Sat.Feb 10, 2024 - Fri.Feb 16, 2024

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Why patient centricity is the answer to the clinical trial enrolment gap 

Pharmaceutical Technology

Research indicates that designing clinical trials with the patient in mind reduces recruitment times and enhances trial performance.

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What We Can Learn from Minority Experiences in Clinical Trials

ACRP blog

“If we are to improve diversity in clinical trials, we need to understand minority experiences, and how these can be improved to support recruitment and retention,” says Heidi Green, PhD, Director of Health Research Equity, COUCH Health. “The Minority Experiences in Clinical Trials (MERIT) project set out to understanding why ethnic minorities are underrepresented, using a qualitative evidence synthesis to identify factors that influence recruitment.

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What I love About Being a CRA (Clinical Research Associate)

ECRG Media's Clinical Research Podcast

What I love About Being a CRA Don't forget to Subscribe for new content! Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group o

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ICMR issues comprehensive guidance on ethical requirements for laboratory validation testing

AuroBlog - Aurous Healthcare Clinical Trials blog

In a significant move aimed at upholding ethical standards in the realm of medical research, the Indian Council of Medical Research (ICMR) has recently released detailed guidelines on the ethical requirements for laboratory validation testing.

Research 147
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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February 14, 2024: In This Friday’s PCT Grand Rounds, Clinical Implications of the MINT Trial

Rethinking Clinical Trials

Dr. Jeffrey Carson In this Friday’s PCT Grand Rounds, Jeffrey Carson of Rutgers Biomedical and Health Sciences will present “Clinical Implications of the MINT Trial: p=0.07.” The Grand Rounds session will be held on Friday, February 16, 2024, at 1:00 pm eastern. Carson is provost-New Brunswick for Rutgers Biomedical and Health Sciences and the Distinguished Professor of Medicine and Richard C.

Trials 152
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Alnylam change to heart drug trial sparks doubts, sinking shares

Bio Pharma Dive

Analysts pressed Alnylam executives on the reasons for the changes to HELIOS-B, a Phase 3 study in ATTR amyloidosis with cardiomyopathy that is important to the company’s future.

More Trending

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Obesity Disrupts Mitochondria, And We May Have Figured Out How

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have revealed in unprecedented detail how obesity affects mitochondria in mice, causing the cellular powerhouses to fragment into smaller pieces. Mitochondria are famous as “powerhouses of the cell,” given their crucial role in generating energy. Yet the vital work of these organelles is often impaired in people with obesity, for reasons that remain unclear.

Scientist 213
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Mastering Ultra-Low Freezer Repair: A Comprehensive Guide

Pharma Mirror

In the dynamic realm of laboratory instruments, ultra-low freezers play a pivotal role in preserving valuable samples and reagents. These sophisticated devices are crucial for various fields, ranging from medical research to pharmaceutical development. Today, we delve into the nuances of ultra-low (also called so low) freezer repair, exploring their main applications and common troubleshooting issues.

Reagent 130
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Hunting a non-opioid painkiller, a biotech startup reveals plans to chase Vertex

Bio Pharma Dive

Latigo Biotherapeutics has raised $135 million to develop drugs that block NaV1.8, a target shared by a Vertex therapy that just succeeded in Phase 3 testing.

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Psychedelic treatments for mental health: Is there substance behind the hype?

Pharmaceutical Technology

The success of recent trials treating mental health problems with psychedelic therapies has driven a rapid rise in investment in the area.

Trials 290
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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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Simulations Reveal What Happens When a Sperm Kisses an Egg

AuroBlog - Aurous Healthcare Clinical Trials blog

The moment when a slithering sperm propels itself head-first into a gelatinous egg is one of sudden change. Within seconds to minutes, chemical changes in the egg’s membrane and outer coat are enacted to block any more sperm from attaching to and entering the oocyte.

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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

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Sage offers details on launch of new postpartum depression pill

Bio Pharma Dive

The company and partner Biogen say signs from payers and doctors suggest the launch of Zurzuvae, the first oral therapy for PPD, is off to a good start.

