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EU approval for J&J’s hepatitis C drug

Olysio can be used in combination with Gilead’s Sovaldi

- PMLiVE

Following the biologic path

Biosimilar regulations in Canada, the US and Europe all have a degree of uncertainty

- PMLiVE

Bayer’s Nexavar recommended for thyroid cancer in EU

CHMP backs extra indication for cancer drug

- PMLiVE

GSK’s Mekinist on course for EU melanoma approval

Only new medicine recommended in latest CHMP opinions

- PMLiVE

EMA warns on stolen Herceptin

Says vials of cancer drug have been tampered with and re-introduced into supply chain

- PMLiVE

EMA to carry out four safety reviews

And recommends against combination of medicines affecting RAS system in latest PRAC highlights

- PMLiVE

EU and Australian regulators collaborate on rare diseases

EMA and Therapeutic Goods Administration to share reports for orphan drugs

- PMLiVE

AbbVie drops legal case against EMA

Accepts publication of new set of redacted Humira data

- PMLiVE

EMA’s Dr Stella Blackburn joins Quintiles

Takes up global head of risk management post

- PMLiVE

GSK withdraws melanoma combo in EU

EMA says it needs more data to review Mekinist and Tafinlar

- PMLiVE

EMA backs Janssen rare disease drug for approval

Castleman's disease treatment Sylvant wins CHMP recommendation

- PMLiVE

Boehringer/Lilly’s empagliflozin among CHMP recommendations

If approved it will be marketed as Jardiance

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