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- PMLiVE

Mysimba

- PMLiVE

Shoring up the framework

European regulators add a measure of clarity to pharma’s uncertainty around Brexit

- PMLiVE

Samsung Bioepis wins CHMP nod for second Humira biosimilar

In addition to Imraldi the regulatory advisors also backed new medicines from AbbVie and Gilead

- PMLiVE

Merck gets CHMP backing for long-delayed oral MS drug

Cladribine, which will be branded as Mavenclad, was originally rejected by the committee in 2010

- PMLiVE

European regulators mull use of… QR codes

EMA’s Heads of Medicines Agencies committee outlines packaging proposals

Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

- PMLiVE

Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog

Panel recommends insulin Lispro Sanofi to treat diabetes

- PMLiVE

EMA develops framework for academia collaborations

Looks to develop the way it works with the academic community

Shire Basingstoke

Shire finally bags EU approval for rare disease drug Natpar

Becomes first licenced treatment for hypoparathyroidism in Europe

EU flag

CHMP backs two rare disease therapies at April meeting

Biogen's Spinraza and BioMarin's Brineura near EU approval

EMA establishes big data taskforce

Will explore how research and medicines development can be supported

- PMLiVE

Pfizer launches new antibiotic Zavicefta in UK and Germany

Biopharmaceutical company Pfizer releases MDR antibiotic

Actelion HQ Switzerland

EU nod for Actelion’s skin cancer drug Ledaga

Still need to meet CHMP post-approval requirements

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