Doctors 306
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UK Agency targets blood thinners in personalised medicine pursuit

Pharmaceutical Technology

The MHRA kicks off phase two of the Yellow Card biobank to explore the genetic link to side effects of direct oral anticoagulants.

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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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The Blood of Exceptionally Long-Lived People Reveals Key Differences

AuroBlog - Aurous Healthcare Clinical Trials blog

Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s. How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know.

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FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.

Allergies 130
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ALS drug from Denali, Sanofi falls short in mid-stage study

Bio Pharma Dive

The disclosure the experimental therapy missed its trial goal comes after Sanofi had earmarked the drug for advancement into Phase 3.

Drugs 294
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Biotechs ride obesity drug wave with novel approaches that go beyond GLP-1RAs

Pharmaceutical Technology

As the market is progressively becoming saturated by GLP-1 receptor agonists, companies are investigating alternative mechanisms of action.

Drugs 264
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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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When You Got Your Period May Impact Dementia Risk, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

The ages at which a person starts and stops menstruating could impact their risk of developing dementia later in life, according to the largest study of its kind.

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2024 predictions: Experts comment on AI, ML and automation

Drug Discovery World

DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. This is part of a series of predictions based on different themes. Here, experts weigh in on the impact of artificial intelligence (AI), machine learning (ML) and automation in the sector. Updesh Dosanjh, Practice Leader for Pharmacovigilance Technology Solutions, IQVIA “In 2024, the traditional pain points of the pharmacovigilance (PV) space will not disappear.

Genome 139
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Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies

Bio Pharma Dive

Kelonia will receive $40 million upfront through a partnership to develop “off-the-shelf” cell therapies for cancer.

In-Vivo 291
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Otsuka wins FDA breakthrough therapy designation for IgAN drug 

Pharmaceutical Technology

This positive news comes after Otsuka’s Phase III Alzheimer’s agitation trial failed to meet its primary endpoint, announced earlier this week.

Drugs 246
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Expiry date for prescription necessary to prevent AMR: AICDF

AuroBlog - Aurous Healthcare Clinical Trials blog

The Kolkata headquartered All India Chemists and Distributors Federation (AICDF), a breakaway group of the AIOCD and a body of pharmaceutical distributors and retailers across the country, has informed the government of West Bengal that a period of use or an expiry date, on the lines of the use of therapeutics, is necessary for doctors’ […]

Doctors 170
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'The Top Line': Gene editing's next act

Fierce Pharma

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

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Two GV partners on biotech’s reset and building their next drug startups

Bio Pharma Dive

Newly named partner Anthony Philippakis and managing partner Krishna Yeshwant spoke with BioPharma Dive about biotech’s newfound optimism and their investing “North Star.

Drugs 228
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FDA approves Eicos’s Aurlumyn for severe frostbite treatment

Pharmaceutical Technology

The US FDA has granted approval for Eicos Sciences' Aurlumyn for adults with severe frostbite to lower the risk of amputation.

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The New Age of Decentralized Clinical Trials

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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Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union Ministry of Ayush will soon amend the Drugs and Cosmetic Rules, 1945 to mandate good manufacturing practices for Homoeopathy drug manufacturing, stipulating procedures for loan licensing in the system of Homoeopathy and specifying timelines for issuance of license, among others.

Licensing 156
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PrecisionLife partners with Metrodora Institute to offer new hope for long COVID sufferers

BioPharma Reporter

PrecisionLife has partnered with healthcare center the Metrodora Institute to jumpstart the diagnosis and treatment options for a range of chronic diseases including long COVID, ME/CFS, ALS and SjÃgren's syndrome.

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Gilead to buy CymaBay in $4.3B deal for liver disease drug

Bio Pharma Dive

The proposed acquisition is a bet on CymaBay’s drug seladelpar, which is now under FDA review in a chronic liver disease called primary biliary cholangitis.

Drugs 300
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GSK to license Elsie’s oligonucleotide discovery platform

Pharmaceutical Technology

GSK has exercised its option for a licence for Elsie Biotechnologies’ discovery platform to detect and develop new oligonucleotides.

Licensing 240
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.