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Regulatory Affairs
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Watch Vaisala's video on What's new in Environmental Monitoring
The Vaisala viewLinc monitoring system: Your controlled environments can be complex. You need a monitoring system to safeguard huge investments, a fail-safe system that monitors a wide range of parameters.
Regulatory Affairs > Videos
Perrigo secures tentative FDA approval for generic version of Suprep oral solution
Perrigo has received tentative approval from the U.S. Food and Drug Administration (FDA) for the generic version of Suprep (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution.
Regulatory Affairs > News
AstraZeneca and Eli Lilly secure FDA fast-track status for Alzheimer’s drug
By PBR Staff Writer
AstraZeneca and Eli Lilly and Company have secured fast track designation from the US Food and Drug Administration (FDA) for AZD3293, an investigational treatment for early Alzheimer’s disease (AD).
Regulatory Affairs > News
EC grants marketing authorization for Gilead’s once-daily truvada to reduce risk of sexually acquired HIV-1
The European Commission has granted marketing authorization for Gilead Sciences' once-daily Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP.
Regulatory Affairs > News
FDA approves Pfizer's Troxyca ER extended-release capsules for pain management
By PBR Staff Writer
Pfizer has secured approval from the US Food and Drug Administration (FDA) for Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules CII with abuse-deterrent properties for the management of pain.
Regulatory Affairs > News
Teva secures European approval for severe asthma drug Cinqaero
Teva Pharmaceutical Industries has secured marketing authorization from the European Commission for Cinqaero (reslizumab) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
Regulatory Affairs > News
Acacia Pharma unveils positive results from phase 3 trial of BAREMSIS to treat PONV
Acacia Pharma has unveiled positive results from a pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (PONV).
Regulatory Affairs > News
FDA approves Heron’s Sustol for chemotherapy-induced nausea and vomiting
By PBR Staff Writer
Heron Therapeutics has secured approval from the US Food and Drug Administration (FDA) for extended-release version of the chemotherapy anti-nausea drug Sustol (granisetron).
Regulatory Affairs > News
Moberg Pharma gets approvals to begin phase 3 trial for MOB-015 in US and Canada
By PBR Staff Writer
Moberg Pharma has secured approvals from the US and Canadian regulators to start phase 3 trial for MOB-015 in the treatment of onychomycosis (nail fungus).
Regulatory Affairs > News
EMA approves single dose administration of Cardiome Pharma's XYDALBA
The European Medicines Agency (EMA) has approved Cardiome Pharma's XYDALBA (dalbavancin) for administration as a single, 30 minute, 1500mg infusion (three 500mg vials).
Regulatory Affairs > News
EU clears Sanofi’s acquisition of Boehringer’s consumer health business
By PBR Staff Writer
French drug maker Sanofi has secured approval from the European Commission for its proposed acquisition of Boehringer Ingelheim’s consumer health business, subject to conditions.
Regulatory Affairs > News
Dynavax announces FDA advisory committee meeting to review HEPLISAV-B BLA
Dynavax Technologies announced that the Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016.
Regulatory Affairs > News
Merck’s Keytruda secures European approval for advanced NSCLC
By PBR Staff Writer
Merck has secured approval from the European Commission for its Keytruda (pembrolizumab) anti-PD-1 therapy to treat patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer (NSCLC) following at least 1 chemotherapy regimen.
Regulatory Affairs > News
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
Novartis' LEE011 breast cancer drug gets US breakthrough therapy designation
By PBR Staff Writer
Novartis' selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has secured breakthrough therapy designation in the US to treat certain forms of breast cancer.
Regulatory Affairs > News

PBR Supplier Recommendations

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
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
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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 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 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 See more
1-15 of 3626 results