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25 April 2017 | By Niamh Marriott, Junior Editor
The Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz's (a Novartis division) biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
2 March 2017 | By Niamh Marriott, Digital Editor
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for Abbvie’s shorter, eight-week treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) as an option for previously untreated adult patients with geotype 1b chronic hepatitis C virus (HCV)…
28 February 2017 | By Niamh Marriott, Digital Editor
If approved by the European Commission, daratumumab can be used for the treatment of adult patients with multiple myeloma...
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Non-inferiority was demonstrated in a Phase 3 trial for the co-primary endpoints of ongoing pregnancy rate and ongoing implantation rate for Rekovelle...
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The CHMP recommends approval of venetoclax monotherapy in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have...
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...
