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Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases
Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.
Regulatory Affairs > News
BioLineRx acquires UK cancer immunotherapeutics company Agalimmune
Clinical-stage biopharmaceutical firm BioLineRx has purchased Agalimmune, a private UK-based company with an anti-cancer immunotherapy platform.
Drug Research > Drug Discovery & Development > News
Merck, Pfizer get FDA nod for Bavencio to treat metastatic Merkel cell carcinoma
By PBR Staff Writer
Merck’s EMD Serono and Pfizer have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) injection 20 mg/mL to treat metastatic Merkel cell carcinoma (mMCC).
Regulatory Affairs > News
WeylChem Group - We Live Know-How
The WeylChem group of companies is an international fine chemicals group, part of International Chemical Investors Group, ICIG. The WeylChem group is a specialised service provider to the agrochemical, pharmaceutical, polymer and specialty chemicals industries, offering custom-, toll-manufacturing and processing services as well as advanced intermediates, reagents and performance products.
Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
NSF: What Does Your Company QMS Look Like? Where Does Senior Management Fit In?
NSF was asked by top management to review the range and extent of GxP quality systems in place and make recommendations for a single company-wide QMS suitable for its modern business model and meeting all anticipated regulatory requirements.
NSF: Does Your Pharmaceutical Quality System Improve Your Competitive Edge?
There are some companies who believe that their Pharmaceutical Quality System (PQS) exists purely for regulatory compliance. We think this attitude is outdated and plainly wrong. At NSF, we believe that your PQS has only one purpose: to improve your competitive edge by guaranteeing the manufacture of high quality medicines at the lowest possible cost. We have worked in partnership with many of our clients to help them improve their PQS and their competitive edge. The following results give you a flavor of what can be achieved and how.
Tech Talk: CHANGING GMP BEHAVIORS with NSF
| By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
White Papers
Biogen wins patent ruling in multiple sclerosis drug case
By PBR Staff Writer
Biogen has won an intellectual property rights ruling over its multiple sclerosis (MS) drug candidate, Tecfidera following a favorable decision from the US Patent and Trademark Office's Patent Trial and Appeal Board.
News
Akashi gets FDA nod to restart clinical development of DMD drug HT-100
Akashi Therapeutics has secured approval from the US Food and Drug Administration (FDA) to resume clinical development of HT-100 (delayed-release halofuginone) in patients with any of the genetic mutations that cause Duchenne muscular dystrophy (DMD).
Contract Research & Services > Clinical Trials > News
GSK, Regeneron to mine gene data from 500000 volunteer participants in UK
Regeneron Pharmaceuticals announced a major research initiative among the Regeneron Genetics Center (RGC), U.K. Biobank and GSK to generate genetic sequence data from the 500,000 volunteer participants in the U.K. Biobank resource.
Drug Research > Drug Discovery & Development > News
Novartis’ serelaxin fails to meet primary endpoint in heart failure study
By PBR Staff Writer
Novartis' RLX030 (serelaxin) has failed to meet its primary endpoint in a phase III acute heart failure (AHF) study.
Contract Research & Services > Clinical Trials > News

PBR Supplier Recommendations

WeylChem Group - We Live Know-How
The WeylChem group of companies is an international fine chemicals group, part of International Chemical Investors Group, ICIG. The WeylChem group is a specialised service provider to the agrochemical, pharmaceutical, polymer and specialty chemicals industries, offering custom-, toll-manufacturing and processing services as well as advanced intermediates, reagents and performance products.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
SHL Healthcare - Developer and Manufacturer for Equipment Solutions
SHL Healthcare develops and manufactures equipment solutions for home, hospital and long-term care use with a focus on patient comfort and functionality. Our broad range of products include medical slings, rehabilitation beds, pressure mattress systems, lifting equipment, medical soft goods and a variety of related accessories. ... 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
NSF Health Sciences Pharma Biotech
NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis. ... Suppliers
CRFweb... from Clindox, Suppliers of Clinical Trial Software
CRFweb is the groundbreaking eCRF application brought to you by Clindox. It sets new standards in web-based, clinical trial software. The combination of a comprehensive feature set, incredibly quick set-up time, simplicity of use and flexible pricing means no trial is too large or too small to be practical. The whole process is genuinely DIY, allowing trial managers to really take control of their trial. ... Contract Research & Services > Clinical Trials > Suppliers
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PBR White Paper Recommendations

Tech Talk: CHANGING GMP BEHAVIORS with NSF By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.... White Papers FlexyCUBE Product Catalog By SYSTAG
SYSTAG - Your Partner in Chemical Development... Automation > Laboratory Instrumentation > White Papers Malvern Instruments: Characterization of Biopharmaceutical Stability with Differential Scanning Calorimetry By Malvern Instruments
Biosimilarity and batch-to-batch comparability. ... White Papers Malvern Instruments: Exploring the impact of particle characteristics on suspension rheology By Malvern Instruments
How particle size, shape and zeta potential influence suspension rheology. Many products are suspensions or dispersions of particles in a liquid medium. Examples range from adhesives, ceramics, paints and inks through to foods, drinks, personal care products and medicines. The physical properties of the dispersed particles in such systems, including particle size, particle size distribution, concentration, electric charge (zeta potential), and even particle shape, can all strongly influence the overall (bulk) rheological properties of a suspension, thereby defining product behavior and functionality. Understanding these interactions is crucial when it comes to achieving desirable product performance, whether it be a stable paint or medicine, workable cement, or a visually appealing shower gel or drink. This white paper examines the impact of particle properties on suspension viscosity, and more broadly on rheological behavior. It looks in some detail at how particle size, shape and zeta potential influence critical aspects of suspension performance such as viscosity and stability and how these properties can be manipulated to tailor this behavior.... White Papers The new MicroCal PEAQ-DSC Automated System By Malvern Instruments
Eight reasons to upgrade from the MicroCal VP-Capillary DSC system. Use of Differential Scanning Calorimetry (DSC) in biopharmaceutical development. Differential scanning calorimetry (DSC) is an established biophysical tool for protein stability characterization during biopharmaceutical drug development. DSC data are used to advance the most stable and 'developable' proteins into the pipeline, and optimize the process and formulation conditions to maintain protein stability during manufacturing and storage.... White Papers See more
1-15 of 55220 results