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- PMLiVE

clinical trial regulation

Roche Basel Switzerland

Roche submits Kadcyla for FDA Real-Time review

Aims to extend use in breast cancer patients

AstraZeneca AZ

US, EU regulators back rapid reviews of AZ’s RSV med

Positive top-line data triggered speedy assessments

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Medicines will take priority over food in no-deal Brexit

The UK is more reliant on the EU for medicines than food, says Hancock

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Vertex gains EU approval for earlier Orkambi use

Cystic Fibrosis drug approved in children aged 2-5 years

- PMLiVE

Europe closer to biosimilar rule change, despite fierce resistance from pharma

EFPIA says it weakens IP commitment - supporters say it will boost exports

- PMLiVE

Crunch time as Brexit deal faces ‘meaningful vote’

Rejecting the deal would either result in a no deal or no Brexit, warns May

- PMLiVE

Time running out for ‘no-deal’ Brexit medicines laws

Needs parliament clearance before 29 March

- PMLiVE

Shire’s angioedema drug Takhzyro claims EU approval

Approval shortly follows a green light in the US

Innovation in merger control and the impact on the pharmaceutical sector

Is focusing on pipeline products enough to assess regulatory risks?

- PMLiVE

Novartis files for approval of MS drug in EU, US

Siponimod could achieve blockbuster status if approved, says analysts

- PMLiVE

GSK to reverse ‘no KOLs’ policy, admitting it has hit marketing

Company seeking to revive lacklustre marketing performance

- PMLiVE

MSD wins key EU approval for Keytruda, Alimta combo

Decision keeps Keytruda well ahead of rival Tecentriq

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