Clinical Trials Data

DCGI gives Nod for Restricted Emergency Use to Itolizumab for moderate to severe COVID-19 patients | 7/12/2020

Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency Use authorisation by the Drugs Controller General of India (DCGI) based on clinical trials data . M/s Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name Alzumab. This indigenous drug has now been …

DCGI gives nod for restricted emergency use for Itolizumab in COVID-19 treatment | 7/11/2020

Comments  Listen to this Article India’s drug regulator has approved Itolizumab, a medicine used to cure severe plaque psoriasis for “restricted emergency use” to treat COVID-19 patients with moderate to severe acute respiratory distress. The approval was given based on clinical trials data , an official communique said. According to a press release M/s Biocon has been manufacturing and marketing this drug for the treatment of patients with …

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DCGI gives nod for ‘restricted emergency use’ of Itolizumab for moderate to severe COVID-19 patients | 7/11/2020

Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted ‘restricted emergency use’ authorisation by the Drugs Controller General of India (DCGI) based on clinical trials data .This indigenous drug has now been repurposed for COVID-19. Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name …

Drug regulator okays psoriasis injection for restricted emergency use in treating COVID-19 patients | 7/11/2020

Home COVID19 Drug regulator okays psoriasis injection for restricted emergency use in treating COVID-19 patients Drug regulator okays psoriasis injection for restricted emergency use in treating COVID-19 patients Last Updated on July 11, 2020 at 2:23 pm New Delhi, July 11: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate …

DGCI approves Itolizumab drug for restricted emergency use on COVID patients | 7/11/2020

DGCI approves Itolizumab drug for restricted emergency use on COVID patients July 11, 2020 New Delhi: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory distress, the Union health ministry said on Saturday. Considering the unmet medical needs in COVID-19, Drugs Controller General of India (DCGI) Dr …

DCGI gives nod for restricted emergency use of Itolizumab injection on COVID-19 patients | 7/11/2020

… of Itolizumab injection on moderate to severe COVID-19 patients amid the rising number of cases across India. The DCGI gave approval to the use of this injection on COVID-19 patient based on clinical trials data . Itolizumab (rDNA origin) is a monoclonal antibody that is already an approved… College Football Season Teeters on the Brink The idea of playing college sports this fall has felt iffy all along, like …

DGCI okays Itolizumab drug for restricted emergency use on COVID patients | 7/11/2020

Biocon, a domestic biopharmaceutical company, has been manufacturing and marketing the drug. Representational image. New Delhi: Based on clinical trials data , India’s drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory distress, the Union health ministry said on Saturday. Considering the unmet medical needs in COVID-19, Drugs Controller General of India (DCGI) Dr …

Personalizing the Power of Clinical Trial Analysis and Data Visualization | 7/2/2020

TOPICS: Clinical Trials Data Analytics July 2, 2020 CluePoints has launch a new business intelligence platform, BEYOND, designed to encompass more than just early risk detection, this extended visualization solution allows Sponsor and CRO users to explore areas of interest in one integrated business intelligence system. CluePoints is a provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. The new, powerful, analytics tool allows users to confidently …

Real-world characterization of blood glucose control and insulin use in the intensive care unit | 7/1/2020

… strategies. However, patient sub-phenotypes have now been identified by clinical and biomolecular profiles within syndromes such as sepsis and acute respiratory distress syndrome (ARDS) 1 , 2 . When these phenotypes are examined in prior clinical trials data , they exhibit strikingly different prognoses and responses to treatment 1 , 3 , 4 . Unpacking this heterogeneity may inform future trials and the provision of individualised treatment approaches. Hyperglycemia remains a commonly encountered complication in …

iBio to be Added to the Russell 2000® and Russell 3000® Indexes NYSE:IBIO | Globe Newswire | 6/26/2020

… two novel vaccines against SARS-CoV-2. Shortly thereafter, we demonstrated manufacturability of both platforms, signed key partnerships with providers of preclinical testing services and adjuvant technologies, and gained support from industry leaders in clinical trials data management. With preclinical immunization data for our IBIO-200 and IBIO-201 COVID-19 vaccine candidates expected in Q3-2020, we see potential additional value-creating milestones in the near term.” FTSE Russell is …

Some Covid-19 trial sponsors never posted other study results in an EU database. Will they hide data again? | STAT | 6/18/2020

