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

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…

Amgen receives positive CHMP opinion to extend indication of Kyprolis

Industry news / 27 May 2016 / 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…

Positive CHMP opinion for Adcetris in post-transplant Hodgkin lymphoma

Industry news / 27 May 2016 / 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…

CHMP positive opinion for teduglutide in paediatric patients

Industry news / 27 May 2016 / 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…

CHMP issues positive opinion for Xtandi label update

Industry news / 8 April 2016 / 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…

CHMP issues positive opinion of AstraZeneca’s pandemic influenza vaccine

Industry news / 5 April 2016 / 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…

 

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