has provided a positive opinion for Advanced Therapy Medicinal Product (ATMP) classification for the company's gene therapy candidate OCU400 to treat Retinitis pigmentosa. A phase 3 study of ...

Ocugen, Inc. has announced that the European Commission has given a positive opinion for the classification of its gene therapy product, OCU400, as an Advanced Therapy Medicinal Product (ATMP) by ...

The Cell and Gene Therapy Catapult (CGT Catapult) presented the data in its UK 2024 Advanced Therapy Medicinal Product (ATMP) Clinical Trials Database. The UK maintained its position as a highly ...

New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

Belgium’s Deputy Prime Minister, Frank Vandenbroucke, called the EU’s joint health technology assessment a model of European cooperation, improving medicine evaluation, reducing costs, and ...

The International Society for Pharmaceutical Engineering (ISPE) has announced planned featured speakers for the 2025 ISPE Aseptic Conference, taking place Monday, 17 March, through Tuesday, 18 March, ...

Ocugen (NASDAQ:OCGN) said it has received a positive opinion from European Medicines Agency regulators for Advanced Therapy Medicinal Product classification for its gene therapy OCU400 in the ...

Pathways to success for this key component of Europe’s new HTA regulation, where thinking beyond the purely technical will be ...

As of March 2018, 10 products have received MA in the EU with Chondrocelect ... and FDA's Breakthrough Designation and Regenerative Medicine Advanced Therapy Designation (2017) have been created to ...

Welcome to the Merck & Company Q4 sales and earnings conference call. [Operator instructions] This call is being recorded.

Most products will be classified as vaccines or chemical medicinal products, but some products, such as those composed of non-synthetic nucleic acids, are considered an advanced therapy medicinal ...

However, since the introduction of this therapy ... highlights the complexity of medicinal product safety and the challenge of assessing potential risks of these advanced therapeutics.