Category: Clinical Trials

September 1, 2023

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 […]

August 21, 2023

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 […]

August 7, 2023

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 […]

July 26, 2023

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 […]

July 17, 2023

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 […]

July 14, 2023

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 […]

July 11, 2023

FDA recently granted full, or traditional, approval to Eisai Pharmaceutical’s Alzheimer’s treatment Leqembi, converting an earlier conditional approval status with further data from a multi-regional study of nearly 1800 patients. Results indicated that the drug slows the rate of cognitive […]

June 28, 2023

The next six months will be full of dramatic moments for the biotechnology industry. The Food and Drug Administration will either be validated or undermined for its decision to grant an early approval to the first gene therapy for Duchenne […]

June 27, 2023

An experimental drug appears to outperform the trendy medications Wegovy and Ozempic for both weight loss and diabetes control, a pair of early clinical trials shows. Retatrutide helped people with obesity drop about one-quarter of their starting weight, on average, […]

June 12, 2023

Many professionals in the life sciences industry are excited about the benefits decentralized clinical trials (DCTs) bring to the clinical research process and specifically to patients. The use of wearables, electronic consent forms, digital outcomes assessments, and other DCT technologies […]

June 6, 2023

Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data […]

June 5, 2023

Biogen has disclosed plans to stop a late-stage clinical trial testing one of its drugs as a potential treatment for Parkinson’s disease. According to a Monday announcement, the decision is due to several factors, including the trial’s complexity and run […]

May 22, 2023

Opening the digital front door to clinical trials means creating a great user experience for patients, clinicians and ultimately sites and sponsors. As anyone in healthcare knows all too well, it has historically been much easier said than done. However, […]

May 19, 2023

Moderna said Friday that one of its rare disease drug programs showed promise in its first clinical trials, according to an early look at the data. The drug is meant to treat propionic acidemia, an uncommon genetic disorder that causes […]

May 15, 2023

Preliminary results for the MenABCWY candidate were presented by the company at the European Society for Paediatric Infectious Diseases congress in Lisbon, Portugal. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even […]

May 4, 2023

This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the […]

May 1, 2023

Flatiron Health is collaborating with Sanofi to redesign the clinical trial experience for sponsors, sites, and patients in the therapeutic area of oncology. The multi-study collaboration will focus on improving clinical trial data acquisition, delivery, and quality through site-facing technology […]

April 20, 2023

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The novel study uses immunotherapy. It involves taking a patient’s own white blood cells, called […]

April 17, 2023

Patient enrollment in clinical trials is time-intensive and costly. In 2015-2016, the average cost to recruit one patient1 to a clinical study was $6,500+ and the average cost to recruit a new patient to replace a lost one was $19,000+. […]

April 3, 2023

Cell and gene therapy clinical research is a field that holds promise for the treatment of many diseases. These therapies involve using living cells or genes to treat or prevent diseases and have the potential to revolutionize how we approach […]