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Regulatory Affairs
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1-15 of 3246 results
Gilead secures approval in Japan for Sovaldi to treat genotype 2 chronic HCV
By PBR Staff Writer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Gilead Sciences' Sovaldi (sofosbuvir) for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis.
Regulatory Affairs > News
FDA grants orphan drug status for CymaBay's MBX-8025 to treat HoFH
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for CymaBay Therapeutics' MBX-8025, a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, to treat homozygous familial hypercholesterolemia (HoFH), an autosomal genetic disease.
Regulatory Affairs > News
Marinus gets FDA orphan drug status for ganaxolone to treat PCDH19 female epilepsy
By PBR Staff Writer
Marinus Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for ganaxolone, a synthetic analog of the endogenous neurosteroid allopregnanolone, to treat protocadherin 19 gene (PCDH19) female epilepsy.
Regulatory Affairs > News
Regulus' RG-012 gets orphan medicinal product designation in Europe to treat alport syndrome
By PBR Staff Writer
The European Commission has granted orphan medicinal product designation for US-based biopharmaceutical firm Regulus Therapeutics' RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 (miR-21) to treat Alport syndrome.
Regulatory Affairs > News
Agios gets FDA orphan drug status for AG-348 to treat pyruvate kinase deficiency
By PBR Staff Writer
Agios Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational medicine AG-348 to treat pyruvate kinase (PK) deficiency, a rare form of hemolytic anemia.
Regulatory Affairs > News
Vertex's Kalydeco gets FDA aapproval for children with cystic fibrosis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Vertex Pharmaceuticals' Kalydeco for use in children aged two to five years with cystic fibrosis (CF).
Regulatory Affairs > News
Selten's PAH treatment tacrolimus gets FDA orphan drug status
By PBR Staff Writer
US-based biopharmaceutical firm Selten Pharma has received orphan drug designation from the US Food & Drug Administration (FDA) for tacrolimus (SPI-026), an investigational Bone morphogenetic protein receptor type II (BMPR2) pathway activator for pulmonary arterial hypertension (PAH).
Regulatory Affairs > News
Novartis's cancer drug Jakavi gets European approval to treat polycythemia vera
By PBR Staff Writer
The European Commission (EC) has granted approval for Swiss drugmaker Novartis' Jakavi (ruxolitinib) to treat adult patients with polycythemia vera (PV), a rare and incurable blood cancer.
Regulatory Affairs > News
Merck's melanoma drug pembrolizumab to be made available for patients under EAMS
By PBR Staff Writer
Merck has announced that anti-PD-1 therapy, pembrolizumab, is the first treatment to be accepted under the UK's new Early Access to Medicines Scheme (EAMS) for the treatment of advanced melanoma.
Regulatory Affairs > News
FDA requests additional data for Lpath's IND for lpathomab
By PBR Staff Writer
The US Food and Drug Administration (FDA) has requested additional analysis of certain data submitted as part of Lpath's recently submitted investigational new drug (IND) application for lpathomab.
Regulatory Affairs > News
UK’s NICE draft guidance recommends apixaban for blood clots
By PBR Staff Writer
The National Institute for Health and Care Excellence (NICE) in the UK has published a new draft guidance which recommends apixaban (Eliquis) as an option for treating and preventing potentially fatal blood clots.
Regulatory Affairs > News
FDA approves Astellas’ NDA for Cresemba to treat zygomycosis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Astellas’ New Drug Application (NDA) for the use of Cresemba (isavuconazonium sulfate) to treat aspergillosis and invasive mucormycosis (also known as zygomycosis).
Regulatory Affairs > News
Axsome’s AXS-02 drug secures US FDA’s Fast Track designation
By PBR Staff Writer
The US FDA has given Fast Track designation for Axsome Therapeutics’ AXS-02 drug to treat pain associated with complex regional pain syndrome (CRPS).
Regulatory Affairs > News
Bayer's BLA for Kovaltry gets FDA acceptance to treat hemophilia A
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Bayer HealthCare's biologics license application (BLA) for BAY 81-8973 (Kovaltry), a recombinant Factor VIII compound, for the treatment of hemophilia A in children and adults.
Regulatory Affairs > News
EMA committee issues positive opinion for Novartis' lung cancer drug Zykadia
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for Novartis' Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Regulatory Affairs > News

PBR Supplier Recommendations

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

Best Practices for Streamlining Electronic Implementation of Established COAs; Copyright January 2015 By ERT
This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.... Regulatory Affairs > White Papers Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study; International Journal of COPD; January 2015. By ERT
This paper presents the results of psychometric assessment data from a COPD eDiary developed by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.... Regulatory Affairs > White Papers The Use of Ambulatory Blood Pressure Monitoring in Drug Development; Copyright, January 2015 By ERT
This white paper delves into the basics of blood pressure, along with the well-documented limitations of standard and digital office blood pressure measurements. It reviews ABPM device functionality, common drug classes where blood pressure monitoring comes into play and compares the advantages and disadvantages of different monitoring options in clinical studies.... Regulatory Affairs > White Papers The Use of Continuous ECG Recordings (Holters) in Drug Development; Copyright, December 2014 By ERT
Continuous 12 lead ECG recorders, often referred to as Holter devices, offer specific advantages to be considered over the standard 12 lead ECGs often collected during clinical trials for cardiac safety. This white paper explores the history of Holters, how sponsors, sites, and patients use these devices, and the benefits of continuous ECG recordings.... Regulatory Affairs > White Papers Predictive Value of Baseline electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) Assessments for Identifying Risk of Prospective Reports of Suicidal Behavior During Clinical Research; Innovations in Clinical Neuroscience; November 2014 By ERT
This meta-analysis examined the ability of baseline eC-SSRS lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants. The review of over 74,000 eC-SSRS assessments determined that increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation.... Regulatory Affairs > White Papers See more
1-15 of 3246 results