Feb 17, 2021 | News, Regulatory
OSE Immunotherapeutics, a clinical stage biotechnology company, announced today (2/17) that it was granted a patent by the European Patent Office (EPO) for its anti-interleukin-7 receptor (IL-7R) antagonist OSE-127/S95011. The patent, set to last until 2037, covers...
Sep 16, 2020 | News, Regulatory
Orphazyme, a biotech company based in Denmark, announced today (9/16) that the FDA has accepted its New Drug Application (NDA) for treatment of Niemann-Pick disease Type C. The genetic disease is both rare as well as fatal, with no currently approved...
Aug 21, 2020 | Clinical Trials, FDA, Globalization, Healthcare, Pharmaceuticals
One of the biggest areas of concern in the pharmaceutical industry, particularly in the United States, is the high costs of new treatments or drug therapies for patients. The recent initiatives from regulatory agencies like the Food and Drug Administration (FDA) to...
Aug 7, 2020 | News, Regulatory
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for Covid. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send almost the entirety...
Jun 4, 2020 | Medical Writing
CSOFT Health Sciences SVP Dr. Nimita Limaye joins us once again to continue her interview on Key Factors Driving Medical Writing Outsourcing Strategy. This time, she focuses on the importance of alignment in terms of business operations, business models and...
