Organize regulatory submissions to health authorities (HAs), including Investigational New Drug (IND)/Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure Agreements (NDA)/Marketing Authorization Applications (MAA), Orphan Drug Application, Breakthrough Applications, safety reports, pre-mee...
I am pleased that LatAm is part of the company’s clinical development operations and hope to see this trend progress further. Clinical trials are all about using good science to improve patients’ lives and also set up patients to access the best care available following their trial. In some...
Clinical trial delays in the first half of 2020 were made up for by these discoveries. The industry of contract manufacturing companies is anticipated to exhibit significant growth potential in the near future. As a result of declining R&D efficiency and rising development costs, the short-term ...
The recent failure of OPDIVO® to slow progression of advanced lung cancer in a treatment-naïve patient population in a clinical trial comparing OPDIVO® with conventional chemotherapy highlights the need for alternative approaches and additional cancer treatments to complement existing therapeutic stan...