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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...
7 July 2016 | By Victoria White, Digital Content Producer
In the recent Referendum, the majority voted against the UK's continued membership of the EU. Now, the EMA has issued a statement on the outcome of the vote...
28 June 2016 | By Victoria White, Digital Content Producer
If approved by the EMA and FDA for both indications, Ocrevus would be the first and only treatment for both forms of multiple sclerosis...
27 June 2016 | By Victoria White, Digital Content Producer
The CHMP has recommended approval of Keytruda for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1...
27 June 2016 | By Victoria White, Digital Content Producer
While a Brexit undoubtedly creates significant issues for the UK pharma industry, opportunities remain for the sector to thrive, according to GlobalData...
2 June 2016 | By Victoria White, Digital Content Producer
PRIME aims to bring treatments to patients faster by enhancing the EMA’s support for the development of investigational medicines...
8 April 2016 | By Victoria White, Digital Content Producer
The CHMP has recommended approval of a type II variation to include data from the TERRAIN trial of Xtandi (enzalutamide) versus bicalutamide...
5 April 2016 | By Victoria White
If approved, this 3‑monthly injection will allow patients to maintain an optimal level of treatment in their blood with fewer administrations...
30 March 2016 | By Victoria White
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency...
24 March 2016 | By Victoria White
Xeljanz is the only oral Janus kinase (JAK) inhibitor approved in more than 45 countries around the world for the treatment of moderate to severe RA...
