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Fresenius Kabi starts United for Clinical Nutrition initiative in Europe with first-of-its-kind clinical study assessing critically ill patients in 11 European countries

BAD HOMBURG, GERMANY – [November 18, 2019] The first patients are about to be enrolled in the EuroPN survey, a clinical study that will assess the nutritional balance and focus on functional outcomes of critically ill patients in about 100 hospitals across 11 European countries. The survey is an important scientific project by United for Clinical Nutrition (UFCN), a global initiative that strives to fight hospital malnutrition and its detrimental effects on patient outcomes. Healthcare... Source: RealWire

Securecell introduces Sephara, a novel, silicon-based in-situ filtration membrane

• Sephara is changing the way automated analytical sampling as well as perfusion processes at the benchtop scale will be performed• Securecell offers an early access program for the Sephara technologyUrdorf (Zurich), Switzerland, 18 November, 2019 – Securecell today announced that it has introduced Sephara, a high performance in-situ filtration membrane for applications in bioprocess sampling and perfusion processes for use in selected bioprocess laboratories. Interested users can participate in an early access program for... Source: RealWire

New Bespoke service for small and emerging Pharma and Biotech companies

A new, tailor-made service for small and emerging Pharma and Biotech companies has just been launched by specialist scientific consulting organization, G&L Scientific. Under the name Bespoke, this niche service will provide fully-integrated Regulatory and Quality support shepherding products through development and on to market.Based and founded on many years of extensive practical experience with more than 2,500 consultants in over 100 countries, the team at G&L has a thorough understanding of the unique needs... Source: RealWire

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology™... Source: RealWire

TSI Reports Enrollment of First 10 Patients in its Phase 2 Ischemic Stroke Clinical Trial and Completion of its Phase 2 Study Protocol in Myocardial Infarction

Studies Aim to Confirm Safety and Efficacy of Novel Bio-inspired Clot-dissolving TherapyCambridge, Mass., October 30, 2019 -- Thrombolytic Science, LLC (TSI) today announced progress with 10 patients enrolled in its prospective, randomized, multicenter Phase 2 clinical trial, designed to confirm the safety and efficacy of the sequential dual-treatment regimen of low-dose tissue plasminogen activator (tPA) and HisproUK (TSI’s mutant prourokinase [proUK]) in 200 ischemic stroke patients. The clinical trial is led by Prof. Diederik Dippel,... Source: RealWire

BioMed X completes Alzheimer’s disease research project

Heidelberg, Germany, October 28th, 2019 – BioMed X announced today the successful completion of their first research collaboration project with AbbVie in the field of tau-mediated neurodegeneration in Alzheimer’s disease. BioMed X received a milestone payment and the results of the project were transferred to AbbVie. The BioMed X team successfully developed research tools to assess disease-associated post-translational modification signatures of the tau protein in the brains and cerebrospinal fluids of sporadic Alzheimer’s patients and... Source: RealWire

G&L Scientific Inc announces the opening of new offices in Basel, Switzerland

Basel, October 2nd, 2019 G&L Scientific Inc., a market-leading, multinational, scientific consultancy with over 25 years at the forefront of Regulatory Affairs and Quality Assurance, has announced the opening of new offices in Basel, Switzerland. The company cites increased demand from clients in Continental Europe as the driver for this latest expansion.“The opening of these additional offices in Switzerland reaffirms G&L’s commitment to both new and existing clients in Europe — an area of key... Source: RealWire

Leading Omani Pharmacy Chain Relies on InfiNet Wireless for High-Bandwidth, Always-On Connectivity

Rapid installation of high capacity, futureproof wireless solutions at its sites ensure round-the-clock, real-time access to dataDubai, United Arab Emirates – August 19, 2019 – InfiNet Wireless, the global leader in fixed wireless broadband connectivity, today announced that it has successfully delivered a comprehensive communication infrastructure to Muscat Pharmacy & Stores LLC, one of Oman’s most well recognized pharmacy chains. Operating over an extensive network of more than 200 suppliers, across 69 outlets, the company... Source: RealWire

Trialbee are Looking for Volunteers with Eczema for Clinical Trial

Is eczema a part of your life? Volunteers needed for clinical trialTrialbee has now made it possible for about 80 candidates with eczema to volunteer in a medical research study around North Yorkshire & Sheffield. The screening period starts mid- September but pre sign-up is already possible. Get started.How can I participate?To be eligible, you must be:18 years of age or olderDiagnosed with moderate to severe eczemaAdvised not to apply creams or moisturizers for dry... Source: RealWire

The Eastern Pathology Alliance to offer Hepatitis C testing services to the wider NHS capitalising on next generation sequencing technology

First and only laboratory in the UK to use equipment from Vela Diagnostics New testing process delivers huge patient benefits in terms of speed, accuracy and reliability yet with costs significantly reduced August 12, 2019 – The Eastern Pathology Alliance (EPA) announces today that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays. Founded in 2012, the EPA has become a centre of... Source: RealWire

Orion Transforms its Clinical Trials with Medidata

Global pharmaceutical company expands use of Medidata Rave Clinical Cloud™ to spur growth and innovationAgreement builds on long-standing relationship since 2006 Unified platform approach creates a single source of truth for greater efficiency and accelerated trialsSelf-sufficient study teams use intuitive, modern interface to quickly and efficiently set up trial protocols LONDON – June 26, 2019 – Medidata (NASDAQ: MDSO) today announced that global pharmaceutical company Orion will consolidate all clinical trials on the Medidata Rave... Source: RealWire

French pharma group signs with Aspera for SAM managed services

Paris, June 11, 2019. Aspera, the leading provider of solutions and services for Software Asset Management (SAM), announced today the signing of a 3 year contract for delivery managed services to an enterprise that figures among the top 5 pharmaceutical companies in the world. USU SAS, a French subsidiary of the USU Group, sells Software Asset Management solutions in France under the name Aspera. In order to manage its software deployments, ensure license compliance, and... Source: RealWire

Medidata recognised as a 2019 UK Great Place to Work®

Company scores high for having a culture of diversity & belonging and work-life balance London, 16th May 2019 – Medidata has been named one of the UK’s Best Workplaces™, published by Great Place to Work®. This recognition highlights the company’s unique, inclusive culture among the many reasons employees take pride in being part of the “Medidatian” community.Established in 1999, Medidata was recognised by its employees as a company that promotes a healthy workplace culture based... Source: RealWire

Medidata NEXT London 2019: Blending the Best of Clinical Development, AI-Enabled Platform Demonstrations and Regulatory Compliance for Leaders in Life Sciences

Attend NEXT London 2019 to explore how the European Life Science landscape can embrace digital transformation to stay ahead of regulatory and market developmentsNovartis, IQVIA, Syneos Health, UK Office for Life Sciences, NIHR, Deloitte and more keynote speakers to share unique insights Conference breakouts offer attendees interactive, hands-on learning opportunities to design, conduct, manage, and monitor the next generation of clinical research studiesLONDON, May 13 2019: Registration is open for Medidata’s NEXT London, the second... Source: RealWire

EAMSP kicks off information campaign about digitization in German healthcare sector

Fighting the allergic reaction to anything new with #neuschnupfenBrussels, Belgium | Hamburg, Germany, May 7, 2019. While online banking, ordering a taxi or doing their weekend shopping with an app has become commonplace for most Germans, many remain cautious when it comes to digital health services. In order to combat this scepticism and to highlight the benefits of digitization in the healthcare sector – with reference to successful innovation in other European countries – the... Source: RealWire

Fresenius Kabi starts United for Clinical Nutrition initiative in Europe with first-of-its-kind clinical study assessing critically ill patients in 11 European countries

BAD HOMBURG, GERMANY – [November 18, 2019] The first patients are about to be enrolled in the EuroPN survey, a clinical study that will assess the nutritional balance and focus on functional outcomes of critically ill patients in about 100 hospitals across 11 European countries. The survey is an important scientific project by United for Clinical Nutrition (UFCN), a global initiative that strives to fight hospital malnutrition and its detrimental effects on patient outcomes. Healthcare... Source: RealWire

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology™... Source: RealWire

TSI Reports Enrollment of First 10 Patients in its Phase 2 Ischemic Stroke Clinical Trial and Completion of its Phase 2 Study Protocol in Myocardial Infarction

Studies Aim to Confirm Safety and Efficacy of Novel Bio-inspired Clot-dissolving TherapyCambridge, Mass., October 30, 2019 -- Thrombolytic Science, LLC (TSI) today announced progress with 10 patients enrolled in its prospective, randomized, multicenter Phase 2 clinical trial, designed to confirm the safety and efficacy of the sequential dual-treatment regimen of low-dose tissue plasminogen activator (tPA) and HisproUK (TSI’s mutant prourokinase [proUK]) in 200 ischemic stroke patients. The clinical trial is led by Prof. Diederik Dippel,... Source: RealWire

