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FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
Regulatory Affairs > News
Neurocrine’s Ingrezza fails in phase II Tourette syndrome study
Neurocrine Biosciences said that the initial phase II Tourette syndrome T-Force GREEN study of INGREZZA (valbenazine), a small molecule VMAT2 inhibitor, did not meet its primary endpoint.
Contract Research & Services > Clinical Trials > News
Debiopharm acquires ImmunoGen’s ADC IMGN529/Debio 1562
Debiopharm International has acquired ImmunoGen's IMGN529/Debio 1562, a clinical-stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphomas (NHL).
Contract Research & Services > Contract Services > News
Inovio’s HIV vaccine succeeds in early stage trial
Inovio Pharmaceuticals' Pennvax-GP HIV vaccine has demonstrated nearly 100% immune response rates in a clinical study.
Contract Research & Services > Clinical Trials > News
FDA approves Merck’s Keytruda for cancer patients with certain biomarkers
The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
Regulatory Affairs > News
UK’s CMA accuses Merck of breaching competition law
The UK’s Competition and Markets Authority (CMA) has issued a statement of objections to pharmaceutical firm Merck Sharp & Dohme Limited (MSD).
Regulatory Affairs > News
NSF International's Pharma Biotech Must-Have App
NSF International, a leading provider of support services for the pharmaceutical industry, providing consulting, training, auditing, testing, remediation, quality systems and regulatory guidance on a global basis, is pleased to announce the launch of its new pharma biotech app.
Press Releases
NSF Regulatory Radar: 21st Century Cures Act, Promoting Innovation
The Cures Act aims to promote Drug Development Tools and Continuous Manufacturing innovations to speed up and enhance the development process of new therapeutics and reduce the failure rate by formalizing them within the regulatory framework.
Press Releases
Novo Nordisk Pharmatech enters important distribution agreement with Azelis for pharmaceutical grade quaternary ammonium compounds
Novo Nordisk Pharmatech A/S has entered into an agreement with Azelis for the distribution of pharmaceutical grade quaternary ammonium compounds (quats) to the pharmaceutical and medical device markets in Germany, Spain Portugal, UK and Ireland.
Production & Manufacturing > Manufacturing > Press Releases
Genentech’s Actemra approved by FDA for giant cell arteritis treatment
Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.
Regulatory Affairs > News
Nektar, Takeda to explore combination cancer therapy approaches
Nektar Therapeutics and Takeda Pharmaceutical have entered into a research collaboration to explore the combination of the former’s lead immuno-oncology candidate, the CD122-biased agonist NKTR-214, with five oncology compounds from the cancer portfolio of Takeda.
Drug Research > Drug Discovery & Development > News
Recordati to buy AstraZeneca’s European beta-blocker treatments for $300m
By PBR Staff Writer
Italian pharmaceutical firm Recordati has agreed to acquire AstraZeneca’s metoprolol-based treatments in Europe for around $300m.
News
Food Safety and Quality: Sizing Up Particles
Particle size analysis is important in many industries. Knowledge of particle size is important in the food industry because it affects the production and handling of ingredients and the formulation, processing, and quality control of food and beverage products. Particle size affects reactivity, solubility, and flowability of ingredients and the texture, mouthfeel, and processing of products.
Press Releases
Particle size analysis of cement using the technique of laser diffraction
The critical strength and curing properties of cement are dependent on the particle size distribution of the cement components. This note describes how laser diffraction can be used as a routine method for cement particle size analysis.

PBR Supplier Recommendations

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 - We Live Know-How
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
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
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PBR White Paper Recommendations

Top tips for avoiding particle sizing failures with your laser diffraction method By Malvern Instruments
Particle size defines the performance of a wide range of different products, including cement, paints, inks, metal powders, cosmetics, foods and drinks. Measuring relevant particle size data is therefore essential in many industries, with laser diffraction usually the technique of choice. Fast, highly automated and suitable for measurement across a broad size range, 0.01 to 3500 microns, modern laser diffraction systems have reduced particle sizing to a matter of sample loading and push button operation, providing that a suitable method is in place.... White Papers Analytical characterisation of mouthfeel in chocolate By Malvern Instruments
The particle size and rheology of the chocolate are critical factors in determining and predicting mouthfeel.... White Papers Biophysical application of calorimetric methods to protein misfolding and aggregation examinations By Malvern Instruments
Unfolded proteins fold into thermodynamically-favorable native structures under the correct physiological conditions for gain of function (Figure 1) [1-4]. The burial of hydrophobic regions in a protein's interior, along with the exposure of hydrophilic residues to aqueous solutions stabilizes native structures and ensures solubility. Active native proteins perform their biological functions through highly regulated intermolecular interactions with their binding partners, under thermodynamic control.... White Papers Sanofi CEPiA Product List By Sanofi CEPiA Production & Manufacturing > Fine & Speciality Chemicals > White Papers Softigel introduces new energy gummies at vitafoods By Softigel pbr
Who hasn´t needed a wake-me-up in the morning or hasn´t dragged a tired body to the end of the day? Regardless how we individually spend our day, the intensity of our routine, the sports practice or the stressful of our labor; the common consequence is the high demand and lack of energy.... Drug Research > Drug Discovery & Development > White Papers See more
1-15 of 55381 results