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FDA grants priority review to Pfizer's antibody-drug conjugate for ALL
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a priority review designation to Pfizer's anti-CD22 antibody-drug conjugate inotuzumab ozogamicin to treat patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
hVIVO says US body begins trial on malaria and Zika vaccine
Biopharmaceutical firm hVIVO PLC on Tuesday said the US National Institute of Health has initiated a phase one clinical trial of AGS-v, an investigational vaccine for mosquito-borne diseases like malaria and Zika.
Contract Research & Services > Clinical Trials > News
Abzena signs antibody manufacturing development deal with University College London
Abzena has entered into a manufacturing agreement with University College London (UCL).
Production & Manufacturing > Manufacturing > News
European Commission conditionally approves Roche’s cancer drug Alecensa
By PBR Staff Writer
Roche's oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were earlier treated with crizotinib.
Regulatory Affairs > News
Haselmeier Introduces the Award-Winning D-Flex. Just one.
The especially flexible disposable pen D-Flex has been given the GOOD DESIGN™ Award. However, the D-Flex stands out in the market primarily thanks to its uniqueness. No comparable product can be deployed so flexibly and at the same time deliver patient safety.
Press Releases
Haselmeier AG Appoints Paul Jansen as Senior Advisor and Member of the Board of Directors
Haselmeier, a leader in the development and manufacturing of drug delivery devices is pleased to announce the appointment of Paul Jansen as Senior Advisor and Member of the Board of Directors of Haselmeier AG. This appointment is a perfect fit to serve the objectives of Haselmeier AG as the innovation organization within the Haselmeier Group.
Press Releases
MicroCal PEAQ-DSC Brochure by Malvern Instruments
Biomolecular stability analysis for the regulated environment
Malvern Instruments' MicroCal PEAQ-DSC Manual
Gold standard protein stability analysis for research applications
MicroCal PEAQ-DSC Automated by Malvern Instruments
Gold standard protein stability analysis for the regulated environment
Chi-Med starts phase II study of savolitinib in pulmonary sarcomatoid carcinoma
Hutchison China MediTech has commenced a phase 2 study of savolitinib in locally advanced or metastatic pulmonary sarcomatoid carcinoma (PSC) in China.
Contract Research & Services > Clinical Trials > News
Modus Therapeutics raises £2.9m to support further development of sevuparin for SCD
Modus Therapeutics has raised SEK32m (£2.9m) from existing investors KDev Investments, Östersjöstiftelsen and Praktikerinvest to support a phase two study of a sickle cell disease (SCD) drug.
Drug Research > Drug Discovery & Development > News
Faron Pharmaceuticals recruits first patient for new Traumakine trial
By PBR Staff Writer
Faron Pharmaceuticals has recruited its first patient to a phase II clinical trial of its lead drug, Traumakine, in the treatment of organ failure after a ruptured abdominal aorta aneurysm (RAAA).
Contract Research & Services > Clinical Trials > News
MicroCal PEAQ-DSC Range from Malvern Instruments
Gold standard protein stability analysis for the regulated environment
Arix Bioscience raises £100m in IPO
Global healthcare and life science company Arix Bioscience has raised £100m in its Initial Public Offering (IPO) on the main market of the London Stock Exchange.
Production & Manufacturing > Manufacturing > News
Momenta announces FDA warning letter to contracted Glatopa’s fill/finish manufacturer
Momenta Pharmaceuticals has announced that Pfizer, Sandoz’s contracted Glatopa (glatiramer acetate injection) fill/finish manufacturing partner has received a warning letter from the FDA.
Production & Manufacturing > Process & Production > News

