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News Article | May 18, 2017
Site: www.prnewswire.com

Abbott Laboratories, AbbVie, Amgen Incorporated, Aptar Pharma, AstraZeneca, Aurobindo Pharma USA Inc., BCM Group LLC, Biogen Incorporated, Centurion Medical Products, Daicel Corporation, Eli Lilly, Ermo, FDA, Forest Laboratories, Janssen, McArdle & Associates, LLC, Merck Research Laboratories, MITSUBISHI GAS CHEMICAL, Nemera, Nipro, Nipro Europe NV, Novo Nordisk A/S, Nye Lubricants, Pfizer Global Pharmaceuticals, Philips – Medisize, Plastibell DTP Holding, Regeneron Pharmaceuitcals Inc, Robert Bosch Packaging Technology Inc, Sandoz Pharmaceuticals, SCHOTT Pharmaceutical Packaging, Schreiner MediPharm, Shire, Smithers Rapra, Takeda, Terumo Pharmaceutical Solutions, TESARO, West Pharmaceuticals Services Inc, Zeon Chemicals L.P. and more. The preliminary attendee list and a series of interviews with key speakers such as SCHOTT, Eli Lilly and Shire are also available to read in the event website's download centre. Pre-Filled Syringes West Coast takes place on June 5th and 6th, 2017 at the Hyatt Regency, San Diego, CA. Further information including a detailed agenda and full speaker line-up is available at www.prefilled-syringes-westcoast.com. For all media inquiries, contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: tarri@smi-online.co.uk. Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/attendee-list-released-for-pre-filled-syringes-san-diego-summit-300460177.html


News Article | May 18, 2017
Site: www.prlog.org

Leading medical device and drug delivery experts from industry and science set to gather at Pre-Filled Syringes West Coast 2017 -- With just over 2 weeks to go, SMi Group have released an attendee list featuring a global audience of scientists, medical device experts and industry leaders fortaking place in San Diego, California. As well as USA representation, other nations present will include Belgium, Denmark, France, Germany, Japan and Sweden.A snapshot of organisations confirmed to join Pre-Filled Syringes West Coast include:Abbott Laboratories, AbbVie, Amgen Incorporated, Aptar Pharma, AstraZeneca, Aurobindo Pharma USA Inc., BCM Group LLC, Biogen Incorporated, Centurion Medical Products, Daicel Corporation, Eli Lilly, Ermo, FDA, Forest Laboratories, Janssen, McArdle & Associates, LLC, Merck Research Laboratories, MITSUBISHI GAS CHEMICAL, Nemera, Nipro, Nipro Europe NV, Novo Nordisk A/S, Nye Lubricants, Pfizer Global Pharmaceuticals, Philips – Medisize, Plastibell DTP Holding, Regeneron Pharmaceuitcals Inc, Robert Bosch Packaging Technology Inc, Sandoz Pharmaceuticals, SCHOTT Pharmaceutical Packaging, Schreiner MediPharm, Shire, Smithers Rapra, Takeda, Terumo Pharmaceutical Solutions, TESARO, West Pharmaceuticals Services Inc, Zeon Chemicals L.P. and more.The preliminary attendee list and a series of interviews with key speakers such asandare also available to read in the event website's download centre Pre-Filled Syringes West Coast takes place on June 5th and 6th, 2017 at the Hyatt Regency, San Diego, CA.Further information including a detailed agenda and full speaker line-up is available at www.prefilled- syringes-westcoast.com ---end---Contact Information:For all media inquiries, contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: tarri@smi-online.co.uk About SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi- online.co.uk


Prebil R.,Jozef Stefan Institute | Stavber G.,Sandoz Pharmaceuticals | Stavber S.,Jozef Stefan Institute
European Journal of Organic Chemistry | Year: 2014

