Regulatory Oversight and Compliance

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.

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.

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.

FDA Gives Guidance on Developing Treatments for Early Alzheimer’s

March 15, 2024

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

EMA Validates Parallel Applications for Datopotamab Deruxtecan in Two Types of Cancer

March 08, 2024

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

Updating Swiss Regulatory Processes in 2024

March 02, 2024

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.