AZ tanks on trial results and questions about Soriot

In announcing its second quarter results on 27 July, AstraZeneca Plc disclosed that the combination of Imfinzi and tremelimumab did not meet the endpoint of improving progression-free survival. The trial will continue until data is also available on overall survival.

Country: United Kingdom

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Sweeping change at GSK

GlaxoSmithKline Plc’s new chief executive plans to slim down the company’s pipeline, reduce costs and focus on respiratory medicines and treatments for HIV and infectious disease as part of a sweeping review of the company’s priorities.

Country: United Kingdom

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Nightstar recruits executive after Series C

UK-based Nightstar Ltd has recruited David Lubner to its board of directors less than a month after raising $45 million in a Series C financing round to advance its lead gene therapy product for choroideremia, an inherited cause of progressive blindness.

Country: United Kingdom

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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.

Country: United States

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Ablynx secures deal with Sanofi

Ablynx NV has secured a collaboration with Sanofi SA to develop products directed at immune-mediated inflammatory diseases. The deal, which includes an upfront payment of €23 million, is the latest endorsement of the Belgian company’s therapeutic protein platform.

Country: Belgium

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Novartis confirms guidance

Novartis expects that the decline in sales and operating profit that the company experienced in 2016 will be mostly halted in 2017. This year, it expects sales will be largely unchanged and the operating profit will be flat or slightly lower. Growth is expected to resume next year. This follows a productivity drive and the successful launch of new products.

Country: Switzerland

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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.

Country: United States

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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.

Country: United States

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Roche haemophilia A study in NEJM

Results from a Phase 3 trial of emicizumab, an experimental treatment for haemophilia A, were published online in the New England Journal of Medicine on 10 July. They showed the treatment achieved a clinically meaningful reduction in bleeding episodes in patients with antibodies to factor VIII replacement therapy.

Country: Switzerland

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Targovax progresses vaccine for pancreatic cancer

There are multiple strategies underway in oncology to exploit new knowledge about the immune system and destroy tumours. Many of these involve building compounds de novo. But every once in a while a company breathes new life into an existing molecule.

Country: Norway

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