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Jul 2017Samumed Receives Orphan Drug Designation from FDA for SM04646
Samumed announced that the US Food and Drug Administration FDA has granted SM a novel small molecule Wnt pathway inhibitor an Orphan Drug Designation ODD for IPF httpbitlygStpOf The FDAs decision to grant an ODD to SM for IPF is another important milestone in the…
25
Jul 2017Seattle Genetics Announces Clinical Collaboration with Genentech
Seattle Genetics Inc a global biotechnology company today announced a clinical collaboration agreement with Genentech a member of the Roche Group for the evaluation of its investigational antibodydrug conjugate ADC SGNLIVA in combination with atezolizumab TECENTRIQ in patients with metastatic triplenegative breast cancer TNBC SGNLIVA…
24
Jul 2017STA Signs Supply Agreement with TESARO
STA Pharmaceutical Co Ltd a WuXi AppTec subsidiary and the leading openaccess capability and technology platform for small molecule pharmaceutical development and manufacturing announces it signed a supply agreement with the oncologyfocused biopharmaceutical company TESARO Inc TESARO for certain starting and intermediate materials for ZEJULA…
press releasesRead more...
25
Jul 2017Technology Innovation, the Key for Healthcare Delivery Excellence
Business Wire IndiaIcons of Healthcare Global Summit Awards The nd Icons of Healthcare Summit a pan Asia forum deliberating the challenges in healthcare delivery celebrating excellence by BERG Singapore was…
25
Jul 2017Johnson & Johnson Announces Encouraging First-in-Human Clinical Data for Investigational HIV Preventive Vaccine
Johnson Johnson today announced encouraging firstinhuman clinical data for an investigational HIV vaccine regimen in development at its Janssen Pharmaceutical Companies In an oral presentation of the early stage Phase…
25
Jul 2017DelMar Pharmaceuticals Receives Approval from China's Human Genetic Resources Administration to Initiate Phase 2 Clinical Trial in Newly Diagnosed GBM
DelMar Pharmaceuticals a biopharmaceutical company focused on the development of new cancer therapies today announced that the Human Genetic Resources Administration of China HGRAC has approved the Companys application to…
EventsRead more...
24-26
Jul 2017World Congress on Nursing Care 2017
Conference Series LLC
Melbourne
25-27
Jul 2017Supply Chain Operations and Compliance in Pharma
Hanson Wade
Sheraton Philadelphia University City Hotel
TOP ARTICLES
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1
Antimicrobial Stewardship Prioritising Quality Access to Healthcare
Antimicrobials treatments that kill or inhibit the growth of microorganisms are effective and necessary in medicine However organisms and microbes have increasi..
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2
Nanotechnology-based Inhalation Treatment for Lung Cancer
The lungs are the primary organ of the respiratory system The respiratory system works with the circulatory system to deliver oxygen from the lungs to the cells..
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3
Improving Biopharma Productivity through Optimal Bioreactor Operation
Generating global revenue of US billion biopharmaceuticals account for one fifth of pharmaceutical market The revenue grows at per cent annually which is doubl..
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4
Parenteral Preparations
INTRODUCTION Parenteral preparations are defined as solutions suspensionsemulsions for injection or infusion powders for injection or infusion gels for injecti..
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5
The Impact of Materials Handling on Facility Design and Operation
Materials handling a fundamental decision All too often the design of pharmaceutical OSD production facilities fails to recognise the impact on and the oppo..
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6
Untapped Opportunities in Southeast Asia
Southeast Asia is a growing pharmaceutical market with an increase in clinical trials in recent years With a population of about million and a total area of m..
Knowledge Bank
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Interviews
Datwyler Pharma Packaging
Senior Manager Global Scientific Affairs
Renaud Janssen PhD is the Senior Manager of Global Scientific Affairs at Datwyler Pharma Packaging He frequently presents on international conferences on subjects related to elastomeric and aluminiumplastic closures for pharmaceutical applications Re..
