Resources
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On-demand webinar presented by Mo Jain, MD, PhD, Founder and CEO, Sapient and Jonathan Usuka, PhD, MBA Chief Business Officer, Sapient
Top R&D Stories of 2023
Through captivating articles, insight pieces, and spotlight interviews, we delve into the remarkable innovations, breakthroughs, and scientific marvels that have defined the landscape of research over the past year.
Clinical Development
Surrogate Biomarkers in NASH and Liver Cirrhosis: Qualifying for Clinical Trial Validation and Legislative Success
Highly involved treatment scenarios and prognostics are required to properly assess best-practice approaches for investigating issues posed by NASH and liver cirrhosis. Surrogate biomarkers present a less invasive approach to assessing these outcomes.
Diagnostic Development
Emergency Use Authorization Issued by FDA for Mpox Virus DNA Test
EUAs exist under FDA regulation to improve the availability of medical countermeasures, such as vaccines and diagnostic tests, during public health emergencies. With future pandemics a tangible possibility, further EUAs for other PCR tests and vaccines are all but certain.
Genomic Biomarkers
Clinical Biomarker Trends to Watch in 2023
The identification of novel clinical biomarkers is set to continue, with further research and investment in fields such as next-gen sequencing and miRNA targeting.
Clinical Development
Keytruda sees Trial Success in Treating Endometrial Cancer Patients
The immunotherapeutic was successfully trialled in patients with endometrial cancer, the results of which Merck said it would discuss with regulatory authorities.
Clinical Development
Eli Lilly Focus on Phase III Trial for Alzheimer’s Treatment Following FDA Fast Lane Setback
The FDA ‘specifically requested’ data from at least 100 patients who received a minimum 12 months’ treatment of Lilly’s drug donanemab before the approval process could progress further.
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