Regulatory Filings and Submissions

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.

The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

Amgen’s Aimovig has become the first and only approved treatment in Japan for treating migraine attacks in adults by blocking the CGRP-R.

FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.