Industry News
FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
AbbVie Gains Nod from NICE for Tepkinly
NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.
EMA Given Grant to Support Establishment of African Medicines Agency
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
FDA Issues Guidance on CAR-T Cell Product Development
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
FDA Give Guidance on Human Genome Editing in Gene Therapies
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
Winners of the 2024 Pharmapack Europe Awards are Announced
The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.
EMA Looks Back at Medicines Approved in 2023
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
CDER Approved 55 Novel Drugs in 2023
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
EMA Starts Safety Review of CAR T-Cell Medicines
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
Precautionary Measures Recommended in Use of Valproate Medicines
The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
A Platform for mRNA Platforms
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.
The Decline and Fall of the Clinician–Scientist
Clinician-Scientists are vital innovation spark plugs, accounting for 40% of Nobel awards in Physiology or Medicine, and two thirds of Big Pharma CSOs.
European Medicines Regulatory Network on Track to Meet Goals
The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.
A Record Year for Disease Elimination
WHO provides a look at the world’s health as the agency turns 75.
FDA Publishes Guidance on Real-Word Data
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.
EMA and FDA Answer Questions About Breakthrough Therapies
The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.
EMA Publishes Guide for Use of AI in Medicine Regulation
The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.
FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
Consent Decree Entered Against Pharmasol
The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.
FDA Announces Advisory Committee for Genetic Metabolic Disease Treatments
The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.
List of Critical Medicines Published in EU
Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.
New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia
Exagamglogene autotemcel seen as synechdoche.
Why We Were Not Properly Winterized for RSV Season
Looking at the role that RSV and pediatric medical practices play in drug shortages.
Lithuania Set to Become Home to Largest Biotech City
The largest biotech hub is set to be built in Lithuania by Northway Group.
Industry Responds to the UK’s Autumn Statement
UK industry body, ABPI, has responded positively to the recent Autumn Statement.
Discussing the Origins of the mRNA Therapeutics Field (Part Two)
Andy Geall, co-founder and chief development officer at Replicate Bioscience continues the discussion on the development history of mRNA therapeutics.
EMA Recommends Rare Blood Cancer Treatment and Seven Other Medicines
Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.
Discussing the Origins of the mRNA Therapeutics Field (Part One)
Andy Geall, co-founder and chief development officer at Replicate Bioscience, discusses the historical context and buildup of the mRNA therapeutics field.
Europe Publishes Electronic Product Information for Selected Medicines
Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.
FDA Publishes Guidance on Container Closure Systems for COVID-19
The document includes recommendations for the reporting and implementation of changes to container closure system components.