A metal-free reaction system of air, NH4NO3(cat), 2,2,6,6-tetramethylpiperidine-1-oxyl (TEMPO)(cat), and H + (cat) is introduced as a simple, safe, inexpensive, efficient and chemoselective mediator for aerobic oxidation of various primary and secondary benzyl and alkyl alcohols, including those bearing oxidizable heteroatoms (N, S, O) to the corresponding aldehydes or ketones. Air oxygen under slight overpressure plays the role of the terminal oxidant, which is catalytically activated by redox cycles of nitrogen oxides released from a catalytic amount of NH4NO3 and cocatalyzed by TEMPO (nitroxyl radical compound), under acidic conditions, which are essential for an overall activation of the reaction system. The synthetic value of this reaction system and its green chemical profile was illustrated by a 10 g scale-up experiment, performed in an open-air system by using a renewable and reusable polymer-supported form of TEMPO (OXYNITROX®S100). The reaction solvent was recovered by distillation under atmospheric pressure, and the pure final product was isolated under reduced pressure; the acid activators (HCl or H 2SO4) were recovered as ammonium salts. A metal-free reaction system of air/NH4NO3(cat)/TEMPO (cat)/H+ (cat) is introduced as a simple, safe, inexpensive, efficient and chemoselective mediator for aerobic oxidation of various primary and secondary benzyl, alkyl and allyl alcohols, including those bearing oxidizable heteroatoms (N, S, O) to the corresponding aldehydes or ketones. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Casar Z.,Sandoz Pharmaceuticals | Steinbucher M.,University of Ljubljana | Kosmrlj J.,University of Ljubljana
Journal of Organic Chemistry | Year: 2010

The first entry to statins via lactonized side chain is reported, exemplified by the synthesis of rosuvastatin. The key step is Wittig coupling of (2S,4R)-4-(tert-butyldimethylsilyloxy)-6-oxotetrahydro-2H-pyran-2-carbaldehyde and phosphonium salt of an appropriately functionalized pyrimidine heterocy'le. One-pot deprotection and hydrolysis of the resulting 4-O-TBS rosuvastatin lactone provided rosuvastatin in high yield. © 2010 American Chemical Society.


Gaziasmilovia I.,Sandoz Pharmaceuticals | Casas-Arce E.,Johnson Matthey | Roseblade S.J.,Johnson Matthey | Nettekoven U.,Solvias A.G. | And 3 more authors.
Angewandte Chemie - International Edition | Year: 2012

Persistent chlorine: Hydrogenation of borolane-substituted vinylic chlorides catalyzed by Ir-P N complexes greatly preserved the chlorine substituent on the hydrogenated product, with only 3-19 % of dechlorinated byproducts present after hydrogenation. The α-chloro boronic ester products are ideal precursors for proteasome-inhibitor-type anti-cancer drugs, a fact which demonstrates the utility of this hydrogenation method. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Kristan K.,Sandoz Pharmaceuticals | Horvat M.,Sandoz Pharmaceuticals
Journal of Pharmaceutical Sciences | Year: 2012

Time and cost are among the most often cited hurdles limiting the rate and extent of adoption of Quality by Design (QbD) and Process Analytical Technology. In this article, we demonstrate that, with appropriate techniques, a key QbD element can be achieved with amount of resources comparable to classical development approach. To control the dissolution rate of a highly soluble drug substance from latex polymer coated pellets, we have examined the effect of key variables affecting the curing process step by an experimental design study. To explore and characterize the Design Space, we have produced and tested 62 distinct pellet samples. To achieve this in a reasonable amount of time, we have developed a scaled-down automated dissolution method that demonstrated excellent correlation to the classical method. By careful planning of experimentation, we were able to obtain all samples from just two batches of pellet cores. The curing process Design Space was explored by statistical modeling of samples obtained from the first batch. Robustness and repeatability of the Design Space at the edge of failure was preliminarily investigated by analysis of selected samples from the second batch with encouraging results. © 2012 Wiley Periodicals, Inc.


