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Genzyme's Cerdelga gets European marketing authorization for Gaucher Disease
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for Genzyme's Cerdelga (eliglustat) capsules, a first line oral therapy for certain adults living with Gaucher disease type 1.
Regulatory Affairs > News
FDA approves Novartis' Cosentyx to treat plaque psoriasis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Swiss drug-maker Novartis' Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Regulatory Affairs > News
European label update of Bayer’s Xarelto now including guidance for use in AF patients undergoing cardioversion
Bayer HealthCare announced the inclusion of specific guidance for doctors treating patients with non-valvular atrial fibrillation (AF) undergoing cardioversion to the European Xarelto (rivaroxaban) Product Information.
Regulatory Affairs > News
Verastem gets European orphan medicinal product status for VS-5584 in mesothelioma
By PBR Staff Writer
The European Commission has granted orphan medicinal product designation for Verastem's VS-5584, a dual mTORC1/2 and PI3K inhibitor, designed to treat patients with mesothelioma.
Regulatory Affairs > News
FDA approves Baxter's Phoxillum Renal Replacement Solution
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Baxter International's Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) for use during continuous renal replacement therapy (CRRT).
Regulatory Affairs > News
Marathon's deflazacort gets FDA fast track status to treat duchenne muscular dystrophy
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Marathon Pharmaceuticals' deflazacort to treat patients with duchenne muscular dystrophy (DMD), a fatal disorder that causes the progressive deterioration of muscle fibers.
Regulatory Affairs > News
Boehringer's nintedanib gets European approval to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
Boehringer Ingelheim has received approval from the European Commission (EC) for nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF), a debilitating and fatal lung disease.
Regulatory Affairs > News
European Commission approves Novartis' psoriasis drug Cosentyx
By PBR Staff Writer
The European Commission (EC) has approved Swiss drug-maker Novartis' Cosentyx (secukinumab, formerly known as AIN457) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
Regulatory Affairs > News
European Commission grants marketing authorisation for Celgene's OTEZLA to treat psoriasis and psoriatic arthritis
Celgene International, a wholly-owned subsidiary of Celgene Corporation, announced that the European Commission (EC) has granted marketing authorisation for OTEZLA (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:
Regulatory Affairs > News
AbbVie secures FDA approval for long-acting Parkinson's treatment DUOPA
The US Food and Drug Administration (FDA) has approved AbbVie's DUOPA (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease.
Regulatory Affairs > News
EMA accepts to review Regeneron and Sanofi's MAA for hypercholesterolemia drug Praluent
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted to review the marketing authorization application (MAA) for Regeneron and Sanofi's Praluent (alirocumab) designed to treat patients with hypercholesterolemia.
Regulatory Affairs > News
FDA grants fast track status for Scynexis' SCY-078 to treat invasive fungal infections
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Scynexis' SCY-078, an oral glucan synthase inhibitor being developed to treat invasive Candidiasis, including Candidemia and invasive Aspergillosis.
Regulatory Affairs > News
Ligand Partner Retrophin receives orphan drug designation for sparsentan
Ligand Pharmaceuticals announced that its partner Retrophin, Inc. has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for Sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).
Regulatory Affairs > News
Daiichi Sankyo's anti-clotting drug Savaysa gets FDA approval
By PBR Staff Writer
Japan-based Daiichi Sankyo has received approval from the US food and Drug Administration (FDA) for its anti-clotting drug, Savaysa (edoxaban tablets).
Regulatory Affairs > News
Sandoz biosimilar filgrastim recommended for approval by FDA committee
Sandoz, a Novartis company, announced that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US.
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
NNIT - The Full Service IT Consultancy Dedicated to Life Sciences
NNIT specialises in using IT to optimise the complex processes inherent in the life sciences industry. We are an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry. ... 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
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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
1-15 of 3243 results