… analysis. Specifically, two-thirds of the 118 Covid-19 trials analyzed are currently run by universities and companies that have no record of uploading clinical study results to the European Union Drug Regulating Authorities Clinical Trials Data base, or EudraCT , which trial sponsors are required to do so under EU rules. Of these, 39 trials are being run by sponsors that, in the past, violated requirements to upload results. Of the …

Are We Ready to Adopt a New Approach to Run Clinical Trials? | 6/16/2020

COVID-19 has put a spotlight on how the industry runs clinical trials, with the pandemic forcing “hundreds of clinical trials to grind to a halt” per an NPR analysis of federal clinical trials data . 1 Since many new and existing studies are not actively enrolling subjects, and monitors are unable to conduct onsite monitoring visits, the industry has the opportunity in the upcoming months to design more efficient ways …

Calculating change from baseline in R | 6/11/2020

As a statistical programmer working on clinical trials data I frequently have to calculate change from baseline. In clinical trials baseline is typically defined as the last measurement prior to a clinical trial subject receiving any study drug. Change from baseline is frequently calculated for laboratory measurements, e.g. hemoglobin concentration in blood. SAS is still the standard used to program datasets in the pharmaceutical industry but R is catching up …

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | PR Newswire | 6/9/2020

Read what people are saying about working here. Braine-l’Alleud Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a …

#Hiring #DevOps #Docker #Data #Software #Chennai #Tamilnadu #Pharma #Science | 5/30/2020

… Immediate Openings for the below positions @ Chennai 1. DEVOPS (7 – 12 Years) 2. Kubernetes / Docker (7 - 12 Years) 3. Data Science Engineer (6 - 12 Years) Experience in life sciences, pharma, or informatics industry with Clinical Trials Data is highly preferred. Share CV to Posted by In subject mention reference by jobs.tirunelveli.me Note: Applicants are advised to research bonafides of advertisers independently. http://jobs.tirunelveli.me/ shall not have any responsibility in this …

Global Interventional Oncology Market Analysis 2020 with Key Player Profiles Including ABK Biomedical Inc., Guerbet, Medtronic Plc and Sirtex Medical | PR Newswire | 5/22/2020

… Johnson & Johnson (U.S.), AngioDynamics, Inc. (U.S.), and Monteris Medical (U.S.). Key Topics Covered: 1 Executive Summary 2 Introduction 3 Market Analysis 3.1 Introduction 3.2 Market Segmentation 3.3 Factors Influencing Market 3.4 Regulatory Affairs 3.5 Clinical Trials Data 3.6 Porter’s Five Force Analysis 3.7 Supply Chain Analysis 3.8 Reimbursement Scenario 3.9 Regulatory Approved Interventional Oncology Products by Company 3.10 Funding Scenario 3.11 Market Share Analysis by Major Players 3.12 Interventional Oncology …

Medical Content Editor | 5/18/2020

… way that makes information much easier for medical frontline professionals to access. Content should be curated with links to the best clinical resources on topics such as COVID-19 treatment, practice guidelines, diagnostics and clinical trials data . Where needed, content should be proactively organized to guide clinicians with the input and guidance of the resource center clinician advisory group. Essential Responsibilities ¡ Research COVID-19 resources across the internet, with …

AI in the Medical Field | 5/11/2020

… instantly, with AI nourishing back recommendations as well as working scenarios bad and the good. Artificial intelligence helps pharma companies find patients for clinical trials. While AI can be used to make sense of clinical trials data , another use of artificial intelligence in the pharmaceutical industry is to find the patients to take them. Read about On Demand App Development Company , Mobile Application Development Toronto and much more related to …

Study: The Lower Your Vitamin D Levels, the Higher Your Risk of Severe COVID-19 ​ | 4/27/2020

Study: The Lower Your Vitamin D Levels, the Higher Your Risk of Severe COVID-19 ​ 0 Scientists Dosing Men With Female Sex Hormones in COVID-19 Clinical Trials Data from 212 COVID-19 patients show that clinical outcomes for how severely you are affected by COVID-19 are directly related to your vitamin D serum levels. Specifically, study authors said: “For each standard deviation increase in vitamin D level, the …

Life Science Analytics Market Demand, Supply, Growth Factors, Latest Rising Trend & Forecast to 2027 | 4/21/2020

… Rising Trend & Forecast to 2027 Life science analytics is used for capitalizing on big data to increase the global collaboration based on accurate clinical research information. The life sciences analytics helps to standardize the clinical trials data and validate its adherence. Advanced analytics aids in early detection of potential risks and also enables to proactively address them. The growth of the life science analytics market can be attributed to the …

