Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs
Search Refinements
Search Results: Regulatory Affairs
1-15 of 3491 results
Amarantus gets FDA orphan drug designation for Eltoprazine to treat PD-LID
Amarantus BioScience has received orphan drug designation from the US FDA for Eltoprazine in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
Regulatory Affairs > News
FDA halts clinical trial of CTI Biopharma’s blood cancer drug
By PBR Staff Writer
The US Food and Drug Administration has put a complete hold on CTI Biopharma’s new blood cancer drug Pacritinib.
Regulatory Affairs > News
UK health agency rejects Sanofi’s cholesterol drug
By PBR Staff Writer
UK’s National Institute of Health and Clinical Excellence (NICE) has recommended that patients with high-cholesterol should not take Sanofi and Regeneron’s new cholesterol lowering injection Praluent, but backed Amgen’s similar drug Repatha.
Regulatory Affairs > News
US FDA delays decision on Sarepta Therapeutics’ drug to treat muscular dystrophy
By PBR Staff Writer
Sarepta Therapeutics has announced that the US Food and Drug Administration (FDA) will require more time to review its drug for muscular dystrophy.
Regulatory Affairs > News
FDA declines to approve Vertex's Kalydeco in people with cystic fibrosis ages 2 and older
The US Food and Drug Administration (FDA) has declined to approve Vertex Pharmaceuticals' Kalydeco (ivacaftor) in people with cystic fibrosis (CF) ages two and older with one of 23 residual function mutations.
Regulatory Affairs > News
US FDA advisory committee votes in favor for Takeda and Lundbeck's Brintellix
By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 to recommend the use of Brintellix (vortioxetine) to treat certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).
Regulatory Affairs > News
FDA expands indication for Merck's Emend nausea and vomiting drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved the use of Merck's single-dose Emend (fosaprepitant dimeglumine) in combination with other antiemetic agents to prevent delayed nausea and vomiting in patients who receive moderately emetogenic chemotherapy (MEC).
Regulatory Affairs > News
EC approves TAGRISSO to treat patients with EGFR T790M mutation-positive NSCLC
The European Commission (EC) has granted conditional marketing authorisation for AstraZeneca's TAGRISSO (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA grants fast track designation for Nimbus' NDI-010976 to treat NASH
The US Food and Drug Administration (FDA) has granted Fast Track designation for NDI-010976, Nimbus Therapeutics' liver-targeted allosteric inhibitor of acetyl-CoA carboxylase (ACC), for the treatment of NASH (non-alcoholic steatohepatitis).
Regulatory Affairs > News
UK regulator approves human gene-editing technique
By PBR Staff Writer
The UK's Human Fertilisation and Embryology Authority (HFEA) has approved a proposal to use new gene editing techniques on human embryos.
Regulatory Affairs > News
Ariad gets FDA nod to start clinical development of AP32788
By PBR Staff Writer
Ariad Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to start clinical development of AP32788, a tyrosine kinase inhibitor (TKI) designed to address an unmet medical need in a subset of non-small cell lung cancers (NSCLCs).
Regulatory Affairs > News
FDA grants breakthrough therapy designation to Lynparza for prostate cancer
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for AstraZeneca's oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
Regulatory Affairs > News
FDA deems Exelixis NDA for cabozantinib to treat advanced renal cell carcinoma
The US Food & Drug Administration (FDA) has determined Exelixis' New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to be sufficiently complete to permit a substantive review.
Regulatory Affairs > News
FDA approves Neos Therapeutics' Adzenys XR-ODT ADHD drug
By PBR Staff Writer
Neos Therapeutics has secured approval from the US Food and Drug Administration (FDA) for Adzenys XR-ODT to treat attention deficit hyperactivity disorder (ADHD) in patients six years and older.
Regulatory Affairs > News
UK's NICE approves Boehringer's Ofev to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
The National Institute for Health and Care Excellence (NICE) of the UK has approved Boehringer Ingelheim's Ofev (nintedanib) to treat idiopathic pulmonary fibrosis (IPF) lung disease.
Regulatory Affairs > News

PBR Supplier Recommendations

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
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
See more

PBR White Paper Recommendations

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 Design-To-Build – Laboratory Handling Equipment By SHL Group
A leading high-end laboratory handling and diagnostics equipment manufacturing company devoted to helping scientists meet challenges regularly faced in the lab, approached SHL Technologies with a request to develop benchtop laboratory tube array handling equipment. This equipment had to be available in a modular set-up and capable of pick-and-place sorting, weight measurement, and barcode reading.... 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 3491 results