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Regulatory Affairs
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Sanaria's preventative vaccine for malaria gets FDA fast track designation
The US Food and Drug Administration (FDA) has granted Fast Track designation for Sanaria's preventative vaccine for malaria, Sanaria PfSPZ Vaccine.
Regulatory Affairs > News
FDA approves Janssen’s new type 2 diabetes combination therapy
By PBR Staff Writer
Janssen Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for a fixed-dose combination therapy to treat adults with type 2 diabetes.
Regulatory Affairs > News
FDA approves Sarepta Therapeutics' Duchenne muscular dystrophy drug
The US Food and Drug Administration (FDA) has granted accelerated approval for Sarepta Therapeutics' EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.
Regulatory Affairs > News
Cynata Therapeutics secures UK MHRA approval for GvHD clinical trial
Australian stem cell and regenerative medicine firm, Cynata Therapeutics, has secured approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to go ahead with its Phase 1 clinical trial of CYP-001 in patients with steroid-resistant graft-versus-host disease (GvHD).
Regulatory Affairs > News
Aralez's YOSPRALA gets FDA approval for secondary CV prevention
The US Food and Drug Administration (FDA) has approved Aralez Pharmaceuticals' once-daily YOSPRALA, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the US.
Regulatory Affairs > News
Shire secures FDA approval for primary immunodeficiency drug
Shire has secured approval from the US Food and Drug Administration (FDA) for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older.
Regulatory Affairs > News
EC approves Cabometyx tablets to treat advanced RCC following VEGF-targeted therapy
By PBR Staff Writer
The European Commission (EC) has approved Cabometyx (cabozantinib) tablets to treat advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Regulatory Affairs > News
European Commission approves BMS' ORENCIA for methotrexate-naive RA patients
The European Commission has approved Bristol-Myers Squibb’s ORENCIA (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX.
Regulatory Affairs > News
FDA approves Amgen's BLINCYTO for pediatric acute lymphoblastic leukemia
The US Food and Drug Administration (FDA) has approved Amgen's supplemental Biologics License Application (sBLA) for BLINCYTO (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
US FDA calls for boxed warnings on two drug classes
The US Food and Drug Administration (FDA) is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.
Regulatory Affairs > News
Pfizer’s Xalkori gets European approval for ROS1-positive advanced NSCLC
By PBR Staff Writer
Pfizer has secured approval from the European Commission (EC) for Xalkori (crizotinib) to treat adults with ROS1-positive advanced non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA approves Sandoz’s Enbrel biosimilar for multiple inflammatory diseases
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Sandoz’s Erelzi, a biosimilar to Amgen's Enbrel, to treat several inflammatory diseases.
Regulatory Affairs > News
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

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 3638 results