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Category: Clinical Trials


Clinical Trials, Research and Development

EMA announces launch of two advice pilots to improve clinical trials in Europe

June 12, 2024

Via: PMLiVE

The pilots aim to improve the quality of applications for clinical trials and lay the foundation for the development of safe and effective medicines in Europe. First launched in January 2022, the ACT EU initiative seeks to transform how clinical […]


Clinical Trials, Research and Development

Trial readout sets up filings for Insmed bronchiectasis drug

May 29, 2024

Via: Pharmaphorum

The phase 3 trial achieved a statistically significant reduction in the frequency of exacerbations in patients with bronchiectasis, a serious, chronic lung disease with no approved treatment that affects around a million people across the US, Europe, and Japan. In […]


Clinical Trials, Research and Development

Nurturing the power of true connections in your clinical trials

May 23, 2024

Via: PMLiVE

But is it really possible to build and sustain connection at this level and, if so, how? To build meaningful and lasting connections, the relationship needs to go both ways. Before we speak, it’s important that we listen. Particularly when […]


Clinical Trials, Research and Development

Dyne shares jump on trial data for muscle disease drugs

May 20, 2024

Via: Biopharma Dive

Dyne’s data are from early-stage trials testing the biotechnology company’s two most advanced drugs. Yet the results, and Dyne’s confidence they could support approval applications, were enough to boost the biotech’s shares by about 22%, swelling its market valuation to […]


Clinical Trials, Research and Development

New metric predicts burden of participating in trials

May 9, 2024

Via: Pharmaphorum

To try to tackle that problem, data analytics specialist Phesi has developed software that can look at the design of a study, gauge how burdensome it will be, and recommend changes to the protocol to lighten the load on patients […]


Clinical Trials, Research and Development

eyeDNA plans pivotal trial of retinitis pigmentosa therapy

May 7, 2024

Via: Pharmaphorum

The new results, presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 meeting in Seattle, USA, suggest that the therapy achieved improvements in vision and may slow down the progression of RP, according to eyeDNA, a newly […]


Clinical Trials, FDA, Regulations, Research and Development

Novartis’ Lutathera receives FDA approval to treat neuroendocrine tumours in paediatric patients

April 25, 2024

Via: PMLiVE

Patients eligible for the therapy will be aged 12 years and older and have somatostatin receptor (SSTR)-positive gastroenteropancreatic NETs, including foregut, midgut and hindgut NETs. The FDA’s decision was supported by positive results from the NETTER-P trial, which evaluated Lutathera […]


Clinical Trials, Industry, Research and Development, Vaccines

Pfizer shares positive late-stage results for RSV vaccine Abrysvo in high-risk adults

April 10, 2024

Via: PMLiVE

RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in certain groups, including older adults, infants and those with certain underlying chronic […]


Clinical Trials, Research and Development

Women want to participate in clinical trials. Lack of flexibility is still a problem.

April 8, 2024

Via: Biopharma Dive

Exclusion of women from clinical trials is rooted in historical tragedy. In the 1950s, nearly 20,000 Americans took part in clinical trials for the drug thalidomide, including 600 pregnant women hoping to ease morning sickness. But the drug caused serious […]


Clinical Trials, Research and Development

Two UK clinical trials launched to identify blood tests for dementia diagnosis

April 5, 2024

Via: PMLiVE

The studies will be funded by the Blood Biomarker Challenge, a multi-million-pound award given by Alzheimer’s Research UK, Alzheimer’s Society, the National Institute for Health and Care Research and Gates Ventures. Affecting more than 944,000 people in the UK, dementia […]


Clinical Trials, Research and Development

After surprise trial failure, ALS doctors brace for one less treatment option

March 12, 2024

Via: Biopharma Dive

For Rick Bedlack, director of the ALS clinic at Duke University, tough times come with the job. He and his team treat about 500 people with the rare, fatal disorder that rapidly erodes nerve cells. Friday, though, was particularly difficult. […]


Clinical Trials, Research and Development

Poor Trial Results May Prompt Maker to Pull ALS Drug Relyvrio From Market

March 11, 2024

Via: Drugs.com

Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a large follow-up study, but the company […]


Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

Novartis shares positive results for spinal muscular atrophy gene therapy Zolgensma

March 6, 2024

Via: PMLiVE

Affecting an estimated one in 10,000 infants globally, SMA is a rare, genetic neuromuscular disease and a leading genetic cause of infant death. Caused by the lack of a functional SMN1 gene, the most severe forms of SMA result in […]


Clinical Trials, Research and Development

Apogee data hint at potential for long-lasting eczema drug

March 5, 2024

Via: Biopharma Dive

The study results represent the first human data from Apogee, which last year became one of the rare preclinical biopharmaceutical companies to succeed in a tough market for initial public offerings. After launching in late 2022, Apogee raised $300 million […]


Clinical Trials, Research and Development

FDA puts hold on Rapt trials of drug for eczema, asthma

February 20, 2024

Via: Biopharma Dive

Analysts have followed Rapt as they view its drug, an oral pill dubbed zelnecirnon, as a possible competitor to Dupixent in conditions like eczema. Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range […]


Clinical Trials, Research and Development

New initiative to improve patient retention in paediatric clinical trials

February 20, 2024

Via: Pharma Times

Innovative Trials has announced a new initiative designed to boost clinical trial patient retention in paediatric studies, in partnership with the Oliver Patch Project, a US charity. The Retention Patch Program is designed to engage directly with children and young […]


Clinical Trials, Research and Development

Trial raises hopes for simple Alzheimer’s blood test

January 23, 2024

Via: Pharmaphorum

Testing a person’s blood for a protein called phosphorylated tau could provide a means of large-scale screening for Alzheimer’s disease (AD), according to a new study. The immunoassay – which has been developed by California biotech ALZpath – focuses on […]


Clinical Trials, Research and Development

Cytokinetics rockets on positive heart drug trial

December 28, 2023

Via: Pharmaphorum

Treatment with the cardiac myosin inhibitor significantly improved exercise capacity in patients with obstructive hypertrophic cardiomyopathy (HCM), an inherited disorder in which the heart muscle becomes thickened and can obstruct blood flow. It is one of the most common reasons […]


Clinical Trials, Research and Development

Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis

December 4, 2023

Via: Biopharma Dive

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples. As the chief scientific officer of large-molecule bioanalysis, Dr. Tom Zhang leverages his expertise to promote ever-evolving automation technologies. He […]


Clinical Trials, Research and Development

AstraZeneca announces launch of new healthtech business Evinova to optimise clinical trials

November 21, 2023

Via: PMLiVE

Evinova will aim to better meet the needs of healthcare professionals, regulators and patients. The new healthtech business aims to bring to market established and scaled digital technology solutions which are already used globally by AZ, to pharmaceutical, biotechnology and […]