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EMA

Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission

Pfizer's PARP Inhibitor Talazoparib Gets FDA Priority Review and EMA Submission

CP Wire

BRCA-mutant breast cancer

metastatic breast cancer

priority review

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Pfizer Receives Good News for Trazimera (trastuzumab) Biosimilar

Pfizer Receives Good News for Trazimera (trastuzumab) Biosimilar

CP Wire

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Regulators flag possible birth defect link to GSK's HIV drug

Regulators flag possible birth defect link to GSK's HIV drug

Yahoo/Reuters

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EMA Validates Bristol-Myers Squibb’s Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer

EMA Validates Bristol-Myers Squibb’s Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer

CP Wire

Bristol-Myers Squibb

metastatic non-small cell lung cancer

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AbbVie Submits Marketing Application to the European Medicines Agency for Risankizumab in Plaque Psoriasis

AbbVie Submits Marketing Application to the European Medicines Agency for Risankizumab in Plaque Psoriasis

CP Wire

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EU Advisory Group Backs Orphan Drug Designation for Alnylam's ALN-TTRsc02 for ATTR Amyloidosis

EU Advisory Group Backs Orphan Drug Designation for Alnylam's ALN-TTRsc02 for ATTR Amyloidosis

CP Wire

ATTR amyloidosis

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Amgen and Allergan Hopeful that Herceptin Biosimilar Approval Will Be Around the Corner

Amgen and Allergan Hopeful that Herceptin Biosimilar Approval Will Be Around the Corner

Xtalks

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EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017

EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017

RAPS.org

Portola Pharmaceuticals

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FDA Approves Drugs Before EMA and Swissmedic, Comparison Finds

FDA Approves Drugs Before EMA and Swissmedic, Comparison Finds

RAPS.org

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Novartis Expects FDA and EMA Approvals for Aimovig in 2018

Novartis Expects FDA and EMA Approvals for Aimovig in 2018

Yahoo/Market Realist

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GSK's shingles vaccine gets green light from EMA panel

GSK's shingles vaccine gets green light from EMA panel

Reuters

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EMA frets drug shortages ahead of Brexit

EMA frets drug shortages ahead of Brexit

Biopharma Dive

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EMA investigates Allergan blockbuster hopeful Esmya on reports of liver damage

EMA investigates Allergan blockbuster hopeful Esmya on reports of liver damage

Fierce Pharma

uterine fibroids

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FDA, EMA and PMDA Plot Harmonized Path for Antibiotics

FDA, EMA and PMDA Plot Harmonized Path for Antibiotics

RAPS.org

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Aftermath of Brexit Could Cripple EMA

Aftermath of Brexit Could Cripple EMA

Xtalks

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Samsung Bioepis first to secure EMA backing for Herceptin biosimilar

Samsung Bioepis first to secure EMA backing for Herceptin biosimilar

BioPharma Dive

Samsung Bioepis

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Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.

Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.

Yahoo/Zacks.com

Vertex Pharmaceuticals

cystic fibrosis

priority review

tezacaftor/ivacaftor

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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

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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

Lexicon Pharmaceuticals

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EMA Restricts Use of Biogen MS Drug

EMA Restricts Use of Biogen MS Drug

RAPS.org

multiple sclerosis

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