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Regulatory Affairs
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European Commission approves new indication for Novartis’ Lucentis eye drug
By PBR Staff Writer
The European Commission has approved the sixth indication for Novartis’ Lucentis, making it the only treatment available for a range of choroidal neovascularization (CNV) conditions.
Regulatory Affairs > News
UK's CMA fines Pfizer and Flynn Pharma for epilepsy drug price hike
By PBR Staff Writer
Pfizer and Flynn Pharma have been fined a record amount for abusing their dominant position in the UK by charging excessive and unfair prices for an anti-epilepsy drug.
Regulatory Affairs > News
Amgen and Allergan submit bevacizumab biosimilar application to EMA
Amgen and Allergan have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab).
Regulatory Affairs > News
GSK seeks EU approval for inhaled triple combo COPD therapy
By PBR Staff Writer
GlaxoSmithKline (GSK) is seeking approval in Europe for once-daily closed triple combination therapy to treat chronic obstructive pulmonary disease (COPD) patients.
Regulatory Affairs > News
FDA approves cardiovascular indication for Jardiance
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a new indication for Jardiance (empagliflozin), a type 2 diabetes treatment from Boehringer Ingelheim and Eli Lilly.
Regulatory Affairs > News
Bristol-Myers Squibb’s Opdivo approved for Hodgkin lymphoma in Europe
By PBR Staff Writer
Bristol-Myers Squibb has secured approval from the European Commission for Opdivo (nivolumab) to treat adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Regulatory Affairs > News
Teva’s Trisenox approved in Europe for first line treatment of APL
By PBR Staff Writer
The European Commission has expanded the scope of Teva Pharmaceutical Industries’ Trisenox, approving its use to treat patients with newly diagnosed acute promyelocytic leukaemia (APL).
Regulatory Affairs > News
FDA extends indication for GSK’s FluLaval Quadrivalent influenza vaccine in infants
By PBR Staff Writer
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) to expand FluLaval Quadrivalent (influenza vaccine) indication.
Regulatory Affairs > News
Amgen’s Parsabiv approved in Europe for sHPT treatment in adults with CKD
By PBR Staff Writer
Amgen has secured approval from the European Commission (EC) for Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Regulatory Affairs > News
Pfizer secures EU approval for Ibrance breast cancer drug
By PBR Staff Writer
Pfizer has secured approval from the European Commission (EC) for Ibrance (palbociclib) to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.
Regulatory Affairs > News
FDA approves Gilead’s Vemlidy to treat chronic hepatitis B virus infection
The US Food and Drug Administration (FDA) has approved Gilead Sciences' Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
Regulatory Affairs > News
NSF Pharma Biotech FREE Webinars
NSF Pharma Biotech Consulting provides a comprehensive catalogue of complimentary webinars for 2017
Regulatory Affairs > Press Releases
FDA approves Amgen’s Enbrel to treat children with plaque psoriasis
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for the expanded use of Enbrel (etanercept) to treat children with chronic moderate-to-severe plaque psoriasis.
Regulatory Affairs > News
Revolutionary Wireless Environmental Monitoring System to Release in May 2017
In the summer 2016, Vaisala announced the latest build of their environmental monitoring system viewLinc. The newest device in the system, VaiNet, will begin shipping in May of 2017 and will feature unmatched signal strength.
Regulatory Affairs > Press Releases
NSF Human Error Prevention: Solutions and Answers
Researchers estimate that 250,000 people die every year from medical errors in the U.S. alone. That is the equivalent of two jumbo jets crashing every day. Worldwide, human error is the third leading cause of death behind heart disease and cancer.
Regulatory Affairs > Press Releases

PBR Supplier Recommendations

NSF Health Sciences Pharma Biotech
NSF partners with you to provide world-class regulatory and compliance consulting, auditing and training on a global basis.... 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
Vaisala - Supplier of Continuous Monitoring Systems for Controlled Life Science Environments
Vaisala is a world leader in environmental and industrial measurement systems and instrumentation. We offer measurement instrumentation, continuous monitoring systems and validation systems to measure and supervise environmental conditions, within regulated or controlled life science environments.... Regulatory Affairs > Suppliers
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
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PBR White Paper Recommendations

Reliable, Long-range Wireless Sensors for Environmental Monitoring By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.... Regulatory Affairs > White Papers Autoinjectors From Planning to Launch By SHL Group
Injectable drug delivery devices such as pen injectors and autoinjectors show a significant growth potential in the future. This white paper focuses on the development process of an autoinjector project from planning to launch and best practices on how to prepare for and address potential challenges along the way.... 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 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 3677 results