Euro Foscan study to boost biolitec's PDT (photodynamic therapy) drug
This article was originally published in Clinica
Executive Summary
German photodynamic therapy company biolitec last week successfully ended a five-year-plus study of its Foscan PDT light-activated drug for head and neck tumours, which was required by the European Medicines Evaluation Agency (EMEA). Jena-based biolitec says the therapy should now be able to retain its approval. Furthermore, completion of the study will lead to "considerably greater" market penetration for the photodynamic therapy (PDT) drug, for which the company is now also preparing to embark on approval negotiations with the US FDA.
You may also be interested in...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.