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NanoViricides inks deal with University of Pittsburgh for ocular resting of drug candidates
NanoViricides has entered into an agreement with the University of Pittsburgh for the testing of its nanoviricides drug candidates in standard animal models of ocular virus infections.
Contract Research & Services > Contract Services > News
ONL Therapeutics gets FDA orphan drug designation for ONL1204 to treat retinal detachment
The US Food and Drug Administration (FDA) has granted orphan drug designation to ONL Therapeutics' ONL1204 for the treatment of retinal detachment.
Regulatory Affairs > News
Crown Bioscience to commercialize University of York's prostate cancer models
Crown Bioscience has reached an agreement with UK’s University of York to exclusively license and commercialize the university’s unique collection of patient-derived xenograft (PDX) models for prostate cancer.
Drug Research > Drug Discovery & Development > News
RedHill Biopharma completes pharmacokinetic study with BEKINDA 12 mg formulation
RedHill Biopharma has completed a first-in-man pharmacokinetic (PK) study of BEKINDA 12 mg formulation, intended to be administered in the Phase II study for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
Contract Research & Services > Clinical Trials > News
EMA accepts Sandoz application for biosimilar to Amgen's Neulasta cancer drug
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted an application to review Sandoz's biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim) cancer drug.
Production & Manufacturing > Process & Production > News
Incyte to stop Janus studies of Ruxolitinib in solid tumor cancers
By PBR Staff Writer
Incyte said it will stop Janus studies of ruxolitinib plus capecitabine in patients with advanced or metastatic pancreatic cancer after the treatment's effectiveness was found to be insufficient.
Contract Research & Services > Clinical Trials > News
University of Michigan forms chronic kidney disease consortium with pharma companies
By PBR Staff Writer
The University of Michigan (U-M) has established a chronic kidney disease (CKD) consortium with several pharmaceutical companies, including AstraZeneca and Eli Lilly and Company.
Drug Research > Drug Discovery & Development > News
Analysis of mAb's and ADC's
The team of Szabolcs Fekete and Davy Guillarme (Univ. Geneva, CH) contributed two new papers about the analysis of monoclonal antibodies (mAb’s) and conjugated molecules in Journal of Pharmaceutical and Biomedical Analysis.
Production & Manufacturing > Manufacturing > Press Releases
EAS-Lecture: Modeling HPLC Method Robustness
Imre Molnár will lecture at Eastern Analytical Symposium in Somerset, New Jersey, on the modeling of HPLC method robustness. Tolerance limits are crucial parameters in U(H)PLC method modeling if a method should yield decent separations, even if many influential factors change ALL at the same time.
Production & Manufacturing > Manufacturing > Press Releases
Amarantus gets FDA orphan drug designation for Eltoprazine to treat PD-LID
Amarantus BioScience has received orphan drug designation from the US FDA for Eltoprazine in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
Regulatory Affairs > News
Lonza, Renova sign manufacturing deal for clinical supply of RT-100 gene therapy
Lonza Houston and Renova Therapeutics have entered into a Manufacturing Services Agreement to develop a scalable manufacturing process and produce cGMP-grade RT-100 (Ad5.hAC6) Drug Product for use in Renova’s future clinical trials.
Production & Manufacturing > Manufacturing > News
Cellceutix meets with FDA for phase 2 clinical trial of Kevetrin for ovarian cancer
Cellceutix executives met this week with staff of the FDA Division of Oncology Products 1 to discuss the Kevetrin Phase 1 study data, as well as a proposed design of a planned Phase 2 trial in patients with ovarian cancer that have resistance to platinum-based therapy.
Contract Research & Services > Clinical Trials > News
Theravance achieves 50% enrollment in all three phase 3 studies of Revefenacin
Theravance Biopharma announced that 50% enrollment has been surpassed in each of the three ongoing clinical trials comprising the Company's Phase 3 program for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) in development for the treatment of chronic obstructive pulmonary disease (COPD).
Contract Research & Services > Clinical Trials > News
Bayer HealthCare selects Oracle solutions to manage clinical monitoring processes
By PBR Staff Writer
Bayer HealthCare, a subgroup of Bayer, has selected two of Oracle's health sciences offerings to oversee and manage its clinical monitoring processes.
Automation > IT & Software > News
Imprimis plans to make cheaper alternative to Retrophin's Thiola kidney stone drug
By PBR Staff Writer
Imprimis Pharmaceuticals is planning to make a cheaper alternative to Retrophin's kidney stone drug, Thiola.
Drug Research > Drug Delivery > News

