European Medicines Agency (EMA) - Articles and news items

Why biosimilars are changing the pharmaceutical industry

Blog, Z Homepage promo / 26 May 2017 / Ho-ung Kim, Head of Strategy and Operations Division for Celltrion Healthcare

We caught up with Celltrion Healthcare’s Ho-ung Kim to find out how biosimilars cut costs, increase access to medicine and are ultimately changing the industry…

Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research

Industry news / 16 May 2017 / European Federation of Pharmaceutical Industries and Associations (EFPIA)

The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with quality medicines

European Medicines Agency’s 2016 annual report published

Industry news / 11 May 2017 / Niamh Marriott, Junior Editor

EMA’s report focuses on key achievements in the areas of medicine evaluation, support to R&D of new and innovative treatments and safety monitoring…

Ireland reiterates bid to host the European Medicines Agency post-Brexit

Industry news / 9 May 2017 / Niamh Marriott, Junior Editor

Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated bySimon Harris…

formulation

AstraZeneca’s new formulation tablets receive positive CHMP opinion

Industry news / 5 May 2017 /

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 formulation of ticagrelor designed for […]

biosimilars

Biosimilars: the future of Pharma? An interview with Boehringer Ingelheim

Blog, Z Homepage promo / 3 May 2017 / 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…

Kevzara

FDA accepts Sanofi and Regeneron’s biologics license resubmission

Industry news / 2 May 2017 / Niamh Marriott, Junior Editor

The FDA has accepted the resubmission of Sanofi and Regeneron Pharmaceuticals’ Biologics License Application for Kevzara (sarilumab)…

Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment

Industry news / 28 April 2017 / 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…

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…

 

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