AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 25, 2024
Illustrative example of damaged skin, in this case from sunburn. (Jennifer A Smith/Getty Images) A rare and potentially fatal skin infection with nightmarish outcomes may soon have a cure.
Bio Pharma Dive
NOVEMBER 25, 2024
Positive results from a study of Winrevair could help the drugmaker achieve sales growth past top-seller Keytruda’s upcoming patent expirations this decade.
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Rethinking Clinical Trials
NOVEMBER 26, 2024
In an article published online this week , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the collection of patient-reported outcome measures (PROMs) in medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, and rural and frontier communities.
Pharmaceutical Technology
NOVEMBER 26, 2024
Gilead and Aelix first teamed up in 2018 for a clinical research collaboration agreement to investigate the vaccine.
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
Fierce Pharma
NOVEMBER 25, 2024
Eight months after snaring an inaugural FDA green light, Merck & Co. is bolstering the case for the chief asset in its $11.5 billion Acceleron acquisition. | In the phase 3 ZENITH study, Merck’s activin signaling inhibitor Winrevair met its primary endpoint of time to first morbidity or mortality event, which included all-cause death, lung transplantation, or hospitalization for at least 24 hours linked to disease worsening in patients with PAH.
Bio Pharma Dive
NOVEMBER 26, 2024
The brain drug developer is letting go of around 41 of its 238 employees, in a move the company says will help “align resources” with its strategic priorities.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 27, 2024
Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.
Rethinking Clinical Trials
NOVEMBER 25, 2024
Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems. “Teams need to be aware of—and perhaps proactively investigate—possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and saf
Bio Pharma Dive
NOVEMBER 27, 2024
The biotechnology company, which sees itself as "pretty conservative," recently put out an ambitious long-term revenue forecast for its schizophrenia and depression medicine Caplyta.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 27, 2024
The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Previous research has shown rilmenidine mimics the effects of caloric restriction on a cellular level.
Pharmaceutical Technology
NOVEMBER 29, 2024
The ESMP platform enables marketing authorisation holders to report shortages and will be mandatory from 2025.
Medical Xpress
NOVEMBER 29, 2024
"Tell a man he shouldn't think of a pink elephant and he can't get that beast out of his mind!
Bio Pharma Dive
NOVEMBER 26, 2024
The deal suggests Roche sees substantial promise in Poseida’s technology, as the offer is 215% above the biotech’s closing share price on Monday.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 24, 2024
In order to better streamline the approval process for manufacturing license to the medical devices units, the Central government is looking at amending the relevant rules in the Medical Device Rules (MDR), 2017 to include various timelines related to grant of manufacturing license to the four classes of medical devices in the country.
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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
Pharmaceutical Technology
NOVEMBER 29, 2024
The government said that men are less likely than women to seek medical help, particularly for mental health issues.
Medical Xpress
NOVEMBER 29, 2024
Emotional body odors may have the potential to enhance the anxiety-reducing effects of mindfulness. This is shown by a pilot study published in the Journal of Affective Disorders, co-authored by researchers from Karolinska Institutet.
Bio Pharma Dive
NOVEMBER 25, 2024
The setback likely removes one competitor to an emerging spinal muscular atrophy medicine from Scholar Rock, but sets the stage for a pair of readouts with implications for weight loss research.
Deltaclinical
NOVEMBER 25, 2024
In September 2024, the FDA released a document regarding the conduct of clinical trials with decentralized elements.
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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.
Pharmaceutical Technology
NOVEMBER 28, 2024
The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.
Medical Xpress
NOVEMBER 29, 2024
New research has pinpointed key cells that could be targeted to prevent painful rheumatoid arthritis flare-ups, offering potential new hope to millions of people with the condition world-wide.
Bio Pharma Dive
NOVEMBER 26, 2024
Shares in Amgen fell by double digits Tuesday on results for the company’s MariTide shot, which is viewed as a potential rival to Wegovy and Zepbound.
XTalks
NOVEMBER 28, 2024
Axsome Therapeutics has released findings from its ENCORE Phase III trial, demonstrating that their investigational drug AXS-12 (reboxetine) significantly reduces cataplexy attacks, improves excessive daytime sleepiness and enhances overall functioning in individuals with narcolepsy. These results highlight reboxetine’s potential as a comprehensive treatment for this challenging sleep-wake disorder.
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.
Pharmaceutical Technology
NOVEMBER 27, 2024
In recent years, the evolution of biologic therapies for severe asthma has paralleled advancements in other chronic conditions such as rheumatoid arthritis and psoriasis, where biologics have also transformed treatment paradigms.
Medical Xpress
NOVEMBER 29, 2024
Using a gene-screening method they created, Stanford Medicine researchers may have discovered why an effective chemotherapy damages heart cells—and they have identified a drug that could keep the heart cells beating.
Bio Pharma Dive
NOVEMBER 27, 2024
Kronos is cutting 83% of its workforce, while Idorsia is considering eliminating as many as 270 jobs. Elsewhere, PTC disclosed negative Phase 2 results for its ALS drug candidate utreloxastat.
XTalks
NOVEMBER 26, 2024
The US Food and Drug Administration (FDA) has approved Attruby (acoramidis) , marking a significant advancement for patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). This progressive disease occurs when misfolded transthyretin (TTR) proteins form amyloid deposits in the heart, leading to cardiac dysfunction. Attruby offers a near-complete stabilization of TTR — over 90 percent — halting the formation of amyloid fibrils that cause tissue damage and addressing the underlying p
Pharmaceutical Technology
NOVEMBER 28, 2024
There are currently no FDA- or EMA-approved treatment options available for any form of frontotemporal dementia.
Medical Xpress
NOVEMBER 29, 2024
A research group led by Prof. Cai Xinxia from the Aerospace Information Research Institute (AIR) of the Chinese Academy of Sciences developed a new method for fabricating high-precision, low-curvature microelectrode arrays (MEAs), which are designed for recording neuronal activities in the brain's deep small volume region. The study was published in Microsystems & Nanoengineering.
Bio Pharma Dive
NOVEMBER 27, 2024
A broad licensing and research alliance will hand Sarepta four clinical-stage candidates, while Arrowhead receives $500 million in cash and another $325 million in equity investment.
Fierce Pharma
NOVEMBER 25, 2024
Incyte’s previously disclosed phase 3 win in relapsed or refract | In the phase 3 inMIND study, Monjuvi—added to Bristol Myers Squibb's Revlimid and Roche's Rituxan—triggered a 57% reduction in the risk of disease progression, relapse or death in R/R FL patients compared with those who were treated with placebo, Revlimid and Rituxan.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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