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- PMLiVE

adverse events

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CHMP backs European approval for six new medicines

Recommends drugs by PTC Therapeutics, Roche, Biogen Idec, Octapharma, Alcon and Veloxis Pharma

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Teva backs laquinimod for MS despite CHMP rejection

EMA confirms negative opinion after re-examination

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Following the biologic path

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

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Bayer’s Nexavar recommended for thyroid cancer in EU

CHMP backs extra indication for cancer drug

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GSK’s Mekinist on course for EU melanoma approval

Only new medicine recommended in latest CHMP opinions

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EMA warns on stolen Herceptin

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

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EMA to carry out four safety reviews

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

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EU and Australian regulators collaborate on rare diseases

EMA and Therapeutic Goods Administration to share reports for orphan drugs

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AbbVie drops legal case against EMA

Accepts publication of new set of redacted Humira data

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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

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