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Regulatory Affairs
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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
European Commission grants marketing authorisation to Lonsurf in mCRC
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for Taiho Pharmaceutical's Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, to treat advanced metastatic colorectal cancer (mCRC).
Regulatory Affairs > News
Collegium Pharmaceutical's Xtampza ER opioid painkiller wins FDA approval
By PBR Staff Writer
Collegium Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for Xtampza ER (oxycodone), a novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain.
Regulatory Affairs > News
FDA committee votes against approval of Sarepta's duchenne muscular dystrophy drug
The US Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review Sarepta Therapeutics' new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 skipping.
Regulatory Affairs > News
Gilead Sciences secures EU approval for new HIV treatment
By PBR Staff Writer
Gilead Sciences has secured marketing authorization from the European Commission (EC) for its fixed-dose combination Descovy (emtricitabine, tenofovir alafenamide) to treat HIV-1 infection.
Regulatory Affairs > News
FDA removes clinical hold Cara Therapeutics' postoperative pain trial for I.V. CR845
By PBR Staff Writer
The US Food and Drug Administration (FDA) has removed the clinical hold on Cara Therapeutics' adaptive phase 3 clinical trial assessing an intravenous formulation (I.V.) of lead product candidate CR845 to treat postoperative pain.
Regulatory Affairs > News
FDA approves Boehringer Ingelheim's Gilotrif for squamous cell lung cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim's supplemental New Drug Application (sNDA) for Gilotrif (afatinib) as new oral treatment option for patients with squamous cell carcinoma (SqCC) of the lung.
Regulatory Affairs > News
FDA to review Bristol-Myers' Opdivo for classical Hodgkin lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Bristol-Myers Squibb's supplemental Biologics License Application (sBLA) to expand the use of its cancer drug Opdivo to treat patients with classical Hodgkin lymphoma (cHL).
Regulatory Affairs > News
FDA committee votes against accelerated approval of Clovis' rociletinib lung cancer drug
By PBR Staff Writer
The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted 12-1 against accelerated approval of Clovis Oncology's rociletinib lung cancer drug.
Regulatory Affairs > News
FDA grants orphan drug status to Appili's ATI-1501 to treat C. difficile in children
By PBR Staff Writer
Appili Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for ATI-1501, a taste-masked reformulation of metronidazole with the potential to treat Clostridium difficile infection (CDI) in children.
Regulatory Affairs > News
FDA approves Venclexta for tough-to-treat type of leukemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) to treat patients with chronic lymphocytic leukemia (CLL) with the 17p deletion who have received at least one prior therapy.
Regulatory Affairs > News
EC approves subcutaneous route of administration in Binocrit's nephrology indication
By PBR Staff Writer
Sandoz, the generic pharmaceuticals division of Novartis, has secured approval from the European Commission (EC) for a type II variation for the addition of a subcutaneous (sc) route of administration in Binocrit’s nephrology indication.
Regulatory Affairs > News
FDA grants orphan drug designation to ANAVEX 3-71 to treat Frontotemporal dementia
By PBR Staff Writer
Clinical-stage biopharmaceutical firm Anavex Life Sciences has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for ANAVEX 3-71 to treat Frontotemporal dementia (FTD).
Regulatory Affairs > News
European Commission approves Novartis' Revolade for children with chronic ITP
By PBR Staff Writer
Novartis has secured approval from the European Commission (EC) for Revolade (eltrombopag) to treat children with pediatric chronic immune thrombocytopenic purpura (ITP).
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 3557 results