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EMA

Roche gets some regulatory love for its breakthrough quest on a PhIII Huntington’s drug

Roche gets some regulatory love for its breakthrough quest on a PhIII Huntington’s drug

Endpoints

Huntington's disease

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Brexit forces EMA to suspend tasks as job loss forecast jumps

Brexit forces EMA to suspend tasks as job loss forecast jumps

Fierce Biotech

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Bluebird’s first gene therapy gets European fast track

Bluebird’s first gene therapy gets European fast track

PM Live

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Alnylam Receives Positive CHMP Opinion for Hereditary Amyloidosis Treatment

Alnylam Receives Positive CHMP Opinion for Hereditary Amyloidosis Treatment

CP Wire

hATTR amyloidosis

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Regulators recall valsartan after finding impurity tied to cancer risk

Regulators recall valsartan after finding impurity tied to cancer risk

Biopharma Dive

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CHMP Issues Positive Opinion to Expand Labeling of Jardiance, Synjardy and Glyxambi to Include Positive Effects on Cardiovascular and Renal Outcomes

CHMP Issues Positive Opinion to Expand Labeling of Jardiance, Synjardy and Glyxambi to Include Positive Effects on Cardiovascular and Renal Outcomes

CP Wire

Boehringer Ingelheim

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Kite Receives Positive Opinion from CHMP for Yescarta in Lymphoma

Kite Receives Positive Opinion from CHMP for Yescarta in Lymphoma

CP Wire

Gilead Sciences

B-cell lymphoma

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CHMP reverses course on neratinib, handing Puma an unexpected win on European marketing vote — shares soar

CHMP reverses course on neratinib, handing Puma an unexpected win on European marketing vote — shares soar

Endpoints

Puma Biotechnology

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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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