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CHMP
This page shows the latest CHMP news and features for those working in and with pharma, biotech and healthcare.
Takeda announces CHMP recommendation for Adcetris in Hodgkin lymphoma
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the antibody-drug conjugate (ADC), which is already approved in the EU for certain lymphoma patients, be used ... The CHMP’s recommendation will now be reviewed
Latest news
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Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine recommended by CHMP
older. The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended marketing authorisation for a single dose of the vaccine, known as Comirnaty Omicron XBB.1.5, in eligible ... The European Commission (EC) will now review
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Roche’s spinal muscular atrophy therapy recommended by CHMP for newborns
The CHMP’s recommendation was supported by an interim analysis of the ongoing RAINBOWFISH study, which included six babies with two or three copies of the SMN2 gene. ... The CHMP’s recommendation will now be reviewed by the European Commission for
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Janssen receives positive CHMP opinion for Talvey in multiple myeloma
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended conditional marketing authorisation for the drug as monotherapy in adult RRMM patients who have received at least three prior ... The CHMP’s recommendation for the
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Bristol Myers Squibb’s Opdivo recommended by CHMP for expanded melanoma use
The Committee for Medicinal Products for Human Use’s (CHMP) decision was supported by positive safety and efficacy results from the phase 3 CheckMate-76K trial, in which Opdivo reduced the ... The CHMP’s recommendation brings us closer to potentially
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Merck granted positive CHMP opinion for Keytruda combination in gastric cancer
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended the anti-PD-1 therapy in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment ... The CHMP’s
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Approximately 158 fully matching, plus 361 partially matching documents found.
Latest Intelligence
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The far-reaching impact of the COVID-19 pandemic on clinical trials
The CHMP is calling for large, randomised controlled trials that are powered to draw clear conclusions on the best therapeutic options.
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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.
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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
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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
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Deal Watch January 2018
In December 2017, the CHMP of the EMA gave a positive opinion recommending a marketing authorisation for Cx601, so it was probably a good time for Takeda to make a move.
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Approximately 0 fully matching, plus 12 partially matching documents found.
Latest appointments
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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.
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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.”.
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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.
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EMA’s Paediatric Committee elects new leaders
Products for Human Use (CHMP).
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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.
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Approximately 3 fully matching, plus 5 partially matching documents found.
Latest from PMHub
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NDA
Year on year, NDA has contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.
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Approximately 0 fully matching, plus 1 partially matching documents found.
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Latest intelligence
- Actinic keratosis – a common skin condition that can lead to skin cancer
- PMGroup talks to Volker Koscielny, Chief Medical Officer at Almirall, about the importance of remaining vigilant about skin checks, the prevalence of actinic keratosis in the UK and the steps...
- Man vs microbe: the fight against antimicrobial resistance
- How the emerging resistance to antibiotics is being exacerbated by a lack of research and development into new antibiotics...
- Is trust the key factor in digital HCP engagement? New whitepaper from Graphite Digital
- Based on research with HCPs in the UK, USA and France, Graphite Digital’s latest whitepaper sheds light on HCP perceptions of pharma-owned digital channels, and what organisations should be prioritising...