BioMed X completes Alzheimer’s disease research project

Heidelberg, Germany, October 28th, 2019 – BioMed X announced today the successful completion of their first research collaboration project with AbbVie in the field of tau-mediated neurodegeneration in Alzheimer’s disease. BioMed X received a milestone payment and the results of the project were transferred to AbbVie. The BioMed X team successfully developed research tools to assess disease-associated post-translational modification signatures of the tau protein in the brains and cerebrospinal fluids of sporadic Alzheimer’s patients and... Source: RealWire

G&L Scientific Inc announces the opening of new offices in Basel, Switzerland

Basel, October 2nd, 2019 G&L Scientific Inc., a market-leading, multinational, scientific consultancy with over 25 years at the forefront of Regulatory Affairs and Quality Assurance, has announced the opening of new offices in Basel, Switzerland. The company cites increased demand from clients in Continental Europe as the driver for this latest expansion.“The opening of these additional offices in Switzerland reaffirms G&L’s commitment to both new and existing clients in Europe — an area of key... Source: RealWire

Trialbee are Looking for Volunteers with Eczema for Clinical Trial

Is eczema a part of your life? Volunteers needed for clinical trialTrialbee has now made it possible for about 80 candidates with eczema to volunteer in a medical research study around North Yorkshire & Sheffield. The screening period starts mid- September but pre sign-up is already possible. Get started.How can I participate?To be eligible, you must be:18 years of age or olderDiagnosed with moderate to severe eczemaAdvised not to apply creams or moisturizers for dry... Source: RealWire

The Eastern Pathology Alliance to offer Hepatitis C testing services to the wider NHS capitalising on next generation sequencing technology

First and only laboratory in the UK to use equipment from Vela Diagnostics New testing process delivers huge patient benefits in terms of speed, accuracy and reliability yet with costs significantly reduced August 12, 2019 – The Eastern Pathology Alliance (EPA) announces today that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays. Founded in 2012, the EPA has become a centre of... Source: RealWire

Orion Transforms its Clinical Trials with Medidata

Global pharmaceutical company expands use of Medidata Rave Clinical Cloud™ to spur growth and innovationAgreement builds on long-standing relationship since 2006 Unified platform approach creates a single source of truth for greater efficiency and accelerated trialsSelf-sufficient study teams use intuitive, modern interface to quickly and efficiently set up trial protocols LONDON – June 26, 2019 – Medidata (NASDAQ: MDSO) today announced that global pharmaceutical company Orion will consolidate all clinical trials on the Medidata Rave... Source: RealWire

Medidata recognised as a 2019 UK Great Place to Work®

Company scores high for having a culture of diversity & belonging and work-life balance London, 16th May 2019 – Medidata has been named one of the UK’s Best Workplaces™, published by Great Place to Work®. This recognition highlights the company’s unique, inclusive culture among the many reasons employees take pride in being part of the “Medidatian” community.Established in 1999, Medidata was recognised by its employees as a company that promotes a healthy workplace culture based... Source: RealWire

Medidata NEXT London 2019: Blending the Best of Clinical Development, AI-Enabled Platform Demonstrations and Regulatory Compliance for Leaders in Life Sciences

Attend NEXT London 2019 to explore how the European Life Science landscape can embrace digital transformation to stay ahead of regulatory and market developmentsNovartis, IQVIA, Syneos Health, UK Office for Life Sciences, NIHR, Deloitte and more keynote speakers to share unique insights Conference breakouts offer attendees interactive, hands-on learning opportunities to design, conduct, manage, and monitor the next generation of clinical research studiesLONDON, May 13 2019: Registration is open for Medidata’s NEXT London, the second... Source: RealWire

Smith & Nephew Adopts One-platform Approach with Medidata to Support Expansion of Study Portfolio

Medical technology company consolidates study management on the Medidata Rave® Clinical Cloud™By using a consolidated platform, data flows seamlessly between electronic data capture (EDC) and clinical trial management system (CTMS) solutionsClinical operations teams can focus on critical study oversight activities rather than data collection and integrationLondon, UK: 1st May 2019 - Medidata (NASDAQ: MDSO) today announced that medical technology business Smith & Nephew (LSE: SN, NYSE: SNN) has consolidated all of its global studies on... Source: RealWire

Medidata Launches Acorn AI™ and Appoints Dr. Rama Kondru as CIO

Acorn AI is designed to answer the most important questions across R&D and commercialisation, enabling customers to improve outcomes for patients and to accelerate growthThe Acorn AI team is led by industry veterans who are shaping the future of life sciencesPowered by Medidata’s standardised and structured clinical data repository, one of the largest in the world, Acorn AI immediately becomes a leading AI company dedicated to life sciencesIndustry visionary, Rama Kondru, Ph.D., is appointed CIO... Source: RealWire

Senior Experts from WHO, HPRA, Wellcome Trust, Centauri Therapeutics to present at 21st Annual Superbugs & Superdrugs Conference in 4 weeks’ time

In just 4 weeks’ time, SMi's 21st Annual Superbugs & Superdrugs Conference will kick off in London, setting out to provide an international audience with key updates on the latest developments in combating antibiotic resistance, including the processes and strategies pharmaceuticals use to develop novel therapeutics that utilise alternative mechanisms to treat multi-drug resistant infections.In the run up to the conference, SMi caught up with this year’s co-chair Lloyd Czaplewski, Director at Chemical Biology Ventures,... Source: RealWire

Lipotype announces “Lipidomics Excellence Award” for Breakthrough Lipidomics Projects

Call for Applications open till 30 March, 2019Dresden/Germany, 16 January, 2019. The international scientific community is called to submit applications for the premiere of the world’s first award for cutting edge contributions to the progress of life sciences through lipidomics, the 2019 “Lipidomics Excellence Award” (LEA) until 30 March, 2019. Prof. Dr. Kai Simons, Professor and Director Emeritus at Max-Planck-Institute for Molecular Cell Biology and Genetics Dresden and Founder and CEO of Lipotype, explains: “Blood... Source: RealWire

PAREXEL Introduces New Dedicated Division to Help Emerging Biotech Companies Reach their Goals Quickly and Cost-Effectively

BOSTON, January 7, 2019 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today introduced a new, dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively. PAREXEL Biotech builds on the Company’s heritage of clinical, regulatory, commercial and technology expertise with enhanced strategic consulting and asset development capabilities, offering a new Biotech-focused team and organizational structure for customers. Led by James Anthony, Global Head... Source: RealWire

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology™... Source: RealWire

The Eastern Pathology Alliance to offer Hepatitis C testing services to the wider NHS capitalising on next generation sequencing technology

First and only laboratory in the UK to use equipment from Vela Diagnostics New testing process delivers huge patient benefits in terms of speed, accuracy and reliability yet with costs significantly reduced August 12, 2019 – The Eastern Pathology Alliance (EPA) announces today that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays. Founded in 2012, the EPA has become a centre of... Source: RealWire

Orion Transforms its Clinical Trials with Medidata

Global pharmaceutical company expands use of Medidata Rave Clinical Cloud™ to spur growth and innovationAgreement builds on long-standing relationship since 2006 Unified platform approach creates a single source of truth for greater efficiency and accelerated trialsSelf-sufficient study teams use intuitive, modern interface to quickly and efficiently set up trial protocols LONDON – June 26, 2019 – Medidata (NASDAQ: MDSO) today announced that global pharmaceutical company Orion will consolidate all clinical trials on the Medidata Rave... Source: RealWire

Medidata NEXT London 2019: Blending the Best of Clinical Development, AI-Enabled Platform Demonstrations and Regulatory Compliance for Leaders in Life Sciences

Attend NEXT London 2019 to explore how the European Life Science landscape can embrace digital transformation to stay ahead of regulatory and market developmentsNovartis, IQVIA, Syneos Health, UK Office for Life Sciences, NIHR, Deloitte and more keynote speakers to share unique insights Conference breakouts offer attendees interactive, hands-on learning opportunities to design, conduct, manage, and monitor the next generation of clinical research studiesLONDON, May 13 2019: Registration is open for Medidata’s NEXT London, the second... Source: RealWire

Worldwide first and only shotgun lipidomics service provider with official GMP certificate

