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Category: Clinical Trials


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 […]


Clinical Trials, Research and Development

Australian retail pharmacy enters clinical trials market

November 15, 2023

Via: Pharmaphorum

The two companies say their partnership could unlock access to millions of customers across a network of more than 550 Chemist Warehouse retail locations in Australia and other countries including New Zealand, Ireland and China, as well as its online […]


Clinical Trials, Research and Development

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

November 13, 2023

Via: Biopharma Dive

Pandemic-era changes may have permanently altered the clinical trial landscape as decentralized clinical trials gain broader acceptance. During COVID-19, more than three-quarters (76%) of pharmaceutical companies, device manufacturers and contract research organizations conducted off-site clinical trials. These types of trials […]


Clinical Trials, Research and Development

5 steps to help increase the odds of clinical trial success

October 16, 2023

Via: Biopharma Dive

Pharmaceutical companies can spend 10 to 15 years and more than $2.3 billion to bring new drugs to market. Despite these significant investments in drug development, 90% of clinical trials fail. For a greater chance of success, pharmaceutical companies must […]


Clinical Trials, Research and Development

MHRA pledges two-week review for low-risk clinical trials

October 12, 2023

Via: Pharmaphorum

The notification scheme stems from the agency’s overhaul of rules announced in March, with the aim of making it “faster and easier” to gain approval and to run clinical trials in the UK – and elevate the country’s position in […]


Clinical Trials, Industry, Pharma, Research and Development

Clinical Trials and their Impact on the Pharma Industry

September 1, 2023

Via: Biopharm International

Clinical trials are essential for establishing the efficacy of new drugs, observing patients’ reactions to treatments, and representing populations of people that may not always be discussed in everyday conversation. Although there are many diseases and disorders that are waiting […]


Clinical Trials, Research and Development

FDA Halts Clinical Trial Enrollment for Gilead’s Magrolimab in AML Studies

August 21, 2023

Via: Biopharm International

On Aug. 21, 2023, Gilead Sciences announced that FDA has placed a partial clinical hold on the company initiating new patients into US studies for magrolimab, an investigational anti-CD47 immunotherapy, to treat acute myeloid leukemia (AML). FDA’s decision follows a […]


Clinical Trials, Research and Development

How the right technology and tools can accelerate progress in rare disease clinical trials

August 7, 2023

Via: Biopharma Dive

Although diseases such as Ehlers-Danlos syndrome, Sanfilippo syndrome and Hemophilia are considered rare, their impact looms large. Rare diseases, defined as occurring in fewer than one in 2,000 individuals, affect more than 300 million people across the globe, and most […]


Clinical Trials, Research and Development

EMA reports actions to improve EU clinical trials conducted during health emergencies

July 26, 2023

Via: PMLiVE

The report presents EU-level actions to address the challenges that were experienced during the COVID-19 pandemic and the outbreak of mpox disease in setting up adequately sized clinical trials across multiple member states. Organised in June 2023, with participation from […]


Clinical Trials, Research and Development

BridgeBio claims success in heart drug trial, rebounding from earlier failure

July 17, 2023

Via: Biopharma Dive

An experimental medicine benefited patients with a deadly heart condition in a closely watched Phase 3 trial, lifting the fortunes of its developer, BridgeBio Pharma, and clearing the way for the biotechnology company to seek U.S. approval. Trial results showed […]


Clinical Trials, Research and Development

Positive data for Caribou Biosciences’ CB-010 candidate

July 14, 2023

Via: Pharma Times

Caribou Biosciences – a company focused on genome-editing – has announced follow-up data from the dose escalation element of its ongoing ANTLER phase 1 trial. This new data set includes all 16 patients treated in dose escalation with the CB-010 […]