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Shire’s gene therapy candidate receives orphan drug status in the US

Investigational factor VIII treatment SHP654 is being developed for haemophilia

FDA approves new robotic surgery device

Senhance System backed for colorectal and gynaecological operations

- PMLiVE

After failing to repeal Obamacare, Trump tries another tack

US president signs executive order encouraging cheaper policies with fewer benefits

Roche - Basel

Roche and J&J picked for ‘revolutionary’ digital health pilot

Firms will line up alongside Apple, Fitbit, Samsung and Verily in FDA pre-certification programme

Roche and J&J picked for ‘revolutionary’ digital health pilot

Firms will line up alongside Apple, Fitbit, Samsung and Verily in FDA pre-certification programme

- PMLiVE

J&J seeks US OK to add CV claim to Invokana label

If approved the treatment could better compete with rivals Jardiance and Victoza

UK flag

Universal flu vaccine heads for UK trials

New vaccine targets core proteins of the virus

- PMLiVE

AbbVie deal with Amgen sets biosimilar Humira launch dates

Agreement will see Europe access the drug over four years earlier than patients in the US

- PMLiVE

Macron, Merkel and May: implications of the 2017 elections for the life science industry

Political instability and policy continuity in Europe’s biggest economies mean a worsening commercial environment stacked with uncertainty

- PMLiVE

FDA wants more data on J&J’s arthritis drug Plivensia

Requests further evidence on the drug’s safety profile after patient deaths link

- PMLiVE

Amgen’s Mvasi is first FDA-approved cancer biosimilar

Offers prospect of lower-cost alternative to Roche's Avastin

FDA approves first substance use mobile medical application

Pear Therapeutics' Reset device offers cognitive behavioural therapy

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