AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 15, 2024
(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.
Pharmaceutical Technology
OCTOBER 15, 2024
Pharmaceutical giants cannot work in a silo to reach net zero. Pharma contract manufactures have a duty to engage with the science-based climate targets, says ACG.
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Worldwide Clinical Trials
OCTOBER 14, 2024
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.
Bio Pharma Dive
OCTOBER 16, 2024
The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.
Speaker: Simran Kaur, Founder & CEO at Tattva 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
BioPharma Reporter
OCTOBER 14, 2024
From exploring the wonders of plants as a curious teen to leading global initiatives at SCIEX, Gitte Barknowitz has carved out an exciting and unconventional career in science.
Pharmaceutical Technology
OCTOBER 18, 2024
An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
OCTOBER 17, 2024
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.
Rethinking Clinical Trials
OCTOBER 16, 2024
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.
Pharmaceutical Technology
OCTOBER 17, 2024
The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2024
(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.
Bio Pharma Dive
OCTOBER 17, 2024
The restructuring, which follows clinical setbacks in Alzheimer’s, Parkinson’s and tremor, will also involve the departure of five senior executives.
Rethinking Clinical Trials
OCTOBER 15, 2024
A new case study from the NIH Pragmatic Trials Collaboratory highlights an interim reassessment of sample size during an ongoing cluster randomized trial. The case study was published this week in the Living Textbook of Pragmatic Clinical Trials. Researchers in cluster randomized trials must account for potential correlation between clusters in the design and analysis of their trial by estimating the intraclass correlation when calculating the target sample size.
Pharmaceutical Technology
OCTOBER 14, 2024
Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 13, 2024
(Valerii Apetroaiei/Getty Images) Exercise is great for improving heart health. But the thought of hitting the gym or going for a jog might put some people off from doing it. And, if you have a heart condition already, such dynamic exercises may not be safe to do.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
OCTOBER 18, 2024
Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.
Rethinking Clinical Trials
OCTOBER 17, 2024
Dr. Margaret Kuklinski and Dr. Stacy Sterling In a pilot study for the GGC4H trial, researchers found that a virtual version of the Guiando Buenas Decisiones program delivered in the context of pediatric primary care was feasible, acceptable, and appealing to pediatricians and parents. The program is a Spanish-language version of the Guiding Good Choices intervention being implemented in the GGC4H trial.
Pharmaceutical Technology
OCTOBER 14, 2024
RHEACELL has been researching ABCB5-positive stem cell therapies for patients with severe immune and inflammation-related diseases for which there are currently no adequate treatment options. Positive feedback from the regulatory authorities on the study program now gives reason to hope that those affected will be able to benefit from this new approach to regenerative medicine in the near future.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 17, 2024
In a setback to Swiss multinational pharma company F-Hoffmann-La Roche, the Delhi High Court has dismissed an application filed by the company seeking injunction against Zydus Lifesciences Ltd’s breast cancer drug Sigrima, a biosimilar of Pertuzumab.
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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.
Bio Pharma Dive
OCTOBER 17, 2024
The French drugmaker will invest 300 million euros into a new entity that will develop lead isotope-based therapies for cancer under the Orano Med brand.
Worldwide Clinical Trials
OCTOBER 14, 2024
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.
Pharmaceutical Technology
OCTOBER 18, 2024
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary cholangitis.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 14, 2024
(Filipp Romanovski/Unsplash) If you look up at the sky on a clear day, you might notice little cobweb-like structures drifting across your field of vision.
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.
Bio Pharma Dive
OCTOBER 16, 2024
The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.
Fierce Pharma
OCTOBER 15, 2024
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.
Pharmaceutical Technology
OCTOBER 14, 2024
Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), regarding the potential sale of a 50% controlling stake in Opella.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 15, 2024
The Directorate General of Foreign Trade (DGFT) has issued Trade Notice No. 19/2024-25, dated October 4, 2024, to provide clarity regarding the Registration-Cum-Membership Certificate (RCMC) requirement for exporters under the Foreign Trade Policy (FTP) 2023.
Advertiser: FourKites
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.
Bio Pharma Dive
OCTOBER 14, 2024
The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.
Fierce Pharma
OCTOBER 18, 2024
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.
Pharmaceutical Technology
OCTOBER 15, 2024
Huawei hosted GITEX's Industrial Digital and Intelligent Transformation Summit and launched joint solutions with partners for ten industries.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 14, 2024
Concerned over the pathetic condition of the traditional medicine retailers in Tamil Nadu, the veteran pharma trader and former president of the Tamil Nadu Chemists and Druggists Association (TN CDA), Mannargudi Ramachandran, has commented that no new registered pharmacist in the state is coming forward to open individual pharmacy shops because of mushrooming of corporate […]
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