Serum Institute of India Ltd

Bhubaneshwar, India

Serum Institute of India Ltd

Bhubaneshwar, India
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À propos de Genkyotex Genkyotex est une société biopharmaceutique leader des thérapies NOX. Cotée sur Euronext Paris et Bruxelles. Genkyotex est implantée en France et, via sa filiale GenKyoTex Suisse SA, en Suisse. Leader des thérapies NOX, son approche thérapeutique unique est basée sur l’inhibition sélective des enzymes NOX qui amplifient de nombreux processus pathologiques comme les fibroses, l’inflammation, la perception de la douleur, l’évolution du cancer et la neurodégénérescence. Genkyotex dispose d’une plateforme permettant d’identifier des petites molécules administrables par voie orale et capables d’inhiber de manière sélective des enzymes NOX spécifiques. Genkyotex développe un portefeuille de candidats médicaments représentant une nouvelle classe thérapeutique ciblant une ou plusieurs enzymes NOX. Son candidat médicament le plus avancé, GKT831, un inhibiteur des NOX1 et 4, devrait entrer en essai clinique de phase II dans la cholangite biliaire primitive (PBC, une pathologie fibrotique orpheline) avant la fin du deuxième trimestre 2017. Ce candidat pourra également être actif dans d’autres indications fibrotiques. Son deuxième produit candidat, GKT771, est un inhibiteur de NOX1 ciblant plusieurs voies dans l’angiogenèse, la perception de la douleur et l’inflammation, et devrait entrer en essai clinique au cours du second semestre 2017. Genkyotex dispose également d’une plate-forme polyvalente, Vaxiclase, particulièrement adaptée au développement d’immunothérapies. Un partenariat sur l'utilisation de Vaxiclase en tant qu'antigène en soi (GTL003) a été établi avec le Serum Institute of India Ltd (Serum Institute), le plus grand producteur de doses de vaccins au monde, pour le développement par le Serum Institute de vaccins de combinaison de cellules multivalentes contre plusieurs maladies infectueuses. Ce partenariat pourrait générer jusqu'à 57 millions de dollars de recettes pour Genkyotex, avant redevances sur les ventes.


News Article | May 9, 2017
Site: www.businesswire.com

LEXINGTON, Mass.--(BUSINESS WIRE)--Xenetic Biosciences, Inc. (NASDAQ: XBIO) (“Xenetic” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, announced today that it will report its financial results for the quarter ended March 31, 2017 in a press release that will be issued pre-market on Tuesday, May 16, 2017. Xenetic’s management team also announced that it will host a quarterly update conference call with a live audio webcast that same day at 8:30 AM ET to review its operational progress, expected near-term milestones and financial report. The conference call and live webcast will be accompanied by a slide presentation. To participate in the call, please dial (877) 407-6914 (domestic) or (201) 493-6709 (international). The live webcast and accompanying slides will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends. Xenetic Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics. Xenetic's proprietary drug development platforms include PolyXen™, which enables next generation biologic drugs by improving their half-life and other pharmacological properties. Xenetic's lead investigational product candidates include oncology therapeutic XBIO-101 (sodium cridanimod) for the treatment of progesterone resistant endometrial cancer (EC), and a polysialylated form of erythropoietin for the treatment of anemia in pre-dialysis patients with chronic kidney disease. Xenetic is also working together with Shire plc (formerly Baxalta, Baxter Incorporated and Baxter Healthcare) to develop a novel series of polysialylated blood coagulation factors, including a next generation Factor VIII. This collaboration relies on Xenetic's PolyXen technology to conjugate polysialic acid (“PSA”) to therapeutic blood-clotting factors, with the goal of improving the pharmacokinetic profile and extending the active life of these biologic molecules. Shire is a significant stockholder of the Company, having invested $10 million in the Company during 2014. The agreement is an exclusive research, development and license agreement which grants Shire a worldwide, exclusive, royalty-bearing license to Xenetic's PSA patented and proprietary technology in combination with Shire's proprietary molecules designed for the treatment of blood and bleeding disorders. Under the agreement, Xenetic may receive regulatory and sales target payments for total potential milestone receipts of up to $100 million plus royalties on sales. Additionally, Xenetic has previously received strategic investments from OPKO Health (Nasdaq: OPK), Serum Institute of India Limited and Pharmsynthez. Xenetic is also developing a broad pipeline of clinical candidates for breakthrough biologics and novel oncology therapeutics in a number of orphan disease indications. For more information, please visit the company's website at www.xeneticbio.com and connect on Twitter, LinkedIn, Facebook and Google+. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of NGS cancer panels, the ability to accurately determine the heritable factors increasing the risk of cancer, permitting tailored treatment, screening and prevention of cancer in patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