Coronavirus pandemic brings hundreds of U.S. clinical trials to a halt | 4/13/2020

… working, what else do I have?” The COVID-19 pandemic has forced hundreds of clinical trials to grind to a halt, stalling research into cancer, strokes, dementia and more, an NPR analysis of federal clinical trials data has found. As Americans have been told to stay home to prevent spreading the novel coronavirus, people enrolled in clinical trials are being notified that those trials have been suspended or won’t begin …

COVID-19 Leads To Stoppage Of Clinical Trials, Jeopardizing Patients’ Care : Shots - Health News : NPR | 4/11/2020

… working, what else do I have?” The COVID-19 pandemic has forced hundreds of clinical trials to grind to a halt, stalling research into cancer, strokes, dementia and more, an NPR analysis of federal clinical trials data has found. As Americans have been told to stay home to prevent spreading the novel coronavirus, people enrolled in clinical trials are being notified that those trials have been suspended or won’t begin …

Coronovirus Pandemic Brings Hundreds Of U.S. Clinical Trials To A Halt | 4/11/2020

… working, what else do I have?” The COVID-19 pandemic has forced hundreds of clinical trials to grind to a halt, stalling research into cancer, strokes, dementia and more, an NPR analysis of federal clinical trials data has found. As Americans have been told to stay home to prevent spreading the novel coronavirus, people enrolled in clinical trials are being notified that those trials have been suspended or won’t begin …

Clinical Trials in Alzheimer’s Disease: A Hurdle in the Path of Remedy | 4/1/2020

… is a required application between the preclinical phase and phases I-IV. Though much of the data obtained at each step of the clinical trial process is available to the public through the NIH clinical trials data base (clinicaltrials.gov), this is still a relatively new level of transparency, having come into place in 2007. Now, over ten years later, it is important to note that regulation and enforcement of timely reporting …

Life Science Analytics Market Future, Size, Share, Growth, Trends and Forecast 2027 | 3/30/2020

Press Releases Life Science Analytics Market Future, Size, Share, Growth, Trends and Forecast 2027 Life science analytics is used for capitalizing on big data to increase the global collaboration based on accurate clinical research information. The life sciences analytics helps to standardize the clinical trials data and validate its adherence. Advanced analytics aids in early detection of potential risks and also enables to proactively address them. The growth of the …

Digital Health

NCCN Policy Summit Explores 21st Century Cures Act and the Impact of Health Information Technology | PR Newswire | 6/10/2020

… Founder , CrowdCare Foundation and Multiple Myeloma Patient; Clay Alspach , JD , Principa l, Leavitt Partners; Anobel Odisho , MD, MPH , Urologist , UCSF Helen Diller Family Comprehensive Cancer Center and Clinical Informatics Lead , UCSF Center for Digital Health Innovation; and Susan Stiles , MHA, MBA, FACHE , Executive, Oncology Business Unit , Cerner Corporation. “Today, it takes an extraordinary effort for patients to access their records at multiple facilities in order to share it so it …

Clinical Data

Vanda Pharmaceuticals CEO’s Proposal on Clinical Trial Data Sharing, COVID-19 and Remdesivir | PR Newswire | 5/20/2020

… by the scientific community and data sharing disclosures are now required by most scientific journals according to the recommendations of the International Committee of Medical Journal Editors. 3 The reason for sharing of clinical data includes allowing the scientific community to independently form their own conclusions from their own analyses, develop new insights from the data, and accelerate discoveries in the field by not having to repeat the same experiments …

Food and Drug Administration

Concert Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Update on Clinical Programs | Business Wire | 4/30/2020

… and Upcoming Milestones CTP-543: An Investigational Treatment for Moderate-to-Severe Alopecia Areata CTP-543 Poised to Advance into Phase 3 Testing. Following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in March 2020, the Company plans to initiate its Phase 3 program of CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete …

National Institutes of Health

TrialScope Launches Website as Free Resource for Researchers, Patients on COVID-19 Trials | PRWeb | 3/24/2020

… clinical trial information, TrialScope has launched CoronaClinicalTrials.com . The website automatically syncs clinical trial information from ClinicalTrials.gov, the national registry of clinical trials. Established by the United States National Library of Medicine at the National Institutes of Health, it houses the largest database of clinical trials. CoronaClinicalTrials.com features a robust search engine, powered by TrialScope technology, that enables site visitors to search for COVID-19 clinical trials by keyword or location …

