EMA

Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra
Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra
Endpoints
Takeda
Novartis
Xiidra
Europe
EMA
dry eye disease
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Vertex : CHMP Grants Positive Opinion For KAFTRIO - KALYDECO In People Ages 12 And Older With CF
Vertex : CHMP Grants Positive Opinion For KAFTRIO - KALYDECO In People Ages 12 And Older With CF
Business Insider
Vertex Pharmaceuticals
Europe
EMA
CHMP
cystic fibrosis
Kalydeco
Kaftrio
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COVID-19 drug remdesivir recommended for EU approval
COVID-19 drug remdesivir recommended for EU approval
Pharmaforum
Gilead
remdesivir
EMA
Europe
CHMP
COVID-19
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Regulators discuss accelerated approvals, Project Orbis at DIA
Regulators discuss accelerated approvals, Project Orbis at DIA
RAPS.org
regulatory
DIA
accelerated approvals
FDA
EMA
Health Canada
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Drug regulators in agreement on coronavirus vaccine trials, FDA official says
Drug regulators in agreement on coronavirus vaccine trials, FDA official says
BioPharma Dive
vaccines
pandemic
COVID-19
FDA
Health Canada
EMA
clinical trials
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Gilead files remdesivir for EU approval, with a verdict possible “in weeks”
Gilead files remdesivir for EU approval, with a verdict possible “in weeks”
Pharmaforum
EMA
Europe
Gilead Sciences
remdesivir
COVID-19
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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
RAPS.org
EMA
Europe
regulatory
clinical trial transparency
COVID-19
pandemic
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EMA extends virtual-only meeting policy through August
EMA extends virtual-only meeting policy through August
Endpoints
EMA
Europe
FDA
COVID-19
pandemic
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CHMP backs BMS’ first-in-class anemia drug Reblozyl
CHMP backs BMS’ first-in-class anemia drug Reblozyl
Pharmaforum
Bristol-Myers Squibb
EMA
CHMP
Reblozyl
anemia
Celgene
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EMA gives thumbs up to key drugs from Novartis, Alexion, Vertex and more
EMA gives thumbs up to key drugs from Novartis, Alexion, Vertex and more
Endpoints
EMA
Europe
Novartis
Alexion
Vertex Pharmaceuticals
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After NIH trial, EMA begins rolling review for remdesivir, setting up potential authorizations in US and Europe
After NIH trial, EMA begins rolling review for remdesivir, setting up potential authorizations in US and Europe
Endpoints
Gilead Sciences
remdesivir
COVID-19
EMA
NIH
FDA
Europe
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FDA, EU authorities update guidance on clinical trials during COVID-19
FDA, EU authorities update guidance on clinical trials during COVID-19
RAPS.org
FDA
EMA
Europe
clinical trials
COVID-19
pandemic
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EMA details new drug supply monitoring system for COVID-19
EMA details new drug supply monitoring system for COVID-19
RAPS.org
EMA
Europe
COVID-19
fast track
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BMS' Opdivo gets another lung cancer shot as FDA, EMA accept chemo combo filings
BMS' Opdivo gets another lung cancer shot as FDA, EMA accept chemo combo filings
Fierce Pharma
Bristol-Myers Squibb
Opdivo
Yervoy
non-small cell lung cancer
FDA
Europe
priority review
EMA
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EMA clears compassionate use of Gilead’s remdesivir for COVID-19
EMA clears compassionate use of Gilead’s remdesivir for COVID-19
Pharmaforum
Europe
EMA
Gilead Sciences
COVID-19
remdesivir
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GSK, Innoviva seek EMA approval for Trelegy Ellipta to treat asthma in adults
GSK, Innoviva seek EMA approval for Trelegy Ellipta to treat asthma in adults
Pharmaceutical Business Review
GSK
Innoviva
EMA
Europe
asthma
Trelegy Elipta
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Dutch biotech sector feel benefits of EMA move, says industry leader
Dutch biotech sector feel benefits of EMA move, says industry leader
Pharmaforum
EMA
Europe
The Netherlands
Brexit
biotech
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Janssen seeks EMA nod for Imbruvica, rituximab combo in previously untreated CLL
Janssen seeks EMA nod for Imbruvica, rituximab combo in previously untreated CLL
Pharmaceutical Business Review
Janssen
JNJ
EMA
Imbruvica
CLL
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With EMA review in progress, Novartis unveils more positive data on asthma therapy
With EMA review in progress, Novartis unveils more positive data on asthma therapy
Endpoints
Novartis
EMA
asthma
QMF149
clinical trials
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Pfizer's Xeljanz gets EMA blood clots warning following FDA's similar move
Pfizer's Xeljanz gets EMA blood clots warning following FDA's similar move
Fierce Pharma
Europe
EMA
ulcerative colitis
Pfizer
Xeljanz
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