Industry News
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.
Contract Packaging Set for High Growth in 2024
According to the Pharmapack Europe 2024 survey results, contract packaging will see growth over the coming 12 months.
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.
Clarivate Highlights 13 Potential Drugs to Watch in Latest Report
Clarivate's Drugs to Watch report highlights 13 potential blockbuster drugs and gamechangers set to launch in 2024.
PharmaKure Gets Nod from MHRA to Trial Drug Targeting Amyloid Deposits
MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.
Leiters Health Recalls Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
The potential for superpotent drug initiated the voluntary recall.
Bridging Gaps and Investing in Change
European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.
Frontrunners in Molecular Glues
Novel molecular glues are transforming targeted protein degradation.
Bringing Collaboration to the Horizon Once More
UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.
Finalizing the European Health Data Space
The EHDS aims to increase access to health data, but how will it impact pharma?
Unlucky for Some
Clarivate has released its 2024 Drugs to Watch report, highlighting 13 therapies with great potential.
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.
InvaGen Pharmaceuticals Recalls Vigabatrin for Oral Solution, USP 500 mg
The product is being voluntarily recalled because of powder leakage due to seal integrity issues.
FDA Releases Compounding Guidance
The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.
FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines
The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.
Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL
Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.
Falling Short
Drug shortages across Europe are being exacerbated by increased demand, struggling supply chains, and manufacturer suspensions.
Renewing the UK Voluntary Pricing Scheme
What does the 2024 VPAS mean for pharma?
New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia
Exagamglogene autotemcel seen as synechdoche.
