Europe

Pharma official: Expect “substantial” revision of ICH stability and specification guidelines
Pharma official: Expect “substantial” revision of ICH stability and specification guidelines
RAPS.org
ICH
Europe
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Biogen gets EU court ruling in favor of blocking Tecfidera generic entry
Biogen gets EU court ruling in favor of blocking Tecfidera generic entry
Seeking Alpha
Biogen
EMA
Europe
MS
multiple sclerosis
Tecfidera
generics
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Europe rues SVB loss as a cornerstone life science supporter
Europe rues SVB loss as a cornerstone life science supporter
EP Vantage
SVB
biotech
life sciences
Europe
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Merck asks EMA to reevaluate rejected Covid-19 antiviral
Merck asks EMA to reevaluate rejected Covid-19 antiviral
Endpoints
Merck
Europe
EMA
COVID-19
Lagevrio
molnupiravir
antivirals
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Medtech industry relieved as Europe’s MDR extension nears final approval
Medtech industry relieved as Europe’s MDR extension nears final approval
Medtech Dive
Medtech
Europe
MDR
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OCI-led CAR-T leukemia therapy receives €2.5m from EIC
OCI-led CAR-T leukemia therapy receives €2.5m from EIC
Pharmaphorum
OneChain
Europe
CAR-T
leukemia
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PharmaEssentia's blood cancer treatment authorized in Europe
PharmaEssentia's blood cancer treatment authorized in Europe
CP Wire
PharmaEssentia
Taiwan
polycythemia vera
ropeginterferon alfa
Europe
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First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission
First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission
BioSpace
CSL
Europe
Hemgenix
gene therapy
hemophilia B
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AstraZeneca's Forxiga nabs expanded heart failure approval in Europe
AstraZeneca's Forxiga nabs expanded heart failure approval in Europe
Fierce Pharma
AstraZeneca
Europe
Forxiga
heart failure
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Abbott Snags Two New Electrophysiology Product Approvals
Abbott Snags Two New Electrophysiology Product Approvals
Medical Devices and Diagnostics Industry
Medtech
devices
Abbott Labs
TactiFlex Ablation Catheter
Europe
atrial fibrillation
Flexibility Ablation Catheter
SE
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New clinical trial system to soon become mandatory in Europe
New clinical trial system to soon become mandatory in Europe
Endpoints
clinical trials
Europe
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EMA weighs new safety guidance for Novartis’ gene therapy Zolgensma
EMA weighs new safety guidance for Novartis’ gene therapy Zolgensma
BioPharma Dive
Novartis
gene therapy
Zolgensma
SMA
Europe
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Illumina Could Face Hefty Fine Over Grail Acquisition
Illumina Could Face Hefty Fine Over Grail Acquisition
Medical Devices and Diagnostics Industry
Illumina
Grail
M&A
antitrust
Europe
diagnostics
Medtech
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After FDA nod, Eisai and Biogen file lecanemab in EU
After FDA nod, Eisai and Biogen file lecanemab in EU
Pharmaphorum
Eisai
Biogen
lecanemab
Europe
Alzheimer's disease
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AstraZeneca, Merck's Lynparza wins EU nod in advanced prostate cancer right after FDA delay
AstraZeneca, Merck's Lynparza wins EU nod in advanced prostate cancer right after FDA delay
Fierce Pharma
AstraZeneca
Merck
Lynparza
Europe
prostate cancer
advanced prostate cancer
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Atara claims first world approval for off-the-shelf T-cell therapy
Atara claims first world approval for off-the-shelf T-cell therapy
Pharmaphorum
Atara Biotherapeutics
Ebvallo
t-cell therapies
Europe
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Biogen's ALS Drug Tofersen Filing Accepted in Europe
Biogen's ALS Drug Tofersen Filing Accepted in Europe
Zacks.com
Biogen
ALS
EMA
Europe
tofersen
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AstraZeneca and Sanofi win big as Europe's human medicines committee endorses approvals, label expansions
AstraZeneca and Sanofi win big as Europe's human medicines committee endorses approvals, label expansions
Fierce Pharma
Europe
AstraZeneca
Sanofi
COVID-19
cancer
GSK
Regeneron
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Dupixent nears EU approval for rare skin disease prurigo nodularis
Dupixent nears EU approval for rare skin disease prurigo nodularis
Pharmaphorum
Sanofi
Regeneron
Dupixent
Europe
prurigo nodularis
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Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster
Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster
Fierce Pharma
Sanofi
GSK
COVID-19
Europe
vaccines
boosters
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