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136-150 of 1862 results
Dynavax says PDUFA date for HEPLISAV-B remains unchanged
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review Dynavax Technologies' Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
Production & Manufacturing > Process & Production > News
Biogen’s Alzheimer’s drug gets FDA fast-track status
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation to Biogen’s investigational Alzheimer’s disease (AD) treatment aducanumab.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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).
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
136-150 of 1862 results