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Tag: 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 […]


Editorial

Man and Machine: What Comes Next as Neuralink and Synchron Start Clinical Trials

May 28, 2024

Via: Camila Mendes

The two companies leading the charge in integrating human physiology with machinery, Neuralink and Synchron, have both entered the human clinical trials stage of research and development. Both companies aim to improve and eventually restore patients’ mobility, filling the unmet […]


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 […]


News

Can a Moderna co-founder change the CRO game?

February 29, 2024

Via: Biopharma Dive

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]


News

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

February 28, 2024

Via: PMLiVE

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]


Cell and Gene Therapy, Industry

Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations

February 27, 2024

Via: World Pharma News

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, […]


FDA, Regulations

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

February 26, 2024

Via: PMLiVE

Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Biosimilars, according to the FDA, are biological products that are highly similar to […]


News

NGM to go private through deal with investment firm

February 26, 2024

Via: Biopharma Dive

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]


FDA, Regulations

FDA’s Drug Safety Priorities for 2023

February 21, 2024

Via: Biopharm International

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]