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5 May 2017 | By
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the adoption of AstraZeneca’s Brilique (ticagrelor) 90mg orodispersible tablets (ODT) as a new method of treatment administration. This opinion is the first step towards the adoption of a new…
3 May 2017 | By Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim
With biosimilars expected to account for 10% of the total biologics market by 2020, we caught up with Boehringer Ingelheim’s Senior VP to find out more…
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...
