NLS NDA

During 2021, the impact of COVID-19 pandemic on the life science industry moved on from initial chock to acceptance and finding a way forward. Throughout the year, COVID has been ever present, but the industry has managed the situation well. Now the sector will have to deal with the after-effects, as restrictions are removed, to […]

The NDA Advisory Board has appointed Dr Susan Jerian a NCI trained oncologist with experience of leadership in the industry and the FDA. Dr. Jerian is a NDA expert in drug and biologic development for hematology and oncology indications, combination product development including companion diagnostics, biosimilars, clinical trial design and regulatory strategy with special emphasis on US FDA […]

Dr Paula Salmikangas, former chair of EMA Committee for Advanced Therapies (CAT), has joined the NDA Advisory Board as Director of Biopharmaceuticals and ATMPs. Dr Salmikangas has a Ph.D. in muscle cell biology and extensive knowledge in biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals. Her main research has focused on cell […]

Werner Van den Eynde, MD, a specialist physician in pharmaceutical medicine, has joined NDA Group to head-up the NDA Advisory Board. Dr. Van den Eynde has extensive international pharmaceutical experience, holding senior positions within Chemo – Exeltis, GE Healthcare, Abbott and Solvay Pharmaceuticals. As Vice President of NDA Advisory Services Ltd, Dr. Van den Eynde […]

AstraZeneca has announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol. The investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) has been studied in opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid pain […]