Dresden / Germany, 16th April 2019 Good Manufacturing Practices (GMP) ensure safety and quality of pharmaceutical products. Lipotype is the worldwide first and only officially GMP certified shotgun lipidomics service provider for pharmaceutical applications. Quality variations can pose direct threats to patient health – especially in the pharma industry. This is why quality control plays a central role in manufacturing and developing pharmaceutical products. GMP certifications are issued by governmental authorities to ensure product quality... Source: RealWire

Exclusive speaker interview with SCHOTT Pharmaceutical Systems released for Pre-Filled Syringes East Coast 2019

SMi Group reports: Senior expert from SCHOTT Pharmaceutical Systems is set to present at Pre-Filled Syringes East Coast Conference in just four weeks’ time in Boston, USA. The 6th Annual Pre-Filled Syringes East Coast conference is returning to Boston, USA in April 8th – 9th 2019. The two-day event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design... Source: RealWire

Registration opens for SMi's 4th Pre-filled Syringes West Coast 2019

Building on last year’s success SMi Group are proud to present the 4th Pre-filled Syringes West Coast 2019 Conference and exhibition in CA, USA.Conference Overview:Pre-Filled Syringes West Coast will gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase the latest and advancements, keeping you at the forefront of a booming industry.Join us June 3rd-4th 2019, in San Diego along with one post-conference workshop: The Secrets to... Source: RealWire

Senior Experts from WHO, HPRA, Wellcome Trust, Centauri Therapeutics to present at 21st Annual Superbugs & Superdrugs Conference in 4 weeks’ time

In just 4 weeks’ time, SMi's 21st Annual Superbugs & Superdrugs Conference will kick off in London, setting out to provide an international audience with key updates on the latest developments in combating antibiotic resistance, including the processes and strategies pharmaceuticals use to develop novel therapeutics that utilise alternative mechanisms to treat multi-drug resistant infections.In the run up to the conference, SMi caught up with this year’s co-chair Lloyd Czaplewski, Director at Chemical Biology Ventures,... Source: RealWire

PAREXEL Introduces New Dedicated Division to Help Emerging Biotech Companies Reach their Goals Quickly and Cost-Effectively

BOSTON, January 7, 2019 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today introduced a new, dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively. PAREXEL Biotech builds on the Company’s heritage of clinical, regulatory, commercial and technology expertise with enhanced strategic consulting and asset development capabilities, offering a new Biotech-focused team and organizational structure for customers. Led by James Anthony, Global Head... Source: RealWire

ATAI Life Sciences acquires majority stake in Perception Neuroscience to develop arketamine therapy for neuropsychiatric diseases

Munich and New York, 03 January 2019 - ATAI Life Sciences AG has acquired a majority stake in New York based Perception Neuroscience, a biopharmaceutical company focused on developing innovative therapies in neuropsychiatry. Perception was founded by Jonathan Sporn, MD, and Jay Kranzler, MD, PhD, both of whom have held multiple senior R&D leadership roles in the pharmaceutical industry and will continue to be minority shareholders. The company has been advised by Bruce Leuchter from... Source: RealWire

PAREXEL Navigates China's Complex Drug Development and Market Landscape for Global Biopharmaceutical Companies with New China Advisory Service

BOSTON, October 31, 2018 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced that the Company has launched a new China Advisory Service to help global biopharmaceutical companies participate in the growing, yet complex market opportunity within China. The offering leverages PAREXEL’s deep experience with and knowledge of the Chinese biopharmaceutical landscape to help companies navigate all aspects of the country’s drug development process. This includes overall strategy, agency engagement and... Source: RealWire

PAREXEL Advances Patient-Centric Drug Development with Introduction of its Patient Innovation Center

BOSTON, September 11, 2018 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced the launch of its Patient Innovation Center, designed to help guide sponsors in their efforts to improve efficiency and success across all areas of biopharmaceutical development including clinical trial design, recruitment, execution and market access. With a patient-centric approach, the Center can help sponsors improve the drug development process by reducing the practical, financial and geographical barriers patients... Source: RealWire

Continuous Listening to Patients and Healthcare Professionals at Heart of 7i Group and Confirmit Collaboration

‘In-the-moment’ insight to contribute to improved patient outcomesLondon and Manchester, UK, New York, NY and Oslo, Norway: 27 March 2018: Confirmit and 7i Group Ltd, a specialist healthcare consultancy, have formed a strategic collaboration to harness their Market Research and pharmaceutical sector knowledge and expertise. The collaboration will enable an enhanced patient-centric approach to drug development and the evolution and delivery of medicines, devices and treatment protocols. 7i will use Confirmit’s text analytics solution, Confirmit... Source: RealWire

PAREXEL Introduces Integrated Medical Writing Solutions Service Offering

Comprehensive end-to-end services enable effective, streamlined communication with key stakeholders across all stages of drug development and commercializationBOSTON, March 21, 2018 – PAREXEL International Corporation, the world’s leading innovator of biopharmaceutical services, today introduced PAREXEL's Medical Writing Solutions, a newly integrated, end-to-end offering that provides a wide variety of communication services needed throughout each critical stage of the drug development and commercialization process.Biopharmaceutical companies today are increasingly in need of high quality documentation to meet... Source: RealWire

PAREXEL and CHA Medical Group Partner to Enhance Early Phase Clinical Research in Korea

Collaboration combines best-in-class offerings from CHA and PAREXEL to enhance early phase clinical trials in growing hub for drug developmentBOSTON, March 13, 2018 – PAREXEL International Corporation, the world’s leading innovator of biopharmaceutical services, today announced an alliance with CHA Medical Group (CHA) to enhance early phase clinical development in Korea. The collaboration is designed to provide biopharmaceutical companies with comprehensive services that leverage PAREXEL’s global clinical research and regulatory expertise with CHA’s experience conducting... Source: RealWire

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology™... Source: RealWire

The Eastern Pathology Alliance to offer Hepatitis C testing services to the wider NHS capitalising on next generation sequencing technology

First and only laboratory in the UK to use equipment from Vela Diagnostics New testing process delivers huge patient benefits in terms of speed, accuracy and reliability yet with costs significantly reduced August 12, 2019 – The Eastern Pathology Alliance (EPA) announces today that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays. Founded in 2012, the EPA has become a centre of... Source: RealWire

MedStar Health and FDA to lead a post-conference workshop at Pre-Filled Syringes West Coast 2019

Developing a Human Factors Validation Plan with Consideration for the Digital Health MarketplaceThis workshop will provide an overview of human factors validation strategies that companies should consider as the pre-filled syringe market increasingly takes on digital health components. A case study of a pre-filled syringe with connection to a mobile app will be utilized throughout the course to demonstrate the concepts under discussion and help participants work through a study plan. The workshop aims to... Source: RealWire

Exclusive speaker interview with SCHOTT Pharmaceutical Systems released for Pre-Filled Syringes East Coast 2019

SMi Group reports: Senior expert from SCHOTT Pharmaceutical Systems is set to present at Pre-Filled Syringes East Coast Conference in just four weeks’ time in Boston, USA. The 6th Annual Pre-Filled Syringes East Coast conference is returning to Boston, USA in April 8th – 9th 2019. The two-day event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design... Source: RealWire

Registration opens for SMi's 4th Pre-filled Syringes West Coast 2019

Building on last year’s success SMi Group are proud to present the 4th Pre-filled Syringes West Coast 2019 Conference and exhibition in CA, USA.Conference Overview:Pre-Filled Syringes West Coast will gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase the latest and advancements, keeping you at the forefront of a booming industry.Join us June 3rd-4th 2019, in San Diego along with one post-conference workshop: The Secrets to... Source: RealWire

Pre-Filled Syringes - Chemical Compatibility and Design Strategies

At SMi’s 2019 Pre-Filled Syringes East Coast USA Conference, industry leaders will meet in Boston to share their insights on best design practice, drug compatibility within the whole supplier chain and challenges with manufacturing and drug delivery. Key highlights include:Cyclo Olefin Polymer (COP) – technical data update• Key properties of COP• Case study. Biologics formulation for COP syringe optimized to eliminating use of surfactant• Case study. Study on protein adsorption/aggregation – COP vs glass• Case... Source: RealWire

Senior Experts from WHO, HPRA, Wellcome Trust, Centauri Therapeutics to present at 21st Annual Superbugs & Superdrugs Conference in 4 weeks’ time

In just 4 weeks’ time, SMi's 21st Annual Superbugs & Superdrugs Conference will kick off in London, setting out to provide an international audience with key updates on the latest developments in combating antibiotic resistance, including the processes and strategies pharmaceuticals use to develop novel therapeutics that utilise alternative mechanisms to treat multi-drug resistant infections.In the run up to the conference, SMi caught up with this year’s co-chair Lloyd Czaplewski, Director at Chemical Biology Ventures,... Source: RealWire

