Susan Haigney

The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.

The agency has published final guidance documents regarding validation and development of analytical procedures.

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

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.

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

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.

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

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 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.

Cherwell Laboratories’ cleanroom microbiology solutions will join AnalytiChem’s group of seven companies across Europe, North America, and Australia.

The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.

The new Europe headquarters will be the hub for the company’s European operations, including production of product.

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

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.

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.