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Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.
Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.
Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions for drugs in its class.Simply shifting one vial of the anti-amyloid antibody from the first infusion to the third infusion of the titration phase of dosing – the period used to achieve therapeutic levels in the body – is enough to lower the incidence of a potentially serious side effect known as ARIA-E, accordi
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.
Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.
Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.
An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.
Dr. Alexander Fanaroff In this Friday’s PCT Grand Rounds, Alexander Fanaroff of the University of Pennsylvania will present “Rigorous Testing of Behavior Change Interventions: Lessons From the BE ACTIVE Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, October 18, 2024, at 1:00 pm eastern. Fanaroff is an assistant professor of medicine at the University of Pennsylvania.
Biogen has revealed encouraging phase 2 results with its anti-CD38 antibody felzartamab in rare kidney disease IgA nephropathy (IgAN), which it hopes could join a series of first-in-class therapies for the disorder.Data reported at the Kidney Week 2024 congress in San Diego showed that felzartamab was able to achieve "substantial" reductions in proteinuria and stabilised kidney function in the 54-subject IGNAZ study that extended for 18 months after the last dose of the antibody.
Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.
Obesity remains one of the most significant public health challenges of the 21st century, not only due to its alarming prevalence but also because of its vast implications on individual and societal health. Recent statistics from the World Health Organization (WHO) reveal that worldwide obesity has nearly tripled since 1975. The latest reports indicate that over 650 million adults and an increasing number of children and adolescents are classified as obese, highlighting a global epidemic that sp
The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.
Dr. Thomas Carton and Dr. Anitha John In this Friday’s PCT Grand Rounds, Thomas Carton of the Louisiana Public Health Institute and Anitha John of George Washington University and the Children’s National Hospital will present “Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study.” The Grand Rounds session will be held on Friday, November 1, 2024, at 1:00 pm eastern.
(Abdullah Durmaz/Getty Images) In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have rocketed to fame as billion-dollar annual sellers for weight loss as well as to control blood sugar levels and reduce the risk of heart disease.
Neuroscience specialist Lundbeck has agreed to buy Longboard Pharmaceuticals for $2.6 billion, expanding its pipeline with an epilepsy drug tipped as a future blockbuster.The Danish drugmaker has offered $60 per share for California biotech Longboard, with the main asset in the deal bexicaserin, an oral, centrally acting serotonin 5-HT 2C receptor super-agonist in late-stage testing for seizures associated with rare forms of epilepsy.
Oxford Medical Products has shared promising safety data from a first-in-human study for its ‘mechanical’ weight loss pill. The pill, called Sirona, is actually a device that presents a new, non-pharmacological approach to managing weight. Sirona is designed as a non-invasive solution for individuals struggling with obesity, offering a safer alternative to traditional weight-loss medications and surgeries.
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.
Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute. BEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.
(juanma hache/Getty Images) When we start to go gray depends a lot on genetics. Your first gray hairs usually appear anywhere between your twenties and fifties. For men, gray hairs normally start at the temples and sideburns. Women tend to start graying on the hairline, especially at the front.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials. Use of modeling and simulation during drug development, otherwise known as model-informed drug development (MIDD), can help researchers make informed decisions when planning and executing clinical trials.
Paragonix Technologies, an innovator in organ transport and preservation solutions, has received US Food and Drug Administration (FDA) 510(k) clearance for its KidneyVault Portable Renal Perfusion System. This clearance allows the KidneyVault system to be used in the US to improve the quality of kidney preservation and ultimately improve outcomes for patients undergoing kidney transplants.
The Cambridge, Massachusetts-based biotech is using what it calls ligand-siRNA conjugates to reach drug targets in the kidney, which historically have been difficult to reach with RNA therapies.
A study has shown that Roche's diabetic macular oedema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, plugging a gap in the data for the drug.Vabysmo (faricimab) has been approved by the FDA for treating DME since 2022, quickly becoming one of the Swiss pharma group's fastest-growing products with sales of $1.1 billion in the first half of the year.
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
(Bambu Productions/DigitalVision/Getty Images) Of all the advice on preventing hangovers, drinking water to prevent dehydration seems like the most sensible. A new study has found no evidence to support claims that drinking a generous amount of water after a night of boozing alleviates the pain the next day.
In a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work. Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare systems leaders will actually use, changes are necessary: Trials need to be faster (2 to 3 years) Trials should
Genomic sequencing is a window into our genetic makeup. For a parent, it could prepare them or help them understand their child’s potential health needs early on. The GUARDIAN (Genomic Uniform-screening Against Rare Diseases In All Newborns) study, recently published in the Journal of the American Medical Association (JAMA) , highlights how adding genome sequencing to newborn screening could reshape early detection for rare genetic conditions.
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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