• Facebook
  • Twitter
  • LinkedIn
  • Google +
  • RSS

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

t-cell therapy cancer cells

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…

renal cell carcinoma

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…

pancreatic cancer

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…

keytruda

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…

Epclusa

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…

Kyprolis

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…

Adcetris

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…

teduglutide

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…

xtandi

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…

influenza vaccine

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…

schizophrenia

CHMP adopts positive opinion of Trevicta for maintenance treatment of schizophrenia

Industry news / 5 April 2016 / Victoria White

If approved, this 3‑monthly injection will allow patients to maintain an optimal level of treatment in their blood with fewer administrations…

eribulin

CHMP adopts positive opinion for eribulin in advanced liposarcoma

Industry news / 5 April 2016 / Victoria White

The European Medicines Agency’s CHMP has adopted a positive opinion for a licence extension for Eisai’s Halaven (eribulin)…

 

Win an Amazon Gift Card worth up to €100!TAKE OUR SURVEY
+ +