Clinical Research

Roche says Alecensa more effective than rival drug in lung cancer

Roche said that its kinase inhibitor Alecensa (alectinib) has produced better results in a Phase 3 trial of patients with a specific type of lung cancer than a rival treatment marketed by Pfizer Inc.

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Location

Switzerland

Positive data for HDAC inhibitor - Medivir

Sweden-based Medivir AB has reported positive Phase 2 data for a recently acquired histone deacetylase (HDAC) inhibitor in a trial of patients with early-stage cutaneous T cell lymphoma (CTCL), a haematologic cancer that presents in the skin.

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Location

Sweden

Sirukumab trial results in The Lancet

A Phase 3 trial in which patients with active rheumatoid arthritis (RA) were treated with the monoclonal antibody sirukumab, or placebo, met its primary endpoint of relief from swelling even in those who had failed to respond to two or more biological drugs.

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Location

United States

Pancreatic cancer trial suspended

An early clinical trial of a candidate treatment for pancreatic cancer developed by Halozyme Therapeutics Inc has been suspended after the independent data monitoring committee determined that it was unlikely to improve the patients’ overall survival.

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Location

United States

Daratumumab study in non-Hodgkin’s lymphoma stopped

A Phase 2 study of the monoclonal antibody daratumumab in three types of non-Hodgkin’s lymphoma has been stopped early because it failed to reach predefined targets for overall response, Genmab A/S announced on 30 March.

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Location

Denmark

Kite says rolling application to FDA finishes soon

Kite Pharma Inc has published further positive data for its lead chimeric antigen receptor (CAR) T cell therapy for cancer, while confirming that its rolling application to the FDA to receive marketing approval should be complete by the end of the first quarter.

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Location

United States

UCART19 cleared for trial in US

The US Food and Drug Administration has given regulatory clearance for a Phase 1 trial of Cellectis SA’s allogeneic, gene-edited cell therapy for the treatment of refractory acute lymphoblastic leukaemia (ALL). The product is being developed by Servier and Pfizer Inc.

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Location

United States

InDex Pharma prepares for Phase 2b study

InDex Pharmaceuticals Holding AB, which is developing treatments for immunological diseases, reported unchanged revenue for 2016 and a widening of its operating deficit as it prepares to take its lead product for ulcerative colitis into a proof-of-concept trial.

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Location

Sweden

Meeting Report: transparency in clinical trials

The coming into force next year of new European rules governing clinical trials will simplify trial application procedures and make more study information available to the public. At a meeting of the European Forum for Good Clinical Practice on 22 February, healthcare professionals discussed how the new rules on transparency should build public confidence in the regulatory system and avoid potentially serious accidents.

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Location

Belgium

Another Alzheimer’s failure

Merck & Co Inc is the latest company to abandon a programme for treating patients with Alzheimer’s disease because the treatment failed to show efficacy. On 14 February, the US company said it was stopping a Phase 2/3 study of verubecestat, an inhibitor of beta-secretase 1 (BACE1).

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Location

United States

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