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121-135 of 1839 results
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
Merck provides regulatory update on bezlotoxumab biologics licensing application
Merck said that the US Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence.
Production & Manufacturing > Process & Production > News
FDA accepts ApeX Therapeutics’ IND for clinical testing of APX3330 in pancreatic cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted ApeX Therapeutics’ investigational new drug (IND) application for clinical testing of APX3330 in pancreatic cancer.
Production & Manufacturing > Process & Production > News
EMA grants orphan drug designation to XOMA 358 to treat congenital hyperinsulinism
By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan drug designation to XOMA 358 to treat congenital hyperinsulinism (CHI).
Production & Manufacturing > Process & Production > News
FDA and EMA accept Bristol-Myers’ filing for expanded Opdivo indications
By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Medicines Agency have accepted to review Bristol-Myers Squibb’s market applications seeking approval to expand the use of Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Production & Manufacturing > Process & Production > News
121-135 of 1839 results