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Accutest, Fox Chase Cancer Center partner on clinical trials for oncology
Accutest Research Laboratories has formed a strategic partnership with Fox Chase Cancer Center - Temple Health for joint work on clinical trials.
Contract Research & Services > Clinical Trials > News
Children’s cancer death rates drop by 24% in last decade
The rate of children dying from cancer has dropped by 24% in the last decade, according to new figures published by Cancer Research UK.
Contract Research & Services > Contract Research > News
Solasia, Lee’s Pharma sign license agreement for Sancuso
Solasia Pharma and Lee’s Pharmaceutical Holdings have entered into an exclusive license agreement for the commercialization and promotion of Sancuso (granisetron transdermal delivery system) in the People’s Republic of China (the PRC) excluding Taiwan, Hong Kong, Macau and the Retained Territory.
Contract Research & Services > Contract Services > News
Lightpoint Medical receives grant to carry out breast cancer clinical trial
Lightpoint Medical has received a €2.4m grant from the European Commission as part of the Horizon 2020 European Union Framework Programme for Research and Innovation, enabling the company to carry out a large-scale clinical trial in breast cancer.
Contract Research & Services > Clinical Trials > News
hVIVO raises £20.5m to support portfolio development
By PBR Staff Writer
Life sciences firm hVIVO has conditionally raised £20.5m to support its development portfolio.
Drug Research > Drug Discovery & Development > News
EC approves Boehringer Ingelheim’s Praxbind anticoagulant reversal agent
By PBR Staff Writer
The European Commission (EC) has approved Boehringer Ingelheim’s Praxbind (idarucizumab) for the specific reversal of Pradaxa (dabigatran etexilate).
Regulatory Affairs > News
Sinclair IS Pharma to sell non-aesthetics business to Alliance Pharma
Sinclair IS Pharma has agreed to sell its non-aesthetics business to Alliance Pharma for £132m.
Production & Manufacturing > OTC > News
FDA approves Seqirus' Fluad for adults aged 65 years and older against seasonal influenza
The US Food and Drug Administration (FDA) has approved Seqirus' Fluad (Influenza Vaccine, Adjuvanted) to help protect those aged 65 years and older against seasonal influenza.
Regulatory Affairs > News
AAIPharma/Cambridge Major Laboratories to invest $15m for laboratories expansion
AAIPharma Services Corp./Cambridge Major Laboratories announced the planned investment of at least $15.8m to expand its laboratories and global headquarters in Wilmington, NC.
Production & Manufacturing > Manufacturing > News
Impax wins European approval for NUMIENT to treat Parkinson's Disease
Impax Laboratories announced that the European Commission (EC) has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease.
Drug Research > Drug Delivery > News
Amgen submits BLA to FDA for ABP 501
Amgen has submitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for ABP 501, a biosimilar candidate to Humira (adalimumab).
Production & Manufacturing > Process & Production > News
EC approves Cotellic/Zelboraf combination to treat advanced melanoma
By PBR Staff Writer
The European Commission (EC) has approved Roche's Cotellic (cobimetinib) for use in combination with Zelboraf (vemurafenib) to treat adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Production & Manufacturing > Process & Production > News
Teva signs licensing deal with Heptares Therapeutics for migraine treatments
By PBR Staff Writer
Teva Pharmaceutical Industries has signed a licensing and drug-discovery agreement to develop novel, small-molecule calcitonin gene-related peptide (CGRP) antagonists discovered by Heptares Therapeutics to treat migraine.
Drug Research > Drug Discovery & Development > News
EC approves expanded label for Pfizer's Xalkori NSCLC drug
By PBR Staff Writer
The European Commission has approved the use of Pfizer's Xalkori (crizotinib) as first-line treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
GSK begins dosing in phase III study of sirukumab for treatment of giant cell arteritis
By PBR Staff Writer
GSK has started dosing in a phase III randomized, double-blind, placebo-controlled study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, to treat giant cell arteritis (GCA).
Contract Research & Services > Clinical Trials > News

