Sat.Nov 11, 2023 - Fri.Nov 17, 2023

article thumbnail

Real-world evidence in pharmaceutical drug development – faster, safer and more relevant?

Bio Pharma Dive

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?

article thumbnail

3 ways decentralized clinical trials could help advance research on rare diseases

Bio Pharma Dive

Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Is Your Participant Reimbursement Software Patient-Centric? Automated Reimbursement through TrialKit Helps You Walk the Walk

Crucial Data Soutions

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.

59
article thumbnail

Not-for-profit alliance advocates for life sciences collaboration

BioPharma Reporter

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.

article thumbnail

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

article thumbnail

Paper details Astellas gene therapy study that led to patient deaths

Bio Pharma Dive

The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.

article thumbnail

Great Britain first to approve CRISPR-based gene therapy

Drug Discovery World

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.

More Trending

article thumbnail

A gene editing biotech’s struggles end with reverse merger

Bio Pharma Dive

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.

article thumbnail

Micron Biomedical receives funds to produce needle-free vaccines

Pharmaceutical Technology

Micron Biomedical has received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.

article thumbnail

Four-Week Experiment Reveals an Ingeniously Simple Way to Boost Your Sleep Quality

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Research 190
article thumbnail

November 15, 2023: In This Friday’s PCT Grand Rounds, Results From the Nudge Demonstration Project

Rethinking Clinical Trials

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.

article thumbnail

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

article thumbnail

World’s first CRISPR medicine approved in UK for sickle cell, beta thalassemia

Bio Pharma Dive

Clearance of Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy in the U.K. comes ahead of expected regulatory decisions in the U.S. and Europe.

Medicine 306
article thumbnail

World’s first CRISPR-based gene therapy approved for sickle cell anaemia

Pharmaceutical Technology

Vertex and CRISPR's Casgevy has received conditional approval in the UK for treating sickle cell and transfusion-dependent beta-thalassemia.

article thumbnail

FDA Approves Powerful New Drug to Counter Obesity Epidemic

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

Fierce Pharma

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.

Trials 144
article thumbnail

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.

article thumbnail

Ajinomoto spices up its biopharma business with gene therapy deal

Bio Pharma Dive

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.

article thumbnail

FDA grants orphan drug designation to MAIA’s glioblastoma agent  

Pharmaceutical Technology

As per the company, the candidate THIO, is the only direct telomere-targeting agent currently in clinical development.

article thumbnail

Mastering Your Body’s Internal Clock Could Be The Key to Success

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

Pfizer's cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

Fierce Pharma

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.

141
141
article thumbnail

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.

article thumbnail

Anthos blood thinner bests Xarelto on safety in mid-stage study

Bio Pharma Dive

Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.

Trials 293
article thumbnail

Xphozah wins orphan drug designation for paediatric hyperphosphatemia

Pharmaceutical Technology

Ardelyx scores another FDA win after Xphyozah was approved by the FDA in October as an add-on therapy for chronic kidney disease patients.

Drugs 246
article thumbnail

An ‘Extra Fold’ in The Human Brain May Delay Early Dementia by Years

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

Vertex, CRISPR Win World’s First Approval for CRISPR-Edited Therapy from UK

BioSpace

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.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

FDA approves new Bristol Myers drug for lung cancer

Bio Pharma Dive

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.

article thumbnail

NHS sets sights on ending cervical cancer by 2040 with HPV vaccine drive

Pharmaceutical Technology

Chief executive Amanda Pritchard says vaccination and screening could make eliminating cervical cancer a reality in the next two decades.

article thumbnail

Amazing Tiny Brain Implant Translates Brain Signals Into Speech

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Scientist 173
article thumbnail

Companies Devise New Ways to Smuggle Drugs Across the Blood-Brain Barrier

BioSpace

To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond.

Drugs 126
article thumbnail

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.

article thumbnail

West Coast investor Red Tree on its San Diego expansion and staying bullish in biotech

Bio Pharma Dive

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.

275
275
article thumbnail

FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Pharmaceutical Technology

The mRNA therapy may help to accelerate the regeneration of the urinary sphincter muscle, treating women with stress urinary incontinence.

article thumbnail

Ministry of Ayush modifies eligibility criteria for National Dhanwantari Ayurveda Award

AuroBlog - Aurous Healthcare Clinical Trials blog

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).

article thumbnail

AbbVie’s Migraine Drug Ubrelvy Scores Victory in Phase III Study

BioSpace

When given hours ahead of an expected episode, a late-stage study showed the preventive benefits of Ubrelvy in safely reducing moderate or severe headaches within 24 hours of treatment.

Drugs 125
article thumbnail

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.