Real World Evidence

COTA Presents Posters at ASH Annual Meeting, Reviewing Complexities of Generating RWD and How it Complements Traditional Clinical Trial Data | PR Newswire | 12/4/2019

BOSTON , Dec. 4, COTA, Inc., a healthcare technology company that uses real-world data (RWD) to bring clarity to cancer care, is presenting posters at the American Society of Hematology Annual Meeting & Exposition, ASH 2019, in Orlando, FL from December 7-10, 2019 . Collectively, the posters review existing challenges for generating RWD and the promise of this data to support new research in cancer biology. “The genetic environment – whether of individual …

Electronic Health Records

COTA Presents Posters at ASH Annual Meeting, Reviewing Complexities of Generating RWD and How it Complements Traditional Clinical Trial Data | PR Newswire | 12/4/2019

… Patient Multiple Myeloma Registry Researchers from COTA and Multiple Myeloma Research Foundation (MMRF) explore challenges associated with existing methods of patient data curation to build the MMRF Registry. Despite a significant investment in electronic health records in the United States , many institutions are unable to provide relevant, research-grade clinical data in a timely, cost-free, and coded manner. A comprehensive, research-focused data abstraction process for coded data exchange …

Advanced Analytics

COTA Presents Posters at ASH Annual Meeting, Reviewing Complexities of Generating RWD and How it Complements Traditional Clinical Trial Data | PR Newswire | 12/4/2019

… through the use of real-world evidence. The Company organizes fragmented, often hidden data from the real world to provide clarity in cancer care. Combining clinical expertise in cancer with proprietary technology and advanced analytics, COTA helps inform decisions and action in oncology. COTA partners with providers, payers, and life science companies to ensure that everyone touched by cancer has a clear path to the right care. To learn more …

Biotech

Metastatic Breast Cancer Alliance Announces Release of MBC Connect 2.0 | PR Newswire | 12/2/2019

PRNewswire/ – The Metastatic Breast Cancer Alliance (MBCA), the largest coalition of nonprofit breast cancer organizations, pharmaceutical/biotech companies, and patient advocates in the U.S., today announced the release of MBC Connect 2.0. MBC Connect is an interactive, web- and mobile-friendly patient experience registry that empowers patients in the U.S. to collaborate with researchers to advance metastatic breast cancer research, and with this new release will also potentially match patients …

Medical Imaging

Owkin Teams up with NVIDIA and King’s College London to Deliver AI to Hospitals While Protecting Patient Data With Federated Learning | PR Newswire | 12/2/2019

… to advance medical research, announces it is teaming up with technology company NVIDIA and King’s College London (KCL) to deliver Federated Learning in the healthcare and life sciences sector. The King’s College London Medical Imaging and AI Centre for Value Based Healthcare (AI4VBH) is one of the world’s most ambitious Federated Learning projects in healthcare. It will initially connect four of London’s premier teaching hospitals before expanding throughout the UK …

Clinical Research

Clinical Data Analyst | 11/27/2019

Nihar Parikh, [email protected] Our client is a dynamic healthcare organization whose goal is to integrate clinical research and patient care to save lives. In this role you will provide support for clinical trials data quality assessment, data standards, analysis scripts and reports, data structure issues, information flow, data transfers and more while working closely with cross-functional teams. You will oversee QA of clinical trials and biomarker results, implementation …

Biosimilars

FDA Approves Pfizer’s Biosimilar, ABRILADA™ (adalimumab-afzb) for Multiple Inflammatory Conditions | Business & Finance | heraldchronicle.com | Business Wire | 11/18/2019

… treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. 2 For full details of indications please see the approved label. “Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” said Richard Blackburn, Global President, Pfizer Inflammation and Immunology. “Our current portfolio of …

Regenerative Medicine

Global Regenerative Medicine Market to Grow Over $81 Billion by 2023 and Market Driven by Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries - ReportsnReports | PR Newswire | 11/13/2019

PUNE, India This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials. The analysis indicates that the global Regenerative Medicine Market was worth $28 billion in 2018 and will grow to over $81 billion by 2023, with a CAGR of 23.3 …

Gene Therapy

Global Regenerative Medicine Market to Grow Over $81 Billion by 2023 and Market Driven by Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries - ReportsnReports | PR Newswire | 11/13/2019

