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Alexion's Soliris secures orphan drug designation (ODD) in Japan to treat neuromyelitis optica
By PBR Staff Writer
Alexion Pharmaceuticals has received orphan drug designation (ODD) from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Soliris (eculizumab) to treat patients with neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder.
Regulatory Affairs > News
EMA committee grants orphan designation for Apitope's ATX-F8-117 to treat haemophilia A
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan medicinal product designation to Apitope's ATX-F8-117 to treat patients with haemophilia A.
Regulatory Affairs > News
Valeant gets FDA approval for ONEXTON gel to treat acne vulgaris
Valeant Pharmaceuticals International has received approval from the Food and Drug Administration (FDA) for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.
Regulatory Affairs > News
FDA extends review period for Novartis’ multiple myeloma investigational compound LBH589
By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the priority review period by up to three months for Novartis' new drug application (NDA) of LBH589 (panobinostat), a potent pan-deacetylase (pan-DAC) inhibitor, in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma.
Regulatory Affairs > News
Celgene gets positive CHMP opinion for OTEZLA to treat psoriasis and psoriatic arthritis
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA (apremilast), the Company's oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:
Regulatory Affairs > News
Genzyme’s Cerdelga secures European CHMP positive opinion
By PBR Staff Writer
Genzyme has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Cerdelga (eliglustat) capsules, an oral treatment for certain adults living with Gaucher disease type 1.
Regulatory Affairs > News
EMA CHMP issues positive opinion for Boehringer's nintedanib to treat IPF
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Boehringer Ingelheim's nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF).
Regulatory Affairs > News
FDA approves Purdue Pharma's Hysingla ER with abuse-deterrent properties
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Purdue Pharma's Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment.
Regulatory Affairs > News
FDA grants fast track status for Merrimack's pancreatic cancer drug MM-398
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Merrimack Pharmaceuticals' MM-398 (nanoliposomal irinotecan injection) to treat patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
Regulatory Affairs > News
Gilead's hepatitis C drug Harvoni gets marketing authorization in Europe
By PBR Staff Writer
Gilead Sciences has received marketing authorization from the European Commission for Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults.
Regulatory Affairs > News
Kite Pharma gets positive opinion for orphan drug designation in Europe for cancer immunotherapy
Kite Pharma, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) products for the treatment of cancer, has announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of diffuse large B cell lymphoma (DLBCL).
Regulatory Affairs > News
Genentech gets FDA approval for Avastin to treat ovarian cancer
By PBR Staff Writer
Roche's subsidiary Genentech has received approval from the US Food and Drug Adminsitartion (FDA) for its Avastin in combination with chemotherapy to treat women with platinum-resistant, recurrent ovarian cancer.
Regulatory Affairs > News
FDA approves Genzyme’s Lemtrada to treat multiple sclerosis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Genzyme's Lemtrada (alemtuzumab) to treat patients with relapsing forms of multiple sclerosis (MS).
Regulatory Affairs > News
GSK seeks European approval for additional indication of eltrombopag to treat SAA
By PBR Staff Writer
GlaxoSmithKline (GSK) is seeking approval from the European Medicines Agency (EMA) for additional indication of eltrombopag (Revolade) to treat adult patients with severe aplastic anaemia (SAA), who have had an insufficient response to immunosuppressive therapy (IST).
Regulatory Affairs > News
NNIT in the Press
NNIT has more than 2,300 employees - more than 700 employees work outside the borders of Denmark – in China​​, the Czech Republic​, the ​Philippines​, Switzerland​ and in the US.
Regulatory Affairs > Press Releases

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
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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 3195 results