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- PMLiVE

adverse events

Biomarin

BioMarin files muscular dystrophy drug in EU

Drisapersen could be the first ‘exon-skipping’ therapy

- PMLiVE

EMA prepares to launch medical literature monitoring service

Will screen documents for 400 active substance groups

EU flag

EMA to stop ‘revolving doors’ committee members

Comes nearly five years after its former director left for a pharma service firm

EISAI

Eisai’s thyroid cancer drug Lenvima nears EU approval

Positive recommendation by the CHMP could see the orphan drug used in Europe within three months

- PMLiVE

EMA elects Dr Christa Wirthumer-Hoche new vice chair

Head of the Austrian regulator succeeds Prof DrWalter Schwerdtfeger

EU flag

New cancer meds and drug extensions top CHMP recommendations

Drugs for rare disease, oncology and diabetes top regulator’s endorsements

Sanofi reception

Sanofi’s Lantus follow-up nears European approval

CHMP backing for Toujeo follows hot on the heels of its US approval by the FDA

EU flag

Jinarc backed for European approval in rare kidney disease

Positive opinion for Otsuka comes just before rare disease awareness day

- PMLiVE

Google-backed genetic testing kit gains FDA approval

23andMe’s DNA test can alert consumers to their risks of certain diseases

- PMLiVE

Google-backed genetic testing kit gains FDA approval

23andMe’s DNA test can alert consumers to their risks of certain diseases

EU flag

EMA defends Humira redaction policy from transparency criticism

Regulator says spirit of trial transparency intact after its handling of AbbVie reports

- PMLiVE

Astellas joins trial data sharing website

Joins Bayer, Boehringer, GSK, Lilly, Novartis, Roche and more

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