Crucial Data Soutions
DECEMBER 19, 2023
The growth of decentralized clinical trial (DCT) strategies may be happening slower than many expected, but it is definitely happening. The post The Advantages of Decentralized Clinical Trials in Diabetes Research appeared first on Crucial Data Solutions.
pharmaphorum
DECEMBER 18, 2023
AI-driven text analytics can revolutionise the clinical trial process by improving data collection and analysis in the biopharma industry. Learn how this technology can enhance efficiency and patient outcomes.
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pharmaphorum
DECEMBER 21, 2023
Patient-centric advertising using zero-party data can provide effective and personalised healthcare marketing while ensuring compliance with legal regulations and industry standards.
Drug Discovery World
DECEMBER 18, 2023
Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution. The human body, a complex tapestry of over 100 trillion cells 1 and 25,000 genes 2 , remains a biological marvel yet to be fully deciphered.
Worldwide Clinical Trials
DECEMBER 20, 2023
In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” His presentation covered various aspects of oncology clinical programs, focusing on study design trends, with reference to both the recently implemented FDA Project Optimus guidance and studies we have seen from sponsors.
Pharmaceutical Technology
DECEMBER 19, 2023
Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 21, 2023
Moderna CEO Stephane Bancel told AFP his company’s experimental vaccine against melanoma could be available in as little as two years, in what would amount to a landmark step against the most serious form of skin cancer. Globally there were an estimated 325,000 new melanoma cases and 57 ,000 deaths from the disease in 2020.
Fierce Pharma
DECEMBER 22, 2023
Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. | Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise.
Pharmaceutical Technology
DECEMBER 22, 2023
As the number of patients with cancers continues to grow globally, research into personalised cancer vaccines is vital.
Bio Pharma Dive
DECEMBER 19, 2023
The biotechnology company’s share price fell more than 10% Tuesday after the disclosure of more data from a small study.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 17, 2023
Sickness in pregnancy, or hyperemesis gravidarum, is common and is thought to affect seven out of ten women at some time in their pregnancy. But, until recently, very little has been known about why it happens.
BioSpace
DECEMBER 17, 2023
The agency is investigating reports of secondary blood cancers in patients who have received certain CAR T cell therapies, but experts say the risk is low and is outweighed by the terminal nature of some cancers.
Pharmaceutical Technology
DECEMBER 18, 2023
Following US and UK approvals, the EMA’s CHMP has recommended conditional approval for Casgevy, with a decision expected in Q1 2024.
Bio Pharma Dive
DECEMBER 19, 2023
The company’s shot targets 21 strains of pneumococcal bacteria and, if approved, would compete with Pfizer’s Prevnar 20.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 20, 2023
In recent years, a growing number of scientific studies have backed an alarming hypothesis: Alzheimer’s disease isn’t just a disease, it’s an infection. While the exact mechanisms of this infection are something researchers are still trying to isolate, numerous studies suggest the deadly spread of Alzheimer’s goes way beyond what we used to think.
BioSpace
DECEMBER 20, 2023
Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.
Pharmaceutical Technology
DECEMBER 21, 2023
Genevoyager has announced the opening of contract development and manufacturing organisation facility to manufacture gene therapy products.
Bio Pharma Dive
DECEMBER 18, 2023
The firm is tracking startups that launched during the biotechnology sector’s peak a few years ago but now need fresh funds to move their programs forward, one of its investors said.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 19, 2023
Just as the shift to shorter days and colder weather can bring with it mood swings and other emotional challenges, the holiday season can also bring about somewhat predictable changes in mood and behavior. Around this time of year, many of us experience more stress, anxiety and frustration than usual.
Fierce Pharma
DECEMBER 19, 2023
On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. | On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. The agency granted a priority review to Roche's filing and plans to make a decision during the first quarter of next year.
Pharmaceutical Technology
DECEMBER 19, 2023
Sanofi and Innate’s cancer collaboration agreement stretches back to 2016, with two of Sanofi’s NK cell engagers in clinical studies.
Bio Pharma Dive
DECEMBER 21, 2023
Ahead of a Phase 3 readout that could come next year, the pharma is paying $130 million in upfront and near-term cash for rights to the retinitis pigmentosa treatment that it didn’t already own.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 20, 2023
The HoD of the Department of Pharmacy Practice at the CL Baid Mehta College of Pharmacy in Chennai, Prof. Guruprasad Mohanta has been bestowed with the prestigious Acharya P C Ray Gold Medal Award 2023 instituted by the Bengal branch of the Indian Pharmaceutical Association (IPA).
pharmaphorum
DECEMBER 18, 2023
To effectively combat rare diseases, it is essential to prioritise the collection and analysis of data. This article explores how pharmaceutical companies are leveraging AI and focusing on orphan drugs to tackle rare diseases.
Pharmaceutical Technology
DECEMBER 20, 2023
The FDA accepted the filing based on NIH-funded Phase III trial interim results, with an approval decision expected in Q1 2024
Bio Pharma Dive
DECEMBER 18, 2023
While the study met its goal, the drug’s benefit was less than analysts had predicted, an outcome that could hasten a planned takeover by Eli Lilly.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 18, 2023
A healthy smile helps us live long, well and happy lives. But just like our bodies, our teeth succumb to age-related changes. So what happens to teeth as you age? And what can you do to ensure your smile lasts the distance? [link] First, what are teeth made of?
Fierce Pharma
DECEMBER 19, 2023
A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. | A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech.
Pharmaceutical Technology
DECEMBER 18, 2023
The Novo Nordisk Foundation has invested Dkr1.8bn in the initiative to develop vaccines for various airborne infection diseases.
Bio Pharma Dive
DECEMBER 19, 2023
A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.
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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.
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