Tag: clinical trials

August 28, 2023

Estimates hold that around half a million people in the U.S. have Parkinson’s, though, due to underdiagnosis or misdiagnosis, some believe the true number is much higher. The disease causes nerve cells in the part of the brain that controls […]

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 27, 2023

Kincell Bio, a technology-forward CDMO focused on cell therapies, has launched having received $36 million in new funding led by Kineticos Ventures. Kincell is a spinout of Inceptor Bio’s CMC, manufacturing and quality organizations formed to accelerate innovator research and […]

July 24, 2023

In January 2022, the Milken Institute published a report, “Cell and Gene Therapies: Looking Ahead to 2022,”1 describing the growth of the CGT industry in 2021. In the U.S., 7 new therapies were approved for commercialization, a similar number were […]

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 […]

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

FDA announced on June 22, 2023 the approval of Elevidys (delandistrogene moxeparvovec-rokl), the first gene therapy for the treatment of children ages four through five years that have Duchenne muscular dystrophy (DMD) and do not have a pre-existing medical reason […]

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 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 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 2, 2023

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical […]

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 12, 2023

Novo, while historically not big on buyouts, has turned to acquisitions over the past couple years to expand its slate of technologies and research programs. In late 2021, it agreed to spend north of $3 billion on Dicerna Pharmaceuticals, a […]

April 11, 2023

Curevo Vaccine, a privately held clinical-stage biotechnology company dedicated to reducing the burden of infectious disease by developing safe and highly effective vaccines, announced Guy De La Rosa has joined the company as its new chief medical officer. “The Curevo […]