PBR Supplier Recommendations

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
New England Biolabs, Inc. - Advanced Resources for Drug Discovery & Development
The past two decades has seen a dramatic rise in the number of protein-based pharmaceuticals (“biologics”) and companion diagnostics. These important areas of clinical and pharmaceutical science are becoming more reliant than ever on cutting edge molecular biology tools and techniques.... Suppliers
Cytec Industries - Premier Supplier of Sulfosuccinate and Specialty Surfactant Technology
Cytec Specialty Additives is a part of Cytec Industries, a multinational specialty materials and chemicals company. Cytec’s focus on innovation, advanced technology and application expertise enables the development, manufacture and supply of technologies that change the way our customers do business and enable them to offer innovative solutions to the industries that they serve. ... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
Lohmann Therapy System (LTS) - Transdermal Therapeutic Systems and Oral Thin Films
LTS is the market leader in alternative drug delivery systems, in the form of transdermal therapeutic systems and oral thin films. We develop and manufacture drug delivery systems that offer patients reliable therapeutic efficacy with total comfort and convenience.... Drug Research > Drug Delivery > Suppliers
Vaisala - Supplier of Continuous Monitoring Systems for Controlled Life Science Environments
Vaisala is a world leader in environmental and industrial measurement systems and instrumentation. We offer measurement instrumentation, continuous monitoring systems and validation systems to measure and supervise environmental conditions, within regulated or controlled life science environments.... Contract Research & Services > Clinical Trials > Suppliers
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PBR White Paper Recommendations

Minding your Caps and Tails – Considerations for Functional mRNA Synthesis By New England Biolabs
Applications of synthetic mRNA have grown and become considerably diversified in recent years. Examples include the generation of pluripotent stem cells (1-3), vaccines and therapeutics (4), and CRISPR/Cas9 genome editing applications (5-7). The basic requirements for a functional mRNA - a 7-methylguanylate cap at the 5´ end and a poly(A) tail at the 3´ end - must be added in order to obtain efficient translation by eukaryotic cells. Additional considerations can include the incorporation of modified bases, modified cap structures and polyadenylation strategies. Strategies for in vitro synthesis of mRNA may also vary according to the desired scale of synthesis. This article discusses options for selection of reagents and the extent to which it influences synthesized mRNA functionality.... White Papers The Benefits of Real-Time Analysis for Process Development By Malvern Instruments
While much effort is expended in optimizing commercially operating plant, getting the process 'right first time' can be far more efficient. Real-time analysis of process parameters provides substantial support during development, streamlining and accelerating the evolution of successful process designs. Taking on-line particle size analysis as an example, this paper considers the rationale for investing in real-time measurement for pilot scale work. Case studies illustrate the various ways in which on-line systems promote efficient process development, easing the transition into profitable manufacture.... White Papers Understanding Yield Stress Measurements By Malvern Instruments
Many complex fluids, such as network forming polymers, surfactant mesophases, emulsions etc do not flow until the applied stress exceeds a certain critical value, known as the yield stress. Materials exhibiting this behavior are said to be exhibiting yield flow behavior. The yield stress is therefore defined as the stress that must be applied to the sample before it starts to flow. Below the yield stress the sample will deform elastically (like stretching a spring), above the yield stress the sample will flow like a liquid.... White Papers Towards a Unified Biophysical Characterization Platform: Combining Dynamic Light Scattering and Raman Spectroscopy to Determine Protein Structure and Stability By Malvern Instruments
The combination of dynamic light scattering (DLS) with Raman spectroscopy has the capability to characterize a wealth of chemical, structural, and physical parameters of therapeutic proteins. Raman spectroscopy simultaneously derives protein secondary structure markers (amide I and III) and tertiary structure markers (aromatic side chains, disulfide bond, hydrogen bonding, local hydrophobicity). These markers can be monitored under controlled conditions by the determination of spectral peak position, shape, and/or intensity. Raman is able to make these structural determinations at formulation concentrations, 50 mg/mL or greater, rather than at the diluted concentrations required by conventional methods, i.e. typically less than a few mg/mL for circular dichroism (CD).... White Papers XRD SYSTEMS By PANalytical
Supporting the pharmaceutical industry with 21 CFR Part 11 compliance readiness.... Automation > Laboratory Instrumentation > White Papers See more
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