Sat.Nov 23, 2024 - Fri.Nov 29, 2024

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A Rare, Fatal Skin Disease Has Been Cured in Patients For The First Time

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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New data could help Merck expand use of cardiovascular drug

Bio Pharma Dive

Positive results from a study of Winrevair could help the drugmaker achieve sales growth past top-seller Keytruda’s upcoming patent expirations this decade.

Sales 287
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November 26, 2024: Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations

Rethinking Clinical Trials

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.

Trials 147
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Gilead adds investigational HIV vaccine to its portfolio from Spanish biotech   

Pharmaceutical Technology

Gilead and Aelix first teamed up in 2018 for a clinical research collaboration agreement to investigate the vaccine.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Merck preps filings after blockbuster-in-waiting Winrevair succeeds in severe PAH study

Fierce Pharma

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.

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Alector turns to layoffs as Alzheimer’s drug fails

Bio Pharma Dive

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.

Drugs 278

More Trending

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Digital transformation expected to shorten drug development timelines

Pharmaceutical Technology

Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.

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November 25, 2024: NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials

Rethinking Clinical Trials

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

Trials 147
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How Intra-Cellular surprised Wall Street by breaking character

Bio Pharma Dive

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.

Medicine 173
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Drugs Like Ozempic May Have a Shrinking Effect on The Heart

AuroBlog - Aurous Healthcare Clinical Trials blog

Cardiac muscle cells in mice. (Martens et al., The Lancet, 2024) Popular weight loss drugs like Ozempic and Wegovy are showing incredible short-term benefits – from boosted metabolic health to pain relief to addiction and cognitive health.

Drugs 190
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Airways unbound: The biologic revolution in asthma treatment  

Pharmaceutical Technology

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.

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FDA Guidance on Decentralized Clinical Trials

Deltaclinical

In September 2024, the FDA released a document regarding the conduct of clinical trials with decentralized elements.

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Biohaven muscle drug misses goal of SMA study, but advances in obesity

Bio Pharma Dive

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.

Medicine 173
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PCI to integrate pharmacists’ database with Healthcare Professional Registry

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacy Council of India (PCI) has sought all the pharmacists who don’t have the ABHA (Ayushman Bharat Health Account) number to attain a number and ensure registration with the DIGI-PHARMed profile with the ABHA number on immediate basis, as part of its efforts to integrate the pharmacists’ list with the Healthcare Professional Registry (HPR).

Pharmacy 190
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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UK Government to launch first ever men’s health strategy

Pharmaceutical Technology

The government said that men are less likely than women to seek medical help, particularly for mental health issues.

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Emotional body odors may enhance the effect of mindfulness therapy

Medical Xpress

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.

Research 120
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Roche to buy cell therapy developer Poseida for $1B

Bio Pharma Dive

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.

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Stem Cells Grown in Space Turn Out to Have a Surprise Advantage

AuroBlog - Aurous Healthcare Clinical Trials blog

(SciePro/Science Photo Library/Getty Images) Stem cells are special in the way they can keep on replicating, and turn themselves into many other types of cell. Now scientists have discovered how their superpowers get a remarkable boost when they’re grown in space.

Scientist 195
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat

Pharmaceutical Technology

The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.

Drugs 246
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Bristol Myers Squibb hands pink slips to 195 workers in NJ as cost-cutting effort rolls on

Fierce Pharma

Bristol Myers Squibb has executed another round of layoffs in its ongoing cost-savings push. | Bristol Myers Squibb has executed another round of layoffs in its ongoing cost-savings push. The company has handed pink slips to 195 more employees, according to a New Jersey Worker Adjustment and Retraining Notification (WARN) update.

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Amgen obesity drug cuts weight in study, but results miss Wall Street’s high mark

Bio Pharma Dive

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.

Drugs 162
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A Common Blood Pressure Drug Extends Lifespan And Slows Aging in Animals

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Drugs 171
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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EMA launches ESMP for better management of drug shortages in EU

Pharmaceutical Technology

The ESMP platform enables marketing authorisation holders to report shortages and will be mandatory from 2025.

Drugs 244
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ASH: Incyte's Monjuvi triumphs in follicular lymphoma phase 3, teeing up FDA filing

Fierce Pharma

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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Kronos, Idorsia plan layoffs; PTC shelves ALS drug

Bio Pharma Dive

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.

Drugs 147
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ICMR invites proposals for clinical studies on medical device and diagnostic technologies under CAR scheme

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has announced an open call for proposals under its Centre for Advanced Research (CAR) scheme to support clinical studies for medical device and diagnostic technologies developed through the ICMR-DHR-Centre of Excellence (CoEs) programme at various IITs.

Research 156
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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CervoMed’s stock rises as FDA grants orphan drug status to dementia drug

Pharmaceutical Technology

There are currently no FDA- or EMA-approved treatment options available for any form of frontotemporal dementia.

Drugs 240
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Novartis plots more than 100 layoffs in New Jersey as part of rework to Xolair, cancer combo field sales teams

Fierce Pharma

While Novartis has largely wrapped up its transformation into a leaner innovative medicines company—which included multiple rounds of staff cuts over the years—employment changes are still afoot at | Novartis is laying off a total of 139 staffers in East Hanover, New Jersey, where the company’s U.S. headquarters is located. The move will primarily affect commercial field sales associates working on the brands Xolair for asthma and allergies and the oncology combo made up of kinase inhibitors Taf

Sales 119
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Sarepta rebuilds drug pipeline with Arrowhead deal

Bio Pharma Dive

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.

Licensing 147
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Bioengineering is the new frontier in advanced technology: Kiran Mazumdar Shaw

AuroBlog - Aurous Healthcare Clinical Trials blog

Digital technologies have transformed biology research to provide in-depth insights into unravelling the mysteries of living systems. Bioengineering is the new frontier in advanced technology, said Kiran Mazumdar-Shaw, chairperson, Biocon Group and Association of Biotechnology Led Enterprises (ABLE). Genetic engineering has unleashed a power house of bio manufacturing in the fermentation industry.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

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