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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...
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 May 2016 | By Victoria White, Digital Content Producer
The EMA’s CHMP has adopted a positive opinion on Gilead’s Epclusa for the treatment of chronic hepatitis C virus...
27 May 2016 | By Victoria White, Digital Content Producer
The CHMP has adopted a positive opinion to extend the indication for Kyprolis to include treatment in combination with dexamethasone in multiple myeloma...
27 May 2016 | By Victoria White, Digital Content Producer
The opinion is for Adcetris for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following ASCT...
27 May 2016 | By Victoria White, Digital Content Producer
The CHMP has adopted a positive opinion of Shire’s Revestive (teduglutide) solution for injection in paediatric patients with short bowel syndrome...
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
This recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared...
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...
5 April 2016 | By Victoria White
The European Medicines Agency’s CHMP has adopted a positive opinion for a licence extension for Eisai’s Halaven (eribulin)...
29 February 2016 | By Victoria White
The CHMP positive opinion is based on the results of the head-to-head LUX-Lung 8 trial in patients with SqCC...
26 February 2016 | By Victoria White
The CHMP opinion of the Type-II variation application for Viekirax + Exviera is supported by data from the Phase 3b TURQUOISE-III study...
26 February 2016 | By Victoria White
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with IL-17A cytokine and inhibits its interaction with the IL-17 receptor...