… tissue regeneration Neurodegenerative diseases e.g., ALS, Alzheimer’s and Parkinson’s Spinal cord injury Musculoskeletal disorders Ocular disease Global Financial Landscape The last few years have been busy for regeneration medicine, cellular therapeutics and the gene therapy industry, with high investment from pharma giants such as Eli Lilly, BMS, Astra Zeneca and Sanofi. Company partnerships were also in motion that included Kite Pharma and Bluebird/Five Prime, Juno and Fate Therapeutics/ Editas …

Rare Disease Research

Sangamo and Pfizer Announce Updated Phase 1/2 Results for SB-525 Investigational Hemophilia A Gene Therapy Showing Sustained Increased Factor VIII Levels | Business Wire | 7/6/2019

BRISBANE, Calif. & NEW YORK- Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE) today announced updated results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. The data showed that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII (FVIII) activity levels. The first two patients treated at the 3e13 vg/kg …

Bristol-Myers

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | PR Newswire | 6/9/2020

Read what people are saying about working here. Braine-l’Alleud Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of … experience required. Understanding of the application of biostatistics to medical/clinical trials data. Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Excellent verbal and written communications skills …

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | Business Wire | 6/9/2020

Read what people are saying about working here. Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around … experience required. Understanding of the application of biostatistics to medical/clinical trials data. Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Excellent verbal and written communications skills …

Bristol-Myers Squibb

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | PR Newswire | 6/9/2020

Read what people are saying about working here. Braine-l’Alleud Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of … experience required. Understanding of the application of biostatistics to medical/clinical trials data. Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Excellent verbal and written communications skills …

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | The Guardian | 6/9/2020

Read what people are saying about working here. Braine-l’Alleud Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of … experience required. Understanding of the application of biostatistics to medical/clinical trials data. Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Excellent verbal and written communications skills …

Novartis

First Industry Datasets Submitted to ASH Research Collaborative Data Hub | PR Newswire | 12/4/2019

WASHINGTON , Dec. 4, The ASH Research Collaborative (ASH RC) has collaborated with two industry leaders, Novartis Pharmaceuticals Corporation (Novartis) and Amgen, to include de-identified patient data from three separate studies of nearly 500 patients living with Sickle Cell Disease (SCD) and more than 1,000 patients with multiple myeloma as part of an unprecedented data sharing initiative. Novartis and Amgen are the first two pharmaceutical companies to provide datasets to …

Writing Plain Language Summaries for Clinical Trials: What We Have Learned So Far, Upcoming Webinar Hosted by Xtalks | PRWeb | 11/18/2019

… features the following speakers: Debra Guerreiro, Associate Director, Plain Language Summary Program Lead, Janssen Data Transparency Dianne Beland, Senior Manager, Clinical Trial Data Sharing/Disclosure, Celgene Corporation Jessica Valencia, PhD, Operational Excellence Expert, Novartis Pharmaceuticals, Patient Engagement & Advocacy Vidhi Vashisht, Associate Director, Clinical Trial Disclosure, Development Operations, Kinapse, a Syneos Health Company Speakers will also share lessons learned from translating English plain language summaries, discuss common pitfalls and recommendations to …

eMDs

TrialScope Launches Clinical Trials Website for EMD Serono | PRWeb | 12/2/2019

TrialScope Launches Clinical Trials Website for EMD Serono Share Article TrialScope, in conjunction with EMD Serono, has launched a new clinical trials website . The site is designed to inform the public and healthcare professionals about clinical trials in general and provide details on EMD Serono clinical trials. EMD Serono Clinical Trials website “Both EMD Serono and TrialScope share a commitment to clinical trial transparency, awareness and patient engagement.” – TrialScope CEO …

EMD Serono and Pfizer Provide Update on Phase III JAVELIN Gastric 100 Trial | PR Newswire | 11/8/2019

… options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company’s home state of Massachusetts. www.emdserono.com . About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany , a leading science and technology company, operates across healthcare, life science and performance materials. Around 56,000 employees work to make a positive difference to millions of people’s …

Celgene

Writing Plain Language Summaries for Clinical Trials: What We Have Learned So Far, Upcoming Webinar Hosted by Xtalks | PRWeb | 11/18/2019

… 2019 at 9am EST (2pm GMT/UK) and features the following speakers: Debra Guerreiro, Associate Director, Plain Language Summary Program Lead, Janssen Data Transparency Dianne Beland, Senior Manager, Clinical Trial Data Sharing/Disclosure, Celgene Corporation Jessica Valencia, PhD, Operational Excellence Expert, Novartis Pharmaceuticals, Patient Engagement & Advocacy Vidhi Vashisht, Associate Director, Clinical Trial Disclosure, Development Operations, Kinapse, a Syneos Health Company Speakers will also share lessons learned from translating English plain …