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Articles
Antimicrobial Stewardship Prioritising Quality Access to Healthcare
Antimicrobials treatments that kill or inhibit the growth of microorganisms are effective and necessary in medicine However organisms and microbes have increasingly begun to resist antimicrobial agents through evolutionary change and mutations Resistance to antimicrobials creates a difficult path for infectious disease medicine because it becomes harder and harder to treat resistant microbes While…
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Research Insights
Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine
Abstract Background Inflammatory breast cancer IBC is a rare aggressive form of breast cancer associated with HER amplification with high risk of metastasis and an estimated median survival of y We performed an openlabel singlearm phase II clinical trial ClinicalTrialsgov NCT to investigate the efficacy and safety of afatinib an irreversible ErbB family inhibitor alone and in combination with vinorelbine…
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Case Studies
Rapid, Comprehensive, And Aff Ordable Mycobacterial Diagnosis With Whole-genome Sequencing: A Prospective Case Study
Abstract Background Slow and cumbersome laboratory diagnostics for Mycobacterium tuberculosis complex MTBC risk delayed treatment and poor patient outcomes Wholegenome sequencing WGS could potentially provide a rapid and comprehensive diagnostic solution In this prospective study we compare realtime WGS with routine MTBC diagnostic workflows Methods We compared…
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Techno Trends
FDA Approves Novartis Kisqali® Femara® Co-Pack to treat metastatic breast cancer
Novartis has announced that its Kisqali Femara CoPack the first and only currently available combination pack with two prescription products in advanced breast cancer has received approval from the US Food and Drug Administration FDA The Kisqali Femara CoPack ribociclib tablets letrozole tablets is used to treat hormone receptorpositive human epidermal growth factor receptor negative HR HER advanced or metastatic…
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White Papers
Launching Global Clinical Trials—best Practices For Efficient And Cost-effective Translations: A Lionsbridge White Paper
Summary The target market for conducting global clinical trials has changed significantly moving beyond pharmaceutical early adopters to the mainstream marketplace This shift has placed a heightened focus on the language challenges and complexity of running a global clinical trial More and more companies are moving toward ascending regions such as India and China to…
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Industry Reports
Sanochemia Pharmazeutika AG (SAC) - Financial and Strategic SWOT Analysis Review
Sanochemia Pharmazeutika AG Sanochemia is a specialty pharmaceutical company that develops and manufactures of innovative drugs and diagnostics in selected indication areas such as neurodegeneration pain and cancer as well as diagnostic products based on contrast media The companys product portfolio includes radiological products including an array of xray imaging…
Advisory Board
Editorial Section
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Strategy
Failing Data Integrity Audit is not an Option
The timetomarket of blooming Asian pharmaceutical companies especially from India and China are being slowed by the increasing concerns of global and local regulators over data integrity How can they meet regulators audit expectation on data integrity and provide assurance…
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Research development
Reviving Pharma R&D Productivity with New Modalities
The pharmaceutical industry is facing a decline in RD productivity However genomics biomarkers and access to human tissue samples are offering a range of well validated but challenging biological targets To seize the opportunity leveraging New Modalities and abolishing silos…
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Clinical Trails
Patient Recruitment
To address the challenges faced in patient recruitment and retention in clinical trials innovative technologies are being utilised in AsiaPacific as well as other regions to optimise the processes involved From patient matching to improving the consent process technology has…
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Manufacturing
Added Costs for Added Protections
The Impact of Implementing Safety Features in Pharmaceutical Packaging and Labelling Serialization Unique Device Identification UDI and aggregation catalyse a paradigm shift for the entire industry and are already impacting the pharmaceutical supply chain In…
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Information Technology
Electronic FDA Submissions
If your time to you is worth savin then you better start swimmin or youll sink like a stone for the times they are a changin Bob Dylan
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Expert Talk
The Asian Healthcare Market
The Asian market is growing rapidly and along with this expansion comes the issue of drug counterfeiting Bernd offers his insight into the key trends affecting this market and what regulatory authorities are expecting manufacturers…