Committee for Medicinal Products for Human Use (CHMP) - Articles and news items

Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment

Industry news / 28 April 2017 / 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…

BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children

Industry news / 26 April 2017 / 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…

Sandoz proposed biosimilars recommended for EU approval

Industry news / 25 April 2017 / Niamh Marriott, Junior Editor

CHMP has adopted positive opinions, separately recommending the approval of both Sandoz’s biosimilar rituximab and biosimilar etanercept in Europe…

AbbVie receives CHMP positive opinion for Hep C tablet combination

Industry news / 2 March 2017 / 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) and minimal to moderate fibrosis. […]

REVLIMID

Janssen’s monoclonal antibody receives positive CHMP opinion to treat multiple myeloma

Industry news / 28 February 2017 / Niamh Marriott, Digital Editor

If approved by the European Commission, daratumumab can be used for the treatment of adult patients with multiple myeloma…

Ferring receives positive CHMP opinion for IVF aid Rekovelle

Industry news / 19 October 2016 / 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…

AbbVie receives CHMP positive opinion for Venclyxto (venetoclax) to treat chronic lymphocytic leukaemia

Industry news / 18 October 2016 / 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…

EU approval in sight as Bellicum’s BPX-501 granted orphan drug designation

Industry news / 5 August 2016 / 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…

Ipsen’s kidney cancer drug receives positive CHMP and ‘Promising Innovative Medicine’ status

Industry news / 25 July 2016 / 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…

Onivyde receives positive CHMP opinion for pancreatic cancer treatment

Industry news / 25 July 2016 / 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…

CHMP positive opinion for Keytruda in NSCLC

Industry news / 27 June 2016 / 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…

Positive CHMP opinion for Gilead’s Epclusa in HCV

Industry news / 27 May 2016 / 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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