Global Regenerative Medicine Market to Grow Over $81 Billion by 2023 and Market Driven by Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries - ReportsnReports | PR Newswire | 11/13/2019

… manufacturing steps in CAR-T therapy? What challenges lie ahead for CAR-T production? Companies Mentioned Astellas Institute for Regenerative Medicine (Ocata Therapeutics) AstraZeneca Athersys Baxter International (Baxalta, Shire) Bayer Caladrius Biosciences (NeoStem) Celgene CHA Biotech Chimerix Cynata Therapeutics Cytori Therapeutics Eisai Genzyme (Sanofi) GSK Janssen InCyte Corp MedImmune MEDIPOST Merck Mesoblast Millennium Pharmaceutical NuVasive Osiris Therapeutics Plasticell Pluristem Therapeutics Pfizer SanBio Current Stem Cell Trials Seattle Genetics Current Stem …

Pfizer

(CHN-Beijing Office) China Dev | 9/9/2019

Pfizer China Dev in Beijing Office , China Resources Managed (budget and FTEs): • None Primary Duties (fundamental components of role-both strategic & operational): Monitoring • Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion. • Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues. Management of Investigator Sites • Proactively manage a number of studies and investigator sites …

Linguamatics Extends Text Analytics Leadership in 2017 | PR Newswire | 12/7/2017

… leveraging I2E. Client representatives from AstraZeneca, Cancer Research UK, Cell Signaling Technology, Huntsman Cancer Institute, Kaiser Permanente, Mundipharma, Penn Medicine, Pfizer, Roche and Sanofi discussed specific I2E use cases, from early drug discovery to clinical … resources, such as scientific literature, patents, Electronic Health Records (EHRs), clinical trials data, news feeds, social media and proprietary content. I2E can be deployed as an in-house enterprise system, or as Software-as-a …

Genentech

Rituxan (rituximab; Biogen/Roche/Chugai/Zenyaku Kogyo) Drug Overview & Product Profiles 2016-2026 | PR Newswire | 7/13/2019

… the treatment of a number of B-cell non-Hodgkin’s lymphomas and for rheumatoid arthritis patients who inadequately respond to anti-tumor necrosis factor therapy. Rituximab is marketed in the US by Roche’s Genentech subsidiary and Biogen under the Rituxan brand name. Outside the US, the drug is marketed by Roche as MabThera, and in Japan it is marketed by Chugai and Zenyaku Kogyo as Rituxan. Despite failing to meet …

Genentech Presents a Broad Range of Data for Hemlibra (Emicizumab-kxwh) Demonstrating Continued Benefits for People With Hemophilia A at the ISTH 2019 Congress | Business Wire | 7/9/2019

SOUTH SAN FRANCISCO, Calif.–( BUSINESS WIRE )–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data for Hemlibra ® (emicizumab-kxwh) across multiple pivotal studies in people with hemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress on July 6-10 in Melbourne, Australia. In total, Genentech presented 21 abstracts from its hemophilia program, including five …

Mundipharma

Global Treanda (bendamustine; Teva/Mundipharma/Eisai Drug Overview & Product Profiles 2017-2026 | PR Newswire | 7/13/2019

DUBLIN , July 12, The “Treanda/Bendeka” report has been added to ResearchAndMarkets.com’s offering. Treanda (bendamustine; Teva/Mundipharma/Eisai) is an intravenous cytotoxic agent. The exact mechanism of action of the drug is still not fully known, but it is a mechlorethamine derivative which has the ability to cause crosslinking between the DNA strands through covalent bond formation. Several pathways have been associated with the cytotoxic activity of Treanda, including the …

Linguamatics Extends Text Analytics Leadership in 2017 | PR Newswire | 12/7/2017

… ways they are leveraging I2E. Client representatives from AstraZeneca, Cancer Research UK, Cell Signaling Technology, Huntsman Cancer Institute, Kaiser Permanente, Mundipharma, Penn Medicine, Pfizer, Roche and Sanofi discussed specific I2E use cases, from early drug … resources, such as scientific literature, patents, Electronic Health Records (EHRs), clinical trials data, news feeds, social media and proprietary content. I2E can be deployed as an in-house enterprise system, or as Software-as-a …

5AM Ventures

Scientist.com Brings Life Science Industry Leaders Together at Faster Science Summit | PRWeb | 5/1/2019

