Regulation & Policy

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

Keytruda approved for multiple solid tumours

Merck & Co Inc’s checkpoint inhibitor Keytruda (pembrolizumab) has been approved in the US for multiple solid tumours that have a common genetic feature known as microsatellite instability-high or mismatch repair deficit.

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Location

United States

Zykadia gets new lung cancer indication

The Novartis tyrosine kinase inhibitor Zykadia (ceritinib) has been approved in the US for the first-line treatment of ALK-positive non-small cell lung cancer following Phase 3 data that showed a significant improvement in progression free survival in patients with the disease.

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Location

Switzerland

Vertex gets regulatory nod

Vertex Pharmaceuticals Inc has received a new approval from the US Food and Drug Administration for its cystic fibrosis treatment Kalydeco (ivacaftor) that triples the number of rare gene mutations that the drug can treat to 33 from 10.

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Location

United States

Japan leads the way on ALS

In a reversal of the usual sequence of events, the Food and Drug Administration has approved a new drug for amyotrophic lateral sclerosis (ALS) two years after the same treatment was authorised for marketing in Japan and South Korea.

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Location

United States

EMA issues Brexit guidance

The European Medicines Agency has issued guidance to companies with centralised marketing authorisations spelling out what they need to do to be in compliance with EU medicines law once Britain leaves the union.

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