Keytruda scores in neoadjuvant triple negative breast cancer combo

Meanwhile, Keytruda is continuing to advance in other indications. In Europe, the Committee for Medicinal Products for Human Use (CHMP) has recommended Keytruda in combination with Inlyta (axitinib) as a

CHMP backs Bayer’s tumour-agnostic drug Vitrakvi

The EMA’s human medicines committee (CHMP) has backed a conditional approval of Vitrakvi (larotrectinib) for the treatment of solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. ... The ‘histology-independent’ treatment

Tecentriq’s triple negative breast cancer use among key CHMP nods

On Friday the CHMP’s most notable ruling was a negative opinion for UCB and Amgen’s severe osteoporosis drug Evenity. ... Nucala.. This CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the

CHMP blocks UCB/Amgen’s Evenity approval for osteoporosis

The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on first-in-class antibody treatment Evenity (romosozumab), putting yet another obstacle in the path of a drug ... void. Now, the EU rejection makes that task even harder.

England to fast-track tumour agnostic drugs like Vitrakvi – if the price is right

Bayer/Loxo’s Vitrakvi is expected to gain CHMP recommendation in the next few months, with full marketing authorisation to likely to follow before the end of 2019.NHS England will

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.