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Regulatory Affairs
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FDA expands indication for Janssen Pharmaceuticals’ Invokamet diabetes drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded indication for Janssen Pharmaceuticals’ Invokamet diabetes medication.
Regulatory Affairs > News
European Commission approves Darzalex for multiple myeloma
By PBR Staff Writer
The European Commission has granted conditional approval to Darzalex (daratumumab) to treat adults with relapsed and refractory multiple myeloma.
Regulatory Affairs > News
European regulator accepts Pfizer's Trumenba marketing authorization application for review
The European Medicines Agency (EMA) has accepted Pfizer's marketing authorization application to review for Trumenba (Meningococcal Group B Vaccine), which was developed to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and above.
Regulatory Affairs > News
UK NICE rejects Roche’s Perjeta breast cancer drug
By PBR Staff Writer
UK’s National Institute for Health and Care Excellence (NICE) has rejected Roche’s Perjeta treatment for breast cancer claiming that it is pricey and would not offer value for money.
Regulatory Affairs > News
FDA approves Genentech's Atezolizumab for advanced urothelial carcinoma
By PBR Staff Writer
Genentech has secured approval from the US Food and Drug Administration for its Tecentriq (atezolizumab) to treat the most common type of bladder cancer, dubbed urothelial carcinoma.
Regulatory Affairs > News
EC grants marketing authorization for Actelion's Uptravi to treat pulmonary arterial hypertension
The European Commission (EC) has granted marketing authorization in the EU for Actelion's orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag) to treat pulmonary arterial hypertension.
Regulatory Affairs > News
FDA approves Bristol-Myers Squibb's Opdivo for classical Hodgkin lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted accelerated approval for Bristol-Myers Squibb's Opdivo (nivolumab) to treat patients with classical Hodgkin lymphoma (cHL).
Regulatory Affairs > News
FDA approves Eisai's Lenvima to treat advanced renal cell carcinoma in combination with Everolimus
The U.S. Food and Drug Administration (FDA) approved LENVIMA (lenvatinib), Eisai's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy.
Regulatory Affairs > News
European Commission approves Alprolix treat haemophilia B
Swedish Orphan Biovitrum AB and Biogen announced that the European Commission (EC) has approved Alprolix (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation.
Regulatory Affairs > News
European Commission approves Bristol-Myers Squibb's two new oncology treatments
By PBR Staff Writer
The European Commission (EC) has approved two new oncology treatments, one for advanced melanoma and the other for multiple myeloma.
Regulatory Affairs > News
FDA expands Imbruvica label to include survival data
By PBR Staff Writer
The US Food and Drug Administration (FDA) has expanded Imbruvica (ibrutinib) label to include overall survival (OS) data in previously untreated chronic lymphocytic leukemia.
Regulatory Affairs > News
SHL at the 2016 Prefillied Syringes Seminar Tokyo
SHL is glad to announce that it is going to participate in the Prefilled Syringe Seminar 2016 Tokyo, organized by PDA Japan Chapter. The seminar will take place at Sola City Conference Center on 17-18 of May 2016.
Regulatory Affairs > Press Releases
FDA approves new formulation of Eisai’s Fycompa to treat seizure disorders
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Eisai’s Fycompa (perampanel) oral suspension as adjunctive therapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures.
Regulatory Affairs > News
FDA approves Acadia's Nuplazid to treat Parkinson’s disease psychosis
By PBR Staff Writer
Acadia Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
Regulatory Affairs > News
Neovacs wins FDA approval to extend phase IIb clinical trial in Lupus to US
The US Food and Drug Administration (FDA) has approved Neovacs' investigational new drug application to extend its ongoing Phase IIb clinical trial of IFNα Kinoid to treat Lupus.
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 3570 results