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1-15 of 55481 results
Arix Bioscience buys stake in Mitoconix Bio
Healthcare and life science firm Arix Bioscience has acquired a stake in Mitoconix Bio as part of an oversubscribed $20m Series A financing round.
Drug Research > Drug Discovery & Development > News
Pfizer breaks ground on new R&D facility in Missouri
Pfizer has broke ground on a research and development (R&D) and process development facility at 875 W. Chesterfield Parkway, Chesterfield in the US state of Missouri.
Production & Manufacturing > Manufacturing > News
Novartis’ etanercept biosimilar approved in Europe to treat inflammatory diseases
By PBR Staff Writer
The European Commission (EC) has approved Novartis’ Erelzi, the biosimilar of Amgen and Pfizer’s Enbrel (etanercept), for the treatment of multiple inflammatory diseases.
Regulatory Affairs > News
Sanofi, Regeneron secure EC approval for Kevzara to treat rheumatoid arthritis
By PBR Staff Writer
Sanofi and Regeneron Pharmaceuticals have secured approval from the European Commission (EC) for Kevzara (sarilumab) in combination with methotrexate (MTX) to treat adult patients with moderately to severely active rheumatoid arthritis (RA) in adult patients.
Regulatory Affairs > News
GPC/SEC analysis of polymer branching
Using triple detection GPC/SEC to understand branching in polymers
Concentration limits for zeta potential measurements in the Zetasizer Nano
Explains the concentration limits for successful zeta potential measurements to be made. A case study is used to illustrate the limits of concentration and describes what happens to the quality of data if the sample concentration is inappropriate.
The power of multi-detector SEC in the analysis of antibodies
How OMNISEC can measure antibody absolute MW independent of size and structural changes.
Setting a benchmark: Using rheology to define the performance of personal care products
Products, quality is often defined by a range of functional and sensory attributes, some of which may be easily measured - such as color - and others which may not. Visual or textural appearance and ease of application exemplify properties in this second category. Ultimately these attributes are assessed subjectively via user feedback, but relying on such information to guide formulation is somewhat impractical, particularly in the early stages of product development. Metrics that reliably correlate with product performance are therefore essential.
Press Releases
Using Taylor Dispersion Analysis to determine oligomeric state of insulin
Taylor dispersion analysis is an emerging biophysical characterization technique that offers unique benefits in the early stages of biopharmaceutical development – providing answers that established techniques cannot effectively handle.
Press Releases
bluebird unveils topline interim data from Starbeam study of Lenti-D in CALD
bluebird bio has released topline interim data from the initial cohort of 17 patients in the ongoing Phase 2/3 Starbeam Study (ALD-102) evaluating its investigational gene therapy Lenti-D in under-18 boys with cerebral adrenoleukodystrophy (CALD).
Contract Research & Services > Clinical Trials > News
FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Roche's emicizumab shows substantial reduction in bleeds in phase III studies
By PBR Staff Writer
Roche’s haemophilia A drug emicizumab has showed a significant effect in the phase III Haven 1 and Haven 2 studies.
Contract Research & Services > Clinical Trials > News
European Medicines Agency recommends approval of Humira biosimilar Imraldi
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis' Imraldi for approval, which is a biosimilar candidate referencing Humira (adalimumab).
Regulatory Affairs > News
Woodley Equipment Attending Outsourcing in Clinical Trials UK & Ireland 2017
Woodley Equipment is attending Outsourcing in Clinical Trials UK and Ireland Conference taking place at the Royal Garden Hotel, London on 28th & 29th June 2017.
Contract Research & Services > Clinical Trials > Press Releases

PBR Supplier Recommendations

Patient Focused Medicines Development (PFMD)
Patients Focused Medicine Development (PFMD) is an open, global and collaborative coalition of patient organisations and advocates, pharma and life sciences industry, HTA bodies, national advisory organisations and regulators. Their aim is to drive meaningful patient engagement by co-creating a standardised and globally adopted framework for patient engagement, so that patients' needs and priorities are at the core of medicines development and lifecycle. PFMD was established in 2015 and currently counts 24 members. Their 'Pledge to Patients' campaign encourages members of the medical community to commit to measurable actions to improve patient engagement.... Drug Research > Drug Delivery > Suppliers
Haselmeier - Self-Injection Devices
Haselmeier is a leading developer and manufacturer of innovative self-injection devices featuring proprietary designs, technology and intellectual property. With over four decades of medical device experience, Haselmeier has built up a world class Design and Development Team – working in compliance with regulatory requirements – for the creation, design and industrialization of our innovative self-injection systems used by pharmaceutical and biotechnology companies worldwide. ... Suppliers
CTL Laboratories - Contract Immune Monitoring and Research
Cellular Technology Limited (CTL), headquartered in Shaker Heights, OH, is a privately held biotechnology company that built its reputation as the global leader in the ELISPOT field over the past two decades by establishing the ELISPOT instrumentation and scientific principles that have helped to define the parameters of ELISPOT research for monitoring of Cell-Mediated Immunity.... Contract Research & Services > Clinical Trials > Suppliers
WeylChem Group of Companies. Better chemistry – achieving more.
WeylChem Group of Companies (WCGC) was established in 2005 as the Fine Chemicals platform of International Chemical Investors Group (ICIG), a privately owned industrial holding company. We are a specialised service provider to the agrochemical, pharmaceutical, polymer and specialty chemicals industries, offering custom-, toll-manufacturing 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
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PBR White Paper Recommendations

NSF asks why Annex 1 is Important to you By NSF Health Sciences Pharma Biotech PBR
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.... White Papers Heightened FDA Enforcement for Sterility Issuesin Pharma Biotech with NSF By NSF Health Sciences Pharma Biotech PBR
NSF analysed all of the warning letters issued to pharma and biologic manufacturers for sterility issues since 2015. This white paper provides detailed insight into our analysis. It includes relative charts and a table with a summary of the regulations cited by the FDA as well as recommendations for closing your compliance gaps. ... White Papers NSF: Essential Rules When Investigating GMP Deviations During Sterile Processing By NSF Health Sciences Pharma Biotech PBR
This white paper by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating pharmaceutical GMP deviations or deficiencies in sterile processing.... White Papers NSF Explains the Points to Consider when Auditing a Terminally Sterilised Drug Product By NSF Health Sciences Pharma Biotech PBR
When conducting an audit of the terminally sterilized pharmaceutical product process, the essential checklist outlined in this white paper by Maxine Fritz will help. ... White Papers SYSTAG: The use of FlexyPAT-HFC for calorimetric measurements By SYSTAG
FlexyPAT is a modular Process Automation Technology that enables automated customer-specific lab reactor systems to be implemented in a very cost-effective manner, including with the integration of existing devices.... Automation > Laboratory Instrumentation > White Papers See more
1-15 of 55481 results