Quality Systems

Articles

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

EMA and HMA Publish Network Strategy for Public Consultation

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

FDA Approves Schizophrenia Treatment that Targets Cholinergic Receptors

Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.

FDA Approves Treatments for Niemann-Pick Disease, Type C

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

Hatch-Waxman Amendments Turn 40

Feliza Mirasol is the science editor for 

The approval of EBGLYSS (lebrikizumab-lbkz) by FDA puts a new biologic treatment for moderate-to-severe atopic dermatitis on the market for patients whose symptoms are not well controlled with topical treatments.

Lilly’s EBGLYSS Offers New First-Line Biologic Treatment for Atopic Dermatitis Following FDA Approval

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

EMA Gives Approval to Several Cancer Treatments

Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.

AstraZeneca’s Imfinzi Gets Expanded Indication in Lung Cancer on FDA Approval

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

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers. 

Submitting Regulatory Applications Connects to Quality

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan.

FDA Approves Pediatric Indication for Non-Surgical Severe Thermal Burn Treatment

Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study.

Regulatory Filings and Submissions