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Process & Production

ARIAD completes rolling submission of NDA for Brigatinib to FDA ARIAD Pharmaceuticals has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA).
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Tonix announces successful end-of-phase 2 meeting with FDA for TNX-102 SL in PTSD Tonix Pharmaceuticals, which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an End-of-Phase 2/Pre-Phase 3 meeting.
Production & Manufacturing > Process & Production > News Alexion Pharmaceuticals’ ALXN1007 secures EU orphan drug status Alexion Pharmaceuticals has secured orphan drug designation from the European Commission for ALXN1007 to treat patients with Graft-Versus-Host Disease (GVHD).
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Mallinckrodt’s DMD drug receives FDA fast track designation
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Mallinckrodt’s request for a fast track designation of its new Duchenne muscular dystrophy (DMD) drug, Synacthen Depot.
Production & Manufacturing > Process & Production > News
European Medical Agency to review Mylan and Biocon’s anti cancer biosimilar
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted for review Mylan's marketing authorization application (MAA) for a proposed biosimilar Trastuzumab to treat several HER2-positive breast and gastric cancers.
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FDA issues complete response letter for Amgen's NDA for Parsabiv
The US Food and Drug Administration (FDA) has issued a Complete Response Letter for Amgen's New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
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Evgen Pharma gets FDA orphan drug designation for stabilised sulforaphane
The US Food & Drug Administration (FDA) has granted Evgen Pharma orphan drug designation for the use of stabilised sulforaphane for the treatment of subarachnoid haemorrhage (SAH).
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FDA grants priority review to Clovis’ rucaparib for advanced BRCA-mutated ovarian cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review status to Clovis Oncology’s new drug application (NDA) for rucaparib as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least two or more prior lines of chemotherapy.
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Watch Vaisala's video on What's new in Environmental Monitoring
The Vaisala viewLinc monitoring system: Your controlled environments can be complex. You need a monitoring system to safeguard huge investments, a fail-safe system that monitors a wide range of parameters.
Production & Manufacturing > Process & Production > Videos
Janssen seeks EU approval for extended use of Darzalex
By PBR Staff Writer
Janssen-Cilag International has submitted an application to the European Medicines Agency (EMA) to expand the existing marketing authorization for its immunotherapy Darzalex (daratumumab) to include combination with standard of care regimens.
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EMA validates Puma Biotechnology's MAA for neratinib
The European Medicines Agency (EMA) has validated Puma Biotechnology's Marketing Authorization Application (MAA) for neratinib.
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EMA accepts for review Portola's MAA for IndexXa Factor Xa inhibitor antidote
Portola Pharmaceuticals announced that the MAA for IndexXa (andexanet alfa; trade name in the US is AndexXa), a Factor Xa inhibitor antidote, has been submitted to the European Medicines Agency (EMA), completed the validation period, and has been accepted for review.
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Portola receives complete response letter from FDA for AndexXa BLA
Portola Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa).
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