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Regulatory Affairs
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1-15 of 3338 results
FDA accepts ZS Pharma's ZS-9 NDA to treat hyperkalemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for filing ZS Pharma's new drug application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia.
Regulatory Affairs > News
Eisai's Lenvima gets FDA breakthrough status for renal cell carcinoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Eisai's in-house developed new anticancer agent Lenvima (lenvatinib mesylate, lenvatinib) for the potential indication of advanced and/or metastatic renal cell carcinoma.
Regulatory Affairs > News
FDA accepts OPKO’s NDA for rayaldee to treat CKD
OPKO Health (OPK) announced that the US Food and Drug Administration (FDA) has accepted for review OPKO’s New Drug Application (NDA) for calcifediol modified-release capsules (proposed trade name, Rayaldee).
Regulatory Affairs > News
EMA confirms successful validation of Teva's reslizumab MAA
By PBR Staff Writer
Teva Pharmaceutical Industries has successfully filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) seeking approval for reslizumab, a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb).
Regulatory Affairs > News
FDA grants breakthrough status for Progenics' Azedra to treat pheochromocytoma and paraganglioma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Progenics Pharmaceuticals' Azedra to treat patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma.
Regulatory Affairs > News
CHPA welcomes House introduction of DXM Abuse Prevention Act
By PBR Staff Writer
The Consumer Healthcare Products Association (CHPA) is pleased to lend its strong support for the DXM Abuse Prevention Act, introduced into the US House of Representatives by US Reps. Bill Johnson (R-OH) and Doris Matsui (D-CA).
Regulatory Affairs > News
Adapt Pharma submits NDA to FDA for Narcan nasal spray
Adapt Pharma Limited has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray, an investigational drug intended to treat opioid overdose.
Regulatory Affairs > News
FDA approves Amgen's Kyprolis for combination use to treat relapsed multiple myeloma
Amgen has announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Kyprolis (carfilzomib) for Injection in combination with Revlimid (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
Regulatory Affairs > News
Shire gets EMA Committee positive opinion for Intuniv to treat ADHD
Shire announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv (guanfacine hydrochloride extended release; GXR) for the treatment of attention deficit/hyperactivity disorder (ADHD) in children and adolescents.
Regulatory Affairs > News
Novartis' Odomzo skin cancer drug gets FDA approval
By PBR Staff Writer
Swiss pharmaceutical firm Novartis has received approval from the US Food and Drug Administration (FDA) for Odomzo (sonidegib, formerly LDE225) 200mg capsules to treat adult patients with locally advanced basal cell carcinoma (laBCC).
Regulatory Affairs > News
Health Canada approves Theravance's Vibativ for HAP/VAP caused by gram-positive bacteria
By PBR Staff Writer
Theravance Biopharma has received approval from Health Canada for Vibativ (telavancin) to treat adults with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (VAP).
Regulatory Affairs > News
Merck’s Keytruda gets European Commission approval to treat advanced melanoma
By PBR Staff Writer
The European Commission (EC) has approved Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), to treat advanced (unresectable or metastatic) melanoma in adults.
Regulatory Affairs > News
Genmab's partner Novartis submits sBLA to FDA for ofatumumab to treat relapsed CLL
By PBR Staff Writer
Danish biotechnology firm Genmab has announced the submission of a supplemental Biologics License Application (sBLA) to the US FDA to use its human monoclonal antibody ofatumumab (Arzerra) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL).
Regulatory Affairs > News
European Commission approves Amgen's Repatha to treat high cholesterol
Amgen announced that the European Commission (EC) has granted marketing authorization for Repatha (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.
Regulatory Affairs > News
Bristol-Myers gets FDA breakthrough therapy status for investigational HIV-1 attachment inhibitor
By PBR Staff Writer
Bristol-Myers Squibb has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents to treat HIV-1 infection in heavily treatment-experienced adult patients.
Regulatory Affairs > News

PBR Supplier Recommendations

Rentschler - High-Performance Biopharmaceutical Development and Manufacturing
Identifying the most appropriate contract manufacturer who can best fulfil what you need for your lead pharmaceutical candidate is a real challenge. With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing.... Regulatory Affairs > Suppliers
ERT - Getting it done. Right.
ERT is a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use by biopharmaceutical companies during clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.... Regulatory Affairs > Suppliers
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 Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... 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
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PBR White Paper Recommendations

Single-Use-Bioprocesses – Hype or Future Technology? By Rentschler
Single-use bioreactors offer many advantages for the manufacturing of biopharmaceuticals. They are used in approximately two thirds of all new bioprocesses in the biopharmaceutical market and have become indispensable in biopharmaceutical development and production processes. ... Regulatory Affairs > White Papers Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems By SHL Group
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.... Regulatory Affairs > White Papers Design-To-Build – Laboratory Handling Equipment By SHL Group
A leading high-end laboratory handling and diagnostics equipment manufacturing company devoted to helping scientists meet challenges regularly faced in the lab, approached SHL Technologies with a request to develop benchtop laboratory tube array handling equipment. This equipment had to be available in a modular set-up and capable of pick-and-place sorting, weight measurement, and barcode reading.... Regulatory Affairs > White Papers Complex Module Manufacturing – IC testing Devices By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers Specialised Project & Technology Transfer – Precision Neurosurgical Equipment By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers See more
1-15 of 3338 results