Regular physical activity may protect against cognitive decline as we get older, but this protective effect may be diminished for people who are not getting enough sleep, according to a new study by UCL researchers. The study, published in The Lancet Healthy Longevity, looked at cognitive function over 10 years in 8,958 people aged 50 and over in England. The research team investigated how different combinations of sleep and physical activity habits might affect people’s cognitive function over time. They found that people who were more physically active but had short sleeps—less than six hours on average—had faster cognitive decline overall, meaning that after 10 years their cognitive function was equivalent to peers who did less physical activity. Lead author Dr. Mikaela Bloomberg (UCL Institute of Epidemiology & Health Care) said, “Our study suggests that getting sufficient sleep may be required for us to get the full cognitive benefits of ...
By Kristen Rogers, CNN Having a fluctuating cholesterol level has been linked with higher risk of Alzheimer’s disease, a new study has found. coldsnowstorm/iStockphoto/Getty Images Editor’s Note: Sign up for CNN’s Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for life. CNN — The fact that having high cholesterol can cause health problems is well known. But a total cholesterol level that fluctuates a lot — either up or down within a five-year period — might also be problematic by raising the risk of later dementia, a new study found. “This study adds to a growing body of evidence showing that addressing certain modifiable risk factors and promoting healthy behaviors can reduce the risk of cognitive decline, possibly reduce the risk of dementia, and protect cognitive health,” said Christopher Weber, director of global science initiatives at the ...
Tyler Patchen News Reporter https://endpts.com/ In June, Saudi Arabia’s Public Investment Fund established Lifera, a contract developer and manufacturer in the pharmaceutical field, and now the company has secured a major client. On Wednesday, Lifera and the Saudi-based vaccine manufacturer Arab Pharmaceutical Company, or Arabio, signed a memorandum of understanding with Sanofi to boost the local vaccine production within Saudi Arabia. Under the terms of the agreement, all three companies will search for opportunities to collaborate to form a localization strategy for developing and producing vaccines. This will include Lifera acting as a contract manufacturer to Sanofi and leveraging Arabio’s distribution experience as well. According to the release, the French pharma will plan to manufacture seven vaccines that are part of the “mandatory immunization schedule” with the intention of making these vaccines more readily available in Saudi Arabia and to potentially export as well. However, the specific vaccines that will be ...
Drug shortages have been in the news for several years, but they worsened during the Covid-19 pandemic, and several pharmacy, regulatory, and physician organisations, in the US and Europe, have recently issued alerts in response. In May, the American Cancer Society declared that chemotherapy drugs were among the top-five drug classes affected by shortages, and numerous oncology medications are currently in short supply according to data from the US Food and Drug Administration (FDA). “The shortages of oncology drugs are primarily in the generic drug market,” says Dr. Kevin Shulman, a professor of medicine and clinical hospitalist at the Clinical Excellence Research Center at Stanford University. There is no financial incentive for big pharma to manufacture older generic medications that are critical to the treatment of several common cancers and very few companies invest in doing so, says Dr. Kristen Rice, medical oncologist with a practice in San Diego, California. ...
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled a new corporate plan that aims to create a faster and more predictable regulatory environment. The plan assigns the agency’s agenda to four key strategic priorities, which are further split into multiple milestones over a three-year span. This includes a focus on public trust, improved access to safe and effective products and the pursuit of new strategic partnerships, based on the 4 July announcement. As part of the corporate plan, the MHRA plans to create faster risk-proportionate regulatory pathways that will support innovation in areas such as artificial intelligence, cell therapy and vaccines, per a document detailing the plan. In the first year, the MHRA aims to launch an improved regulatory management system that will streamline its services and increase the use of self-service. The agency also seeks to optimise service delivery times in priority areas in the second ...
After AstraZeneca and National Resilience made recent inroads into the United Arab Emirates, Sanofi has emerged as the next pharmaceutical giant setting its sights on the Middle East.The French pharma is linking up with Saudi drugmakers Arabio and Lifera—the latter of which is wholly owned by the kingdom’s sovereign wealth fund PIF—to bolster production of vaccines in Saudi Arabia. Under a newly minted memorandum of understanding, the companies will explore a range of potential prophylactic initiatives, including the enlistment of Lifera as a contract manufacturer to Sanofi, plus the build-out of a new manufacturing plant utilizing the latest vaccine tech. Sanofi will further share biotechnological know-how to initially manufacture seven vaccines included in Saudi Arabia’s mandatory immunization schedule, the partners said in a press release Wednesday. Arabio, for its part, will leverage its local and regional distribution strength to help supply the shots and other biopharmaceutical products to the Saudi ...
Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
If the face mask fits, it’s much safer—say Flinders University medical experts after developing a low-cost way to customize N95 filtering facepiece respirators (FFRs) for health workers on the front line of the pandemic and respiratory viruses such as influenza. Researchers say the decrease in “leakage” and greater comfort for the wearer whose face has been personally fitted could also have applications to improving respirator and mask safety in a wide range of industrial settings in health care and beyond. The article, “Personalized 3D-printed frames to reduce leak from N95 filtering facepiece respirators: a prospective crossover trial in health care workers” has been published in the Journal of Occupational and Environmental Hygiene. “Individually and anatomically personalized 3D-printed face frames represent a rapidly scalable technology to significantly improve health care worker protection and comfort, and fit-testing pass rates,” says Flinders University cardiology research fellow Darius Chapman. Working with public hospital workers ...
In people with myelodysplastic neoplasms (MDS), a usually benign form of chronic lymphocytic leukemia, the body produces too few functional blood cells. Affected individuals suffer from anemia—a lack of red blood cells or hemoglobin—which can be a precursor to acute leukemia. Compared to the standard treatment, luspatercept can increase hemoglobin levels in MDS patients and help them to avoid blood transfusions. These are the findings of an international clinical trial led by Professor Uwe Platzbecker from Leipzig University and the University of Leipzig Medical Center in collaboration with a large international research team. Every year, around 4,000 people in Germany alone are diagnosed with myelodysplastic neoplasms (MDS). In these patients, the healthy maturation of blood cells is disrupted, which can lead to anemia, infections and an increased risk of bleeding. High-risk MDS is characterized by rapid progression, severe symptoms and often a transition to acute leukemia that results in a ...
Tyler Patchen News Reporter Ipca Laboratories, an India-based maker of active pharmaceutical ingredients, was cited for several quality and testing issues during a recent FDA inspection. The FDA inspected an Ipca manufacturing facility in Ratlam, India, between June 5 and June 13, and investigators made a total of 11 observations. The FDA said the company failed to properly investigate root causes for deficient API batches. In April, Ipca had received a complaint saying there were “metal-like particles and magnet particles” in some products. The regulator also said the facility’s quality unit did not issue a recall of an unnamed product that did not meet specific impurity standards. Inspectors found that Ipca did not conduct the correct contamination testing of a drug substance that was redacted from the report and therefore was not aware of potential hazards. Laboratory tests on manufactured APIs were found to be deficient by inspectors, as were ...
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