Regulatory Lessons For Advanced Therapy Makers: A Case Study
Executive Summary
Developing advanced therapy medicinal products is not easy, but the head of regulatory affairs at Swedish cell therapy company Immunicum has some useful tips for SMEs that could help them navigate their development more easily.
You may also be interested in...
EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions
After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.
English Funding For Aquipta Targets AbbVie’s Migraine Drug To 170,000 People
Aquipta is the first oral treatment that NICE has recommended for preventing chronic migraines in the fourth-line setting, and the second oral treatment for episodic migraines in the same setting. The drug has already secured reimbursement in Scotland, Sweden and Israel.
Quotable: Top Experts On Policy Hot Topics
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.