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Regulatory Affairs
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FDA approves Imbruvica for relapsed/refractory marginal zone lymphoma
The US Food and Drug Administration (FDA) has granted an accelerated approval to Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma (MZL), a rare type of Non-Hodgkin's Lymphoma.
Regulatory Affairs > News
European Commission approves Suliqua to treat adults with type 2 diabetes
Sanofi has secured approval from the European Commission for Suliqua, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
Regulatory Affairs > News
Paralysed by Complexity? Solutions that Work
Over-complexity is the silent killer for many companies, and it’s a proven fact. The largest 200 companies in the Global Fortune 500 listing lose approximately 10.2% of shareholder value every year due to complexity
Regulatory Affairs > Press Releases
Scottish Medicines Consortium approves Zepatier to treat chronic hepatitis C
By PBR Staff Writer
A new medicine intended to treat chronic hepatitis C is one of four accepted by the Scottish Medicines Consortium (SMC) for routine use in NHS Scotland.
Regulatory Affairs > News
Gilead gets European approval for hepatitis B drug Vemlidy
Gilead Sciences has received marketing authorization from the European Commission for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for chronic hepatitis B virus (HBV) infection treatment in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
Regulatory Affairs > News
FDA grants orphan drug status for Sangamo’s SB-318 genome editing treatment for MPS I
Sangamo Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its genome editing product candidate, SB-318, to treat Mucopolysaccharidosis Type I (MPS I).
Regulatory Affairs > News
FDA approves Egalet’s opioid prescription painkiller
By PBR Staff Writer
Egalet has secured approval from the US Food and Drug Administration (FDA) for Arymo ER (morphine sulfate) C-II, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain.
Regulatory Affairs > News
Genentech’s Lucentis gets FDA approval for myopic choroidal neovascularization
Genentech’s Lucentis (ranibizumab injection) 0.5 mg has been approved by the US Food and Drug Administration (FDA) for the treatment of patients with myopic choroidal neovascularization (mCNV).
Regulatory Affairs > News
FDA grants orphan drug designation for Marinus' ganaxolone to treat FXS
By PBR Staff Writer
Marinus Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its CNS-selective GABAA modulator, ganaxolone, to treat Fragile X Syndrome (FXS).
Regulatory Affairs > News
Innocoll receives refusal to file letter from FDA for post-surgical pain candidate
By PBR Staff Writer
The US Food and Drug Administration (FDA) has issued a Refuse-to-File letter halting further review of Innocoll's new drug application (NDA) for its post-surgical pain candidate Xaracoll.
Regulatory Affairs > News
Novo Nordisk gets FDA approval for Tresiba's use in children
Novo Nordisk secured approval from the US Food and Drug Administration (FDA) for an expanded use for Tresiba (insulin degludec) injection to improve glycemic control in children and adolescents with both type 1 and type 2 diabetes.
Regulatory Affairs > News
Pfizer announces EC approval for Nimenrix in infants six weeks of age and older
Pfizer has secured approval from the European Commission (EC) for an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age.
Regulatory Affairs > News
FDA drops boxed warning on Pfizer's smoking cessation drug
The U.S. Food and Drug Administration (FDA) has approved updates to Pfizer’s CHANTIX (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events.
Regulatory Affairs > News
Intercept's Ocaliva gets EC approval to treat primary biliary cholangitis
Intercept Pharmaceuticals has secured conditional approval from the European Commission (EC) for Ocaliva (obeticholic acid) to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Regulatory Affairs > News
European Commission approves Ferring's REKOVELLE (follitropin delta)
Ferring Pharmaceuticals has secured marketing authorisation from the European Commission (EC) for REKOVELLE (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), intended to be used in controlled ovarian stimulation for developing multiple follicles in women undergoing assisted reproductive technologies (ART), like an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Regulatory Affairs > News

PBR Supplier Recommendations

NSF Health Sciences Pharma Biotech
NSF partners with you to provide world-class regulatory and compliance consulting, auditing and training on a global basis.... 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
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
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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 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
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