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Nov 2018Enable Injections Enters into Strategic Partnerships with UCB and Apellis Pharmaceuticals
Enable Injections Inc a patientcentric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of highvolume therapeutics today announced it has entered into development agreements with Apellis Pharmaceuticals and most recently UCB Enable Injections currently has partnerships with five companies to deliver…
14
Nov 2018Ferring Pharmaceuticals Enters Exclusive Agreement with INVO Bioscience
Ferring Pharmaceuticals announced today that it has signed an agreement to acquire from INVO Bioscience Inc the exclusive US commercialization rights for the INVOcell intravaginal culture IVC system which comprises the INVOcell IVC device retention device and holding block The INVOcell IVC device uses a…
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Nov 2018Ziopharm Oncology Announces Immuno-oncology Clinical Supply Agreement with Regeneron
Ziopharm Oncology Inctoday announced a clinical supply agreement with Regeneron Pharmaceuticals Inc to evaluate Ziopharms AdRTShIL plus veledimex in combination with Regenerons PD antibody Libtayo cemiplimabrwlc to treat patients with recurrent glioblastoma rGBM AdRTShIL plus veledimex is an investigational gene therapy designed to induce and…
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Nov 2018BridgeBio Pharma LLC Signs Joint Collaboration Agreement with Cincinnati Children's to Accelerate Development of Genetic Disease Therapeutics
BridgeBio Pharma LLC and Cincinnati Childrens Hospital Medical Center today announced they are entering into a research collaboration to identify and develop genetic disease therapies This partnership will combine BridgeBios strengths in therapeutic development for diseases of high unmet need with Cincinnati Childrens worldclass researchers…
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Nov 2018Strides enters into strategic partnership with SUDA Pharmaceuticals for the US market
Strides Pharma Science Limited Strides has announced that its stepdown wholly owned subsidiary Strides Pharma Global Pte Limited Singapore has entered into an exclusive product development licensing and supply agreement with SUDA Pharmaceuticals Ltd for its novel drug SUDH an oral spray of sumatriptan to…
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Nov 2018Ardelyx Announces FDA Acceptance of the Filing of its New Drug Application for Tenapanor for the Treatment of Patients with IBS-C
Ardelyx Inc today announced that the US Food and Drug Administration FDA has accepted for review the New Drug Application NDA for tenapanor for the treatment of patients with irritable…
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Nov 2018NeuroRx Receives FDA Breakthrough Therapy Designation for NRX-101, First Oral Drug Targeting Suicidal Bipolar Depression
NeuroRx a clinical stage biopharma company focused on the development of Rapid Acting Antidepressants RAADs that target the brains NMDA receptor has been granted Breakthrough Therapy Designation by the US…
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Nov 2018NMPA Accepts Biosimilar New Drug Application for IBI303, a Biosimilar Candidate to Humira(R) (adalimumab)
Innovent Biologics Inc Innovent a worldclass Chinabased biopharmaceutical company that develops and commercializes high quality drugs announced today that National Medical Products Administration NMPA successor to CFDA has accepted its…
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Nov 2018Theravance Biopharma Highlights Expanded COPD Indication for Trelegy Ellipta in Europe
Theravance Biopharma Inc Theravance Biopharma today highlighted that the European Commission authorized an expanded label for oncedaily Trelegy Ellipta fluticasone furoateumeclidiniumvilanterol FFUMECVI recognizing the products effect on exacerbations and making…
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Nov 2018Generon Receives Investigative New Drug (IND) Approval from China SFDA for A-319 to Treat Patients with B Cell Malignancies
Generon Corporation a leading biopharmaceutical company in China today announced it received approval for the Companys Investigational New Drug IND application from the State Food and Drug Administration SFDA of…
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Nov 2018World ADC San Diego 2018
Hanson Wade Ltd
Marriott Marquis San Diego
13-15
Nov 2018Microbiome Human Nutrition
Hanson Wade
Sheraton Boston Hotel
13-15
Nov 2018Computational Drug Development for Biologics Summit
Hanson Wade Ltd
The Westin Boston Waterfront
13-15
Nov 2018Cell & Gene Therapy Manufacturing 2018
IQPC Ltd
DoubleTree by Hilton Hotel London
TOP ARTICLES
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1
Identification of MicroRNAs and Their Targets in Cancer
Although our cells are well equipped with regulatory checkpoints transformation of normal cells to malignant cancerous cells often occurs as a genetic disease W..
