McMaster University researchers Dena Zeraatkar and Tyler Pitre have found that the drug solriamfetol is the most effective treatment for excessive daytime sleepiness (EDS) for people with obstructive sleep apnea (OSA). The standard treatment for OSA is a positive airway pressure (PAP) mask that uses compressed air to support lung airways during sleep. However, some people with OSA still experience EDS and may benefit from anti-fatigue medication. Zeraatkar and Pitre published their results in the Annals of Internal Medicine. “The most important thing that people with OSA should do is use their PAP machine, but if they are still sleepy there are options in the form of medications that can reduce their tiredness.” Tyler Pitre, first author, resident physician in internal medicine at McMaster University and incoming respirology fellow at the University of Toronto “Fifteen to 30 per cent of people in North America have a diagnosis ...
Animal studies indicate that a new COVID-19 vaccine developed at Rutgers may provide more durable protection against SARS-CoV-2 and its emerging variants than existing vaccines. “We need a better vaccine, one that provides years of robust protection with fewer booster shots against a variety of SARS-CoV-2 strains. Our data suggest this vaccine candidate might be able to do that,” said Stephen Anderson, associate professor of Molecular Biology and Biochemistry in SAS, resident member of the Rutgers Center for Advanced Biotechnology and Medicine and senior author of the paper in Vaccines. Existing COVID vaccines often provide some protection against serious disease and death. However, these vaccines typically elicit temporary bursts of protective antibodies that rapidly wane, even after booster doses, leaving most individuals vulnerable to potentially dangerous repeat infections. This new vaccine, dubbed MT-001, might provide longer-lasting protection against many COVID-19 varieties. “Thankfully, the current vaccines saved many lives, but they’re ...
After raking in billions with its Pfizer-partnered vaccine, BioNTech is turning to new ventures as its revenues plummet. BioNTech reported first-quarter revenues of €1.27 billion (1.4 billion), a far cry from 2022’s first-quarter haul of €6.37 billion ($7.03 billion). Despite the downturn, the quarter went “fully to our expectations,” CFO Jens Holstein said on a conference call. Sales-wise, the current quarter should be the weakest of 2023, Holstein said. The company’s COVID-19 vaccine revenue guidance for 2023 stands at €5 billion ($5.4 billion), which is “something we can live with,” the CFO added. Meanwhile, BioNTech believes the United States’ transition to a commercial COVID-19 vaccine market could provide new growth opportunities. But as its pandemic-related business struggles, BioNTech is busy advancing its pipeline as it looks for its next big growth driver. The company’s pipeline includes multiple oncology ventures, including an HER2-targeted antibody-drug conjugate (ADC) that it’s working on with ...
The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards. Equipped with advanced isolator technology, the Pleasant Prairie facility adheres to the highest current good manufacturing practice (CGMP) standards. It is designed to manufacture a broad range of injectable medications and will provide hospitals and clinicians access to affordable, safe, and critical-need medicines. Nexus Pharmaceuticals President and CEO Usman Ahmed said: “We are thrilled to receive the EIR for our Pleasant Prairie facility. “This is a major milestone for our company and reflects our commitments to reshoring sterile pharmaceutical manufacturing to the US. “We are proud of our team’s hard work and focus on achieving a ...
Children and adolescents face greater risk of inflammatory bowel disease (IBD) when exposed to antibiotics or a Western diet at early ages, or when their family has higher socioeconomic status, according to a study being presented today at Digestive Disease Week® (DDW) 2023. “Pediatric IBD cases are rising globally, and approximately 1 in 4 of all IBD cases are now diagnosed before age 21,” said Nisha Thacker, the study’s lead author and a gastrointestinal dietitian. A unique concern about pediatric IBD is the impact that the inflammation has on a child’s growth and the progression of puberty, so parents should be aware of this condition and the modifiable factors that influence it. As a part of her PhD studies, at The University of Newcastle in Australia, she conducted a meta-analysis of 36 observational studies representing approximately 6.4 million children. Thacker found that any exposure to antibiotics before age 5 was ...
