Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Compassionate use programme

- PMLiVE

AbbVie and Boehringer’s psoriasis drug Skyrizi gets CHMP nod

Analysts say the drug could be a best-in-class candidate in the therapy area

- PMLiVE

EMA could follow FDA’s Xeljanz blood clot warning

European agency in step with FDA after safety doubts

- PMLiVE

‘Inflexible’ NICE blocking access to rare disease drugs

Spinraza most high profile example of access problem

- PMLiVE

Big opportunities in big data, but EMA and industry just getting started

250m genomes sequenced, but data trapped in silos

- PMLiVE

Industry aghast as EU Parliament backs biosimilar rule change

The change could come into effect in 2021

- PMLiVE

Industry concerned about ‘rushed’ Brexit withdrawal legislation

The Patents Amendment could weaken the UK’s IP framework, warns biopharma

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

- PMLiVE

Medicines will take priority over food in no-deal Brexit

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

- PMLiVE

European Medicines Agency departs London ahead of Brexit

Regulator moving to Amsterdam, as Novartis adds voice to no-deal warnings

- PMLiVE

EMA says Lilly’s Lartruvo should not be prescribed

First time EMA has acted on accelerated approval follow-up

- PMLiVE

Vertex gains EU approval for earlier Orkambi use

Cystic Fibrosis drug approved in children aged 2-5 years

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links