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- PMLiVE

AAR

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EMA says adaptive pathways programme still needs refinement

Scheme aims to accelerate patient access to new drugs

- PMLiVE

Amgen enters into $540m immunotherapy collaboration

Acquires global rights to Advaxis’ preclinical oncology candidate ADXS-NEO

Brextinction

Evolution predicts tragic consequences from the UK's choice

- PMLiVE

EMA suspends generic drugs on data integrity concerns

Reports by FDA and WHO find evidence of data manipulation by Semler Research Centre

- PMLiVE

HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

EU flag

EU proposes reforms to make first-in-human trials safer

New guideline revision paper “takes into account lessons learnt” from fatal Bial trial

- PMLiVE

Novartis gets FDA panel backing for biosimilar Enbrel

However Amgen claims patent protection for the psoriatic arthritis therapy is valid until 2029

- PMLiVE

Amgen’s Humira biosimilar moves closer to US approval

FDA committee backs company's version of AbbVie's blockbuster

- PMLiVE

Gilead’s Zydelig passes EMA safety review

Risk of ‘serious infections’ outweighed by cancer drug’s benefits

- PMLiVE

EMA: ‘business as usual’ – for now – after Brexit

And says it will be up to remaining EU members to decide on its future location

- PMLiVE

Pfizer set to snap up Bind’s assets for $20m

Biotech approves 'stalking horse' bid from the pharma giant

- PMLiVE

Amgen’s Kyprolis wins new indication in Europe

Regulators have handed the treatment a less restrictive licence in multiple myeloma 

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