Regulation & Policy

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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Drug approved in US for enzyme deficiency

An enzyme replacement therapy, Brineura (cerliponase alfa), has been approved in the US for children with a rare inherited disorder that primarily affects the nervous system. The disorder, tripeptidyl peptidase-1 (TPP1) deficiency, is a form of Batten disease.

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Location

United States

Durvalumab is approved by the FDA

AstraZeneca Plc has received an accelerated approval in the US for its checkpoint antibody Imfinzi (durvalumab), which is expected to be the cornerstone of a prospective portfolio of immune oncology products targeting a variety of cancers.

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Location

United Kingdom

Novartis drug is approved for AML

Novartis has secured US approval for a new kinase inhibitor, Rydapt (midostaurin), to treat patients with FLT3-mutated acute myeloid leukaemia (AML) in combination with chemotherapy. The approval also covers a diagnostic designed to detect the mutation.

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Location

United States

EMA gives positive opinion for Spinraza

The European Medicines Agency has issued a positive opinion for the antisense oligonucleotide medicine Spinraza (nusinersen) to treat patients with spinal muscular atrophy, a rare genetic disease that causes muscle weakness and a progressive loss of movement.

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Location

United Kingdom

Vernalis application turned back by FDA

Vernalis Plc has had its application for the cough-cold medicine CCP-07 turned back by the US Food and Drug Administration, with the result that the product will not reach the US market as quickly as planned.

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Location

United Kingdom

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