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Akcea gets FDA orphan drug status for volanesorsen to treat familial chylomicronemia syndrome
Akcea Therapeutics, a wholly-owned subsidiary of Isis Pharmaceuticals announced that the US Food and Drug Administration has granted Orphan Drug Designation to volanesorsen (ISIS-APOCIIIRx) for the treatment of patients with Familial Chylomicronemia Syndrome (FCS).
Regulatory Affairs > News
Gilead's Harvoni gets Japanese approval to treat genotype 1 chronic hepatitis C
By PBR Staff Writer
US-based biopharmaceutical firm Gilead Sciences has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat chronic hepatitis C genotype 1 infection in adults.
Regulatory Affairs > News
Adaptimmune gets FDA acceptance for IND application for MAGE-A10 T in NSCLC patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted UK-based biopharmaceutical firm Adaptimmune Therapeutics' investigational new drug (IND) application for autologous genetically modified T-cells expressing enhanced T cell receptors (TCRs) specific for its therapeutic candidate MAGE A10 (MAGE-A10 T) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA approves Spriaso's NDA for codeine antitussive with anti-histamine
By PBR Staff Writer
The US food and Drug Administration (FDA) has granted approval for Spriaso's new drug application (NDA) for Tuxarin ER, a high strength long acting Rx cough/cold combination product containing codeine and chlorpheniramine.
Regulatory Affairs > News
Gilead submits NDA to FDA for single tablet regimen R/F/TAF to treat HIV
By PBR Staff Writer
Gilead Sciences has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for an investigational, once-daily single tablet combination regimen to treat HIV-1 infection in adult and pediatric patients 12 years of age and older.
Regulatory Affairs > News
Santen files IND application with FDA for DE-122 to treat wet AMD
By PBR Staff Writer
Santen Pharmaceutical has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) seeking approval to begin clinical studies for DE-122 to treat wet age-related macular degeneration (wet AMD).
Regulatory Affairs > News
Theravance gets marketing authorization for Vibativ in Russia to treat gram-positive bacterial infections
By PBR Staff Writer
Theravance Biopharma has received marketing authorization from the Ministry of Health of the Russian Federation for Vibativ (telavancin) to treat complicated skin and soft tissue infections, as well as nosocomial pneumonia, caused by Gram-positive bacteria, including methicillin-resistance Staphylococcus aureus (MRSA).
Regulatory Affairs > News
Aridis gets FDA fast track status for pneumonia drug Aerucin
By PBR Staff Writer
US-based Aridis Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for its fully human monoclonal antibody Aerucin to treat hospital-acquired and ventilator-associated pneumonia caused by pseudomonas aeruginosa.
Regulatory Affairs > News
BioBlast gets orphan drug status for cabaletta in Europe to teat spinocerebellar ataxia
BioBlast Pharma (ORPN), a clinical-stage orphan disease-focused biotechnology company, announced that it has been granted Orphan Drug Designation by the European Commission for Cabaletta for the treatment of Spinocerebellar Ataxia (SCA).
Regulatory Affairs > News
Podcast – Industrial Design Considerations for Auto Injectors
The design, development and manufacturing of a successful auto injector project requires not only the seamless collaboration between the biopharmaceutical company and key partners, but also robust design and manufacturing capabilities that can ultimately reflect the desired device characteristics. With industrial design often the initial starting point of a project, possessing a strong in-house industrial team can mean more efficient communication with production teams which can lead to faster prototyping and design verification.
Regulatory Affairs > Press Releases
CDC Advisory Committee votes to recommend Pfizer's serogroup B meningococcal disease vaccination
By PBR Staff Writer
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend Pfizer's serogroup B meningococcal disease vaccination including Trumenba (meningococcal group B vaccine) for adolescents and young adults 16 through 23 years of age.
Regulatory Affairs > News
AveXis' gene therapy treatment for spinal muscular atrophy gets EMA orphan drug status
By PBR Staff Writer
US-based gene therapy company AveXis has secured orphan drug designation from the European Medicines Agency (EMA) for its gene transfer therapeutic currently in clinical development in the US to treat type 1 Spinal Muscular Atrophy (SMA), an autosomal-recessive genetic disorder.
Regulatory Affairs > News
FDA approves Eisai's Fycompa to treat primary generalized tonic-clonic seizures
Eisai announced that its US subsidiary Eisai Inc. has received approval from the US Food and Drug Administration (FDA) for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
Regulatory Affairs > News
FDA grants fast track status for Forum's encenicline to treat cognitive impairment in schizophrenia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation to Forum Pharmaceuticals' lead compound encenicline, which is being developed to treat cognitive impairment in schizophrenia.
Regulatory Affairs > News
XOMA gets FDA orphan status for XOMA 358 to treat congenital hyperinsulinism
XOMA Corporation (XOMA), a leader in the discovery and development of therapeutic antibodies, announced XOMA 358, a fully human allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and downstream insulin signaling, has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of congenital hyperinsulinism (HI).
Regulatory Affairs > News

PBR Supplier Recommendations

Rentschler - High-Performance Biopharmaceutical Development and Manufacturing
Identifying the most appropriate contract manufacturer who can best fulfil what you need for your lead pharmaceutical candidate is a real challenge. With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing.... Regulatory Affairs > Suppliers
ERT - Getting it done. Right.
ERT is a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use by biopharmaceutical companies during clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.... Regulatory Affairs > Suppliers
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world. ... Regulatory Affairs > Suppliers
SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
NNIT - The Full Service IT Consultancy Dedicated to Life Sciences
NNIT specialises in using IT to optimise the complex processes inherent in the life sciences industry. We are an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry. ... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

Single-Use-Bioprocesses – Hype or Future Technology? By Rentschler
Single-use bioreactors offer many advantages for the manufacturing of biopharmaceuticals. They are used in approximately two thirds of all new bioprocesses in the biopharmaceutical market and have become indispensable in biopharmaceutical development and production processes. ... Regulatory Affairs > White Papers Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems By SHL Group
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.... Regulatory Affairs > White Papers Design-To-Build – Laboratory Handling Equipment By SHL Group
A leading high-end laboratory handling and diagnostics equipment manufacturing company devoted to helping scientists meet challenges regularly faced in the lab, approached SHL Technologies with a request to develop benchtop laboratory tube array handling equipment. This equipment had to be available in a modular set-up and capable of pick-and-place sorting, weight measurement, and barcode reading.... Regulatory Affairs > White Papers Complex Module Manufacturing – IC testing Devices By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers Specialised Project & Technology Transfer – Precision Neurosurgical Equipment By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers See more
1-15 of 3315 results