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151-165 of 1873 results
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
EMA validates Puma Biotechnology's MAA for neratinib
The European Medicines Agency (EMA) has validated Puma Biotechnology's Marketing Authorization Application (MAA) for neratinib.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
Neurotrope submits amended protocol to FDA for phase 2 clinical trial of bryostatin-1
Neurotrope's subsidiary Neurotrope BioScience has submitted to the Food and Drug Administration (FDA) an amended protocol for its Phase 2 clinical trial of lead candidate bryostatin-1 for the treatment of advanced Alzheimer’s disease.
Production & Manufacturing > Process & Production > News
FDA advisory committees recommend approval of Egalet’s abuse-deterrent Arymo ER
By PBR Staff Writer
A US advisory panel has recommended approval of Egalet’s Arymo ER abuse-deterrent opioid treatment.
Production & Manufacturing > Process & Production > News
FDA issues CRL to ADMA Biologics' BLA for RI-002
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the ADMA Biologics' Biologics License Application (BLA) for RI-002, an Intravenous Immune Globulin (IVIG), for the treatment of patients with Primary Humoral Immunodeficiency Disease (PIDD).
Production & Manufacturing > Process & Production > News
LSK BioPharma announces successful outcome from End-of-Phase 2 meeting with FDA for apatinib
LSK BioPharma (LSKB) announced the successful completion and positive outcome of an End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA) for apatinib, an investigational drug for treatment of solid tumors.
Production & Manufacturing > Process & Production > News
Merck's Ebola Zaire vaccine gets accelerated review designations in US and Europe
By PBR Staff Writer
Merck’s experimental Ebola Zaire vaccine, V920, has received accelerated review status in the US and European Union.
Production & Manufacturing > Process & Production > News
151-165 of 1873 results