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European Medicines Agency (EMA) - Articles and news items

BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children

Industry news / 26 April 2017 / Niamh Marriott, Junior Editor

CHMP has adopted a positive opinion for the company’s MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease…

AbbVie’s HCV/ compensated cirrhosis drug achieved 99% SVR12 rate

Industry news / 24 April 2017 / Niamh Marriott, Junior Editor

AbbVie announced that 99% (145/146) of chronic hepatitis C virus (HCV) infected patients with genotype and compensated cirrhosis (Child-Pugh A)…

AstraZeneca’s potential drug for neuromyelitis optica spectrum disorder receives EU orphan designation

Industry news / 30 March 2017 / Niamh Marriott, Junior Editor

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the European Medicines Agency (EMA) has granted orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Serialisation reconciliation: a blind spot in your finished product’s manufacturing compliance?

Blog, Z Homepage promo / 30 March 2017 / Pasi Kemppainen, Executive Consultant, Pharma Serialisation and Traceability

Pharma serialisation expert, Pasi Kemppainen, gives us his insights on how serialisation reconciliation can ensure product integrity and patient safety…

AbbVie receives CHMP positive opinion for Hep C tablet combination

Industry news / 2 March 2017 / Niamh Marriott, Digital Editor

The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for Abbvie’s shorter, eight-week treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) as an option for previously untreated adult patients with geotype 1b chronic hepatitis C virus (HCV) and minimal to moderate fibrosis. […]

REVLIMID

Janssen’s monoclonal antibody receives positive CHMP opinion to treat multiple myeloma

Industry news / 28 February 2017 / Niamh Marriott, Digital Editor

If approved by the European Commission, daratumumab can be used for the treatment of adult patients with multiple myeloma…

Novartis receives positive CHMP opinion for lung cancer combination

Industry news / 27 February 2017 / Niamh Marriott, Digital Editor

The EMA approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with non-small cell lung cancer…

First biosimilar mAb in oncology granted EU approval

Industry news / 23 February 2017 / Niamh Marriott, Digital Editor

The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union (EU)…

EMA validates Gilead’s marketing application for their Hep C therapy

Industry news / 23 January 2017 / Niamh Marriott, Digital Editor

The application is supported by data from two Phase 3 studies, which evaluated 12 weeks of the fixed-dose combination in antiviral-experienced patients…

FDA extends review period for Eli Lilly’s rheumatoid arthritis drug

Industry news / 16 January 2017 / Niamh Marriott, Digital Editor

Baricitinib is also being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a phase 3 trial for patients…

FDA accepts Mylan and Biocon’s biosimilar biologics license application

Industry news / 12 January 2017 / Niamh Marriott, Digital Editor

This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers…

Phase II trial for F2G’s antifungal drug following EU approval

Industry news / 11 January 2017 / Niamh Marriott, Digital Editor

F901318 is the first member of a novel class of systemic antifungal agents targeting life threatening mould infections and acting through a target…