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Category: Research and Development


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 […]


Clinical Trials, Research and Development

Trial readout sets up filings for Insmed bronchiectasis drug

May 29, 2024

Via: Pharmaphorum

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 […]


Manufacturing, Mergers and Acquisitions, Research and Development

AGC Biologics and BioConnection Team Up on Biopharma Drug Development and Manufacturing

May 24, 2024

Via: Biopharm International

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 […]


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 […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Addressing Performance, Scalability, and Regulatory Challenges to Accelerate Cell Therapy Manufacturing

May 16, 2024

Via: Biopharm International

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 […]


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 […]


Manufacturing, Research and Development

Scientists reveal new method that could reduce waste from drug manufacturing

April 26, 2024

Via: Pharma Times

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 […]


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 […]


Manufacturing, Research and Development

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

April 10, 2024

Via: Biopharma Dive

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 […]


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 […]


Manufacturing, Research and Development

Installation of Cytiva’s Aseptic Filling Workcell Aimed at Raising White Raven’s Manufacturing Efficiency

March 21, 2024

Via: Biopharm International

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 […]


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. […]


Manufacturing, Research and Development

Advanced technologies in unlocking the future of drug manufacturing

March 11, 2024

Via: Biopharma Dive

As the manufacturing landscape changes, it opens the door to pursuing hybrid opportunities that push the boundaries of technological advancement in the field. As an Industry Leader in two key domains: flow chemistry and biocatalysis, Asymchem has developed an innovative […]


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 […]