PBR Supplier Recommendations

MEGGLE – Experts in Excipients: The Whole World of Lactose
MEGGLE Excipients & Technology is a global leader in the manufacture of lactose for the pharmaceutical industry. Supporting supply chain security with manufacturing facilities in Europe and North America, MEGGLE offers a broad product portfolio of lactose excipients, co-processed technologies and excipient contract manufacturing.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
Russell Finex - Fine Mesh Separation Technology
Russell Finex are worldwide leaders in fine mesh separation technology, designing and manufacturing vibratory sieves, separators, self-cleaning in-line filters and ultrasonic systems.... Production & Manufacturing > Process & Production > Suppliers
Chemoswed - Suppliers of Active Pharmaceutical Ingredients
Chemoswed is the reliable Swedish custom synthesis specialist, supplying active ingredients since 1944. With a background in Pharmacia, Chemoswed is since 1996 an independent entity within the DuPont group, offering cost-effective, turn-key solutions to API needs worldwide.We have established unparalleled experience and technology, enabling efficient development and production of quality active pharmaceutical ingredients in quantities from 100 grams to 50 tons.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
JRS Pharma - Bringing Health Science to Life
JRS Pharma offers a complete portfolio of excipients and coatings, along with technical expertise and biopharma services. Our product portfolio provides our customers with a wide range of solutions for the development and manufacture of oral dosage forms. With over 135 years of experience, 7 R&D centers, 31 production sites, and 25 sales offices, we are dedicated to serving the health science industry worldwide. ... Suppliers
Sartorius Group - Laboratory and Process Technology Provider
Sartorius is one of the world's leading providers of laboratory and process technologies and equipment. Their innovative products and high-quality services help customers around the globe implement complex and quality-critical processes in biopharmaceutical production and laboratory environments in a time- and cost-efficient way.... Automation > Laboratory Instrumentation > Suppliers
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PBR White Paper Recommendations

Together to Minimize Risks - Meeting the Demand for Vigilance By APCER Life Sciences
Whether marketing innovative new therapies, biosimilars, or generics, your company's adverse event (AE) reports are in demand. Responding to an expanding matrix of global reporting regulations has been the norm in pharmacovigilance for more than a decade. Even as profit margins shrink, your company must continually submit increasing volumes of AE cases and meet strict timelines to stay in compliance. Now, with increased transparency of safety information, regulatory systems are just the first stop for individual case safety reports (ICSRs). ... White Papers Together for Safer Therapies - A Model for Clinical Safety By APCER Life Sciences
With profit margins and public trust declining across the life sciences sector, both the funding and the patients needed for clinical studies are becoming precious resources. Companies must gain insights from every data point obtained in every trial - and efficacy is only half of the equation for measuring health outcomes and potential returns.... White Papers Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D By Butterworth Laboratories Ltd
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.... White Papers DryLab®4 - An Overview By Molnár-Institute
Exploring DryLab basics, method development strategy and DryLab benefits.... Production & Manufacturing > Manufacturing > White Papers DryLab®4 - Next Generation in HPLC Modeling By Molnár-Institute
DryLab® is the leading software solution for HPLC method development, optimization, troubleshooting, robustness testing and training. With less than 12 experimental runs, DryLab® is the only tool capable of delivering over one million precise chromatograms predictions and display the results in its user friendly interface. Its enhanced features will transform your chaotic method development into a comfortable and streamlined workflow, as well as increasing your productivity.... Production & Manufacturing > Manufacturing > White Papers See more
1-15 of 53283 results