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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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Committee for Medicinal Products for Human Use (CHMP)
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Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...
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BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children
26 April 2017 | By Niamh Marriott, Junior Editor
CHMP has adopted a positive opinion for the company's MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease...
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Sandoz proposed biosimilars recommended for EU approval
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.
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AbbVie receives CHMP positive opinion for Hep C tablet combination
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)…
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Janssen’s monoclonal antibody receives positive CHMP opinion to treat multiple myeloma
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...
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Ferring receives positive CHMP opinion for IVF aid Rekovelle
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...
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AbbVie receives CHMP positive opinion for Venclyxto (venetoclax) to treat chronic lymphocytic leukaemia
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...
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EU approval in sight as Bellicum’s BPX-501 granted orphan drug designation
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...
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Ipsen’s kidney cancer drug receives positive CHMP and ‘Promising Innovative Medicine’ status
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...
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Onivyde receives positive CHMP opinion for pancreatic cancer treatment
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...
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CHMP positive opinion for Keytruda in NSCLC
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...
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Positive CHMP opinion for Gilead’s Epclusa in HCV
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...
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Amgen receives positive CHMP opinion to extend indication of Kyprolis
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...
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Positive CHMP opinion for Adcetris in post-transplant Hodgkin lymphoma
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...
