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AstraZeneca's Lynparza gets European approval to treat BRCA-mutated ovarian cancer
By PBR Staff Writer
AstraZeneca has received approval from the European Commission (EC) for Lynparza (olaparib) capsules 400mg twice daily as the first therapy to treat adults with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Regulatory Affairs > News
FDA accepts filing Apotex's biosimilar application for pegfilgrastim
By PBR Staff Writer
The US Food and Drug Administration has accepted for filing Canadian pharmaceutical firm Apotex's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta.
Regulatory Affairs > News
NICE recommends Boehringer's Pradaxa to treat and prevent recurrence of DVT and PE
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has granted approval for Boehringer Ingelheim's dabigatran etexilate (Pradaxa) for use by the National Health Service to treat and prevent the recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
Regulatory Affairs > News
ViiV Healthcare seeks Japan's approval for combination drug to treat HIV
By PBR Staff Writer
ViiV Healthcare has submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the single-pill regimen combining dolutegravir, abacavir and lamivudine, to treat HIV infection.
Regulatory Affairs > News
FDA approves two higher dosage strengths of Orexo's ZUBSOLV
Orexo has received approval from the US Food and Drug Administration (FDA) of two higher dosage strengths of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence.
Regulatory Affairs > News
Immunovaccine receives FDA fast track status for DPX-Survivac to treat ovarian cancer
Immunovaccine, a clinical stage vaccine and immunotherapy company, announced that DPX-Survivac, the company's lead cancer vaccine candidate, has been granted fast track designation by the US Food and Drug Administration (FDA) as maintenance therapy in subjects with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival.
Regulatory Affairs > News
GlaxoSmithKline seeks EMA approval for extended indication for ambrisentan to treat PAH
By PBR Staff Writer
GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) to widen the uses for which its pulmonary arterial hypertension (PAH) treatment ambrisentan (Volibris) can be marketed.
Regulatory Affairs > News
Ignyta receives WHO approval of Nonproprietary name Entrectinib for RXDX-101
Ignyta, a precision oncology biotechnology company, today announced that the World Health Organization (WHO) has approved the international nonproprietary name (INN) “entrectinib” for the company’s lead product candidate, RXDX-101.
Regulatory Affairs > News
AstraZeneca's Moventig gets European marketing authorization for opioid-induced constipation
By PBR Staff Writer
AstraZeneca has received marketing authorization from the European Commission (EC) for Moventig (naloxegol) to treat opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Regulatory Affairs > News
FDA approves Amgen's XGEVA to treat Hypercalcemia
Amgen announced that the US Food and Drug Administration (FDA) has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
Regulatory Affairs > News
Bayer submits marketing authorization application for BAY 81-8973 in Europe
Bayer HealthCare has submitted an application for marketing authorization to the European Medicines Agency (EMA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.
Regulatory Affairs > News
EMA Committee finds no evidence of serious events in Novartis Fluad vaccine
By PBR Staff Writer
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there was no evidence that Novartis-manufactured flu vaccine, Fluad, caused serious events including deaths in Italy.
Regulatory Affairs > News
FDA approves Amgen's BLINCYTO to treat relapsed or refractory B-Cell precursor ALL
By PBR Staff Writer
Amgen has announced that the US Food and Drug Administration (FDA) has granted approval of BLINCYTO™ (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
FDA approves Sanofi's Priftin to treat latent tuberculosis infection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Sanofi's Priftin (rifapentine), an antimycobacterial, in combination with isoniazid (INH) for a new indication to treat latent tuberculosis infection (LTBI) in patients two years of age and older at high risk of progression to tuberculosis (TB) disease.
Regulatory Affairs > News
European Commission approves Astellas' prostate cancer drug enzalutamide
By PBR Staff Writer
The European Commission (EC) has granted a variation to amend the marketing authorization for Astellas Pharma's enzalutamide (XTANDI) to treat men with metastatic castration-resistant prostate cancer (mCRPC).
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
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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
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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
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