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5 December 2016 | By 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...
18 November 2016 | By Niamh Louise Marriott, Digital Content Producer
The FDA granted priority review to the PKC412 (midostaurin) new drug application as treatment for acute myeloid leukaemia...
18 November 2016 | By 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...
10 November 2016 | By 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.
7 November 2016 | By 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)...
4 November 2016 | By 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...
20 October 2016 | By 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...
19 October 2016 | By 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...
10 October 2016 | By 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...
7 October 2016 | By 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...
25 August 2016 | By 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...
5 August 2016 | By 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...
25 July 2016 | By Niamh Louise Marriott, Digital Content Producer
Ipsen announced that CHMP & EMA have provided a positive opinion for Cabometyx for the treatment of advanced renal cell carcinoma (RCC) in adults...
25 July 2016 | By Niamh Louise Marriott, Digital Content Producer
The positive opinion is based on a pivotal Phase 3 study showing that Onivyde combined with chemotherapy significantly increased overall survival in patients with metastatic pancreatic cancer...
18 July 2016 | By Victoria White, Digital Content Producer
At an estimated $4billion a year, the reference product, Humira, is among the European Union's largest single drug expenditures...