… Scientist.com Original Service, Trial Insights , was also unveiled at the conference. Exclusively available through Scientist.com, Trial Insights curates publicly-available clinical trials data from at least seven different sources, including ClinicalTrials.gov, and presents useful metrics … its founding in 2007, Scientist.com has raised $32 million from 5AM Ventures, Leerink Transformation Partners and Heritage Provider Network among others. Visit scientist.com to learn more. Join Scientist.com on social media: YouTube , LinkedIn , Twitter , Facebook …

Scientist.com Launches Trial Insights, A Transformative Clinical Trials Data Analytics Solution | Business Wire | 4/16/2019

Scientist.com Launches Trial Insights, A Transformative Clinical Trials Data Analytics Solution The world’s largest online marketplace rolls out empowering researchers with on demand to help drive therapeutic decisions April 16, 2019 07:55 AM Eastern Daylight … its founding in 2007, Scientist.com has raised $32 million from 5AM Ventures, Leerink Transformation Partners and Heritage Provider Network among others. Visit scientist.com to learn more. Join Scientist.com on social media: YouTube , LinkedIn , Twitter , Facebook …

Leerink Transformation Partners

Scientist.com Brings Life Science Industry Leaders Together at Faster Science Summit | PRWeb | 5/1/2019

… Scientist.com Original Service, Trial Insights , was also unveiled at the conference. Exclusively available through Scientist.com, Trial Insights curates publicly-available clinical trials data from at least seven different sources, including ClinicalTrials.gov, and presents useful metrics … in 2007, Scientist.com has raised $32 million from 5AM Ventures, Leerink Transformation Partners and Heritage Provider Network among others. Visit scientist.com to learn more. Join Scientist.com on social media: YouTube , LinkedIn , Twitter , Facebook and - Instagram …

Scientist.com Launches Trial Insights, A Transformative Clinical Trials Data Analytics Solution | Business Wire | 4/16/2019

Scientist.com Launches Trial Insights, A Transformative Clinical Trials Data Analytics Solution The world’s largest online marketplace rolls out empowering researchers with on demand to help drive therapeutic decisions April 16, 2019 07:55 AM Eastern Daylight … in 2007, Scientist.com has raised $32 million from 5AM Ventures, Leerink Transformation Partners and Heritage Provider Network among others. Visit scientist.com to learn more. Join Scientist.com on social media: YouTube , LinkedIn , Twitter , Facebook and Instagram …

Brigham and Women's Hospital

Merck and Pfizer’s SGLT2 Inhibitor STEGLATROTM (ertugliflozin) Meets Primary Endpoint in VERTIS CV Trial for Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease | Business Wire | 6/16/2020

KENILWORTH, N.J. & NEW YORK- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced the presentation of results from the Phase 3 VERTIS CV cardiovascular (CV) outcomes trial that evaluated STEGLATRO (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, versus placebo, added to background standard of care treatment, in more than 8,200 patients with type 2 diabetes and atherosclerotic CV …

Merck and Pfizer’s SGLT2 Inhibitor STEGLATROTM (ertugliflozin) Meets Primary Endpoint in VERTIS CV Trial for Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease | Business Wire | 6/16/2020

Coronavirus News Support Local Journalism Now, more than ever, the world needs trustworthy reporting—but good journalism isn’t free. Please support us by subscribing. Subscribe AP Merck and Pfizer’s SGLT2 Inhibitor STEGLATROTM (ertugliflozin) Meets Primary Endpoint in VERTIS CV Trial for Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease Jun 16, 2020 Save KENILWORTH, N.J. & NEW YORK–(BUSINESS WIRE)–Jun 16, 2020– Merck (NYSE: MRK), known as MSD outside …

Memorial Sloan Kettering Cancer Center

European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma | PR Newswire | 10/28/2019

… with untreated advanced or metastatic RCC with a clear cell component. The study included patients across risk groups (International Metastatic Renal Cell Carcinoma Database Consortium [IMDC]: 21% favorable, 62% intermediate and 16% poor; Memorial Sloan Kettering Cancer Center [MSKCC]: 22% favorable, 65% intermediate and 11% poor). The primary efficacy endpoints were progression-free survival (PFS) as assessed by a Blinded Independent Central Review (BICR) using RECIST v1.1 and overall survival …

Blood Cancer Experts Discuss Latest Treatment Innovations at NCCN 2019 Annual Congress: Hematologic Malignancies(tm) | 9/10/2019

