List view / Grid view
2 May 2017 | By Niamh Marriott, Junior Editor
The FDA has accepted the resubmission of Sanofi and Regeneron Pharmaceuticals’ Biologics License Application for Kevzara (sarilumab)...
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...
26 April 2017 | By 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...
24 April 2017 | By 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)...
30 March 2017 | By 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).
30 March 2017 | By 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...
2 March 2017 | By 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)…
28 February 2017 | By Niamh Marriott, Digital Editor
If approved by the European Commission, daratumumab can be used for the treatment of adult patients with multiple myeloma...
27 February 2017 | By Niamh Marriott, Digital Editor
The EMA approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with non-small cell lung cancer...
23 February 2017 | By Niamh Marriott, Digital Editor
The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union.
23 January 2017 | By 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...
16 January 2017 | By Niamh Marriott, Digital Editor
The US Food and Drug Administration (FDA) has extended the review period for Eli Lilly and Incyte’s new drug application for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA).
12 January 2017 | By Niamh Marriott, Digital Editor
This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers...
11 January 2017 | By 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...
13 December 2016 | By Niamh Louise Marriott, Digital Editor
The European Medicines Agency (EMA) has accepted for review the marketing authorisation application for Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
