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EMA

- PMLiVE

EMA’s Stella Blackburn appointed president of International Society for Pharmacoepidemiology

Will continue as Agency’s risk management development and scientific lead

- PMLiVE

The journey to market access 5.0

Few in pharma are unaware of the importance of delivering demonstrable value in collaboration with payers. But are we serious about patient outcomes?

EMA wants pharma to see commercial potential in paediatric R&D

Publishes list of research needs for children’s cardiovascular medicines

- PMLiVE

J&J responds to FDA concerns over Xarelto in ACS

Responds to regulator about missing clinical trial data

- PMLiVE

MHRA’s Dr June Raine to chair new EMA pharmacovigilance committee

Pharmacovigilance Risk Assessment Committee (PRAC) will lead implementation of reforms

- PMLiVE

Merck KGaA acquires cancer drug from Symphogen

Will pay up to €495m for investigational metastatic colorectal cancer treatment

- PMLiVE

Market access webinar series begins with UK healthcare changes

Experts convene for first Sudler & Hennessey and Kantar Health online event

FDA sued for approving high dose of Eisai’s Alzheimer’s drug Aricept

Consumer rights group Public Citizen claims the high-strength dose is unsafe

Roche - Basel

Roche says pipeline will balance cancer drug patent losses

Has 11 new molecular entities in late-stage portfolio and 11 line extensions

Novartis building

FDA panel backs Novartis’ updated cystic fibrosis drug

New version of inhaled tobramycin therapy is simpler to use

- PMLiVE

US drug approval numbers fall despite pharma investing more in R&D

Stricter FDA policies are partly to blame for the decline says GBI Research

INC Research promotes Susan Akers-Smith to senior oncology role

She takes up the position of VP of early phase oncology development

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