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European Commission approves BMS- Pfizer's Eliquis to treat DVT, PE
By PBR Staff Writer
The European Commission (EC) has approved Bristol-Myers Squibb (BMS) and Pfizer's Eliquis, an oral selective Factor Xa inhibitor, for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as prevention of recurrent DVT and PE in adults.
Regulatory Affairs > News
Roche gets European approval for leukemia treatment Gazyvaro
By PBR Staff Writer
Swiss health-care firm Roche has received approval from the European Commission for Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy to treat people with previously untreated chronic lymphocytic leukemia (CLL) who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy).
Regulatory Affairs > News
Alimera' ILUVIEN gets marketing authorization in Norway to treat chronic DME
By PBR Staff Writer
US-based biopharmaceutical firm Alimera Sciences has received marketing authorization from the Norwegian Medicines Evaluation Board for ILUVIEN to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Regulatory Affairs > News
CHMP recommends Allergan's OZURDEX to treat diabetic macular edema
By PBR Staff Writer
Allergan has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending extension of the marketing authorization for OZURDEX to treat adult patients with vision loss due to diabetic macular edema (DME).
Regulatory Affairs > News
European CHMP adopts positive opinion for Gilead’s Zydelig to treat chronic lymphocytic leukemia and follicular lymphoma
Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL).
Regulatory Affairs > News
EMA committee recommends full approval of Imbruvica to treat two blood cancers
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the granting of full marketing approval for Pharmacyclics' Imbruvica (ibrutinib) in the European Union (EU).
Regulatory Affairs > News
FDA grants Genentech’s Avastin priority review for recurrent platinum-resistant ovarian cancer
Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
Regulatory Affairs > News
Regulus gets FDA orphan drug status for RG-012 to treat Alport Syndrome
By PBR Staff Writer
US-based biopharmaceutical firm Regulus Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for RG-012, a single stranded, chemically modified oligonucleotide.
Regulatory Affairs > News
CTI BioPharma expands access to PIXUVRI with approval in Israel
BioPharma has received approval from the Israeli Ministry of Health (MOH) for PIXUVRI (pixantrone).
Regulatory Affairs > News
Boehringer gets FDA breakthrough status for IPF treatment for nintedanib
By PBR Staff Writer
Germany-based Boehringer Ingelheim has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational therapy nintedanib to treat idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease.
Regulatory Affairs > News
Pendopharm gets Health Canada approval for hepatitis C drug Ibavyr
By PBR Staff Writer
Pendopharm, a division of Pharmascience, has secured Health Canada approval and market availability of IBAVYR (ribavirin tablets), the first stand-alone oral ribavirin for the treatment of chronic hepatitis C virus (HCV) infections in Canada.
Regulatory Affairs > News
FDA accepts sBLA, grants priority review for Genentech’s cervical cancer therapy Avastin plus
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application (sBLA) and granted priority review for Avastin (bevacizumab) plus chemotherapy to treat women with persistent, recurrent or metastatic cervical cancer.
Regulatory Affairs > News
Sunovion gets Canadian approval for Aptiom to treat partial-onset seizures
By PBR Staff Writer
Sunovion Pharmaceuticals Canada has received approval from Health Canada for Aptiom (eslicarbazepine acetate) for use as a once-daily adjunctive drug (AED) to treat partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.
Regulatory Affairs > News
European Commission grants orphan drug status to Zafgen for beloranib to treat PWS
By PBR Staff Writer
US-based biopharmaceutical firm Zafgen has received orphan drug designation from the European Commission (EC) for beloranib to treat patients with Prader-Willi syndrome (PWS).
Regulatory Affairs > News
Bristol-Myers to submit BLA in US for melanoma drug Opdivo
By PBR Staff Writer
US-based Bristol-Myers Squibb (BMS) is planning a third quarter submission of a Biologics Licensing Application (BLA) to the US Food and Drug Administration (FDA) for Opdivo (nivolumab) for previously treated advanced melanoma.
Regulatory Affairs > News

PBR Supplier Recommendations

7PSolutions - Climate Control Solutions
7PSolutions™ was founded in 2010 to fulfill an unmet need in the life sciences and transportation industries: a single solution for climate control, security and quality management through every stage of the supply chain. ... Regulatory Affairs > Suppliers
TOPRA - Healthcare Regulatory Affairs
TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector.... Regulatory Affairs > Suppliers
Toxikon Europe - Preclinical Safety Studies and QC Testing for the Life Science Community
For more than 30 years Toxikon has been a leading contract research organisation (CRO) providing high-quality preclinical safety studies to the life science community. Toxikon operates state-of-the-art facilities in the US as well as Europe, both locations being FDA registered and ISO 17025 accredited. As a CRO the company offers services in worldwide GMP-GLP compliance testing for the medical, pharmaceutical and biotech industries.... Regulatory Affairs > Suppliers
NSF Health Sciences Pharma Biotech
Since its foundation in 1986, NSF Health Sciences Pharma Biotech has risen to become Europe's largest provider of pharmaceutical education and training with an outstanding international reputation in the fields of pharmaceutical quality management and regulatory compliance. NSF now brings that reputation to the US, complementing its EU expertise with experts in FDA and other markets to offer education and training programs, consultancy and auditing services.... 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
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PBR White Paper Recommendations

2014: What Will YOU Change? By NSF Health Sciences Pharma Biotech PBR
As one year closes and another one beckons it’s a time for reflection, looking back as well as forward. How did you do in 2013, and what does 2014 and beyond look like? For many, 2013 has been a real rollercoaster on the business and compliance front.... Regulatory Affairs > White Papers Human Error: Causes and Prevention By NSF Health Sciences Pharma Biotech PBR
As a leading consultancy and training provider to the pharma, biotech and devices industries, we are privileged to work with people who are both motivated and smart. In fact, our industries employ more PhDs and graduates than many other sectors! Yet, when you read through some recent 483s, you are left wondering why respected organisations, staffed with intelligent people, do some very illogical things.... Regulatory Affairs > White Papers How the Vaisala Continuous Monitoring System Aids Compliance with Title 21 CFR Part 11 and EU GMP Annex 11 By Vaisala pbr
This white paper outlines how Vaisala’s Continuous Monitoring System helps to meet the requirements of Title 21 CFR Part 11 and EU GMP Annex 11 as they apply to environmental monitoring and validation.... Regulatory Affairs > White Papers GMP Warehouse Mapping - Step-by-Step Guidelines for Validating Life Science Storage Facilities By Vaisala pbr
This step-by-step paper describes how to map a warehouse to comply with internationally recognized GMPs and regulatory requirements.... Regulatory Affairs > White Papers Monitoring Systems - Sorting Out Wireless By Vaisala pbr
This white paper describes the most common methods of connecting sensors to a monitoring system focusing on selecting wireless options. ... Regulatory Affairs > White Papers See more
1-15 of 3076 results