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Regulatory Affairs
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Oxford BioMedica secures UK MHRA approval to manufacture drugs at new facilities
By PBR Staff Writer
Oxford BioMedica has secured approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for investigational medicinal products at its new facilities.
Regulatory Affairs > News
Sanofi wins FDA approval of Adlyxin to treat adults with type 2 diabetes
Sanofi announced that the US Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.
Regulatory Affairs > News
US FTC approves Teva’s $40.5bn deal for Allergan’s generics business
By PBR Staff Writer
The US Federal Trade Commission (FTC) has approved Teva Pharmaceutical Industries’ proposed $40.5bn acquisition of Allergan’s generics business.
Regulatory Affairs > News
FDA lifts clinical hold on CGF166
GenVec, a clinical-stage gene delivery company, was notified by its collaborator, Novartis, that the Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.
Regulatory Affairs > News
FDA raises concerns over manufacturing practice of Valeant’s new ophthalmic solution
By PBR Staff Writer
The US Food and Drug Administration has raised concerns over manufacturing practice of Valeant Pharmaceuticals International’s new eye drop.
Regulatory Affairs > News
European CHMP recommends Shire’s Onivyde to treat metastatic adenocarcinoma
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Shire’s Onivyde (irinotecan pegylated liposomal formulation) to treat metastatic adenocarcinoma.
Regulatory Affairs > News
European CHMP adopts positive opinion on Gilead’s Type II variation application for Truvada
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' Type II variation application for Truvada for reducing the risk of sexually acquired HIV.
Regulatory Affairs > News
FDA approves Relistor tablets to treat OIC in chronic non-cancer pain adults
By PBR Staff Writer
The US Food and Drug Administration has approved Relistor (methylnaltrexone bromide) tablets to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Regulatory Affairs > News
FDA approves expanded label for NAMZARIC to treat moderate to severe Alzheimer's disease
Allergan and Adamas Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
Regulatory Affairs > News
European Commission approves AstraZeneca’s Qtern to treat type 2 diabetes
By PBR Staff Writer
AstraZeneca has secured approval from the European Commission (EC) for Qtern tablets to treat type 2 diabetes.
Regulatory Affairs > News
Perrigo wins FDA approval fo romeprazole and sodium bicarbonate capsules, 20mg/1100mg
The U.S. Food and Drug Administration has approved Perrigo's ANDA for omeprazole and sodium bicarbonate capsules, 20mg/1100mg.
Regulatory Affairs > News
Fera Pharmaceuticals and Oakwood Labs announce ANDA approval of Levothyroxine Sodium for Injection
Fera Pharmaceuticals and Oakwood Laboratories announced that on June 29, 2016, the FDA approved their ANDA for 100 and 500 mcg Levothyroxine Sodium for Injection.
Regulatory Affairs > News
Celgene’s Revlimid approved in Europe for relapsed or refractory mantle cell lymphoma
By PBR Staff Writer
Celgene has secured approval from the European Commission for Revlimid (lenalidomide) to treat patients with relapsed/refractory mantle cell lymphoma (MCL).
Regulatory Affairs > News
Eisai and Arena Pharmaceuticals secure regulatory approval of VENESPRI in Mexico
Eisai and Arena Pharmaceuticals announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has granted regulatory approval of the chronic weight management agent VENESPRI (lorcaserin HCl: U.S. brand name: BELVIQ) for commercialization by Eisai Laboratorios, S. de R.L. de C.V. (Eisai Mexico) in Mexico.
Regulatory Affairs > News
Shire’s Xiidra secures FDA approval for dry eye disease
By PBR Staff Writer
Shire has secured approval from the US Food and Drug Administration (FDA) for its Xiidra (lifitegrast ophthalmic solution) to treat signs and symptoms of dry eye disease.
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

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 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 3610 results