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Clinical Trials Directive

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EC: Search for Rasi’s replacement could take six months

Commission tells PMLiVE process could still be impacted by the procedure's complexity

- PMLiVE

EFPIA looks to ABPI for comms director

Andrew Powrie-Smith will join EU pharma trade body in New Year

- PMLiVE

Novartis’ heart failure drug on EMA’s fast track

Candidate is the first cardiovascular drug to get accelerated review in the EU

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Orphan drugs in latest CHMP recommendations

EMA advisers back new products from Genzyme, Boehringer and others

- PMLiVE

EMA recommends two AbbVie treatments for hepatitis C

Exviera and Viekirax backed for use in Europe

- PMLiVE

US proposes tighter rules on clinical trial reporting

If approved, data from around 650 additional studies per year will be released

- PMLiVE

EMA leaderless as tribunal forces Guido Rasi out

Court annuls appointment of executive director due to selection process concerns

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EU watchdog raps EMA for redacted AbbVie data

Issues over the redaction of clinical study reports

Biogen Idec building

EMA starts review of Biogen Idec’s haemophilia A therapy

Elocta already on the market in the US, Canada and Australia

- PMLiVE

EFPIA promotes pharma’s contribution to Europe

Launches Pharmafigures website to detail industry investment

- PMLiVE

Orphan drugs lead CHMP recommendations

Clinuvel's Scenesse is first drug set for European approval to treat rare intolerance to sunlight

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