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November 2016

 

 

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RedHill Biopharma Ltd. announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) discussing the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.
Subject to final minutes of the meeting, the FDA has accepted RedHill's manufacturing plan towards filing the CMC package as part of a potential U.S. New Drug Application (NDA) to be submitted for RHB-105, subject to successful completion of the planned confirmatory Phase III study.

Bristol-Myers Squibb Company and Infinity Pharmaceuticals, Inc. announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 in patients with advanced solid tumours. The dose-escalation portion exploring IPI-549 as a monotherapy in Infinity’s phase 1 study is continuing, and the first dose-escalation cohort studying IPI-549 in combination with Opdivo, a PD-1 immune checkpoint inhibitor, is expected to begin this fall.

Bristol-Myers Squibb Company  and Nitto Denko Corporation announced the companies have entered into an agreement granting Bristol-Myers Squibb exclusive worldwide rights for the development and commercialization of Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations, which includes Nitto’s lead asset ND-L02-s0201, currently in Phase 1b study for the treatment of advanced liver fibrosis.

Recruitment for M.Pharm, B.Pharm, D.Pharm at HLL Lifecare - 200 vacancies | Government Jobs

HLL Lifecare Limited is a Mini Ratna Company of Govt. of India under the Ministry of Health & Family Welfare. HLL, a schedule B Public Sector Enterprise is today a multi product, multi unit organization addressing various public health challenges. The company with five manufacturing units and marketing offices throughout the country is engaged in the manufacturing and marketing of a wide range of contraceptives and healthcare products. The company has also ventured into Infrastructure Development, Procurement & Consultancy Services, setting up of Life Spring Hospitals, Women's Health Pharma Division and setting up of Diagnostic Centres.

Post: Pharmacist/Assistant Pharmacist, Pharmacy Assistant

Multiple openings in pharmaceutical R&D at Career pharma Consultancy

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Work as a Marketing Manager at Titan Laboratories Pvt. Ltd.

Titan Laboratories Pvt. Ltd. is the one of select few Company in india with dedicated state of art WHO GMP facility for producing high quality Sustained and Modified Release Pellets, DC Granules& Taste Masked Granules. The plant is located in green belt of mahad industrial zone about 180Kms from mumbai. It is strategically located on well connected Mumbai-Goa Highway.

Post: Marketing Executive - 2 posts

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR ANALYSIS OF GATIFLOXACIN & ITS IMPURITY

{ DOWNLOAD AS PDF }

 

ABOUT AUHTOR
Narendra M.Petha, J.G.Patil,Mr J.G.Chandorkar

Indofil Industries Ltd, Gujarat
jchandorkar-icc@modi.com

ABSTRCT 
Gatifloxacin is a antibacterial agent, Rapid, sensitive and selective analytical method is essential for monitoring the different reactions steps involved in process development of Gatifloxacin. A simple isocratic reverse phase High Performance Liquid Chromatographic [HPLC] method was developed for simultaneous separation of different intermediates and other impurities. The method was utilized successfully in analyzing the reaction streams, related substances in final product and for the assay in drug.

Trovagene, Inc, a developer of circulating tumour DNA (ctDNA) molecular diagnostics, announced that the US Patent and Trademark Office has issued Patent No 9,453,265 entitled "Method for Detection of High Risk Human Papillomavirus." The patent encompasses directed methods of detecting high-risk HPV infections by identifying mutations in the E1 gene of HPV in the urine of a patient, expanding the intellectual property covering Trovagene's Precision Cancer Monitoring (PCM) technology. Trovagene now has 91 patents issued and 72 patent applications pending in the US and internationally.

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"Issuance of this patent further strengthens Trovagene's extensive patent portfolio supporting our Precision Cancer Monitoring platform," said Bill Welch, chief executive officer of Trovagene.

Trovagene is submitting a manuscript this quarter that provides data validating the sensitivity and specificity of its HR-HPV, high-risk human papillomavirus urine test in comparison with the Roche Cobas HPV test. "The data in this manuscript will show that urine sampling is a viable testing alternative, particularly to access women who do not participate in routine screening programs," said Mark Erlander, chief scientific officer of Trovagene


Complementing the recently submitted manuscript, and adding to the body of clinical evidence supporting the sensitivity and specificity of Trovagene's HR-HPV urine-based test, two abstracts have been accepted for presentation at the HPV 2017 31st International Papillomavirus Conference. The first demonstrates clinical performance of urine and cervical samples in a Chinese screening population. These results support the utility of urine testing for cervical cancer screening among this population. The second abstract describes the analytical performance of the Trovagene HPV-HR urine test

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Qiagen N.V., a leading global provider of sample to insight solutions, announced the validation of new and improved sequencing  chemistry for its GeneReader NGS System, the world’s first complete Sample to Insight solution making the benefits of next-generation sequencing (NGS) accessible to any laboratory.

Mylan N.V.  and Biocon Ltd.  announced submission of Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S.