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European Medicines Agency (EMA) - Articles and news items

guselkumab

EMA to review Janssen’s plaque psoriasis monoclonal antibody

Industry news / 5 December 2016 / Niamh Louise Marriott, Digital Editor

Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development…

Novartis’ acute myeloid leukaemia drug granted FDA priority review

Industry news / 18 November 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA granted priority review to the PKC412 (midostaurin) new drug application as treatment for acute myeloid leukaemia…

EC approval for Lilly’s soft tissue sarcoma drug Olaratumab

Industry news / 18 November 2016 / Niamh Louise Marriott, Digital Content Producer

This conditional marketing authorisation is based on data from the Phase 2 portion of the pivotal JGDG trial and followed a positive recommendation from…

Mabion sign supply and commercialisation agreement with Mylan

Industry news / 10 November 2016 / Niamh Louise Marriott, Digital Content Producer

Mabion signed a long-term development and commercialisation agreement with Mylan Ireland a wholly owned subsidiary of Mylan N.V. for its biosimilar…

FDA grants priority review for Novartis’ first-line treatment of HR+/HER2- advanced breast cancer

Industry news / 7 November 2016 / Niamh Louise Marriott, Digital Content Producer

The US Food and Drug Administration (FDA) accepted Novartis’ new drug application (NDA) for filing and granted priority review for LEE011 (ribociclib)…

Mundipharma announces EU regulatory submission for Nyxoid

Industry news / 4 November 2016 / Niamh Louise Marriott, Digital Content Producer

Studies showed that Nyxoid is bioequivalent to injectable naloxone as a first line treatment for opioid overdose, with an intranasal 1.8 mg dose…

Sanifit launches Phase II calciphylaxis study

Industry news / 20 October 2016 / Niamh Louise Marriott, Digital Content Producer

Calciphylaxis is a serious and rare condition characterised by vascular calcification and thrombosis leading to necrosis of the skin and fatty tissue…

EU approval for Abeona’s gene therapy to treat Sanfilippo Syndrome Type A

Industry news / 19 October 2016 / Niamh Louise Marriott, Digital Content Producer

Gene therapy program ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA), a rare autosomal recessive disease…

head and neck cancer

‘Game-changing’ immunotherapy doubles head and neck cancer survival

Industry news, Z Homepage promo / 10 October 2016 / Niamh Louise Marriott, Digital Content Producer

An immunotherapy drug has been hailed as a ‘game changer’ after being found to greatly improve survival for patients with relapsed head and neck cancer…

neimann

Vtesse doses first patient in Phase 2b/3 Niemann-Pick Type C1 trial

Industry news / 7 October 2016 / Niamh Louise Marriott, Digital Content Producer

The VTS-270 clinical program is aimed at treating the neurological disease that is the primary cause of child mortality with Niemann-Pick Type C1 disease…

EMA accepts to review Mylan and Biocon’s cancer biosimilar

Industry news / 25 August 2016 / Niamh Louise Marriott, Digital Content Producer

Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA…

EU approval in sight as Bellicum’s BPX-501 granted orphan drug designation

Industry news / 5 August 2016 / Bellicum Pharmaceuticals

Bellicum Pharmaceuticals, a clinical stage biopharmaceutical company, has been granted orphan drug designations for both its T-cell therapy product candidate BPX-501 for treatment in hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid…

 

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