ATAI Life Sciences acquires majority stake in Perception Neuroscience to develop arketamine therapy for neuropsychiatric diseases

Munich and New York, 03 January 2019 - ATAI Life Sciences AG has acquired a majority stake in New York based Perception Neuroscience, a biopharmaceutical company focused on developing innovative therapies in neuropsychiatry. Perception was founded by Jonathan Sporn, MD, and Jay Kranzler, MD, PhD, both of whom have held multiple senior R&D leadership roles in the pharmaceutical industry and will continue to be minority shareholders. The company has been advised by Bruce Leuchter from... Source: RealWire

PAREXEL Navigates China's Complex Drug Development and Market Landscape for Global Biopharmaceutical Companies with New China Advisory Service

BOSTON, October 31, 2018 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced that the Company has launched a new China Advisory Service to help global biopharmaceutical companies participate in the growing, yet complex market opportunity within China. The offering leverages PAREXEL’s deep experience with and knowledge of the Chinese biopharmaceutical landscape to help companies navigate all aspects of the country’s drug development process. This includes overall strategy, agency engagement and... Source: RealWire

PAREXEL Advances Patient-Centric Drug Development with Introduction of its Patient Innovation Center

BOSTON, September 11, 2018 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced the launch of its Patient Innovation Center, designed to help guide sponsors in their efforts to improve efficiency and success across all areas of biopharmaceutical development including clinical trial design, recruitment, execution and market access. With a patient-centric approach, the Center can help sponsors improve the drug development process by reducing the practical, financial and geographical barriers patients... Source: RealWire

Devon Partnership NHS Trust Boosts Productivity and Patient Safety while Maximising Coverage with My Flu Jab App Hosted by UKCloud Health

Cloud-based Digital Health App Developed by Devon Partnership NHS Trust Enables Easier Recording, Real-time Reporting and Improved External SubmissionLondon - 19 April 2018 – UKCloud Health, the easy to adopt, easy to use and easy to leave assured cloud services company, today announced the successful completion of a collaboration with Devon Partnership NHS Trust to implement My Flu Jab App, a cloud-based app developed by the Trust to support staff during the winter flu period.... Source: RealWire

PAREXEL Introduces Integrated Medical Writing Solutions Service Offering

Comprehensive end-to-end services enable effective, streamlined communication with key stakeholders across all stages of drug development and commercializationBOSTON, March 21, 2018 – PAREXEL International Corporation, the world’s leading innovator of biopharmaceutical services, today introduced PAREXEL's Medical Writing Solutions, a newly integrated, end-to-end offering that provides a wide variety of communication services needed throughout each critical stage of the drug development and commercialization process.Biopharmaceutical companies today are increasingly in need of high quality documentation to meet... Source: RealWire

PAREXEL and CHA Medical Group Partner to Enhance Early Phase Clinical Research in Korea

Collaboration combines best-in-class offerings from CHA and PAREXEL to enhance early phase clinical trials in growing hub for drug developmentBOSTON, March 13, 2018 – PAREXEL International Corporation, the world’s leading innovator of biopharmaceutical services, today announced an alliance with CHA Medical Group (CHA) to enhance early phase clinical development in Korea. The collaboration is designed to provide biopharmaceutical companies with comprehensive services that leverage PAREXEL’s global clinical research and regulatory expertise with CHA’s experience conducting... Source: RealWire

PAREXEL Introduces Biological Sample Lifecycle Management Service to Address Growing Demand Across Drug Development

Solution combines global laboratory logistics expertise with leading sample tracking software to optimize the management and care of human biological samples throughout their lifecycleBOSTON, February 12, 2018 – PAREXEL International Corporation, the world’s leading innovator of biopharmaceutical services, today launched its Biological Sample Lifecycle Management service, enabling optimal use of human biological samples. The new service enables biopharmaceutical clients to more efficiently manage their often irreplaceable patient biological sample assets from informed consent and collection... Source: RealWire

A focus on the areas of the biggest growth, hitting on key topics and the most recent studies in the PFS field

Just 2 weeks remain until SMi opens its doors to host the conference, “Pre-Filled Syringes Europe” set to take place in London on 17 – 18 January.This year’s event is focusing on the areas of the biggest growth for the market, hitting on key topics in discussions and paralleling the most recent studies in the field.Key topics are:Considerations of the latest regulations and guidelines from the European bodies and the international platform (MHRA, Merck)Discussions on... Source: RealWire

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology™... Source: RealWire

Unisys Launches ActiveInsights™ PharmaTrack to Provide Enhanced Visibility and Management of the Entire Pharmaceutical Supply Chain

Combining existing expertise in its Life Sciences & Healthcare and Travel & Transportation verticals, new software solution leverages leading-edge Unisys Stealth® security and predictive analytics to address drug theft and counterfeiting and enhance patient safetyLondon, UK., May 23, 2017 – Unisys Corporation (NYSE: UIS) today launched PharmaTrack, new software that combines leading security, advanced data analytics and compliance technology in a single, unified platform to provide life sciences and healthcare companies enhanced visibility and oversight... Source: RealWire

Cancer virotherapy has high potential in China

As one of the highest achievements of Latvia with high export potential to China, cancer virotherapy was mentioned during the "16+1 Summit" held in Riga last week.Chinese Premier Li Keqiang addressed the Sixth China and Central and Eastern European (CEE) Countries Economic and Trade Forum in Riga. Latvia has been entrusted with the organisation of key events in cooperation between Central and Eastern European countries and China - the "16+1 Summit" and related side events... Source: RealWire

PAREXEL Wins Best Technological Development In Clinical Trial Award At The 11th Annual Scrip Awards

LONDON, December 18, 2015 - PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, announced today that its Country Allocation Technology won the Best Technological Development in Clinical Trials Award at the 2015 Scrip Awards. The award recognises the importance of PAREXEL’s Country Allocation Technology across the drug development value chain.Country selection, patient recruitment, and patient enrollment are among the most fundamental needs in drug development. Delays in one of these areas can... Source: RealWire

PAREXEL Launches IMPACT® Express Clinical Trial Management System

London, 1 December, 2015 — PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today introduced IMPACT® Express Clinical Trial Management System (CTMS). IMPACT Express provides a quick-to-implement, cost-effective clinical trial management solution to simplify clinical trial management and monitoring for small to mid-sized biopharmaceutical companies.Clinical trials are the most expensive component of the drug development process. Use of a single, unified clinical trial management system plays a vital role in helping biopharmaceutical... Source: RealWire

DeltaXML Announces DITA Compare's FrameMaker Plugin

Bringing greater flexibility to writers authoring and reviewing DITA content in FrameMaker, DeltaXML is pleased to announce our DITA Compare FrameMaker Plugin. Working in co-operation with Adobe, this latest development from DeltaXML represents the next step in supporting highly flexible and specialised DITA comparisons within Adobe FrameMaker itself.The Plugin has a variety of features designed to support authors and reviewers of DITA content. These features include word by word differencing, CALS and HTML table processing... Source: RealWire

PAREXEL Launches LIQUENT InSight® 6.0 Regulatory Information Management Platform

London, 31 March, 2015 - PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today introduced the latest version of its Regulatory Information Management (RIM) platform: LIQUENT InSight® 6.0. The LIQUENT InSight platform supports the entire regulatory product lifecycle, from early planning of registration targets through product retirement, with robust submission planning, publishing, viewing and registration management capabilities.While biopharmaceutical companies and the patients who can benefit from new drugs are located throughout the... Source: RealWire

Aseptix signs global technology license with Ecolab

December 2014, Loenen aan de Vecht, The Netherlands: Aseptix Health Sciences NV, the specialist in next generation antimicrobials headquartered in the Netherlands, today announced a global license agreement with Ecolab. Under the agreement, Ecolab will acquire a global license for Professional Markets on Aseptix technologies and acquire the Professional Products Division of Aseptix. Aseptix currently sells its Aseptix-branded professional products in Europe and India, mainly to healthcare, food processing and pharmaceutical clients.Aseptix is the inventor... Source: RealWire

PAREXEL International Announces Acquisition Of ClinIntel, Extending Leadership In Randomisation And Trial Supply Management

London, UK, October 3, 2014 - PAREXEL International Corporation (Nasdaq: PRXL)("PAREXEL" or the "Company"), a global clinical research organisation, announced today that the Company has acquired all of the outstanding equity securities of privately-owned ClinIntel, a provider of clinical Randomisation and Trial Supply Management (RTSM) services, based in the United Kingdom. ClinIntel's offerings will be combined into the ClinPhone® RTSM suite and are designed to make patient randomisation and clinical supply chain solutions more efficient. ... Source: RealWire

