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- PMLiVE

tenofovir alafenamide

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Gilead’s triple HIV drug approval prompts GSK lawsuit

ViiV claims bictegravir infringes its patent estate

Roche Basel Switzerland

Roche wins CHMP backing for Hemlibra

Haemophilia A treatment on course for European approval

Bristol-Myers Squibb (BMS) building

BMS’ Yervoy picks up another indication in Europe

The EC licenses the immuno-oncology treatment for children with skin cancer

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MHRA: No change for pre-Brexit products after UK exits the EU

And UK plans to follow EU rules for an implementation period after March 2019

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Health coverage across state lines

Despite a total lack of legislative wins, the new administration has made its presence felt at home and abroad

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Gilead adds to CAR-T assets with Cell Design Labs buyout

Gains full control of the biotherapeutics firm following its acquisition of Kite Pharma

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CAR-T therapies show long-term benefits in lymphoma

Novartis’ Kymriah and Gilead’s Yescarta both achieve significant complete response in lymphoma patients

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Dynavax receives FDA green light for hepatitis B vaccine

Heplisav-B becomes first and only two-dose hep B vaccine approved in the US

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Novartis files CAR-T therapy CTL109 in Europe

Analysts predict Kymriah could become a $1bn-plus product in Europe

EU flag

EU’s 10-year paediatric meds report – not bad, but can do better

Paper highlights the lack of ‘major therapeutic advances’ in children’s medicine

- PMLiVE

Gilead wins European approval for triple hep C combination Vosevi

The treatment brings together sofosbuvir, velpatasvir and voxilaprevir

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Kite wins FDA approval for blood cancer drug Yescarta

Becomes the first CAR-T therapy approved in the US for B-cell lymphoma

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