Quality Systems

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

December 14, 2023

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

FDA Announces Advisory Committee for Genetic Metabolic Disease Treatments

December 13, 2023

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

Sanofi to Terminate Rare Disease Drug Licensing Agreement with Maze Therapeutics in Wake of FTC’s Challenge

December 13, 2023

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

List of Critical Medicines Published in EU

December 13, 2023

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

December 11, 2023

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

FDA Releases Compounding Guidance

December 11, 2023

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

December 04, 2023

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

December 04, 2023

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.

Training for Operational Excellence

December 03, 2023

The bio/pharmaceutical industry is struggling with the challenge of staffing and training.

Revitalizing Quality Management Processes through Digitalization

December 02, 2023

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.