PAREXEL Names Dr. Sy Pretorius Chief Scientific Officer

To lead integration of Company’s global scientific expertise and services to meet end-to-end customer drug development needsLONDON, UK, 27 May, 2014 – PAREXEL International (NASDAQ: PRXL), a leading global biopharmaceutical services organisation, today named Dr. Sy Pretorius its Chief Scientific Officer. Dr. Pretorius currently serves as the Company’s Corporate Vice President and Worldwide Head of Early Phase, and will continue in that capacity in addition to assuming his expanded responsibilities.As Chief Scientific Officer, Dr. Pretorius... Source: RealWire

Ex-ARM CEO East backs Oxehealth’s vision for vital sign technology applications

Appointment of Warren East to Advisory Board endorses market opportunity for human signs monitoring Oxehealth, the spin-out from the University of Oxford's Institute of Biomedical Engineering, today underlined its intention of delivering on the high growth potential of its non-contact vital signs technology with the appointment of a highly experienced technology innovator: Warren East.Recently announced CBE recipient, Warren is former ARM CEO, board member of Rolls Royce, De La Rue, Dyson and BT, and winner... Source: RealWire

Teva welcomes landmark 'victory for patient' in Intellectual Property case

LONDON, 30 April 2013 - Teva UK Limited (Teva) has welcomed the judgment of the Court of Appeal today in support of its case against AstraZeneca relating to the validity of the patent covering quetiapine ER (a generic version of Seroquel®). This ruling confirmed the decision of the UK High Court in March 2012 that AstraZeneca's patent was invalid.Seroquel®, an antipsychotic treatment, was launched in its generic form quetiapine by Teva on expiry of the... Source: RealWire

SEP, The Pan European Specialty Urology Company, Acquires Mitem®

Speciality European Pharma Limited (SEP), the pan European urology focused specialty pharmaceutical company, is pleased to announce its acquisition of the product Mitem® from Curasan AG. Mitem is currently sold in Germany. SEP takes over German distribution rights and plans to introduce the product into other European markets once Marketing Authorisations are granted.Mitem is an injectable mitomycin product used either on its own or in combination with other therapies in the treatment of a range... Source: RealWire

Building on a successful launch, the EMAUD market access programme opens enrolment for a second year

EMAUD, the only complete and innovative course on pharmaceutical Market Access designed around the life cycle of a drug, is starting its second academic year on October 2010. Created and developed by Professor Mondher Toumi, at Lyon 1 University, EMAUD delivers high quality training for international students, at a time when market access has become the key driver of pharmaceutical companies' revenue. With contributions from key European agencies, renowned universities and leading pharmaceutical companies, EMAUD... Source: RealWire

New State-of-the-Art Radiochemistry Facility Fully Operational

First Custom "Preps" ShippedCambridgeshire, UK, 21 June 2010 - Quotient Bioresearch, a leading provider of early stage and specialist drug development services to pharmaceutical, biotechnology and medical device clients worldwide, today announced that its new, state-of-the-art radiochemistry facility in Cardiff, UK is fully operational and that shipments of radiolabelled products have commenced. All staff have successfully transferred from the former site operated by Amersham Radiolabelling Services to the new facility.The new facility, located close to... Source: RealWire

Saxony and Great Britain expand cooperation in state-of-the-art medical diagnostics

"Medical Innovation & Diagnostics" – Start-ups bring research results into clinical practice rapidly London’s King's College and the Saxon University of Excellence TU Dresden maintain a particularly close cooperation. In 2015, the two universities founded the "transCampus" for joint projects in research and medical education. Under the motto "Medical Innovation & Diagnostics", start-ups from Saxony and Great Britain will present themselves for the first time to a wider audience. We invite you to learn more... Source: RealWire

Medidata recognised as a 2019 UK Great Place to Work®

Company scores high for having a culture of diversity & belonging and work-life balance London, 16th May 2019 – Medidata has been named one of the UK’s Best Workplaces™, published by Great Place to Work®. This recognition highlights the company’s unique, inclusive culture among the many reasons employees take pride in being part of the “Medidatian” community.Established in 1999, Medidata was recognised by its employees as a company that promotes a healthy workplace culture based... Source: RealWire

Medidata NEXT London 2019: Blending the Best of Clinical Development, AI-Enabled Platform Demonstrations and Regulatory Compliance for Leaders in Life Sciences

Attend NEXT London 2019 to explore how the European Life Science landscape can embrace digital transformation to stay ahead of regulatory and market developmentsNovartis, IQVIA, Syneos Health, UK Office for Life Sciences, NIHR, Deloitte and more keynote speakers to share unique insights Conference breakouts offer attendees interactive, hands-on learning opportunities to design, conduct, manage, and monitor the next generation of clinical research studiesLONDON, May 13 2019: Registration is open for Medidata’s NEXT London, the second... Source: RealWire

Smith & Nephew Adopts One-platform Approach with Medidata to Support Expansion of Study Portfolio

Medical technology company consolidates study management on the Medidata Rave® Clinical Cloud™By using a consolidated platform, data flows seamlessly between electronic data capture (EDC) and clinical trial management system (CTMS) solutionsClinical operations teams can focus on critical study oversight activities rather than data collection and integrationLondon, UK: 1st May 2019 - Medidata (NASDAQ: MDSO) today announced that medical technology business Smith & Nephew (LSE: SN, NYSE: SNN) has consolidated all of its global studies on... Source: RealWire

Medidata Launches Acorn AI™ and Appoints Dr. Rama Kondru as CIO

Acorn AI is designed to answer the most important questions across R&D and commercialisation, enabling customers to improve outcomes for patients and to accelerate growthThe Acorn AI team is led by industry veterans who are shaping the future of life sciencesPowered by Medidata’s standardised and structured clinical data repository, one of the largest in the world, Acorn AI immediately becomes a leading AI company dedicated to life sciencesIndustry visionary, Rama Kondru, Ph.D., is appointed CIO... Source: RealWire

Lipotype announces “Lipidomics Excellence Award” for Breakthrough Lipidomics Projects

Call for Applications open till 30 March, 2019Dresden/Germany, 16 January, 2019. The international scientific community is called to submit applications for the premiere of the world’s first award for cutting edge contributions to the progress of life sciences through lipidomics, the 2019 “Lipidomics Excellence Award” (LEA) until 30 March, 2019. Prof. Dr. Kai Simons, Professor and Director Emeritus at Max-Planck-Institute for Molecular Cell Biology and Genetics Dresden and Founder and CEO of Lipotype, explains: “Blood... Source: RealWire

UKCloud Health joins the Global Alliance for Genomics and Health (GA4GH) to support greater collaboration across the UK healthcare, research, life sciences and technology sectors

Providing a secure, UK sovereign platform to help accelerate innovation and enhance collaboration between GA4GH members, UKCloud Health and its thriving partner ecosystemLondon – 16 July 2018 – UKCloud Health, the easy to adopt, use, and leave assured cloud services company, today announced that it has become a member of the Global Alliance for Genomics and Health (GA4GH), an international, non-profit alliance that is focused on accelerating the potential of research and medicine to advance... Source: RealWire

PAREXEL Introduces Biological Sample Lifecycle Management Service to Address Growing Demand Across Drug Development

Solution combines global laboratory logistics expertise with leading sample tracking software to optimize the management and care of human biological samples throughout their lifecycleBOSTON, February 12, 2018 – PAREXEL International Corporation, the world’s leading innovator of biopharmaceutical services, today launched its Biological Sample Lifecycle Management service, enabling optimal use of human biological samples. The new service enables biopharmaceutical clients to more efficiently manage their often irreplaceable patient biological sample assets from informed consent and collection... Source: RealWire

Hampleton Partners Advises In Sale Of BaseCase, A Life Sciences Data Visualisation Company, To Certara

BaseCase’s customer engagement platform will enhance Certara’s position as the leading technology-enabled life sciences decision support and consulting organisation.London, 2nd February 2018 - Hampleton Partners, the international mergers and acquisitions advisory firm for technology companies, has advised BaseCase Management GmbH, a data visualisation software as a service (SaaS) company, headquartered in Berlin, Germany, with offices in New York, on its sale to Princeton, New Jersey-based Certara, the global leader in model-informed drug development and regulatory... Source: RealWire

Open Accelerator announces winning Life Science Start-ups

Second edition of accelerator unveils seed funding winnersMilan, 21st December 2017 - Zcube today announces the winners of the second edition of its Open Accelerator programme aimed at Life Science start-ups and entirely supported by the Italian company: Zambon.The winners and their awards are as follows:ANANAS LIVER: A drug delivery system for chronic hepatitis limiting undesired side-effects in patients – University of Padua – Award: 100,000 euro seed investment and access to Zambon’s campus: OpenZone;BIOREK:... Source: RealWire

