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Bayer's Ciprofloxacin DPI gets FDA orphan drug designation
By PBR Staff Writer
Bayer HealthCare has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) to treat patients with non-cystic fibrosis bronchiectasis (NCFB).
Regulatory Affairs > News
FDA grants orphan drug designation to Emergent's anthrax vaccine BioThrax
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation to Emergent BioSolutions' (EBS) BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.
Regulatory Affairs > News
Cubist seeks FDA approval for new antibiotic to treat cUTI and cIAI
By PBR Staff Writer
US-based Cubist Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval of its investigational antibiotic ceftolozane/tazobactam to treat Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).
Regulatory Affairs > News
GSK obtains Canadian approval for Incruse Ellipta
By PBR Staff Writer
GlaxoSmithKline (GSK) has obtained marketing approval in Canada for its Incruse Ellipta (umeclidinium, as umeclidinium bromide), a new once-daily long-acting muscarinic antagonist (LAMA) approved for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Regulatory Affairs > News
FDA, European Commission grant orphan drug status to Boehringer's volasertib
By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Commission (EC) have granted orphan drug designation for Germany-based Boehringer Ingelheim's volasertib to treat patients with acute myeloid leukaemia (AML), an aggressive cancer of the bone marrow and blood.
Regulatory Affairs > News
FDA accepts NDA for combination drug to treat type 2 diabetes
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted the filing of the new drug application (NDA) for Boehringer Ingelheim and Eli Lilly's investigational combination tablet of empagliflozin and linagliptin to treat adults with type 2 diabetes (T2D).
Regulatory Affairs > News
FDA extends market exclusivity of BioMarin's Phenylketonuria drug Kuvan for six months
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted BioMarin Pharmaceutical's Kuvan (sapropterin dihydrochloride) Powder for Oral Solution and Tablets a six-month pediatric exclusivity extension.
Regulatory Affairs > News
BMS files NDA to FDA for combination tablet to treat HIV-1
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, for the treatment of HIV-1 infection.
Regulatory Affairs > News
Trinidad & Tobago Ministry of Health approves Janssen's prostate cancer drug Zytiga
By PBR Staff Writer
The Chemistry, Food & Drugs Division of the Trinidad & Tobago Ministry of Health has approved the introduction of Janssen's Abiraterone Acetate in the country for the treatment of patients with metastatic castration-resistant prostate cancer.
Regulatory Affairs > News
FDA grants breakthrough therapy status for Celladon' heart failure treatment Mydicar
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Celladon's lead product candidate, Mydicar, for reducing hospitalisations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative.
Regulatory Affairs > News
Boehringer's Pradaxa gets FDA approval for DVT, PE treatment
By PBR Staff Writer
Germany-based pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).
Regulatory Affairs > News
SHL in Korea: Insight into the Changing World of Auto Injectors
The global injectable drug delivery device technologies market was valued at approximately $10.2bn in 2012 and is expected to grow at a CAGR rate of 11% to $17.2bn by 2017.
Regulatory Affairs > Press Releases
Bristol-Myers files NDAs to FDA for daclatasvir and asunaprevir to treat hepatitis C
By PBR Staff Writer
US-based biopharmaceutical firm Bristol-Myers Squibb (BMS) has submitted new drug applications (NDAs) to the US Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor, indicated for the treatment of Hepatitis C.
Regulatory Affairs > News
Apricus gets approval for erectile dysfunction drug Vitaros in Luxembourg
By PBR Staff Writer
Apricus Biosciences has secured national phase approval from the Ministry of Health of Luxembourg for Vitaros, a topical on-demand treatment for erectile dysfunction (ED).
Regulatory Affairs > News
FDA approves expanded use of Dyax's HAE drug Kalbitor
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expansion of the indication for Dyax's Kalbitor (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older.
Regulatory Affairs > News

PBR Supplier Recommendations

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
INFOTEHNA Group - Pharmaceutical Software Solutions
INFOTEHNA Group is a leading provider of software solutions for the life sciences industries. We develop and deliver integral enterprise content, process management and regulatory compliance.... 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 2985 results