Quality Systems

Making Lifecycle Management More Efficient in Europe

April 02, 2024

Plans to update the European Union’s variation framework have been finalized.

Looking at the Potential Impact of JCA on Pharma

April 02, 2024

The European pharma industry needs to be prepared for the new clinical data requirements.

Streamlining Variations

April 02, 2024

A revised regulatory variation framework should make lifecycle management more efficient in Europe.

Amneal Pharmaceuticals Recalls Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL

March 30, 2024

The company is voluntarily recalling the product for potential super potent bottles due to overfilling.

J&J's Nipocalimab for FNAIT Gets on Fast Track for Approval

March 30, 2024

FDA granted fast track designation to nipocalimab, which J&J is developing for helping alloimmunized pregnant adults treat FNAIT, a rare disease that poses risk to the fetus or newborn.

AstraZeneca Gains FDA Nod for Ultomiris, a Treatment for Managing NMOSD

March 29, 2024

FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.

AbbVie Gains Landos Biopharma and Full FDA Approval for ADC Product

March 28, 2024

The Landos acquisition adds a lead asset in autoimmune and inflammatory disease to AbbVie's portfolio, while the company's ADC, ELAHERE, gets full FDA approval.

Par Pharmaceutical Recalls Treprostinil Injection 20 mg/20 mL (1 mg/mL)

March 22, 2024

The company is recalling one lot of the product because of the potential presence of silicone particulates.

FDA Greenlights Orchard Therapeutics' Gene Therapy for Children's MLD; AGC Biologics Selected for Manufacturing

March 20, 2024

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

Filtration Clarification Needs in Annex 1

March 16, 2024

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.