EMA sees approval numbers rise in 2018

Lastly, the EMA’s key human medicines committee, the CHMP, has a new chairman.

Novartis withdraws EU filing for canakinumab

On Friday the EMA said its Committee for Medicinal Products for Human Use (CHMP) had "concerns" over the application, and was minded to issue a negative opinion on the filing, and

Biogen picks up another drug from wide-ranging Ionis alliance

Among others in late-stage development are AB Sciences’ tyrosine kinase inhibitor masitinib, which was turned down by the CHMP in April at its first attempt for EU approval, and Orion

CHMP backs Sanofi’s all-oral sleeping sickness drug

CHMP round-up. Fexinidazole was one of four new medicines recommended for approval by the CHMP at its meeting last week. ... The CHMP also gave its blessing to various line extensions for already-market drugs.

Roche pulls EU Tecentriq/Avastin filing in kidney cancer

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has said that Roche opted to withdraw the application via a letter that said the trial results “are not sufficient ... CHMP changes its mind on Opdivo/Yervoy. There was better news for

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

Drug R&D

Europe vs the US: New drug product approvals

In the US, five biosimilars were approved in 2016. In the EU, eight new approvals for biosimilars were recommended for approval by the CHMP in 2016; four of these were still

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.