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2
Smart Nano-Enabled Drug Carrier in Combating Tumor Development and Progress
Introduction The worldwide report of mortality due to lethal disease cancer is common and progressive nowadays Although nanomedicine advances in tumor biolog..
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3
Are you Ready for EU FMD?
With the deadline looming for enactment of EU FMD and US DSCSA Vikash Pushpraj Senior Vice President rfxcel explains how achieving compliance is about much more..
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4
Life-style, Environment, and Lack of Prediabetes Diagnosis Fueling Diabetic Epidemic
Introduction For the past ten years ample evidence exists to suggest that what we eat and how we live determines how our body and genes behave A rapid rise i..
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5
Cancer Stem Cell (CSC) Inhibitors
Cancer as a group of heterogeneous diseases very well known Unimaginable amounts of money and manhours have been spent in finding cure for this deadly disease H..
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6
Enhancement of the Aqueous Solubility and Permeability of Poorly Water- Soluble Drugs
Introduction Combinatorial chemistry High Throughput Screening technique HTS and other computeraided methods have proved their usefulness for drug design and..
Knowledge Bank
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Interviews
Merck
Staff Engineer, Manufacturing Science and Technology, South East Asia
Karen Chan is a process engineer at Merck Pte Ltd Chan has six years of experience in the biopharmaceutical industry and two years of experience in research development She provides technical support in areas such as process development troubleshoot..
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Articles
Identification of MicroRNAs and Their Targets in Cancer
Although our cells are well equipped with regulatory checkpoints transformation of normal cells to malignant cancerous cells often occurs as a genetic disease While awareness on the various cancercausing factors has been raised worldwide the incidence of cancer continues to increase each year To further complicate matters existing cancer treatments can be rendered ineffective…
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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
Alnylam’s ONPATTRO to Treat Patients with Hereditary ATTR Amyloidosis in Adults
Alnylams ONPATTRO patisiran lipid complex injection is a firstofitskind RNA interference RNAi therapeutic used to treat the polyneuropathy of hereditary transthyretinmediated hATTR Amyloidosis in adults RNAi is a completely new approach to the treatment of these diseases targeting the faulty protein that is causing the disease rather than treating the symptoms RNAi therapeutic is an entirely new class of medicines…
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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
Statin Drug Interactions and Related Adverse Reactions
Statins are generally well tolerated with a low frequency of adverse events but since statins are prescribed on a longterm basis many patients will typically receive pharmacological therapy for concomitant conditions during the course of statin treatment and potentially interacting…
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Research development
Stem Cell and Gene Delivery
These days gene and stem cell therapies have the potential to make the substantial impact on the treatment of several diseases However there are pros and cons of each strategy but the optimal selection of gene delivery vector or stem…
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Clinical Trials
Managing Clinical Trial Agreements
Clinical Trial Agreements set out how a clinical trial will be run at the site and are an essential GCP document There are a number of key factors that determine whether a Clinical Trial Agreement is successful in achieving that…
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Manufacturing
Drug Concentration Assurance of Continuous Tablet Manufacturing
In the pharmaceutical industry Real Time Release RTR can be facilitated by the development of a highly efficient control system The drug concentration in final tablet is one of the most critical quality attributes that…
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Information Technology
R&D DATA HUB
Faster decision making and better trial oversight at all levels requires truly next generation data integration and analytics Source and format agnostic data aggregation aided by modern data lake architecture and advanced analytics deliver interactive…
