Europe

Samsung Bioepis first to secure EMA backing for Herceptin biosimilar
Samsung Bioepis first to secure EMA backing for Herceptin biosimilar
BioPharma Dive
Samsung Bioepis
EMA
Europe
biosimilars
Herceptin
Roche
breast cancer
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GSK’s triple-med COPD inhaler wins recommendation for approval in EU
GSK’s triple-med COPD inhaler wins recommendation for approval in EU
Drug Delivery Business News
GSK
COPD
Trelegy Ellipta
Europe
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Biogen, Samsung Humira copy wins EU approval
Biogen, Samsung Humira copy wins EU approval
Fierce Pharma
Biogen
Samsung Bioepis
Europe
Humira
AbbVie
Imraldi
biosimilars
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EMA and FDA will now share trade secrets, allowing both regulators to act on each other’s inspection reports
EMA and FDA will now share trade secrets, allowing both regulators to act on each other’s inspection reports
Endpoints
FDA
EMA
Europe
trade secrets
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Drug blocked by European regulators improves quality of life for MS patients
Drug blocked by European regulators improves quality of life for MS patients
Drug Delivery Business News
Europe
MS
multiple sclerosis
cladribine
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Intas Pharmaceuticals offered $1.5bn for 3 divisions of Teva’s in Europe
Intas Pharmaceuticals offered $1.5bn for 3 divisions of Teva’s in Europe
GoInPharma
Intas
India
M&A
Teva Pharmaceutical
Europe
Women's Health
oncology
pain management
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Kite shoots for first CAR-T OK in Europe, staying one step behind Novartis in US race
Kite shoots for first CAR-T OK in Europe, staying one step behind Novartis in US race
Endpoints
Kite Pharma
CAR-T
Europe
Novartis
axicabtagene ciloleucel
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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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