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1-15 of 50136 results
Genervon reports Phase IIa trial results of GM6 drug in ALS and PD
By PBR Staff Writer
Genervon Biopharmaceuticals has reported results from its two Phase IIa double blinded, randomized, placebo controlled clinical trials of its drug candidate GM6 in patients with Amyotrophic Lateral Sclerosis (ALS) and Parkinson’s disease (PD).
Contract Research & Services > Clinical Trials > News
Studying Low-Affinity Fragments of Ligands by ITC
| By Malvern Instruments
Molecular recognition is a fundamental prerequisite to all biological processes from enzymatic catalysis to signal transduction. The modern pharmaceutical industry is built upon the concept of selective intervention in such systems (1). Furthermore, similar concepts are being implemented, through supramolecular chemistry, to develop novel smart materials, components for nanotechnology and molecular electronics (2). If we are to harness the full potential of molecular recognition, it is essential that we understand the subtle interplay between structure and thermodynamics in complex formation.
White Papers
Pharmaceutical Excipient Characterisation
| By Malvern Instruments
The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product. These are generally identified through an assessment of the extent to which the variation in a specific attribute, for example particle size, can impact the drug product’s quality and performance.
White Papers
Differentiation and Characterisation of Subvisible Particulates in Therapeutic Protein Products
| By Malvern Instruments
The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life.
White Papers
Revealing Kinase Inhibitor Mechanisms: ITC Leads the Way
| By Malvern Instruments
The kinome of an organism is the set of protein kinases in its genome and these protein-modifying enzymes are potential targets in a number of therapeutic areas. Studies to characterise the human kinome, together with the explosion of available kinase crystal structures over recent years, have led to an increased focus on kinases as potential targets for pharmaceutical intervention.
White Papers
Ten Ways to…Optimise Rheology to Increase Dispersion/Colloidal/Emulsion Stability
| By Malvern Instruments
The following ten points highlight general methods of designing and interpreting rheological tests to optimise sample stability.
White Papers
Identification of Agglomerates Using Automated Image Analysis
| By Malvern Instruments
The identification of agglomerates is seen as a challenge across many different industries. Automated image analysis systems provide a means for the classification of agglomerates, by differentiating particles based on their morphological parameters. The inclusion of spectroscopic measurements alongside imaging (MDRS) aids in understanding the type of agglomeration occurring with the sample.
White Papers
New Accessories for the Mastersizer 3000 Support Smarter Pharmaceutical Particle Size Analysis
New 'third anniversary' accessories for the Mastersizer 3000 from Malvern Instruments reduce the time and cost of developing and validating robust methods for pharmaceutical particle size analysis. Correlations between particle size and bioavailability make particle size analysis a critical activity for the pharmaceutical industry.
Press Releases
SSB’s Production Facility Design for WuXi AppTec Receives Honorable Mention at the ISPE Facility of the Year Awards 2014
The WuXi AppTec bulk cell culture production facility designed by Sartorius Stedim Biotech (SSB), a leading international supplier of pharmaceutical and biotech equipment, received an honorable mention in the 2014 Facility of the Year Awards. The awards were presented by the International Society for Pharmaceutical Engineering (ISPE) at its Annual Meeting in Las Vegas last week.
Automation > Laboratory Instrumentation > Press Releases
Amicus Therapeutics reports positive phase III data from fabry monotherapy study 011
Amicus Therapeutics (FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has announced additional positive data from a Phase 3 study (Study 011) of the oral small molecule chaperone migalastat HCl ("migalastat") in Fabry disease patients with amenable mutations.
Contract Research & Services > Clinical Trials > News
EYLEA injection shows better gains in visual acuity than both bevacizumab and ranibizumab in NIH-sponsored DME study
Regeneron Pharmaceuticals, has announced that in the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network comparative effectiveness study in patients with Diabetic Macular Edema (Protocol T), EYLEA (aflibercept) Injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline at 52 weeks compared to both bevacizumab (Avastin/Genentech) and ranibizumab injection (Lucentis/Genentech), the primary endpoint of the study.
Drug Research > Drug Discovery & Development > News
GSK update on current development status of the GSK/NIH Ebola vaccine candidate
With the Ebola crisis in West Africa continuing, GSK is working closely with the World Health Organization (WHO), regulators and other partners to respond to the outbreak, to accelerate development of our investigational Ebola vaccine and to ramp up production as quickly as possible.
Drug Research > Drug Discovery & Development > News
Amgen files Lawsuit against Sanofi and Regeneron for patent infringement
By PBR Staff Writer
Amgen announced that it filed a lawsuit in the United States (US) District Court of Delaware against Sanofi, Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals for patent infringement of US Patent Numbers 8,563,698, 8,829,165, and 8,859,741.
Production & Manufacturing > Process & Production > News
Sponsor and CRO Pharmacovigilance Alliances
| By PRA Health Sciences
Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. In the past, outsourced safety services were limited due to concerns about confidentiality, data security and liability in cases of regulatory non-compliance, which are all still important considerations today.
Contract Research & Services > Contract Research > White Papers
China Biologic gets approval to manufacture human prothrombin complex concentrate at Shandong Taibang facility
China Biologic Products, a leading fully integrated plasma-based biopharmaceutical company in China, announced that the company has received approval from the China Food and Drug Administration for commercial manufacturing of human prothrombin complex concentrate at its Shandong Taibang facility.
Production & Manufacturing > Manufacturing > News

