Quality Systems

Articles

Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).


Treatment for XLH Receives Approval in Switzerland

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes. 

FDA Smooths Transition of Biologic Approvals

The European Commission (EC) has approved Pfizer’s treatment for wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), Vyndaqel (tafamidis).

European Commission Issues Approval of Pfizer’s Vyndaqel

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma.


EMA’s PRAC Recommends Restricted Use of Cyproterone

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.


EPO Confirms Novelty of CRISPR/Cas9 Gene Editing System Patent

The National Institute for Health and Care Excellence (NICE) has issued guidance in Feb. 2020 stating that it does not recommend the combination therapy of pembrolizumab with axitinib for the treatment of advanced renal cell carcinoma in adults.


NICE Issues Draft Guidance on Kidney Cancer Combination Therapy

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

ICH to Revise Quality Risk Management Guideline

Sean Milmo is a freelance writer based in Essex, UK.

The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.

Brexit: What Happens Next for Pharma?

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended that Givlaari (givosiran) be granted marketing authorization in the European Union.


CHMP Recommends Marketing Authorization of First AHP Treatment

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

Regulatory/GMP Compliance, Europe