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1-15 of 4924 results
Xenon’s acne drug XEN801 fails in phase 2 trial
By PBR Staff Writer
A phase 2 trial of Xenon Pharmaceuticals’ acne drug XEN801 has failed to meet its efficacy endpoints in patients having moderate to severe acne.
Contract Research & Services > Clinical Trials > News
Akashi gets FDA nod to restart clinical development of DMD drug HT-100
Akashi Therapeutics has secured approval from the US Food and Drug Administration (FDA) to resume clinical development of HT-100 (delayed-release halofuginone) in patients with any of the genetic mutations that cause Duchenne muscular dystrophy (DMD).
Contract Research & Services > Clinical Trials > News
Novartis’ serelaxin fails to meet primary endpoint in heart failure study
By PBR Staff Writer
Novartis' RLX030 (serelaxin) has failed to meet its primary endpoint in a phase III acute heart failure (AHF) study.
Contract Research & Services > Clinical Trials > News
Lilly’s abemaciclib meets primary endpoint in phase 3 breast cancer trial
By PBR Staff Writer
A phase 3 study of Lilly’s breast cancer drug, abemaciclib, in combination with fulvestrant, has met its primary endpoint of progression-free survival (PFS).
Contract Research & Services > Clinical Trials > News
Nektar’s NKTR-181 shown to reduce chronic pain in phase 3 trial
Nektar Therapeutics’ NKTR-181 has met primary and secondary endpoints in phase 3 SUMMIT-07 study in chronic pain.
Contract Research & Services > Clinical Trials > News
Novartis’ heart failure drug Entresto improves glycemic control in Phase III study
Novartis has unveiled results of a new post-hoc analysis in a subgroup of patients with reduced ejection fraction heart failure (HFrEF) and diabetes indicating that Entresto (sacubitril/valsartan) tablets enahanced glycemic control, as evaluated by hemoglobin A1c (HbA1c) testing, compared to ACE-inhibitor enalapril.
Contract Research & Services > Clinical Trials > News
Amgen's Repatha lowers heart attack, stroke risk in phase 3 study
By PBR Staff Writer
A phase 3 study has demonstrated that Amgen’s cholesterol drug Repatha reduces low-density lipoprotein cholesterol (LDL-C) levels and risk of cardiovascular events.
Contract Research & Services > Clinical Trials > News
Catalyst Pharmaceuticals’ neuromuscular drug succeeds in seven-patient trial
By PBR Staff Writer
Catalyst Pharmaceuticals said its experimental drug to treat patients with a severe form of myasthenia gravis (MG), a debilitating neuromuscular disease, met the main goals of a study.
Contract Research & Services > Clinical Trials > News
AstraZeneca's Lynparza shows significant survival benefit in ovarian cancer study
By PBR Staff Writer
A phase 3 clinical trial evaluating AstraZeneca's PARP inhibitor Lynparza (olaparib) as maintenance therapy in ovarian cancer demonstrated a pronounced extension in survival compared to placebo.
Contract Research & Services > Clinical Trials > News
Indivior plans to file NDA for schizophrenia drug in Q4 2017
Indivior has unveield positive top-line 12-Month phase 3 results confirming long-term safety profile of RBP-7000 in patients with schizophrenia.
Contract Research & Services > Clinical Trials > News
Synairgen eyes lung fibrosis trial after positive data from LOXL2 inhibitor program
By PBR Staff Writer
Synairgen is on track to begin the initial clinical trial of a new lung fibrosis treatment later this year after pre-clinical work showed more evidence of improved breathing.
Contract Research & Services > Clinical Trials > News
BerGenBio signs deal with Merck to test lung and breast cancer combo
BerGenBio has signed a collaborative agreement with Merck focused the clinical study of BGB324 with Keytruda (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
Contract Research & Services > Clinical Trials > News
Mereo BioPharma committee recommends continuation of BGS-649 study
Mereo BioPharma said that an independent data monitoring committee has recommended to continue all three different dose arms of the Phase 2b BGS-649 study after a prospectively defined interim analysis of safety and efficacy.
Contract Research & Services > Clinical Trials > News
TG Therapeutics’ cancer drug meets primary end point in phase 3 trial
By PBR Staff Writer
TG Therapeutics’ cancer drug, TG-1101 (ublituximab), in combination with AbbVie’s Imbruvica (ibrutinib), has met its primary end point in a phase 3 study in chronic lymphocytic leukemia (CLL) patients.
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
LABORATORIOS INIBSA - Pharmaceutical Contract Manufacturing Company
LABORATORIOS INIBSA is a pharmaceutical contract manufacturing company. We have more than 60 years' experience and belong to the INIBSA GROUP. INIBISA supplies products and services to Biotools, Inibsa Dental and Inibsa Hospital, as well as other pharmaceutical companies through our contract manufacturing division. From our facilities in Lliçà de Vall, 20km from Barcelona LABORATORIOS INIBSA currently supplies more than 50 countries worldwide.... Contract Research & Services > Clinical Trials > 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
Quintiles - Bringing People and Knowledge Together for a Healthier World
Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment.... Contract Research & Services > Clinical Trials > 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
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PBR White Paper Recommendations

A Survival Guide to Temperature Data in Life Sciences, by Almac By Almac
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)1 as well as Good Distribution Practices Supply Chain Integrity2 has made the most significant impact. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire supply chain. The industry is facing stricter compliance demands from regulations and regulatory agencies are not always given clear guidance.... Contract Research & Services > Clinical Trials > White Papers Almac: Changing the Dynamics of Temperature Controlled Shipping Solutions By Almac
In the typical clinical trial today, the cost of shipping and distributing supplies accounts for approximately 60 percent of the overall clinical supply chain. And when the cost of product spoilage from temperature excursions is added into the mix, it is no wonder that pharmaceutical companies, Clinical Research Organizations (CROs), and logistics vendors are all eagerly searching for efficiencies and ways to carve costs out of the process.... Contract Research & Services > Clinical Trials > White Papers Almac Explores Interactive Response Technology: An Untapped Source of Historical and Real-Time Data for Risk-Based Monitoring By Almac
Risk-based monitoring has attracted the support of a diverse group of organisations in recent years. Regulators have released guidance encouraging the use of risk-based approaches to clinical trial quality, vendors have created technologies to support such methods, and large pharma companies have pooled their resources to drive adoption. Yet, despite this flurry of activity, the industry has overlooked a potentially useful source of real-time and historical data.... Contract Research & Services > Clinical Trials > White Papers Almac Presents Modern Perspectives on Peptide Synthesis, an Introduction By Almac
The complexity of synthetic peptide products, whether as reagents used in research or as therapeutic APIs, is increasing. As researchers understand more about the biochemical systems which are targeted, and invent ever more sophisticated products, manufacturing methods must keep pace. We look in this article at a number of challenging product classes, the specific problems they present, and potential solutions: Long peptides; Multi-peptide cocktails; Site-specifically modified products.... Contract Research & Services > Clinical Trials > White Papers Almac: Crystallisation of Pharmaceutical Compounds By Almac
The Almac Group explores the chemist's role in protecting intellectual property. It provides development and manufacturing services for Active Pharmaceutical Ingredients (APIs) to pharmaceutical industries worldwide. Over the past 40 years, we have made numerous discoveries that have become powerful intellectual properties (IPs) for our customers.... Contract Research & Services > Clinical Trials > White Papers See more
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