In the report Indian Influenza Market By Product Type (Vaxigrip, Influvac) - Forecast 2020, the analysts have endeavoured to address the current scenario of Indian influenza industry, factors favouring growth of the market, and the major roadblocks restraining the influenza vaccines market. Additionally, the report includes the study of opportunities, which are available in the Indian influenza market. With increasing pandemic as well as seasonal outbreak and rising awareness among people about these vaccines, the Indian influenza vaccine market is poised to scale newer acmes. Moreover, increasing disposable income, increasing incidences of influenza, introduction of new vaccines, entry of new players, and rising R&D investments are set to further boost the market's growth. Owing to such factors, the Indian influenza market is anticipated to grow at a healthy CAGR during the forecast period (2015-2020). The Indian Influenza market has reported a remarkable growth in recent years, and is presenting ample opportunities to the industry's players. With increasing pandemic as well as seasonal outbreak and rising awareness among people about these vaccines, the Indian influenza vaccine market is poised to scale newer acmes. Moreover, increasing disposable income, increasing incidences of influenza, introduction of new vaccines, entry of new players, and rising R&D investments are set to further boost the market's growth. Owing to such factors, the Indian influenza market is anticipated to grow at a healthy CAGR during the forecast period (2015-2020). Furthermore, the report covers detailed description of the current scenario of the Indian influenza vaccine market, and its future forecast till 2020. Indian Influenza Vaccines market is analyzed in both volumes in doses, and value in US$ for the period from 2015 through to 2020. The report also provides detailed bifurcation of Indian influenza market on the basis of product type, such as Vaxigrip, Influvac, and others.  The report also provides the potential market for influenza vaccines. Moreover, the report highlights the mergers and acquisitions that have taken place in the Indian influenza market. Pricing analysis along with the regulatory scenario governing the Indian influenza market has also been mentioned in the report. Furthermore, the report provides the details about the distribution channel for influenza vaccines in the Indian industry. The latter half of the report provides competitive landscape including the market share of key players, such as Cipla Ltd., Bharat Biotech, Serum Institute of India, Abbott, Lupin Ltd, and others. A brief business overview and financial information about each of these players has been provided in the report, along with the company overviews and financial revenues of the key participants to develop their positions in the global market. The recent development and strength-weakness analysis of every player has also been presented to assist the investors in developing an understanding of the strategies of major players. Overall, the research contains exhaustive information that will help clients in formulating market strategies and assessing opportunity areas in the Indian Influenza market. 4.4.2 Upsurge in the Number of Product Launches For more information about this report visit Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/indian-influenza-vaxigrip-influvac-market-2017----forecast-2020---research-and-markets-300454240.html


The present disclosure relates to the field of immunoassays for Gram negative bacteria, in particular N. meningitidis. The disclosure provides a simple and affordable immunoassay to quantitate polysaccharides in meningococcal vaccines for the evaluation of antigen content and lot-to-lot manufacturing consistency. The inventors have found a Sandwich ELISA that can be applicable for the quantitation and identification of N. meningitidis serogroup X polysaccharide in a multivalent meningococcal polysaccharide-protein conjugate vaccine as well as in a multivalent meningococcal plain polysaccharide vaccine. Said assay employs a polyclonal antibody as capture antibody and a novel monoclonal antibody against serogroup X polysaccharide as detection antibody. Further the assay is rapid, robust and reproducible.


