The approval of the first topical gene therapy for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) marks a significant milestone in the field of dermatology and…
On April 26th, 2023, the largest reform of the EU pharmaceutical legislation in over 20 years by the European Commission has been published and aims to make the legal framework…
The FDA has approved a new cell therapy for patients with blood cancers, known as Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery…
The European Medicines Agency (EMA) is introducing a number of new features to the PRIority MEdicines (PRIME) scheme to strengthen its support for the development of medicines in areas of…
Last week, the U.S. Food and Drug Administration (FDA) released a new draft guidance regarding clinical trials considerations to support accelerated approvals: Clinical Trial Considerations to Support Accelerated Approval of…
Recently, the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) has published its 2023 Work Plan. In this report the Committee highlights the actions and activities on the regulation…
Recently, the European Medicines Agency (EMA) has published its Human Medicines Highlights 2022 report, a report including figures on the authorisation of medicines and a selection of new treatments that…
The Office of Tissues and Advanced Therapies (OTAT) from the FDA’s Center for Biologics Evaluation and Research (CBER) hosted last week a town hall answering stakeholder questions related to the…
On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications (CTA). It will serve as the single-entry point for…
Understanding labor costs is essential for businesses to price their products effectively and remain competitive. Direct and indirect labor costs represent the two primary categories of labor expenses that need…