PAREXEL Announces Enhanced Global Data Operations Offering to Drive Efficiencies for Life Science Companies

Solution now features Clinical Metadata Repository to meet evolving data standards while providing seamless and more timely workflow for clients from data collection, through analysis to submissionBOSTON, December 18, 2017 – PAREXEL International Corporation, a leading global biopharmaceutical services provider, today introduced its enhanced Global Data Operations (GDO) solution, with augmented processes and expertise that further bolsters its world leading clinical data services, including data management, statistical programming and biostatistics. The enhanced offering is designed... Source: RealWire

PAREXEL Launches Perceptive® Cloud for the Life Sciences Industry

Cloud Platform Built on Microsoft Azure Delivers PAREXEL’s Valued Informatics Solutions on a Global, Trusted Architecture; Represents the First Offering of PAREXEL and Microsoft Alliance BOSTON, December 12, 2017 – PAREXEL International Corporation, a leading global biopharmaceutical services organization, today introduced the Perceptive® Cloud to the life sciences industry, as part of the organization’s recent alliance with Microsoft Corp. Perceptive Cloud elevates PAREXEL Informatics solutions into an enhanced cloud infrastructure built on Microsoft Azure, combining... Source: RealWire

Microsoft and PAREXEL form cloud technology alliance aimed at accelerating the pace of drug development

Companies seek to drive digital transformation of the biopharmaceutical industry by combining PAREXEL’s drug development expertise with Microsoft Azure.REDMOND, Wash., and BOSTON — Oct. 24, 2017 — Microsoft Corp. and PAREXEL International Corp., a leading global biopharmaceutical services organization, on Tuesday announced a technology development alliance aimed at driving innovation across the life sciences industry with technology powered by Microsoft Azure. The collaboration between Microsoft and PAREXEL is designed to help the industry accelerate drug... Source: RealWire

Bridgehead Software Expands Global Product Marketing Team

Rob Quinn Joins the Company to Leverage His Extensive Clinical Software Experience to Lead the Product Marketing Function, WorldwideWOBURN, Mass. and Ashtead, UK – September 26, 2017 – BridgeHead Software, a leader in healthcare data management, today announced the addition of Rob Quinn to lead Global Product Marketing. He brings more than 15 years’ experience in healthcare IT product marketing and will be instrumental in driving BridgeHead’s solution strategy and go-to-market initiatives. “Just as today’s... Source: RealWire

PAREXEL Launches Real-World Data Service Offering to Drive Value Demonstration of New Treatments

Integrated offering to be provided by new dedicated service group under PAREXEL® AccessBOSTON, September 6, 2017 - PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that it has launched a new end-to-end service offering to provide real-world data insights that help life science companies more effectively demonstrate product value. “In an increasingly competitive market, leveraging data to demonstrate value is critical. However, unstructured data can make it difficult to overcome... Source: RealWire

New Bespoke service for small and emerging Pharma and Biotech companies

A new, tailor-made service for small and emerging Pharma and Biotech companies has just been launched by specialist scientific consulting organization, G&L Scientific. Under the name Bespoke, this niche service will provide fully-integrated Regulatory and Quality support shepherding products through development and on to market.Based and founded on many years of extensive practical experience with more than 2,500 consultants in over 100 countries, the team at G&L has a thorough understanding of the unique needs... Source: RealWire

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology™... Source: RealWire

InfinityQS signs partnership with Irish integration specialist ONG Automation LTD

Latest addition to the company’s global channel partner program will support manufacturers to improve production quality and real-time process control ONG Automation, the Irish Industrial Automation System Integrator, has signed a partnership with InfinityQS, the global provider of Manufacturing Quality Intelligence software and services. Originally founded in County Cork, Ireland, ONG Automation operates internationally, specialising in areas including Pharmaceutical, Food & Beverage, Manufacturing, Energy, Medical Devices and Semiconductor. The company’s highly skilled engineers take pride... Source: RealWire

Worldwide first and only shotgun lipidomics service provider with official GMP certificate

Dresden / Germany, 16th April 2019 Good Manufacturing Practices (GMP) ensure safety and quality of pharmaceutical products. Lipotype is the worldwide first and only officially GMP certified shotgun lipidomics service provider for pharmaceutical applications. Quality variations can pose direct threats to patient health – especially in the pharma industry. This is why quality control plays a central role in manufacturing and developing pharmaceutical products. GMP certifications are issued by governmental authorities to ensure product quality... Source: RealWire

Exclusive speaker interview with SCHOTT Pharmaceutical Systems released for Pre-Filled Syringes East Coast 2019

SMi Group reports: Senior expert from SCHOTT Pharmaceutical Systems is set to present at Pre-Filled Syringes East Coast Conference in just four weeks’ time in Boston, USA. The 6th Annual Pre-Filled Syringes East Coast conference is returning to Boston, USA in April 8th – 9th 2019. The two-day event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design... Source: RealWire

Registration opens for SMi's 4th Pre-filled Syringes West Coast 2019

Building on last year’s success SMi Group are proud to present the 4th Pre-filled Syringes West Coast 2019 Conference and exhibition in CA, USA.Conference Overview:Pre-Filled Syringes West Coast will gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase the latest and advancements, keeping you at the forefront of a booming industry.Join us June 3rd-4th 2019, in San Diego along with one post-conference workshop: The Secrets to... Source: RealWire

Pre-Filled Syringes - Chemical Compatibility and Design Strategies

At SMi’s 2019 Pre-Filled Syringes East Coast USA Conference, industry leaders will meet in Boston to share their insights on best design practice, drug compatibility within the whole supplier chain and challenges with manufacturing and drug delivery. Key highlights include:Cyclo Olefin Polymer (COP) – technical data update• Key properties of COP• Case study. Biologics formulation for COP syringe optimized to eliminating use of surfactant• Case study. Study on protein adsorption/aggregation – COP vs glass• Case... Source: RealWire

Jennewein Biotechnologie and Yili Group join forces in China for microbiome research and human milk oligosaccharides to bring innovation to the largest baby food market

China represents the largest market for baby food globallyHuman milk oligosaccharides are key for the development of a healthy infant microbiomeHohhot, China & Rheinbreitbach, Germany – Jennewein Biotechnologie GmbH, the global leader in the research and manufacture of human milk oligosaccharides (HMO), and Inner Mongolia Yili Industrial Group (Yili Group), China’s leading dairy company, announce today the signing of a Memorandum of Understanding on infant microbiome and human milk oligosaccharides, with the goal to develop... Source: RealWire

PAREXEL Navigates China's Complex Drug Development and Market Landscape for Global Biopharmaceutical Companies with New China Advisory Service

BOSTON, October 31, 2018 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced that the Company has launched a new China Advisory Service to help global biopharmaceutical companies participate in the growing, yet complex market opportunity within China. The offering leverages PAREXEL’s deep experience with and knowledge of the Chinese biopharmaceutical landscape to help companies navigate all aspects of the country’s drug development process. This includes overall strategy, agency engagement and... Source: RealWire

G&L Scientific announces the appointment of Jessica Kokosinski as Vice President, Regulatory Affairs

Warren, NJ, 6 March, 2018 - G&L Scientific Inc, a leading provider of Clinical Research and Regulatory Affairs consulting to the healthcare industry, is delighted to announce the appointment of Jessica Kokosinski as Vice President, Regulatory Affairs.Jessica has successfully set up and led numerous long-term, large-scale regulatory engagements and teams across the entire product lifecycle, from clinical development to new product filings and post-approval activities for pharmaceutical, biologics and consumer health products. Her collaborative and... Source: RealWire

A focus on the areas of the biggest growth, hitting on key topics and the most recent studies in the PFS field

Just 2 weeks remain until SMi opens its doors to host the conference, “Pre-Filled Syringes Europe” set to take place in London on 17 – 18 January.This year’s event is focusing on the areas of the biggest growth for the market, hitting on key topics in discussions and paralleling the most recent studies in the field.Key topics are:Considerations of the latest regulations and guidelines from the European bodies and the international platform (MHRA, Merck)Discussions on... Source: RealWire

Open Accelerator announces winning Life Science Start-ups

Second edition of accelerator unveils seed funding winnersMilan, 21st December 2017 - Zcube today announces the winners of the second edition of its Open Accelerator programme aimed at Life Science start-ups and entirely supported by the Italian company: Zambon.The winners and their awards are as follows:ANANAS LIVER: A drug delivery system for chronic hepatitis limiting undesired side-effects in patients – University of Padua – Award: 100,000 euro seed investment and access to Zambon’s campus: OpenZone;BIOREK:... Source: RealWire

