J&J catches up to Merck, files Ebola vaccine in Europe

This announcement comes  hot-on-the-heels of Merck/MSD winning a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its own investigational V920 ... J&J has already won an accelerated assessment from the CHMP for

Merck wins CHMP recommendation for Ebola vaccine

Products for Human Use (CHMP). ... This positive opinion from CHMP represents important progress towards licensure of a vaccine to provide protection from Ebola virus disease to people in areas affected by the Ebola Zaire virus,” said

CHMP says OK to UCB/Amgen’s Evenity for osteoporosis after appeal

The Committee for Medicinal Products for Human Use (CHMP) issued a  negative opinion on first-in-class antibody Evenity (romosozumab) in June, but re-examined the drug after an appeal by ... The CHMP’s recommendation is for use of the drug in patients

Astellas’ Xospata scores positive CHMP recommendation

Could become a potential option for hard-to-treat leukaemia. Japanese pharma Astellas has won a positive recommendation from the EMA’s Committee for Medical Products for Human Use (CHMP) for

Half of European cancer drug trials ‘biased’, says BMJ

Committee for Medicinal Products for Human Use (CHMP),” said the authors in an accompanying  blog post.

Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019

The gene therapy gained recommendation from the EMA’s CHMP in March for non-beta0/beta0 adolescents and adults.

Bluebird: on a mission to ‘recode’ the DNA of healthcare

The European Medicines Agency’s CHMP committee recommended conditional marketing authorisation for Zynteglo (autologous CD34+ cells encoding β A-T87Q-globin gene) at the end of March, setting it up for ... transfusions. The positive CHMP opinion is

The European Medicines Agency: PRIME’d for access?

Early signs are looking good: Novartis’ Kymriah (tisagenlecleucel) and Gilead/Kite’s Yescarta (axicabtagene ciloleucel) secured positive opinions from EMA's Committee for Medicinal Products for Human Use (CHMP) in June

Deal Watch January 2018

ex-US rights to Cx601 with double digit royalties due on net sales (DW Issue 73).  In December 2017, the CHMP of the EMA gave a positive opinion recommending a marketing

Drug safety

MHRA names vice-chair of Commission on Human Medicines

Commissioners also frequently attend the European Committee on Human Medicinal Products (CHMP) meetings as part of the UK delegation.

Kite Pharma appoints head of regulatory affairs

international agencies – FDA, EMA/CHMP, Health Canada, and PMDA – at multiple levels will be critical to Kite's further advancement and planning.”.

CHMP names France's Pierre Demolis vice-chair

The European Medicines Agency (EMA) has appointed France's Dr Pierre Demolis as vice-chair of the Committee for Medicinal Products for Human Use (CHMP). ... Dr Demolis' appointment comes after six years serving as a member of the CHMP.

EMA’s Paediatric Committee elects new leaders

Products for Human Use (CHMP).

DH names new chief executive of the MHRA

Hudson is also the UK delegate and vice chairman of the Committee on Human Medicinal Products (CHMP) at the European Medicines Agency.

Wordbird helps ellaOne® fly over the counter

In addition, Wordbird has provided consultancy in responding to CHMP questions during the reclassification process.

NDA

Year on year, NDA has contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.