Bio Pharma Dive

JANUARY 24, 2023

The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.

Clinical Trials 315

Clinical Trials Clinical Trials Drugs Medicine 315

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Worldwide Clinical Trials

JANUARY 6, 2025

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Bio Pharma Dive

APRIL 18, 2022

Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

Clinical Trials 297

Clinical Trials Clinical Trials Marketing Medicine 297

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success. A promising new medicine has now […]

Clinical Trials 246

Clinical Trials Clinical Trials Protein Scientist 246

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2025

A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.

Regulation 112

Regulation Drugs Vaccination Vaccine 112

Pharmaceutical Technology

OCTOBER 3, 2024

Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.

Manufacturing 130

Manufacturing Medicine Production Trials 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

Production 188

Production Clinical Trials Clinical Trials Compliance 188

Worldwide Clinical Trials

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. As personalized medicine continues to evolve, the choice of sample collection method will play a pivotal role in shaping its future.

Medicine 182

Medicine DNA Compliance Clinical Trials 182

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 21, 2022

The Union Ministry of Ayush’s ‘One Herb, One Standard’ policy mandates evaluation of drug standards and quality control in medicinal plants.

Medicine 185

Medicine Drugs Clinical Trials Clinical Trials 185

Worldwide Clinical Trials

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients. Securing the supply chain.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

NOVEMBER 20, 2022

This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK. NICE’s technology appraisals calculate appropriate costs for drugs using the incremental cost-effectiveness ratio (ICER).

Drugs 279

Drugs Medicine Antibody Clinical Trials 279

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 7, 2024

A drug used to treat diabetes slowed the progression of motor issues associated with Parkinson’s disease, a study published in the New England Journal of Medicine said Wednesday. Parkinson’s is a devastating nervous system disorder affecting 10 million people worldwide, with no current cure.

Drugs 242

Drugs Medicine Clinical Trials Clinical Trials 242

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.​

FDA Approval 245

FDA Approval Drugs Medicine Clinical Trials 245

Velocity Clinical Research

MARCH 23, 2025

Clinical trials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2% Whats Causing the Outflow?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

Camargo

NOVEMBER 22, 2021

In this Q&A, Andrea discusses their experience, especially as it relates to the two clinical trials Tom participated in. We were getting tools to help manage our lives and medicines to manage Tom’s symptoms. We wanted to participate in a clinical trial. And I started researching trials.

Clinical Trials 198

Clinical Trials Clinical Trials Trials Research 198

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 8, 2024

The Drugs Technical Advisory Board (DTAB) has suggested to the ministry of health and family welfare (MoHFW) to write to the ministry of corporate affairs to mandate the pharma companies to spend almost one per cent of their net profit for providing free medicines in medicine banks as part of the Corporate Social Responsibility (CSR). […]

Medicine 185

Medicine Pharma Companies Drugs Clinical Trials 185

Velocity Clinical Research

NOVEMBER 12, 2024

Over the past decade, Germany’s share of global clinical trial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

NOVEMBER 29, 2024

Automated Industrial Robotics have delivered a bespoke Just in Time PACE system to CPI’s new Medicines Manufacturing Innovation Centre.

Manufacturing 130

Manufacturing Medicine Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

Research 147

Research Clinical Trials Clinical Trials Immune Response 147

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 5, 2022

The National AIDS Control Organization (NACO) has resumed one-month dispensation of HIV medicines nationwide following intervention by the Union ministry of health and family welfare. The […].

Medicine 186

Medicine Drugs Clinical Trials Clinical Trials 186

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

Research 130

Research Clinical Trials Clinical Trials Immune Response 130

World of DTC Marketing

NOVEMBER 5, 2021

It’s being positioned as an anti-obesity drug, but one study by Novo Nordisk has shown that people who stop taking Wegovy after a few months tend to regain much of their lost weight within a year. In addition, people who lost weight on Wegovy in clinical trials had nutritional counseling and had to stay on a strict diet.

Drugs 271

Drugs Pharmacy Clinical Trials Clinical Trials 271

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

Clinical Trials 234

Clinical Trials Clinical Trials FDA Approval Trials 234

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 6, 2023

There is a growing concern about the lack of stringent norms on disposal of unused and expired medicines that pose a threat to health and the environment. The key issue is the lack of dedicated guidelines on the disposal under the Drugs & Cosmetics Act.

Medicine 185

Medicine Cosmetics Drugs Clinical Trials 185

Rethinking Clinical Trials

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinical trial diversity and cardiovascular health for all.

Clinical Trials 138

Clinical Trials Clinical Trials Trials Cardiology 138

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

Clinical Development 341

Clinical Development Clinical Trials Clinical Trials Trials 341

Worldwide Clinical Trials

AUGUST 10, 2023

The event provided a unique opportunity to interact with a large and diverse group of fellow stakeholders, expanding my perspective on the impact of psychedelic clinical trials. Psychedelic Research at Worldwide Since 2017, Worldwide Clinical Trials have supported a myriad of sponsors leading the way in psychedelic research programs.

Clinical Trials 246

Clinical Trials Clinical Trials Trials Clinical Research 246

Pharmaceutical Technology

NOVEMBER 1, 2022

Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. To be named Intrinsic Medicine following closing, the combined company will be led by current Intrinsic CEO Alexander Martinez and president and COO Jason Ferrone.

Medicine 147

Medicine Clinical Trials Clinical Trials Drugs 147

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Dermatology 130

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 22, 2022

Indian drug regulators have sought pharmacovigilance (PV) for neuropathic pain drugs gabapentin and pregabalin due to cardiovascular related adverse event citing a study by American medical journal Cardiovascular Diabetology.

Drugs 203

Drugs Regulation Vaccination Vaccine 203

XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. It’s very positive and it’s going to help move forward the pathway for new drugs.”

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

Pharmaceutical Technology

APRIL 20, 2023

The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Drug development had to change.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Nurses 130

XTalks

JANUARY 8, 2024

Getting a drug to market used to be a relatively simple and straightforward affair. Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. That’s just not the case anymore.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Gene Therapy 105

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Drugs 246

Drugs FDA Approval Development Marketing 246