Enabling the Next Generation of Pre-Filled Syringes from Design to Manufacturing

SMi’s next annual conference in the global series of events on Pre-Filled Syringes will return to Boston, Massachusetts next April with Pre-Filled Syringes East Coast 2018. Growing year on year, the 5th annual conference and exhibition has already attracted an international audience of medical device experts and senior industry specialists from Belgium, Finland, France, Japan, United Kingdom and USA.“Over the past decade, pre-filled syringe venues have grown significantly in terms of content and attendance and... Source: RealWire

Europe's Leading Pre-Filled Syringes Summit to Showcase New Innovations from Leading Manufacturing and Pharmaceutical Experts

Aimed at capturing emerging trends in PFS injector technology, regulation and patient centric drug delivery, SMi Group’s flagship conference and exhibition on Pre-Filled Syringes will gather a global audience of over 100 senior PFS experts and big pharma when it returns to Central London on 17th and 18th January 2018 for its 10th annual show.“We are delighted to chair this forum which has been drafted with great care to allow for the very best discussions... Source: RealWire

PAREXEL Expands Global Regulatory Services with Addition of Senior Executives from FDA and Oncology Industry

New Appointments Enhance PAREXEL’s Leadership and Expertise in Bringing Commercially Viable, Reimbursable Products to MarketBOSTON, November 15, 2017 — PAREXEL, a leading global biopharmaceutical services provider, today announced the appointment of three former senior regulatory consulting executives from the U.S. Food and Drug Administration (FDA) and Oncology industry positions. The new hires are part of PAREXEL’s Global Integrated Product Development and Compliance team and will be focused on helping PAREXEL clients deliver commercially viable, reimbursable... Source: RealWire

Saxony and Great Britain expand cooperation in state-of-the-art medical diagnostics

"Medical Innovation & Diagnostics" – Start-ups bring research results into clinical practice rapidly London’s King's College and the Saxon University of Excellence TU Dresden maintain a particularly close cooperation. In 2015, the two universities founded the "transCampus" for joint projects in research and medical education. Under the motto "Medical Innovation & Diagnostics", start-ups from Saxony and Great Britain will present themselves for the first time to a wider audience. We invite you to learn more... Source: RealWire

Fresenius Kabi starts United for Clinical Nutrition initiative in Europe with first-of-its-kind clinical study assessing critically ill patients in 11 European countries

BAD HOMBURG, GERMANY – [November 18, 2019] The first patients are about to be enrolled in the EuroPN survey, a clinical study that will assess the nutritional balance and focus on functional outcomes of critically ill patients in about 100 hospitals across 11 European countries. The survey is an important scientific project by United for Clinical Nutrition (UFCN), a global initiative that strives to fight hospital malnutrition and its detrimental effects on patient outcomes. Healthcare... Source: RealWire

New Bespoke service for small and emerging Pharma and Biotech companies

A new, tailor-made service for small and emerging Pharma and Biotech companies has just been launched by specialist scientific consulting organization, G&L Scientific. Under the name Bespoke, this niche service will provide fully-integrated Regulatory and Quality support shepherding products through development and on to market.Based and founded on many years of extensive practical experience with more than 2,500 consultants in over 100 countries, the team at G&L has a thorough understanding of the unique needs... Source: RealWire

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology™... Source: RealWire

Hitachi and Centre Léon Bérard cancer center in Lyon to launch a research collaboration in the fight against cancer with AI

Hitachi, Ltd. (TSE:6501, “Hitachi”) and Centre Léon Bérard (CLB), a leading French Comprehensive Cancer Center in Lyon-France, announced today that they have entered into an agreement to jointly promote research and development aimed at improving the efficiency of diagnosis and treatment of cancer and established a new research laboratory called Hitachi Lyon Lab on the CLB site, starting November 5th.In this collaboration, Hitachi and CLB will conduct research and development of novel technologies to detect... Source: RealWire

BioMed X completes Alzheimer’s disease research project

Heidelberg, Germany, October 28th, 2019 – BioMed X announced today the successful completion of their first research collaboration project with AbbVie in the field of tau-mediated neurodegeneration in Alzheimer’s disease. BioMed X received a milestone payment and the results of the project were transferred to AbbVie. The BioMed X team successfully developed research tools to assess disease-associated post-translational modification signatures of the tau protein in the brains and cerebrospinal fluids of sporadic Alzheimer’s patients and... Source: RealWire

Trialbee are Looking for Volunteers with Eczema for Clinical Trial

Is eczema a part of your life? Volunteers needed for clinical trialTrialbee has now made it possible for about 80 candidates with eczema to volunteer in a medical research study around North Yorkshire & Sheffield. The screening period starts mid- September but pre sign-up is already possible. Get started.How can I participate?To be eligible, you must be:18 years of age or olderDiagnosed with moderate to severe eczemaAdvised not to apply creams or moisturizers for dry... Source: RealWire

The Eastern Pathology Alliance to offer Hepatitis C testing services to the wider NHS capitalising on next generation sequencing technology

First and only laboratory in the UK to use equipment from Vela Diagnostics New testing process delivers huge patient benefits in terms of speed, accuracy and reliability yet with costs significantly reduced August 12, 2019 – The Eastern Pathology Alliance (EPA) announces today that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays. Founded in 2012, the EPA has become a centre of... Source: RealWire

Orion Transforms its Clinical Trials with Medidata

Global pharmaceutical company expands use of Medidata Rave Clinical Cloud™ to spur growth and innovationAgreement builds on long-standing relationship since 2006 Unified platform approach creates a single source of truth for greater efficiency and accelerated trialsSelf-sufficient study teams use intuitive, modern interface to quickly and efficiently set up trial protocols LONDON – June 26, 2019 – Medidata (NASDAQ: MDSO) today announced that global pharmaceutical company Orion will consolidate all clinical trials on the Medidata Rave... Source: RealWire

Medidata recognised as a 2019 UK Great Place to Work®

Company scores high for having a culture of diversity & belonging and work-life balance London, 16th May 2019 – Medidata has been named one of the UK’s Best Workplaces™, published by Great Place to Work®. This recognition highlights the company’s unique, inclusive culture among the many reasons employees take pride in being part of the “Medidatian” community.Established in 1999, Medidata was recognised by its employees as a company that promotes a healthy workplace culture based... Source: RealWire

Medidata NEXT London 2019: Blending the Best of Clinical Development, AI-Enabled Platform Demonstrations and Regulatory Compliance for Leaders in Life Sciences

Attend NEXT London 2019 to explore how the European Life Science landscape can embrace digital transformation to stay ahead of regulatory and market developmentsNovartis, IQVIA, Syneos Health, UK Office for Life Sciences, NIHR, Deloitte and more keynote speakers to share unique insights Conference breakouts offer attendees interactive, hands-on learning opportunities to design, conduct, manage, and monitor the next generation of clinical research studiesLONDON, May 13 2019: Registration is open for Medidata’s NEXT London, the second... Source: RealWire

Smith & Nephew Adopts One-platform Approach with Medidata to Support Expansion of Study Portfolio

Medical technology company consolidates study management on the Medidata Rave® Clinical Cloud™By using a consolidated platform, data flows seamlessly between electronic data capture (EDC) and clinical trial management system (CTMS) solutionsClinical operations teams can focus on critical study oversight activities rather than data collection and integrationLondon, UK: 1st May 2019 - Medidata (NASDAQ: MDSO) today announced that medical technology business Smith & Nephew (LSE: SN, NYSE: SNN) has consolidated all of its global studies on... Source: RealWire

Perforce Software: Medical Device Industry Survey Reveals 75% Satisfaction With Hybrid Development Method, Lowered Confidence in Compliance

Survey of 270 professionals shows only 38% “Very confident” they could pass a surprise audit; productivity and visibility challenges from manual development processes also raisedMINNEAPOLIS, MN, April 23, 2019 — Perforce Software, a provider of solutions to enterprise teams requiring productivity, visibility, security, and scale along the development lifecycle, released the results of a global survey of medical device professionals today. Key findings suggest ongoing struggles with manual development, a trend-bucking shift toward hybrid development... Source: RealWire

Medidata Launches Acorn AI™ and Appoints Dr. Rama Kondru as CIO

Acorn AI is designed to answer the most important questions across R&D and commercialisation, enabling customers to improve outcomes for patients and to accelerate growthThe Acorn AI team is led by industry veterans who are shaping the future of life sciencesPowered by Medidata’s standardised and structured clinical data repository, one of the largest in the world, Acorn AI immediately becomes a leading AI company dedicated to life sciencesIndustry visionary, Rama Kondru, Ph.D., is appointed CIO... Source: RealWire

