There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
Featured Posts
The New Jersey Rare Disease Alliance will hold its annual Rare Disease Day commemoration on February 27 at the New Jersey Business and Industry Association (NJBIA).
Greenphire and Exostar announced a partnership that facilitates the adoption, accessibility and use of clinical research site payment solutions.
University of Missouri researchers have found that luteolin, a natural compound found in herbs such as thyme and parsley, and vegetables such as celery and broccoli, could reduce the risk of developing metastasis originating from triple-negative breast cancer in women.
A recent study published in Nature suggests there exists a biological barrier on human life expectancy that effectively can not be broken.
Bristol-Myers Squibb Co.’s immuno-oncology treatment Opdivo has now been approved in five tumor types in under two years by the U.S. FDA.
Before there are new therapies to set a firm apart, there is a far more fundamental need that competitiveness will ultimately hinge on: high-quality, diversified, annotated human biospecimens.
UK Biopharma and life after Brexit
Biomedicine, Brexit, Business, EMA, EU, European Economic Area, European Free Trade Association (EFTA), Life Sciences, Marketing Authorization Application (MAA), Medical Devices, National Institute for Health and Care Excellence (NICE), Orphan Drug Designation, Personalized Medicine, Pharma, Pharmacovigilance, Pricing, R&D, Switzerland, United Kingdom, World Trade Organisation (WTO)Paul Ranson, of global law firm Morgan Lewis’ London Life Science’s Practice, examines how the UK Biopharma must now adapt to a changing landscape.
While acknowledging the many complexities of product development, sponsor teams should factor in these six guiding principles when planning programs for regulatory submission.
Almost every reported concomitant medication has a reason – and many, if not all of these reasons should be reported as adverse events.