PBR Supplier Recommendations

NSF Health Sciences Pharma Biotech
NSF International’s pharma biotech services 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
Biovian - cGMP Contract Manufacturing of Biopharmaceuticals
Biovian is a dynamic and effective new generation one-stop-shop CMO in cGMP contract manufacturing of biopharmaceuticals. Biovian's services cover the full range from antigen isolation, expression, vector construction, cell line cultivation, cGMP protein purification to product fill and finish.... Suppliers
MSP Kofel – Analytical Accessories and Software Specialists
MSP Kofel provides analytical scientists with software and databases for interpretation, confirmation and archival of spectra, chromatographic data, structures and chemical compound information.... Suppliers
Sanofi CEPiA - Suppliers of APIs, Custom Synthesis and Pharmaceutical Contract Manufacturing
CEPiA (Commercial & External Partnership, Industrial Affairs) is an organization fully dedicated to third-party activities within the industrial affairs of Sanofi. ... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
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PBR White Paper Recommendations

Malvern Instruments Discusses GPC/SEC Analysis of Polymer Solutions Used in Inkjet Printing By Malvern Instruments
Inkjet printing of polymer solutions is an area of interest for depositing precise, high-throughput patterns of functional polymer. The applications of the polymer patterns include OLEDs, organic circuits, and textiles. The efficacy of this printed pattern can be negatively impacted by the concentration and viscosity of the polymer solution, the molecular weight and molecular weight distribution of the polymer, and level of branching in the polymer. Therefore, it is of keen interest to understand the effect of inkjet printing on the degradation of polymers. In this application note, the molecular weight (MW) and molecular weight distribution (MWD) of various polymers is shown as a function of time during inkjet printing. The data shown in this application note is from references [1-2].... White Papers Malvern Instruments: Gold Nanoparticle Applications and Characterization by Nanoparticle Tracking Analysis By Malvern Instruments
This work is a review of nanoparticle size and concentration analysis in gold colloid applications. Gold nanoparticles are one of the most popular and extensively researched type of nanoparticle. A Google Scholar search of the term "gold nanoparticles" results in over 500,000 hits. Applications range from the biological to the material, and include nanomedicine, drug delivery, cancer diagnostics, biological scaffolds, biosensors, contrast agents, catalysts, and CMP slurries for the manufacturing of microprocessor [1].... White Papers Malvern Instruments compares metal powders from different atomization processes using automated image analysis By Malvern Instruments
Image analysis is an ideal tool for characterizing the size and shape distributions of atomized metal powders. The manufacture of complex shaped metal parts by Metal Injection Molding (MIM) is a growing industry. The shape and size of metal powders play an important role in determining process efficiency and properties of the final MIM components. Spherical powder particles are typically favored by MIM manufacturers looking to achieve best tolerances and properties in final components. Therefore, it is important to monitor atomized powder to ensure that particles of the desired shape and size are produced.... White Papers Malvern Instruments Explores Nanobubble Applications and Characterization By Malvern Instruments
Malvern Instruments conducts an in depth review of ultra-fine bubble (nanobubble) applications and characterization examples. The generation, measurement, and applied technologies of so-called nanobubbles or ultra-fine bubbles, with diameter ranging from tens to hundreds of nanometers, are evolving dramatically in recent years. The unique properties of nanobubbles makes them attractive for a number of applications such as facility cleaning, food disinfection, and water treatment, as well as possibilities in fields such as disinfecting food products, pharmaceutical delivery, decontamination, and manufacturing of functional materials. Preliminary market research conducted by the Fine Bubble Industries Association shows the size of the fine bubble business increasing from USD 20 million in 2010 to USD 4.3 billion in 2020.... White Papers Synergy of Complementary Nanomaterial Characterization Techniques: NTA+DLS By Malvern Instruments
Dynamic Light Scattering (DLS) is a mature and proven technology for nanomaterial characterization. Nanoparticle Tracking Analysis (NTA) is a more recent addition to the spectrum of particle characterization techniques and has many similarities to DLS, leading to some confusion as to their relative capabilities. The broad range of measurement capabilities for each technique is complementary in nature, providing a wealth of valuable information. The differences between the two techniques allow the data from one technology to validate and support the other. ... White Papers See more
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