Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.
AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.
GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.
Clinician-Scientists are vital innovation spark plugs, accounting for 40% of Nobel awards in Physiology or Medicine, and two thirds of Big Pharma CSOs.
The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.
WHO provides a look at the world’s health as the agency turns 75.
The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.
The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.
The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.
The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.
