Europe

EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns
EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns
Endpoints
EMA
Pfizer
Europe
Xeljanz
post-marketing studies
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EU universities are miserably lax at reporting clinical trial results, analysis suggests
EU universities are miserably lax at reporting clinical trial results, analysis suggests
Endpoints
Europe
clinical trial data
clinical trials
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Lynparza on cusp of EU approval for advanced ovarian cancer
Lynparza on cusp of EU approval for advanced ovarian cancer
Pharmaforum
AstraZeneca
Lynparza
Europe
CHMP
ovarian cancer
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AZ and MSD’s Lynparza gets EU nod for hard-to-treat breast cancer
AZ and MSD’s Lynparza gets EU nod for hard-to-treat breast cancer
Pharmaforum
AstraZeneca
Merck
Lynparza
BRCA-mutant breast cancer
Europe
breast cancer
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After falling short on prelim OS data, EMA tells Aveo it wants to see something better on its long suffering tivo this summer — or else
After falling short on prelim OS data, EMA tells Aveo it wants to see something better on its long suffering tivo this summer — or else
Endpoints
Aveo Oncology
tivozanib
EMA
Europe
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Teva wins EU nod for Ajovy migraine prophylactic
Teva wins EU nod for Ajovy migraine prophylactic
Drug Delivery Business News
Teva Pharmaceutical
Europe
migraines
Ajovy
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AbbVie's massive Humira discounts are stifling Netherlands biosimilars: report
AbbVie's massive Humira discounts are stifling Netherlands biosimilars: report
Fierce Pharma
AbbVie
Humira
biosimilars
drug pricing
Europe
Netherlands
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First gene therapy to treat rare blood disease nears European approval
First gene therapy to treat rare blood disease nears European approval
Stat
Bluebird Bio
Europe
LentiGlobin
gene therapy
beta-thalassemia
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Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars
Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars
RAPS.org
EMA
Europe
biosimilars
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As Brexit row become increasingly anarchic, is UK’s reputation with pharma suffering?
As Brexit row become increasingly anarchic, is UK’s reputation with pharma suffering?
Pharmaforum
Brexit
UK
Europe
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Sanofi may airlift medicines into UK after Brexit
Sanofi may airlift medicines into UK after Brexit
Pharmaforum
Sanofi
UK
Europe
Brexit
vaccines
flu vaccines
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Aimmune's peanut allergy immunotherapy clears European PhIII with flying colors, paving way for first US, EU therapeutic approval
Aimmune's peanut allergy immunotherapy clears European PhIII with flying colors, paving way for first US, EU therapeutic approval
Endpoints
Aimmune
peanut allergy
Europe
EMA
FDA
AR-101
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AZ’s diabetes drug Forxiga approved in EU for type 1 disease
AZ’s diabetes drug Forxiga approved in EU for type 1 disease
Pharmaforum
AstraZeneca
type 1 diabetes diabetes
Europe
Forxiga
Farixga
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Brexit delay offers biopharma more time to prepare for a no-deal
Brexit delay offers biopharma more time to prepare for a no-deal
BioCentury
Europe
UK
Brexit
drug shortages
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EMA sounds its own safety alarm for Pfizer blockbuster, but they’re also not forcing a limit on dosing — yet
EMA sounds its own safety alarm for Pfizer blockbuster, but they’re also not forcing a limit on dosing — yet
Endpoints
Pfizer
Xeljanz
Europe
EMA
rheumatoid arthritis
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Roche clinches EU approval for MabThera in rare autoimmune indication — will it boost dwindling sales amid biosimiar competition?
Roche clinches EU approval for MabThera in rare autoimmune indication — will it boost dwindling sales amid biosimiar competition?
Endpoints
Roche
MabThera
Rituxan
Europe
biosimilars
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Merck notches fourth lung cancer approval in Europe for flagship Keytruda
Merck notches fourth lung cancer approval in Europe for flagship Keytruda
Endpoints
Merck
Keytruda
metastatic squamous non-small cell lung cancer
Europe
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Pharma urges politicians to stop no-deal Brexit in today’s vote
Pharma urges politicians to stop no-deal Brexit in today’s vote
Pharmaforum
Brexit
UK
Europe
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Celgene Submits MS Drug for Approval in Europe, FDA Filing on Track
Celgene Submits MS Drug for Approval in Europe, FDA Filing on Track
Xconomy
Celgene
Bristol-Myers Squibb
Europe
FDA
M&A
MS
multiple sclerosis
ozanimod
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Bayer files prostate cancer drug darolutamide with EU regulators
Bayer files prostate cancer drug darolutamide with EU regulators
Pharmaforum
Bayer
Europe
darolutamide
prostate cancer
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