Sacubitril with valsartan in heart failure: differentiated value added

16 June 2016 - Addendum results in a revised benefit assessment for patients with type 2 diabetes mellitus. ...

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NICE publishes appraisal consultation for cobimetinib hemifumarate (Cotellic) for patients with malignant melanoma

16 June 2016 - NICE has published an appraisal consultation for Roche's cobimetinib hemifumarate (Cotellic). ...

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Updated NICE quality standard identifies areas for breast cancer improvement

15 June 2016 - NICE’s latest quality standard published today says people who have been diagnosed with a type of early ...

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Roche’s Gazyvaro approved in Europe in combination with bendamustine for people with previously treated follicular lymphoma

16 June 2016 - This is the second approval in Europe for Gazyvaro based on a positive phase III study. ...

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Shire and Kamada announce FDA approval of expanded label for self-infusion of Glassia for the treatment of emphysema due to severe AAT deficiency

15 June 2016 - Glassia is the only FDA approved alfa-1 antitrypsin (human) augmentation treatment that patients can self-infuse at home. ...

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Osimertinib mesylate in lung cancer: no assigned additional benefits

15 June 2016 - No direct comparative studies / effects in historical comparisons too small for statements for additional benefits. ...

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Orfadin 20 mg capsules approved in the US

15 June 2016 - Swedish Orphan Biovitrum AB (Sobi) announced today that the FDA has approved a higher strength 20 mg ...

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Health Canada approves Inflectra (biosimilar Infliximab) for three additional indications: Crohn's disease, fistulising Crohn's disease and ulcerative colitis

14 June 2016 - Hospira today announced that Inflectra (biosimilar infliximab) has been approved by Health Canada for three additional indications, ...

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FDA approves AspireAssist obesity device

14 June 2016 - The U.S. FDA today approved a new obesity treatment device that uses a surgically-placed tube to drain ...

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NICE recommends laser device to help thousands of men with an enlarged prostate

14 June 2016 - Thousands of men could benefit from laser treatment for an enlarged prostate as recommended in new guidance ...

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Prostate cancer drug decision 'grossly unfair'

13 June 2016 - A charity has said it is "grossly unfair" that men with advanced prostate cancer in Scotland will ...

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Shire receives FDA breakthrough therapy designation for SHP621 and SHP625, investigational products for rare gastro-intestinal conditions

13 June 2016 - Shire today announced that the U.S. FDA has granted breakthrough therapy designation for two investigational products for ...

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SMC - June 2016 decisions

13 June 2016 - Treatments for Parkinson’s disease, advanced leukaemia and asthma among four new medicines accepted for routine use in ...

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FDA approves vaccine to prevent cholera for travelers

10 June 2016 - The U.S. FDA today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 ...

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NICE’s Eylea guideline ‘out of touch with clinical practice’

9 June 2016 - Bayer says it is disappointed that NICE is supporting NHS use of anti-VEGF therapy Eylea to treat ...

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