Industry News
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.
mRNA: Unparalleled Potential as a Drug
Chris Spivey, editorial director for BioPharm International, discusses mRNA advances and the background for the leading scientific conference for the field, with host and co-organizer CureVac CEO Dr. Alexander Zehnder.
Alliance for mRNA Medicines Officially Launched in Germany
The Alliance for mRNA Medicines (AMM) was officially launched at the 11th International mRNA Health Conference in Berlin, Germany.
European Commission Searches for Committee Experts
The EC is calling for interested parties for their safety and orphan drug committees.
ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA
According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.
FDA Provides Guidance on Remote Facility Evaluations
The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.
Salary Survey for Pharma Scientists Shows Increase of 6.7% Since 2022
A recent AAPS Salary Survey shows a rising trend in compensation for pharmaceutical scientists since 2022.
Bio/Pharma Industry Has Strong Showing at CPHI 2023 (Barcelona)
CPHI Barcelona has strong showing as bio/pharma industry moves confidently into 2024.
CPHI Barcelona: CMOs Expected to Account for 45% Available Bio Capacity in 2027
As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.
Winners of the 2023 CPHI Pharma Awards Announced
The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.
EMA Creates Mechanism for Support during Drug Shortages
The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.
CPHI Annual Report: VC Capital Investment and Contract Services Growth in 2024
The report indicates a rise in biotech funding and subsequent growth for pharma contract services.
