Europe

EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda
EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda
RAPS.org
EMA
Europe
Pfizer
Bavencio
Novartis
Rydapt
Lexicon Pharmaceuticals
Xermelo
Vanda
Fanaptum
Nektar
Onzeald
Daiichi Sankyo
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Nektar’s pitch on early cancer drug OK runs into a regulatory brick wall
Nektar’s pitch on early cancer drug OK runs into a regulatory brick wall
Endpoints
Nektar
regulatory
Onzeald
Europe
Daiichi Sankyo
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What Brexit means for drug regulation
What Brexit means for drug regulation
Pharmafile
regulation
UK
Europe
Brexit
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EMA Restricts Use of Biogen MS Drug
EMA Restricts Use of Biogen MS Drug
RAPS.org
Europe
EMA
Biogen
MS
multiple sclerosis
Zinbryta
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EuroBiotech Report: Brexit, BioNTech success, GlaxoSmithKline inks AI deal, Silence takes Alnylam to court and Shire makes cuts
EuroBiotech Report: Brexit, BioNTech success, GlaxoSmithKline inks AI deal, Silence takes Alnylam to court and Shire makes cuts
Fierce Biotech
Europe
biotech
Brexit
BioNTech
GSK
artificial intelligence
Sanofi
Exscientia
Silence Therapeutics
RNAi
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Lilly’s Olumiant, spurned by FDA, gets nod from NICE
Lilly’s Olumiant, spurned by FDA, gets nod from NICE
Fierce Pharma
FDA
NICE
Europe
Eli Lilly
olumiant
rheumatoid arthritis
Humira
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Janssen gets EU nod for continuous manufacturing
Janssen gets EU nod for continuous manufacturing
BioPharma Dive
Janssen
Europe
drug manufacturing
Prezista
HIV
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Novartis scores second biosimilar approval in two weeks
Novartis scores second biosimilar approval in two weeks
BioPharma Dive
Novartis
biosimilars
Enbrel
Europe
Sandoz
Erelzi
Roche
Rituxan
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Aveo soars as long-beleaguered cancer drug nears approval
Aveo soars as long-beleaguered cancer drug nears approval
Fierce Biotech
Aveo
Europe
tivozanib
kidney cancer
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Takeda set to open new German manufacturing facilities
Takeda set to open new German manufacturing facilities
BioPharma Dive
Takeda
Germany
Europe
drug manufacturing
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EMA Recommends New HCV, Cancer and MS Drugs for Approval
EMA Recommends New HCV, Cancer and MS Drugs for Approval
RAPS.org
Europe
EMA
hepatitis C
multiple sclerosis
breast cancer
renal cell carcinoma
AbbVie
Maviret
Gilead Sciences
Vosevi
Biogen
Amgen
Samsung Bioepis
biosimilars
Humira
Novartis
Kisqali
EUSA
Fotivda
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Novo Nordisk files to add Lantus-matching CV data to Tresiba's European label
Novo Nordisk files to add Lantus-matching CV data to Tresiba's European label
Fierce Pharma
Novo Nordisk
Lantus
Tresiba
diabetes
Europe
EMA
insulin
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Johnson & Johnson wins last regulatory nod needed for Actelion acquisition
Johnson & Johnson wins last regulatory nod needed for Actelion acquisition
Drug Delivery Business News
JNJ
Actelion
M&A
EU
Europe
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Pfizer’s Trumenba to challenge GlaxoSmithKline's Bexsero with EU nod
Pfizer’s Trumenba to challenge GlaxoSmithKline's Bexsero with EU nod
Fierce Pharma
Pfizer
Trumenba
GSK
Bexsero
Europe
vaccines
meningococcal B
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EMA recommends 11 drugs for approval in May meeting
EMA recommends 11 drugs for approval in May meeting
BioPharma Dive
EMA
Europe
Sanofi
AstraZeneca
LEO Pharma
Novartis
Pfizer
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Sanofi’s insulin biosimilar wins EMA committee recommendation
Sanofi’s insulin biosimilar wins EMA committee recommendation
Drug Delivery Business News
Sanofi
insulin
biosimilars
EMA
Europe
Lispro
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EU drugmakers urge June decision on new location for watchdog
EU drugmakers urge June decision on new location for watchdog
Yahoo/Reuters
Europe
EMA
Brexit
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EMA panel recommends nod for Sanofi, Regeneron's arthritis drug
EMA panel recommends nod for Sanofi, Regeneron's arthritis drug
Yahoo/Reuters
Europe
EMA
Sanofi
Regeneron
rheumatoid arthritis
Kevzara
Sarilumab
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Brexit and biopharma: The UK/EU divorce begins
Brexit and biopharma: The UK/EU divorce begins
BioPharma Dive
Brexit
EU
Europe
UK
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Seeking a lift, Novo launches ultrafast-acting insulin in European markets
Seeking a lift, Novo launches ultrafast-acting insulin in European markets
Fierce Pharma
Novo Nordisk
diabetes
insulin
Europe
UK
Fiasp
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