… Saul Rosenberg Professor of Lymphoma , Stanford University School of Medicine and Andrew D. Zelenetz, MD, PhD , Medical Director, Quality Informatics , Memorial Sloan Kettering Cancer Center . The Congress will address new, emerging, and novel therapeutic agents … to help healthcare providers improve outcomes for their patients.” “The clinical trials data and updated recommendations that we’re presenting can help clinicians to optimize and individualize treatment selection, minimize toxicities, and manage adverse events,” said …

Mayo Clinic

Montmed announces positive clinical trial data on SiteSmart™ | PR Newswire | 10/4/2019

… al. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab. 2013;39(5)445-53. doi: 10.1016/j.diabet.2013.05.006. 2. Frid A, et al. Worldwide Injection techniques questionnaire study. Mayo Clinic Proc. 2016;91(9):1212-1223. doi: 10.1016/j.mayocp.2016.06.011. 3. Forum for Injection Techniques (FIT). http://fit4diabetes.com SOURCE Montméd Related Links http://montmed.ca …

Blood Cancer Experts Discuss Latest Treatment Innovations at NCCN 2019 Annual Congress: Hematologic Malignancies™ | PR Newswire | 9/10/2019

… to share expert consensus on the latest evidence, in order to help healthcare providers improve outcomes for their patients.” “The clinical trials data and updated recommendations that we’re presenting can help clinicians to optimize and … the University of Pennsylvania Yi Lisa Hwa , APRN, CNP, DNP , Mayo Clinic Cancer Center Lauren N. Spendley , MSN, AGNP-BC, AOCN , Dana-Farber Cancer Institute Laura J. Zitella , MS, RN, ACNP-BC, AOCN , UCSF Helen …

Kaiser Permanente

Blood Cancer Experts Discuss Latest Treatment Innovations at NCCN 2019 Annual Congress: Hematologic Malignancies™ | PR Newswire | 9/10/2019

… to share expert consensus on the latest evidence, in order to help healthcare providers improve outcomes for their patients.” “The clinical trials data and updated recommendations that we’re presenting can help clinicians to optimize and … Fisher , MD , Fox Chase Cancer Center Michael M. Green , MD , Kaiser Permanente Jarrod Holmes , MD , Annadel Medical Group Michaela Liedtke , MD , Stanford Cancer Institute Thomas G. Martin III , MD , UCSF Helen Diller Family Comprehensive Cancer …

Linguamatics Extends Text Analytics Leadership in 2017 | PR Newswire | 12/7/2017

… the innovative ways they are leveraging I2E. Client representatives from AstraZeneca, Cancer Research UK, Cell Signaling Technology, Huntsman Cancer Institute, Kaiser Permanente, Mundipharma, Penn Medicine, Pfizer, Roche and Sanofi discussed specific I2E use cases, from … resources, such as scientific literature, patents, Electronic Health Records (EHRs), clinical trials data, news feeds, social media and proprietary content. I2E can be deployed as an in-house enterprise system, or as Software-as-a …

Laura Wood

Orthotic Devices Pipeline Assessment, 2019 Report - ResearchAndMarkets.com | Business Wire | 11/12/2019

… quarter 2019 financial results 6.30 Apr 26, 2019: Nationally recognized expert in consumerism joins Henry Ford Health System 7 Appendix For more information about this report visit https://www.researchandmarkets.com/r/v9zk4j Contacts ResearchAndMarkets.com Laura Wood, Senior Press Manager [email protected] 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 …

Pedicle Screw Systems - 2019 Medical Devices Pipeline Assessment - ResearchAndMarkets.com | Business Wire | 11/12/2019

… governance appointment of two new board members 6.20 Jul 25, 2019: Stryker reports second quarter 2019 operating results 7 Appendix For more information about this report visit https://www.researchandmarkets.com/r/9jckwa Contacts ResearchAndMarkets.com Laura Wood, Senior Press Manager [email protected] 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 …

Bristol, Connecticut

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | PR Newswire | 6/9/2020

Read what people are saying about working here. Braine-l’Alleud Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of … experience required. Understanding of the application of biostatistics to medical/clinical trials data. Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Excellent verbal and written communications skills …

Biostatistician - Bristol-Myers Squibb - Eigenbrakel | Globe Newswire | 6/9/2020

Bristol- Purpose: As part of Biometrics & Data Sciences (BDS), the biostatistician is a member of cross-functional development teams, who contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions … experience required. Understanding of the application of biostatistics to medical/clinical trials data. Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Excellent verbal and written communications skills …