Naversnik K.,Sandoz Pharmaceuticals | Rojnik K.,Hoffmann-La Roche
Value in Health | Year: 2012

Objectives: Probabilistic uncertainty analysis is a common means of evaluating pharmacoeconomic models and exploring decision uncertainty. Uncertain parameters are assigned probability distributions and analyses performed by Monte Carlo simulation. Correlations between input parameters are rarely accounted for despite recommendations from several guidelines. By outlining theoretical reasons for including correlations and showing numerous examples of existing correlations, we appeal to the analyst to consider input dependencies. Our objective is to review the available methods to do so, give technical details on implementation and show, by using examples of published studies, the effect input correlations have on model outputs. Methods: A hierarchy of methods for dealing with correlations in Monte Carlo simulation is presented and used. The choice of method depends on the amount of information available on dependency and consists of functional modeling, joint distributions/copulas, and coupling of marginal distributions. Results: We induced input correlation with various methods and showed that in most cases the choice of optimal decision remained the same as in the independent scenario. There was, however, a significant change in the value of further information because of inducing input correlations. The results were similar for various dependency structures and were mainly a function of the strength of correlation, as measured by the linear correlation coefficient. Conclusion: Probabilistic uncertainty analysis reflects joint uncertainty across input parameters only when dependence among input parameters is accounted for. © 2012, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Jevsevar S.,Sandoz Pharmaceuticals | Kunstelj M.,Sandoz Pharmaceuticals | Porekar V.G.,Slovenian National Institute of Chemistry
Biotechnology Journal | Year: 2010

Since the first PEGylated product was approved by the Food and Drug Administration in 1990, PEGylation has been widely used as a post-production modification methodology for improving biomedical efficacy and physicochemical properties of therapeutic proteins. Applicability and safety of this technology have been proven by use of various PEGylated pharmaceuticals for many years. It is expected that PEGylation, as the most established technology for extension of drug residence in the body, will play an important role in the next generation therapeutics, such as peptides, protein nanobodies and scaffolds, which due to their diminished molecular size need halflife extension. This review focuses on several factors important in the production of PEGylated biopharmaceuticals enabling efficient preparation of highly purified PEG-protein conjugates that have to meet stringent regulatory criteria for their use in human therapy. Areas addressed are PEG properties, the specificity of PEGylation reactions, separation and large-scale purification, the availability and analysis of PEG reagents, analysis of PEG-protein conjugates, the consistency of products and processes and approaches used for rapid screening of pharmacokinetic properties of PEG-protein conjugates. © 2010 Wiley-VCH Verlag GmbH & Co. KGaA.


Casar Z.,Sandoz Pharmaceuticals
Current Organic Chemistry | Year: 2010

Satins are the most frequently prescribed and efficient drugs for treatment of lipid disorders. These drugs represent one of the most valuable therapeutic classes of compounds in the pharmaceutical sector. Since their discovery as fungal metabolites, many structural modifications have been performed during the past 30 years to obtain structurally refined and even more potent derivatives. These modifications led to the group of fully synthetic statins which are frequently addressed as super-statins. Structurally these compounds consist of a heterocyclic core attached to the chiral 3,5-dihydroxy-6-heptenoic or heptanoic acid side chain. Given their economical importance and well-established therapeutic applications with new indications continuously rising, much effort has been devoted to the improvement of primary synthetic strategies towards super-statins. Indeed, high consumption and multi-ton world wide production of super-statins pose continuous challenge for their economical and eco-friendly synthesis which makes super-statins attractive synthetic target for the organic chemist. Therefore, over the past two decades synthetic chemists have developed an assortment of routes to super-statins. In pur- suit to develop easy and practical approaches to superstatins array of new and innovative strategies have been developed. Many of these are outstanding synthetic achievements, especially in the area of chiral side chain synthesis. This review highlights the main methods for the synthesis of super-statin chiral side chain and heterocyclic core building blocks and provides a comprehensive survey of the evolution of synthetic approaches to marketed super-statins: fluvastatin, atorvastatin, rosuvastatin and pitavastatin. © 2010 Bentham Science Publishers Ltd.


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