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- PMLiVE

Wilson Therapeutics

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

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

- PMLiVE

GSK’s Shingrix sails through FDA advisory committee

Shingles vaccine data proved safe and effective, says the panel

FDA poised to start digital health pilot

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

- PMLiVE

Germany will be first EU launch market for new Soliris indication

Alexion 'currently evaluating' additional European launches for its orphan drug

- PMLiVE

Ironwood claims FDA OK for former AZ gout drug

Duzallo will be launched in the US before the end of this year

- PMLiVE

Setback for J&J as FDA panel turns down arthritis drug sirukumab

US regulator concerned with the drug’s safety

AstraZeneca AZ

Clock starts ticking on FDA review of AZ’s acalabrutinib

If approved, the BTK inhibitor could achieve annual peak sales of $5bn

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