Category: Research and Development

July 15, 2024

Revolution Medicines is one of a handful of biotechnology and pharmaceutical firms looking to exploit drug research advances that have made RAS mutations easier to target. Mutations in the gene are frequently a trigger for cancers of the lungs, pancreas […]

July 1, 2024

The Lexington plant is a central production hub for UniQure, which describes it as “one of the world’s leading, most versatile, gene therapy manufacturing facilities.” The company has for years pitched it as a competitive advantage in the field, affording […]

June 26, 2024

The analysis found that historical abuses in clinical trials and negative experiences patients may have experienced with their own medical care have generated a reluctance – particularly among communities with lower socioeconomic status – to participate in studies. One example […]

June 25, 2024

New Zealand-based contract manufacturing organisation Douglas Pharmaceuticals – which sponsored the 329-patient BEDROC trial and supplied the ketamine tablets – is now planning a phase 3 programme that could support regulatory filings. The results have been published in the journal Nature Medicine […]

June 12, 2024

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 […]

May 29, 2024

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 […]

May 24, 2024

On May 22, 2024, AGC Biologics and BioConnection, a contract manufacturing organization specializing in aseptic filling of vials and syringes for clinical and commercial production, announced that they have entered into a new strategic partnership. Under the agreement, the companies […]

May 23, 2024

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 […]

May 20, 2024

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 […]

May 16, 2024

To date, the FDA has approved 36 cell and gene therapy products. In the past decade, new cell therapy modalities such as chimeric antigen receptor T-cell (CAR-T) immunotherapies have emerged as promising treatments especially for many types of cancers. There […]

May 9, 2024

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 […]

May 7, 2024

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 […]

April 26, 2024

Scientists from the University of Edinburgh’s School of Chemistry have revealed a new sustainable method of manufacturing complex molecules that could reduce waste produced during drug production. The method published in Nature Chemistry could help to prevent severe side effects […]

April 25, 2024

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 […]

April 10, 2024

The enrollment pause could affect at least one ongoing Phase 3 study of Novartis’ pill, which is approved for use in advanced and metastatic disease. That clearance is limited to people whose tumor can be treated with hormone drugs but […]

April 10, 2024

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 […]

April 8, 2024

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 […]

April 5, 2024

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 […]

March 21, 2024

On March 19, 2024, Cytiva and White Raven, a Belgium-based contract development and manufacturing organization (CDMO), announced that White Raven has selected Cytiva’s SA25 Aseptic Filling Workcell for its fill/finish site. The installation of the workcell will complete White Raven’s […]

March 12, 2024

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. […]