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Lilly's Trulicity type 2 diabetes drug gets FDA approval
By PBR Staff Writer
Eli Lilly and Company has received approval from the US Food and Drug Administration for Trulicity (dulaglutide) as a treatment option for adults with type 2 diabetes.
Regulatory Affairs > News
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
Manuel Zahn to Attend GMP-BERATER Tage 2014
Manuel Zahn, founder and managing director of 3R Pharma Consulting will attend the GMP-BERATER Tage 2014. The meeting will see a small group of GMP experts meet and discuss new GMP regulations and will share their experiences at Schloss Reinach, near Freiburg, Germany, 8-9 October 2014.
Regulatory Affairs > Press Releases
Soligenix secured FDA clearance of Phase III trial of lymphoma drug SGX301
By PBR Staff Writer
US-based biopharmaceutical firm Soligenix has entered into an agreement with the US Food and Drug Administration (FDA) on the design of a major Phase III clinical trial assessing its product SGX301 (synthetic hypericin) to treat cutaneous T-cell lymphoma (CTCL).
Regulatory Affairs > News
GSK resolves risk management violation issue at Montana facility in US
By PBR Staff Writer
British drug-maker GlaxoSmithKline (GSK) has resolved the issue of Clean Air Act violation, associated with its failure to submit a risk management plan at its facility in Hamilton, Montana, US.
Regulatory Affairs > News
FDA committee recommends approval of Natpara to treat hypoparathyroidism
NPS Pharmaceuticals, a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, has announced that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 that the available data support the approval of Natpara (rhPTH [1-84]) for the long-term treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH.
Regulatory Affairs > News
US FDA approves Baxter and Halozyme's Hyqvia to treat primary immunodeficiency
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Baxter and Halozyme Therapeutics' Hyqvia as a subcutaneous treatment for adult patients with primary immunodeficiency (PI).
Regulatory Affairs > News
FDA approves Takeda and Orexigen's Contrave for chronic weight management
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals USA and Orexigen Therapeutics’ Contrave (naltrexone HCI and bupropion HCI) extended-release tablets for chronic weight management.
Regulatory Affairs > News
FDA grants orphan drug status for Viamet's VT-1129 to treat cryptococcal meningitis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Viamet Pharmaceuticals' VT-1129, a potent and selective, oral, antifungal agent, to treat cryptococcal meningitis, a life-threatening invasive fungal infection of the lining of the brain and spinal cord.
Regulatory Affairs > News
Lilly and Boehringer's insulin glargine product gets European marketing approval
By PBR Staff Writer
Eli Lilly and Company and Boehringer Ingelheim have received marketing authorization from the European Commission (EC) for their insulin glargine product to treat diabetes in adults, adolescents and children aged two years and above.
Regulatory Affairs > News
Roche's RoACTEMRA gets European approval to treat early rheumatoid arthritis
By PBR Staff Writer
The European Commission has approved Roche's RoACTEMRA (tocilizumab) for use in patients with severe, active and progressive rheumatoid arthritis (RA) who previously have not been treated with methotrexate (MTX).
Regulatory Affairs > News
FDA approves ferric citrate for CKD dialysis patients with hyperphosphatemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Keryx Biopharmaceuticals for ferric citrate (formerly Zerenex) to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Regulatory Affairs > News
FDA approves Merck's anti-PD-1 therapy Keytruda
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Merck's Keytruda (pembrolizumab) to treat patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Regulatory Affairs > News
Bayer seeks marketing approval for aflibercept solution for injection in Japan
By PBR Staff Writer
Bayer Yakuhin has submitted marketing authorization application (MAA) in Japan for aflibercept solution for injection into the eye in patients with macular edema secondary to branch retinal vein occlusion (BRVO).
Regulatory Affairs > News
Halozyme gets fast track status for PEGPH20 program in metastatic pancreatic cancer
By PBR Staff Writer
Halozyme Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its program investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel to treat patients with metastatic pancreatic cancer.
Regulatory Affairs > News

PBR Supplier Recommendations

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 - Designer, Developer & Supplier of Auto Injectors & Pen Injectors
SHL (Scandinavian Health Ltd.) is the world's largest privately-owned designer, developer and supplier of advanced drug delivery devices.... Regulatory Affairs > Suppliers
INFOTEHNA Group - Pharmaceutical Software Solutions
INFOTEHNA Group is a leading provider of software solutions for the life sciences industries. We develop and deliver integral enterprise content, process management and regulatory compliance.... Regulatory Affairs > Suppliers
7PSolutions - Climate Control Solutions
7PSolutions™ was founded in 2010 to fulfill an unmet need in the life sciences and transportation industries: a single solution for climate control, security and quality management through every stage of the supply chain. ... Regulatory Affairs > Suppliers
TOPRA - Healthcare Regulatory Affairs
TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector.... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

NSF Health Sciences Journal – Summer 2014: What is the Biggest Risk Facing Your Company? By NSF Health Sciences Pharma Biotech PBR
At NSF Health Sciences our objective is to help you do the basics to PhD level and to help you to deliver high quality medicines on time in full. Our education courses described on page 22-27 are designed to help you excel at doing the basics and change behaviours in the workplace. The articles in this edition of the Journal are designed to do the same. Simple, readable, provocative and informative. ... Regulatory Affairs > White Papers 2014: What Will YOU Change? By NSF Health Sciences Pharma Biotech PBR
As one year closes and another one beckons it’s a time for reflection, looking back as well as forward. How did you do in 2013, and what does 2014 and beyond look like? For many, 2013 has been a real rollercoaster on the business and compliance front.... Regulatory Affairs > White Papers Human Error: Causes and Prevention By NSF Health Sciences Pharma Biotech PBR
As a leading consultancy and training provider to the pharma, biotech and devices industries, we are privileged to work with people who are both motivated and smart. In fact, our industries employ more PhDs and graduates than many other sectors! Yet, when you read through some recent 483s, you are left wondering why respected organisations, staffed with intelligent people, do some very illogical things.... Regulatory Affairs > White Papers How the Vaisala Continuous Monitoring System Aids Compliance with Title 21 CFR Part 11 and EU GMP Annex 11 By Vaisala pbr
This white paper outlines how Vaisala’s Continuous Monitoring System helps to meet the requirements of Title 21 CFR Part 11 and EU GMP Annex 11 as they apply to environmental monitoring and validation.... Regulatory Affairs > White Papers GMP Warehouse Mapping - Step-by-Step Guidelines for Validating Life Science Storage Facilities By Vaisala pbr
This step-by-step paper describes how to map a warehouse to comply with internationally recognized GMPs and regulatory requirements.... Regulatory Affairs > White Papers See more
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