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CHMP
This page shows the latest CHMP news and features for those working in and with pharma, biotech and healthcare.
Vertex’s triple CF therapy scores recommendation from CHMP
Other highlights from EMA’s CHMP’s June meeting include Idefirix and remdesivir. ... As previously reported, the CHMP also recommended approval of Gilead Science’s antiviral drug remdesivir, which has now been dubbed Veklury.
Latest news
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Remdesivir closes in on receiving first EU approval for treatment for COVID-19
The CHMP has recommended granting a conditional marketing authorisation to remdesivir under the Veklury brand name – the same used for the drug in Japan where it has approval under emergency use ... who saw their time to recovery cut from 18 to 12 days,
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In virtual meeting, CHMP backs Sanofi’s myeloma drug Sarclisa
The CHMP positive opinion is for Sarclisa (isatuximab) as a treatment for patients with relapsed and refractory multiple myeloma in combination with Bristol-Myers Squibb’s Pomalyst (pomalidomide) and dexamethasone – a ... The EMA typically issues a
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EMA calls for pooled EU research into COVID-19 therapies
The agency’s Committee for Medicinal Products for Human Use (CHMP) is aware of a number of planned investigational studies to treat patients under compassionate use or similar protocols with investigational ... drugs. In response, the CHMP has deemed
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Modest meeting sees only two drugs recommended by CHMP
The CHMP recommended a marketing authorisation of Japanese pharma company Shionogi’s antimicrobial drug Fetcroja (cefiderocol) for the treatment of infections caused by Gram-negative organisms in adults with limited treatment ... As the CHMP aptly put
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Eisai agrees to pull obesity drug Belviq after safety alert
Belviq was never launched in Europe because Arena withdrew its marketing application amid resistance from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which was uncomfortable with the
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Approximately 116 fully matching, plus 288 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
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
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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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Wordbird helps ellaOne® fly over the counter
In addition, Wordbird has provided consultancy in responding to CHMP questions during the reclassification process.
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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.
More from PMHub
Approximately 0 fully matching, plus 2 partially matching documents found.
COVID-19 Updates and Daily News
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- Remdesivir closes in on receiving first EU approval for treatment for COVID-19
- Syneos Health appoints trio of senior hires
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- The best work in healthcare communications shines at virtual Communiqué Awards
- Mearns & Pike, Electric Putty and Evoke KYNE make a clean sweep at Communiqué 2020
- 90TEN scoops Communiqué Communications Consultancy of the Year Award for the Second Year Running
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PMHub
Empowering Strategic Performance Ltd
OUR GOAL: To help clients Metamorph™ Science into Action that changes healthcare to improve the lives of patients. Empowering Strategic...
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