Lung cancer accounts for more than 20% of cancer deaths in the UK A new UK study has revealed the potential of using artificial intelligence (AI) to help doctors diagnose lung cancer earlier. LIBRA, which was led by researchers from the Royal Marsden NHS Foundation Trust, the Institute of Cancer Research, London, and Imperial College London, used data from the CT scans of nearly 500 patients with large lung nodules – abnormal growths – to develop an AI model. The Royal Marsden Cancer Charity, the National Institute for Health and Care Research, RM Partners and Cancer Research UK also supported the study. To assess how effective the new model was at predicting cancer, the team used a measure called the area under the curve (AUC). An AUC of one would indicate a perfect model, while 0.5 would be expected if the model was randomly guessing. The results, which have ...
Reviewed by Lily Ramsey, LLM Investigators at Brigham and Women’s Hospital and collaborating institutions evaluated the dual-therapeutic effect of gene therapy in a clinically relevant model for common form of bone cancer. With a worldwide incident rate of 3.4 cases per million people per year, osteosarcoma is one of the most common bone cancers affecting children and adolescents. The current gold standard treatment option requires extensive surgical intervention and chemotherapy that leads to a poor prognosis and decreased quality of life. Due to the aggressive nature of the disease, the surgical intervention usually involves total reconstruction of the limbs or, in most cases, amputation. Researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, in collaboration with investigators at University College Dublin (UCD), Massachusetts Institute of Technology (MIT), and Trinity College Dublin (TCD), have identified a potential therapeutic target and developed a unique delivery ...
By LabMedica International staff writers Image: PocDoc offers the world’s first app based five marker lipid test (Photo courtesy of PocDoc) Cardiovascular disease (CVD), accountable for 32% of global deaths annually, is the world’s leading cause of death. These largely preventable fatalities highlight the urgent need for improved access to CVD testing and subsequent treatment, a pressing concern worldwide. Now, an innovative diagnostic tool for CVD enables early detection by facilitating accurate blood testing via a smartphone or tablet, with results accessible through an app. PocDoc (Cambridge, UK) has pioneered a groundbreaking smartphone-based lipid test capable of delivering a 5 marker lipid panel via the PocDoc app in under six minutes, with results instantaneously shared with the healthcare system. This technology allows lipid testing to extend beyond the confines of general practice surgeries, thereby drastically enhancing accessibility to testing and subsequently preventing more individuals from developing CVD. Despite its ...
Six months after Gilead got a smackdown in the United States for its drug to treat hepatitis delta virus (HDV), bulevirtide has scored a regulatory win in Europe. The Committee for Medicinal Products for Human Use (CHMP) has given bulevirtide a thumbs up for patients with HDV and compensated liver disease. If the European Commission signs off on the entry inhibitor, it will become the only authorized treatment for HDV in Europe. Known commercially as Hepcludex, the drug received conditional approval in Europe three years ago. Since then, a phase 3 trial has demonstrated the effectiveness and safety of the treatment. Gilead hoped the results of the MYR301 study—which were released in June of last year and showed significant viral declines after 48 weeks of treatment—would pave the way for approval in the U.S. But the FDA sent Gilead a complete response letter (CRL) citing manufacturing and delivery concerns. The regulator did not ask Gilead to conduct another ...
While Biogen’s attempts to resurrect a crucial Tecfidera patent in the U.S. floundered, the company is chalking up a win in Europe. The European Commission has ruled that Biogen’s multiple sclerosis drug Tecfidera will have market protections until February 2025, Biogen revealed in a filing. This comes after a March decision from the European Union’s Court of Justice that went in Biogen’s favor and blocked generic versions of Tecfidera. The appeal ruling made the drug entitled to European market protections through at least February 2024, which Biogen swiftly sought to enforce against would-be generic rivals. Meanwhile in the U.S., Biogen took its Tecfidera patent case all the way to the Supreme Court after a court ruled the patent invalid in 2020. The patent was originally slated to expire in 2028 until a district judge decided in Viatris’ favor, agreeing with the argument that Biogen didn’t adequately describe its invention. With that, Viatris’ generic was cleared ...
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