is a rare condition that occurs in infants most often within the first ten days of life, resulting from an infection in the umbilical ...
The COVID-19 pandemic has created the need for healthcare professionals to employ diagnostic tests as close as possible to the patient and provide rapid actionable results. An increasing number of tests are conducted outside hospital labs directly in Emergency Departments (ED) or at the Point of Care (POC). This market is especially active in the U.S. Now, a fast and innovative syndromic testing solution perfectly matches these new medical needs. bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has obtained U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). Designed for use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in around 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory ...
The influenza virus represents a significant public health concern, annually causing epidemics with high morbidity and mortality rates. The virus is known for its high mutation rate and the existence of multiple subtypes, which require varied clinical approaches. Consequently, there is a critical need for an accurate, rapid, and portable method to differentiate between influenza virus subtypes to manage virus transmission and inform clinical treatment decisions. Researchers have now developed a spatial encoding of a centrifugal microfluidic disc-integrated smartphone-controlled (SEDphone) platform for detecting influenza virus subtypes. In a study, researchers from the Hefei Institutes of Physical Science of the Chinese Academy of Sciences (Anhui, China) developed a novel approach that combines Loop-mediated Isothermal Amplification (LAMP) with CRISPR/Cas12a technologies for rapid and accurate detection of various influenza viruses. This method amplifies target sequences using LAMP and detects them through CRISPR/Cas12a-mediated trans-cleavage activity, thus cleaving reporter probes and emitting fluorescent signals. ...
By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
Revolution Medicines drug RMC-6236 increased progression-free survival in patients with advanced cases of pancreatic ductal adenocarcinoma. With these results, the biotech is preparing for a Phase 3 clinical trial in this indication, the most common type of pancreatic cancer. By Frank Vinluan Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer. Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236. This small molecule is ...
Lyme disease is the most common animal-to-human transmitted disease in the United States, with around 476,000 people diagnosed and treated annually, and its incidence has been increasing. If not addressed promptly and effectively, those affected may experience persistent symptoms known as Post-Treatment Lyme Disease Syndrome, which include issues with concentration and memory, dizziness, fatigue, body aches, depression, and sleep disturbances. Currently, the standard diagnostic approach involves an antibody blood test that detects the immune system’s response to the bacteria responsible for Lyme disease. Now, urine testing could revolutionize Lyme disease detection and diagnosis thanks to its many advantages over existing techniques. Researchers at George Mason University (Fairfax, VA, USA) have developed a urine test for Lyme disease that detects the Borrelia bacteria, which causes Lyme disease. This advancement allows for the confirmation of an infection shortly after a tick bite, leading to timely treatment and helping to avoid the ...
In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI) Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). Nilesh Gupta, Managing Director, Lupin said, “We are pleased to receive the EIR with VAI status from the USFDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide.”
ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. By Frank Vinluan Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ. The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer. BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce an immune ...
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