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IVD

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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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Novartis files CAR-T therapy CTL109 in Europe

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

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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

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AAA’s orphan drug Lutathera wins EU green light

The first-in-class drug treats adults with GEP-NET

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EMA sets aside £32m for temporary staff to help with Brexit move

As agency warns current tender system needs to be updated

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EMA faces ‘permanent damage’ if forced to go to an unpopular city

Warns eight candidate cities wouldn't retain minimum staff numbers it needs

Tightening medical device safety

European legislators seek to reduce patient exposure to safety risks

FDA poised to start digital health pilot

Forms a key part of the agency's new digital innovation action plan

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UK life sciences sector sets out its post-Brexit growth proposals

Review helmed by Sir John Bell outlines a wide-ranging strategy

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Most of the EU would like to host the EMA

Nineteen member states will compete to host the agency when it leaves the UK

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EU and UK pharma leaders appeal directly to Brexit negotiators

EFPIA, ABPI and BIA warn Michel Barnier and David Davies an unorderly withdrawal could hit medicine supplies

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