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RetroSense gets FDA orphan drug status for RST-001 to treat retinitis pigmentosa
By PBR Staff Writer
US-based RetroSense Therapeutics has received orphan drug designation from the Food and Drug Administration (FDA) for its lead product RST-001 to treat retinitis pigmentosa (RP), a genetic condition which leads to the progressive degeneration of rod and cone photoreceptors.
Regulatory Affairs > News
FDA grants accelerated approval for Pfizer' meningococcal B vaccine Trumenba
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted accelerated approval for Pfizer's Trumenba (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25 years.
Regulatory Affairs > News
FDA grants breakthrough therapy status for Merck's lung cancer drug Keytruda
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Merck's anti-PD-1 therapy Keytruda (pembrolizumab) to treat patients with advanced non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
Mundipharma's Targin receives CHMP positive opinion to treat restless legs syndrome
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Mundipharma's Targin as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome (RLS).
Regulatory Affairs > News
Baxter's Obizur gets FDA approval to treat adults with acquired hemophilia A
By PBR Staff Writer
Baxter International has received approval from the US Food and Drug Administration (FDA) for Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] to treat bleeding episodes in adults with acquired hemophilia A (AHA).
Regulatory Affairs > News
EMA committee recommends AstraZeneca's ovarian cancer drug Lynparza
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending AstraZeneca's marketing authorization of ovarian cancer drug Lynparza (olaparib) as monotherapy.
Regulatory Affairs > News
NICE recommends Bayer's rivaroxaban as option for secondary prevention in ACS
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued its Appraisal Consultation Document (ACD) recommending Bayer HealthCare's Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome (ACS).
Regulatory Affairs > News
EMA grants orphan status for GW Pharmaceuticals' Epidiolex to treat Dravet syndrome
By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
Regulatory Affairs > News
NICE recommends GSK's skin cancer drug Tafinlar
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending GlaxoSmithKline's (GSK) Tafinlar (dabrafenib) to treat certain NHS patients with melanoma, a type of skin cancer.
Regulatory Affairs > News
FDA approves Auxilium's Xiaflex to treat Dupuytren's Contracture
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Auxilium Pharmaceuticals' Xiaflex (collagenase clostridium histolyticum or CCH) to treat up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.
Regulatory Affairs > News
Novartis' plaque psoriasis drug candidate AIN457 gets FDA committee recommendation
By PBR Staff Writer
The US Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has approved Novartis' AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, to treat moderate-to-severe plaque psoriasis in adult patients.
Regulatory Affairs > News
Pharmacyclics' Imbruvica gets European approval to treat two blood cancers
By PBR Staff Writer
The European Commission (EC) has granted marketing approval for Pharmacyclics' Imbruvica (ibrutinib), a first-in-class, oral, once-daily, non-chemotherapy treatment for patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL).
Regulatory Affairs > News
Health Canada issues notice of compliance for Gilead hepatitis C drug Harvoni
By PBR Staff Writer
Health Canada has issued a Notice of Compliance for Gilead Sciences' Harvoni (ledipasvir 90 mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat chronic hepatitis C genotype 1 infection in adults.
Regulatory Affairs > News
FDA approves Boehringer's Ofev to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
The US Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' Ofev (nintedanib) capsules to treat idiopathic pulmonary fibrosis (IPF).
Regulatory Affairs > News
Genentech gets FDA approval for Esbriet to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
Genentech, Roche's subsidiary, has received approval from US Food and Drug Administration (FDA) for Esbriet (pirfenidone) to treat patients with idiopathic pulmonary fibrosis (IPF).
Regulatory Affairs > News

PBR Supplier Recommendations

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
SHL Technologies - Contract Development and Manufacturing
SHL Technologies is a Contract Development and Manufacturing Organisation (CDMO) that provides OEM and ODM services for various industrial sectors from electronics to healthcare and medical.... 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
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
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PBR White Paper Recommendations

NSF Health Sciences Journal – Summer 2014: What is the Biggest Risk Facing Your Company? By NSF Health Sciences Pharma Biotech PBR
At NSF Health Sciences our objective is to help you do the basics to PhD level and to help you to deliver high quality medicines on time in full. Our education courses described on page 22-27 are designed to help you excel at doing the basics and change behaviours in the workplace. The articles in this edition of the Journal are designed to do the same. Simple, readable, provocative and informative. ... Regulatory Affairs > White Papers 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 See more
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