Patent
Serum Institute Of India Ltd. | Date: 2013-01-18

Thermostable polysaccharide based lyophilized vaccines are disclosed, particularly polysaccharide-protein conjugate vaccines and methods for preparation thereof. In an exemplary embodiment, a stabilized vaccine composition consists essentially of at least one polysaccharide-protein conjugate, at least one amorphous excipient, and a buffer component.


The present invention relates to the field of immunoassays for Gram negative bacteria, in particular N.meningitidis. The invention provides a simple and affordable immunoassay to quantitate polysaccharides in meningococcal vaccines for the evaluation of antigen content and lot-to-lot manufacturing consistency. The inventors have found a Sandwich ELISA that can be applicable for the quantitation and identification of N.meningitidis serogroup X polysaccharide in a multivalent meningococcal polysaccharideprotein conjugate vaccine as well as in a multivalent meningococcal plain polysaccharide vaccine. Said assay employs a polyclonal antibody as capture antibody and a novel monoclonal antibody against serogroup X polysaccharide as detection antibody. Further the assay is rapid, robust and reproducible.


Patent
Serum Institute of India Ltd. | Date: 2013-01-29

The invention provides immunogenic polysaccharide protein conjugates comprising capsular polysaccharides from N. Meningitidis serogroup X and methods for preparation thereof. The present invention relates to N. meningitidis X saccharide-carrier protein conjugates prepared by a conjugation reaction. Accordingly, the instant invention relates to multivalent meningococcal polysaccharide protein conjugate composition comprising capsular saccharide from serogroups X and at least one capsular saccharide from A, C, W135 and Y wherein, i) polysaccharides A C W135 X are sized mechanically whereas polysaccharide Y is sized chemically, ii) all saccharide are conjugated to carrier protein via a linker with a cyanylation conjugation chemistry iii) all saccharide to protein ratios in final conjugates are between 0.2-0.6 and iv) at least two different carrier proteins selected from the group consisting of TT, DT and CRM197 are utilized.


The present invention relates to a rapid and reproducible Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) based method for quantifying residual 4-pyrrolidinopyridine(4-PPY) in polysaccharide- protein conjugate vaccines prepared by cyanylation conjugation chemistry using 1-Cyano-4-pyrrolidinopyridinium tetrafluorborate (CPPT).Said assay comprises of heating sample containing polysaccharide protein conjugate at a temperature between 60C and 90C for a duration between 2hrs and 3hrs followed by RP-HPLC.Further present method does not require any tedious sample preparation and none of the sample matrix interferes with the 4-PPY peak.Said method is applicable for quantification of 4-PPY in any polysaccharide-protein conjugate bulk or vaccine samples.


Patent
Serum Institute Of India Ltd. | Date: 2013-11-18

The instant invention provides improved culture, fermentation and purification conditions for preparing Neisseria meningitidis polysaccharides. The invention in particular relates to a novel fermentation medium, optimal feed solution addition strategies and an improved purification process devoid of any chromatographic methods for obtaining high yield of Neisseria meningitidis X polysaccharide.


Patent
Serum Institute Of India Ltd. | Date: 2015-12-09

The instant invention provides significant improvement in bacterial capsular polysaccharide yield at fermentation harvest stage, particularly Neisseria meningitidis capsular polysaccharides by gradual addition of an antifoam agent alongwith an optimal feed solution from log phase onwards. Specifically, antifoam increases optical density of the culture thereby resulting in higher capsular polysaccharide yield of about 2 to 2.5 gm/L at fermentation harvest stage wherein polysaccharide obtained has optimal average molecular weight of about 800KDa to about 1200KDa and has minimum load of contaminants like proteins and nucleic acid. The antifoam agent of the present invention was found to be bifunctional such that it increased the polysaccharide productivity as well as resulted in effective defoaming thereby making said fermentation process suitable for further scale-up.

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