Regulation & Policy

FDA designation for Spark

A gene therapy developed by Spark Therapeutics Inc for an inherited retinal disease has received a paediatric designation from the US Food and Drug Administration. The decision is the agency’s way of highlighting the treatment’s potential for children and young adults.

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Location

United States

FDA approves new adjuvant for breast cancer

The US Food and Drug Administration has approved Nerlynx (neratinib), a new drug for lowering the risk of recurrent breast cancer in patients who have been treated with a regimen that includes trastuzumab, the targeted therapy for HER2-positive breast cancer.

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Location

United States

ODAC recommends CAR-T cell therapy

An advisory committee to the US Food and Drug Administration has unanimously recommended that the agency approve the first engineered T cell therapy for cancer CTL019. The vote is not binding on the FDA, but the agency usually follows the recommendations of its advisory committees.

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Location

United States

New treatment for sickle cell disease approved in US

The first new drug for sickle cell disease in nearly 20 years has been approved by the US Food and Drug Administration. The treatment, Endari (L-glutamine oral powder), lowers oxidant damage to red blood cells thereby reducing complications of the disease.

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Location

United States

FDA offers plan to raise generic competition

The US Food and Drug Administration has made its first move to bring drug prices down under the new leadership of Commissioner Scott Gottlieb.

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Location

United States

New combination treatments for HCV

Following an accelerated assessment, the European Medicines Agency is recommending two new combination drugs to treat infections caused by the hepatitis C virus (HCV). Both therapies are direct-acting antivirals and effective against all genotypes of the virus.

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Location

United Kingdom

FDA approves drug to prevent HAE

The US Food and Drug Administration has approved the first C1 esterase inhibitor for the prophylaxis of hereditary angioedema, a rare protein deficiency that can cause swelling of the limbs or airway. The product, Haegarda, was developed by CSL Behring LLC.

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Location

United States

EU Clinical Trial Regulation delayed

The coming into effect of new legislation governing the conduct of clinical trials in the EU has been delayed again due to difficulties with the development of the underlying IT system, the European Medicines Agency announced on 16 June.

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Location

United Kingdom

FDA Advisory Committee to review CTL019

Novartis’ candidate chimeric antigen receptor T (CAR T) cell therapy for cancer is scheduled to be reviewed on 12 July by the US Food and Drug Administration’s Oncologic Drugs Advisory Committee, according to Oxford BioMedica Plc, which is supplying lentiviral vector for the product.

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Location

United Kingdom

New ATMP recommended for cartilage repair

A cartilage repair product developed by co.don AG of Germany received a positive opinion from the European Medicines Agency on 19 May, making it the ninth advanced therapy medicinal product (ATMP) to be assessed for marketing in Europe.

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Location

United Kingdom

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