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Galenica to commercialize Roche’s Mircera in US and Puerto Rico By PBR Staff Writer
Serbian pharmaceutical firm Galenica has entered into an exclusive license agreement for the commercialization of Swiss drug-maker Roche’s prescription medicine Mircera (methoxy polyethylene glycol-epoetin beta) in the US and Puerto Rico.
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Akron Biotech enters into strategic partnership with Cognate BioServices Cognate BioServices and Akron Biotechnology are pleased to announce a strategic partnership that brings two industry leaders together to provide a more complete package of services to their clients.
Contract Research & Services > Contract Services > News Inovio, GeneOne Life Science partner for MERS immunotherapy clinical development By PBR Staff Writer
US-based Inovio Pharmaceuticals has collaborated with GeneOne Life Science to advance its DNA vaccine into a Phase I clinical trial in healthy volunteers for the treatment of Middle East Respiratory Syndrome (MERS), a respiratory disease.
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SciClone to develop and commercialize Theravance's Vibativ in China
By PBR Staff Writer
Theravance Biopharma has entered into a development and commercialization agreement with SciClone Pharmaceuticals, under which the latter will have exclusive development and commercial rights for the antibiotic Vibativ (telavancin) in China and certain adjacent territories.
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NeuroVive, Sanofi enter commercialization deal for Ciclomulsion in South Korea
By PBR Staff Writer
NeuroVive Pharmaceutical Asia group has collaborated with Sanofi’s local affiliate for the development and commercialization of CicloMulsion in South Korea to treat reperfusion injury in cardiovascular disease.
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Amgen to terminate participation in co-development and commercialization of brodalumab with AstraZeneca
Amgen announced the Company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca.
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Tribute acquires US rights to Fibricor and commercial expansion into US Market
Tribute Pharmaceuticals Canada a specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada and the US, is pleased to announce that its wholly owned subsidiary, Tribute Pharmaceuticals International, a Barbados corporation, has acquired the US rights to Fibricor and its related authorized generic from a wholly owned step-down subsidiary of Sun Pharmaceutical Industries Ltd.
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OCTC, Bryla CMC-Reg Consulting to deliver CMC services for pharmaceutical industry
By PBR Staff Writer
The Ohio Clinical Trials Collaborative (OCTC) and Bryla CMC-Reg Consulting have entered into a co-marketing agreement to leverage the synergies of the two organizations in delivering services to industry.
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Janssen, Achillion to develop new oral regimens to treat hepatitis C virus
By PBR Staff Writer
Janssen Pharmaceuticals has entered into an exclusive worldwide license and collaboration arrangement to develop and commercialize one or more of Achillion Pharmaceuticals' lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422 and sovaprevir.
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Genmab, BioNTech to develop bispecific antibody products using DuoBody technology
By PBR Staff Writer
Danish biotechnology firm Genmab has entered into an agreement with Germany-based BioNTech to jointly research, develop and commercialize bispecific antibody products using Genmab's DuoBody technology platform.
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Amino Acid Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
The European Pharmacopeia (Ph Eur) is moving away from the historical Thin Layer Chromatography technique (TLC) for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.
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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.
| By Butterworth Laboratories Ltd
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.
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Elemental Impurity Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.
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