Registration opens for SMi's 4th Pre-filled Syringes West Coast 2019

Building on last year’s success SMi Group are proud to present the 4th Pre-filled Syringes West Coast 2019 Conference and exhibition in CA, USA.Conference Overview:Pre-Filled Syringes West Coast will gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase the latest and advancements, keeping you at the forefront of a booming industry.Join us June 3rd-4th 2019, in San Diego along with one post-conference workshop: The Secrets to... Source: RealWire

Securecell introduces Sephara, a novel, silicon-based in-situ filtration membrane

• Sephara is changing the way automated analytical sampling as well as perfusion processes at the benchtop scale will be performed• Securecell offers an early access program for the Sephara technologyUrdorf (Zurich), Switzerland, 18 November, 2019 – Securecell today announced that it has introduced Sephara, a high performance in-situ filtration membrane for applications in bioprocess sampling and perfusion processes for use in selected bioprocess laboratories. Interested users can participate in an early access program for... Source: RealWire

Leading Omani Pharmacy Chain Relies on InfiNet Wireless for High-Bandwidth, Always-On Connectivity

Rapid installation of high capacity, futureproof wireless solutions at its sites ensure round-the-clock, real-time access to dataDubai, United Arab Emirates – August 19, 2019 – InfiNet Wireless, the global leader in fixed wireless broadband connectivity, today announced that it has successfully delivered a comprehensive communication infrastructure to Muscat Pharmacy & Stores LLC, one of Oman’s most well recognized pharmacy chains. Operating over an extensive network of more than 200 suppliers, across 69 outlets, the company... Source: RealWire

The Eastern Pathology Alliance to offer Hepatitis C testing services to the wider NHS capitalising on next generation sequencing technology

First and only laboratory in the UK to use equipment from Vela Diagnostics New testing process delivers huge patient benefits in terms of speed, accuracy and reliability yet with costs significantly reduced August 12, 2019 – The Eastern Pathology Alliance (EPA) announces today that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays. Founded in 2012, the EPA has become a centre of... Source: RealWire

Medidata recognised as a 2019 UK Great Place to Work®

Company scores high for having a culture of diversity & belonging and work-life balance London, 16th May 2019 – Medidata has been named one of the UK’s Best Workplaces™, published by Great Place to Work®. This recognition highlights the company’s unique, inclusive culture among the many reasons employees take pride in being part of the “Medidatian” community.Established in 1999, Medidata was recognised by its employees as a company that promotes a healthy workplace culture based... Source: RealWire

Medidata NEXT London 2019: Blending the Best of Clinical Development, AI-Enabled Platform Demonstrations and Regulatory Compliance for Leaders in Life Sciences

Attend NEXT London 2019 to explore how the European Life Science landscape can embrace digital transformation to stay ahead of regulatory and market developmentsNovartis, IQVIA, Syneos Health, UK Office for Life Sciences, NIHR, Deloitte and more keynote speakers to share unique insights Conference breakouts offer attendees interactive, hands-on learning opportunities to design, conduct, manage, and monitor the next generation of clinical research studiesLONDON, May 13 2019: Registration is open for Medidata’s NEXT London, the second... Source: RealWire

EAMSP kicks off information campaign about digitization in German healthcare sector

Fighting the allergic reaction to anything new with #neuschnupfenBrussels, Belgium | Hamburg, Germany, May 7, 2019. While online banking, ordering a taxi or doing their weekend shopping with an app has become commonplace for most Germans, many remain cautious when it comes to digital health services. In order to combat this scepticism and to highlight the benefits of digitization in the healthcare sector – with reference to successful innovation in other European countries – the... Source: RealWire

Smith & Nephew Adopts One-platform Approach with Medidata to Support Expansion of Study Portfolio

Medical technology company consolidates study management on the Medidata Rave® Clinical Cloud™By using a consolidated platform, data flows seamlessly between electronic data capture (EDC) and clinical trial management system (CTMS) solutionsClinical operations teams can focus on critical study oversight activities rather than data collection and integrationLondon, UK: 1st May 2019 - Medidata (NASDAQ: MDSO) today announced that medical technology business Smith & Nephew (LSE: SN, NYSE: SNN) has consolidated all of its global studies on... Source: RealWire

Perforce Software: Medical Device Industry Survey Reveals 75% Satisfaction With Hybrid Development Method, Lowered Confidence in Compliance

Survey of 270 professionals shows only 38% “Very confident” they could pass a surprise audit; productivity and visibility challenges from manual development processes also raisedMINNEAPOLIS, MN, April 23, 2019 — Perforce Software, a provider of solutions to enterprise teams requiring productivity, visibility, security, and scale along the development lifecycle, released the results of a global survey of medical device professionals today. Key findings suggest ongoing struggles with manual development, a trend-bucking shift toward hybrid development... Source: RealWire

MedStar Health and FDA to lead a post-conference workshop at Pre-Filled Syringes West Coast 2019

Developing a Human Factors Validation Plan with Consideration for the Digital Health MarketplaceThis workshop will provide an overview of human factors validation strategies that companies should consider as the pre-filled syringe market increasingly takes on digital health components. A case study of a pre-filled syringe with connection to a mobile app will be utilized throughout the course to demonstrate the concepts under discussion and help participants work through a study plan. The workshop aims to... Source: RealWire

Medidata Launches Acorn AI™ and Appoints Dr. Rama Kondru as CIO

Acorn AI is designed to answer the most important questions across R&D and commercialisation, enabling customers to improve outcomes for patients and to accelerate growthThe Acorn AI team is led by industry veterans who are shaping the future of life sciencesPowered by Medidata’s standardised and structured clinical data repository, one of the largest in the world, Acorn AI immediately becomes a leading AI company dedicated to life sciencesIndustry visionary, Rama Kondru, Ph.D., is appointed CIO... Source: RealWire

PAREXEL Introduces New Dedicated Division to Help Emerging Biotech Companies Reach their Goals Quickly and Cost-Effectively

BOSTON, January 7, 2019 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today introduced a new, dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively. PAREXEL Biotech builds on the Company’s heritage of clinical, regulatory, commercial and technology expertise with enhanced strategic consulting and asset development capabilities, offering a new Biotech-focused team and organizational structure for customers. Led by James Anthony, Global Head... Source: RealWire

PAREXEL Announces Several New Patient-Centric Innovations to Address Drug Development Challenges

Solutions Built on the Perceptive Cloud Platform Leverage Mobile and Wearable TechnologyBOSTON, October 9, 2018 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced that it has developed several new solutions that take a patient-centric approach to addressing drug development. Built on the Perceptive® Cloud platform and leveraging PAREXEL’s relationship with Microsoft, the solutions incorporate mobile and wearable technology to increase access to data and improve the patient experience in clinical... Source: RealWire

Big Data revolution driving $13.4 billion healthtech M&A deals says Hampleton Partners

Amazon, Apple, Google and IBM healthtech investments are forcing incumbents to make defensive M&A deals Record private equity investment in healthtech London, UK - 21 September 2018 The latest Healthtech M&A Market Report from international technology mergers and acquisitions advisors, Hampleton Partners, reveals how Big Data is fast becoming the common currency that lies at the heart of high-value business models in the healthtech sector. In addition to booming strategic investment in the sector, the... Source: RealWire

PAREXEL Announces Appointment of Two Key Executives

BOSTON, August 17, 2018 – PAREXEL International Corporation, the world’s leading innovator of biopharmaceutical services, today announced the appointment of Greg Rush as Executive Vice President and Chief Financial Officer and Michele Fournier as Senior Vice President and Chief Human Resources Officer. Mr. Rush joins PAREXEL after serving as Executive Vice President and Chief Financial Officer of Syneos Health, Inc. (formerly known as INC Research Holdings, Inc.) from August 2013 to August 2017. Mr. Rush... Source: RealWire

UKCloud Health joins the Global Alliance for Genomics and Health (GA4GH) to support greater collaboration across the UK healthcare, research, life sciences and technology sectors

Providing a secure, UK sovereign platform to help accelerate innovation and enhance collaboration between GA4GH members, UKCloud Health and its thriving partner ecosystemLondon – 16 July 2018 – UKCloud Health, the easy to adopt, use, and leave assured cloud services company, today announced that it has become a member of the Global Alliance for Genomics and Health (GA4GH), an international, non-profit alliance that is focused on accelerating the potential of research and medicine to advance... Source: RealWire