Short for Research to Accelerate Cures and Equity, the RACE Act went into effect on August 18, 2020, and significantly increased the number of required studies devoted to pediatric cancer research, drugs, and therapies. Originally enacted in August 2017, as a part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), the RACE Act is an amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) which was created to extend user-fee programs for drugs, medical devices, and biosimilars, as well as other biological products. Key Factors of the…
Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract basis. Contract Research Organizations are hired to offer research support and conduct clinical trials to safely and efficiently bring life-saving drugs and vaccines to market. Lasting partnerships between CROs and pharmaceutical companies are vital to the long-term success of ongoing programs and clinical trials. When a CRO fails to meet certain criteria relating to safety protocols or deadlines it can leave some companies questioning whether…
At the commencement of her national campaign in July 2016, the former UK Prime Minister Theresa May stated, “It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry.” This still holds true today. Despite this, according to the Freedom of Information Act, as of 2017, the number of EU academics and staff departing the United Kingdom was up by over 35% compared to years prior. In fact, many companies, Biotech included, have been leaving the UK for the Netherlands only adding to…
We've compiled a guide to the presentations & forums our BioAgilytix team members will be participating in throughout the 2020 WRIB Virtual Meeting so you can join in the conversations too.
As COVID-19 lockdowns begin to lift, the question is: where do we go from here? BioAgilytix is in a highly unique position to help both biopharma & companies with testing to keep their work on track: whether that means progressing clinical trials or reopening their businesses and offices safely.
A recent study using triple-edited ‘NYCE’ cells shows the possibilities of multiplex genome editing to effectively treat complex diseases like some cancers. We explore the promising results.
BioAgilytix's Regan Reynolds shares how her own diagnostic journey with Ankylosing Spondylitis (AS) inspired her to participate in a non-interventional research project on how AS is diagnosed and treated in the USA.
As the pharma & biotech industry is working around the clock to address the unprecedented COVID-19 health crisis, they are also giving the world hope that we will overcome these trying times. We highlight some of the important solutions in development & why we're all pushing forward: because to create new breakthroughs, you can't stop science.
New data suggests Cytokine Release Syndrome in patients with severe cases of COVID-19 may cause death. See how BioAgilytix can apply our validated MSD cytokine/chemokine panels to support cytokine monitoring in COVID-19 vaccine & therapeutic programs.
With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. We've compiled some recent industry articles on the latest topics to share with you.