Articles

Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.

Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone 

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% 

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle. 

FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

EnteroBiotix is harnessing the power of the microbiome to target an array of diseases.

Frontrunner in Microbiome Therapeutics

Jennifer Markarian is a contributing editor for 

PAT is crucial to process control and real-time release in continuous manufacturing of solid-dosage drugs. 

Implementing Process Analytical Technology

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Technological advances will help ease pressure on pharma supply chains, allowing for greater visibility and less uncertainty.

Keeping Europe’s Medicines Stocked

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

Eli Lilly to Cap Out-Of-Pocket Insulin Costs at $35

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines. 

Outsourcing Still Vital

Soaring energy costs are compounding the challenges currently being faced by the European bio/pharma industry.

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