PBR Supplier Recommendations

Mexichem Fluor - Pure Quality
Mexichem Fluor is the world leader in medical propellants and we have many years of experience operating to the highest current Good Manufacturing Practice (cGMP) standards. Our detailed understanding of the needs, standards and regulatory requirements of the pharmaceutical sector, coupled with our expertise in fluorine chemistry, makes us unique in our industry.... Production & Manufacturing > Fine & Speciality Chemicals > 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
FeF Chemicals - Insulin Human and Benzalkonium Chloride Products
FeF Chemicals is a Novo Nordisk company that specialises in the supply of ingredients for the biopharmaceutical and pharmaceutical industries, such as insulin human for cell culture media and cGMP manufactured quaternary ammonium compounds (usually referred to as quats) such as benzalkonium chloride, cetrimide and cetrimonium bromide.... Production & Manufacturing > Manufacturing > Suppliers
Fujifilm Diosynth Biotechnologies - Biopharmaceutical Process Development and Manufacturing Services
We are one of the world’s leading suppliers of contract process development and manufacturing services for the biopharmaceutical industry. Created in April 2011, Fujifilm Diosynth Biotechnologies has more than 900 employees, operating from two sites in Billingham, UK, and the Research Triangle Park in North Carolina, US.... Production & Manufacturing > Manufacturing > Suppliers
IDDI - eClinical and Biostatistical Services for Phase I to IV Clinical Trials
Established for more than 23 years, International Drug Development Institute (IDDI), has grown thanks to its niche positioning as a major service provider in the trial design and collection, analysis and reporting of clinical research data. IDDI combines expert methodology in biostatistics with innovative integrated technology (eClinical suite of made-to-measure secure web systems: IWRS and web coding integrated to EDC) to optimise the design and conduct of clinical trials. ... Suppliers
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PBR White Paper Recommendations

Studying Low-Affinity Fragments of Ligands by ITC By Malvern Instruments
Molecular recognition is a fundamental prerequisite to all biological processes from enzymatic catalysis to signal transduction. The modern pharmaceutical industry is built upon the concept of selective intervention in such systems (1). Furthermore, similar concepts are being implemented, through supramolecular chemistry, to develop novel smart materials, components for nanotechnology and molecular electronics (2). If we are to harness the full potential of molecular recognition, it is essential that we understand the subtle interplay between structure and thermodynamics in complex formation.... White Papers Pharmaceutical Excipient Characterisation By Malvern Instruments
The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product. These are generally identified through an assessment of the extent to which the variation in a specific attribute, for example particle size, can impact the drug product’s quality and performance.... White Papers Differentiation and Characterisation of Subvisible Particulates in Therapeutic Protein Products By Malvern Instruments
The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life.... White Papers Revealing Kinase Inhibitor Mechanisms: ITC Leads the Way By Malvern Instruments
The kinome of an organism is the set of protein kinases in its genome and these protein-modifying enzymes are potential targets in a number of therapeutic areas. Studies to characterise the human kinome, together with the explosion of available kinase crystal structures over recent years, have led to an increased focus on kinases as potential targets for pharmaceutical intervention.... White Papers Ten Ways to…Optimise Rheology to Increase Dispersion/Colloidal/Emulsion Stability By Malvern Instruments
The following ten points highlight general methods of designing and interpreting rheological tests to optimise sample stability.... White Papers See more
1-15 of 50136 results