Bio Pharma Dive
NOVEMBER 13, 2023
Regulatory agencies have set the framework and use cases for RWE. How can these increase the probability of success or efficiency in a pre-clinical and clinical drug development program?
Bio Pharma Dive
NOVEMBER 13, 2023
Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.
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Crucial Data Soutions
NOVEMBER 14, 2023
What does patient-centricity mean to you? For some, this means making the process of collecting patient data as easy as. The post Is Your Participant Reimbursement Software Patient-Centric? Automated Reimbursement through TrialKit Helps You Walk the Walk appeared first on Crucial Data Solutions.
BioPharma Reporter
NOVEMBER 16, 2023
The Pistoia Alliance is a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D. It has just announced its four new strategic priorities made up of global pharma and tech representatives to deliver new project ideas to drive industry change.
Bio Pharma Dive
NOVEMBER 16, 2023
The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.
Drug Discovery World
NOVEMBER 16, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the world’s first gene therapy for sickle-cell disease (SCD) and transfusion-dependent β-thalassemia (TDT). Casgevy (exagamglogene autotemcel, or exa-cel) is the first medicine to be licensed that uses gene editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 15, 2023
Since halting work on a sickle cell treatment early this year, Graphite Bio has laid off staff, shed assets and, now, agreed to be subsumed via a merger with Lenz Therapeutics.
Pharmaceutical Technology
NOVEMBER 17, 2023
Micron Biomedical has received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2023
So much of our health is tied to banking good quality sleep every night, and a new four-week experiment has revealed a simple way anyone can improve the quality of their slumber: keeping the bedroom well-ventilated.
Rethinking Clinical Trials
NOVEMBER 15, 2023
In this Friday’s PCT Grand Rounds, Michael Ho and Sheana Bull of the University of Colorado will present “Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results From the Nudge Study.” The Grand Rounds session will be held on Friday, November 17, 2023, at 1:00 pm eastern. Nudge is an NIH Pragmatic Trials Collaboratory Demonstration Project.
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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
NOVEMBER 16, 2023
Clearance of Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy in the U.K. comes ahead of expected regulatory decisions in the U.S. and Europe.
Pharmaceutical Technology
NOVEMBER 16, 2023
Vertex and CRISPR's Casgevy has received conditional approval in the UK for treating sickle cell and transfusion-dependent beta-thalassemia.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 12, 2023
The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.
Fierce Pharma
NOVEMBER 15, 2023
In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.
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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
NOVEMBER 13, 2023
Forge Biologics operates a contract manufacturing business as well as develops its own gene therapies, which appears to have attracted the Japan-based food and biotechnology company.
Pharmaceutical Technology
NOVEMBER 13, 2023
As per the company, the candidate THIO, is the only direct telomere-targeting agent currently in clinical development.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 15, 2023
Timing is everything. For early risers and late-nighters alike, listening to your internal clock may be the key to success. From the classroom to the courtroom and beyond, people perform best on challenging tasks at a time of day that aligns with their circadian rhythm.
Fierce Pharma
NOVEMBER 14, 2023
Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. | Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule capabilities at its site in Sandwich in Kent in the U.K. The move is a consequence of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October.
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
NOVEMBER 13, 2023
Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.
Pharmaceutical Technology
NOVEMBER 16, 2023
Ardelyx scores another FDA win after Xphyozah was approved by the FDA in October as an add-on therapy for chronic kidney disease patients.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 16, 2023
Few people had probably heard of frontotemporal dementia until earlier this year, when the family of actor Bruce Willis announced the 68-year-old had been diagnosed with the condition. Frontotemporal dementia is a rare disease – thought to account for only one in every 20 cases of dementia.
BioSpace
NOVEMBER 15, 2023
The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.
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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
Bio Pharma Dive
NOVEMBER 16, 2023
Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.
Pharmaceutical Technology
NOVEMBER 15, 2023
Chief executive Amanda Pritchard says vaccination and screening could make eliminating cervical cancer a reality in the next two decades.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 13, 2023
As we speak, our brains choreograph an intricate dance of muscles in our mouths and throats to form the sounds that make up words. This complex performance is reflected in the electrical signals sent to speech muscles.
Antidote
NOVEMBER 14, 2023
For Carla Greenbaum, M.D., growing up in the era of space travel and the moon landing kindled a lifelong interest in science. That interest influenced her career trajectory, and she’s now a leading investigator at Benaroya Research Institute where she has studied the natural history of type 1 diabetes (T1D) since 2000. Her work focuses on finding the cause of autoimmunity and developing targets for treatment, which she finds “incredibly exciting and inspiring—like landing on the moon!
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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.
Bio Pharma Dive
NOVEMBER 16, 2023
Red Tree Venture Capital plans to tap into San Diego’s biotech pipeline as it works to build a West Coast competitor to Boston-area investors.
Pharmaceutical Technology
NOVEMBER 16, 2023
The mRNA therapy may help to accelerate the regeneration of the urinary sphincter muscle, treating women with stress urinary incontinence.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 13, 2023
The Union Ministry of Ayush has come out with the revised guidelines governing the National Dhanwantari Ayurveda Award to be conferred to renowned ayurvedic practitioners, while celebrating the Ayurveda Day every year on the day of Dhanwantari Jayanti (Dhanteras).
Antidote
NOVEMBER 17, 2023
Achondroplasia, also known as achondroplastic dwarfism or ACH, is a rare disorder characterized by short stature, a large head, and short arms and legs. It is the most common type of skeletal dysplasia, the umbrella term that identifies hundreds of conditions , and occurs in about one in 15,000 to 35,000 births.
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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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