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Breaking News | Clinical Trials | Drug Development | Trials & Filings
FDA Accepts Airway Therapeutics’ IND for COVID Treatment
To initiate a Phase 1b trial to confirm the feasibility of intratracheal administrations of AT-100 and its beneficial safety and tolerability profile.Kristin Brooks 04.12.21
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Breaking News | Clinical Trials | CRO News | Industry News
Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ
Offers full-service human absorption, metabolism, and excretion (hAME) studies with radiolabeled compounds.Tim Wright, Editor, Contract Pharma 04.09.21
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Breaking News | Clinical Trials | CRO News
Merck KGaA Selects PRA’s Remote Patient Monitoring Platform
Adding layer of technology to HGH treatments aims to facilitate better patient compliance.Kristin Brooks 04.08.21
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Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
Alkermes, Merck Enter Clinical Trial and Supply Agreement
To evaluate nemvaleukin alfa in combination with Keytruda in patients with platinum-resistant ovarian cancer.Tim Wright, Editor, Contract Pharma 04.07.21
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Breaking News | Clinical Trials | Drug Development | Industry News
Sound Pharmaceuticals Receives $3.1M NIH Grant for COVID Treatment
To support the testing of SPI-1005 in two Phase 2 clinical trials for the treatment of COVID-19.Kristin Brooks 04.06.21
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Breaking News | Clinical Trials | CRO News | Drug Development
Moleculin Selects IQVIA Biotech to Advance COVID Treatment
IQVIA to manage the company's effort to begin potential clinical trials of WP1122 for the treatment of COVID-19.Kristin Brooks 04.06.21
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Clinical Trials | Drug Development | QA/QC
RBQM Comes of Age: COVID as a Catalyst for Change
Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.Online Exclusives Kristin Brooks, Managing Editor 04.01.21
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Clinical Trials | CRO News | Information Technology
PPD, Clinical Ink Partner on Near Real-Time Access to Endpoint Data
Jointly develop systemic lupus erythematosus assessment review process to enhance data quality and research site personnel experiences and efficiencies.Kristin Brooks 03.24.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Trials & Filings
CureVac Expands Late-stage Trials of COVID Vax Candidate
Further analysis to determine efficacy of the vaccine candidate for new virus variants.Krisitn Brooks 03.22.21
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Clinical Trials | Drug Development
Regulatory Practices in a Post-Pandemic World
Envisioning the new normal for clinical development.Dr. Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 03.22.21
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Breaking News | Clinical Trials | Drug Development | Trials & Filings
Gilead, Novo Nordisk Expand NASH Alliance
Phase II trial to investigate Novo’s semaglutide and a combination of Gilead’s cilofexor and firsocostat, alone and in combination in cirrhosis due to NASH.Kristin Brooks 03.18.21
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Breaking News | Clinical Trials | Drug Development | Trials & Filings
Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy
Phase 2 clinical trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2.Kristin Brooks 03.16.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
Novavax Confirms Efficacy Against Original and Variant COVID-19 Strains
Final analysis of NVX–CoV2373 in UK trial confirms 96% efficacy against original strain of COVID-19 and 86.3% against the B.1.1.7 variant.Kristin Brooks 03.12.21
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Clinical Trials | Information Technology
The Evolution of Clinical Research Technology to Support Remote Collaboration
Pioneering change with technology advancements that yield high reward with tolerable risk.Angela Gill Nelms, COO for Florence Healthcare 03.11.21
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Clinical Trials | Information Technology
Data Management Trends
Pandemic-fueled patient centricity is creating new challenges and opportunities for data management teams.Deepu Joseph, Global Head & VP of Clinical Data Management 03.05.21
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Breaking News | Clinical Trials
Strata Oncology Unveils Strata PATH Trial
The new platform clinical trial will evaluate FDA-approved therapies in novel biomarker profiles learned from real-world data.Charles Sternberg, Assistant Editor 03.02.21
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Breaking News | Clinical Trials | CRO News | Information Technology
Alimentiv Acquires McDougall Scientific
Niche CRO specializes in statistical analysis, data management, reporting, and clinical trial design.Kristin Brooks 03.02.21
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Breaking News | Clinical Trials | Collaborations & Alliances | Industry News | Information Technology
Ashfield Engage, Popit Form Digital Monitoring Collaboration
Partner to improve patient adherence through supplemental real-time personalized support.Tim Wright, Editor, Contract Pharma 02.26.21
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Bio News | Breaking News | cGMP Manufacture | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
RedHill and Cosmo Strengthen Manufacturing Agreements
Secures manufacturing capacity of Movantik for opioid-induced constipation and RHB-204, currently in a Phase 3 study for pulmonary NTM disease.Tim Wright, Editor, Contract Pharma 02.19.21
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Breaking News | Clinical Trials | CRO News
PPD Awarded US Army RPA Develop PTSD Drugs
Adaptive platform clinical research trial design aims to expedite potential new treatments for veterans.Kristin Brooks 02.18.21
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Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
Samsung Biologics, National OncoVenture, and Eutilex Obtain IND Approval from FDA
For EU101(NOV1801), an anti-4-1BB therapeutic monoclonal antibody.Tim Wright, Editor, Contract Pharma 02.12.21
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Clinical Trials | Information Technology
Top 5 Things to Know Before Selecting Clinical Trial Technology
Look for a future-proof model, innovative vendors - not cutting-edge technology, and focus on user-centered design and interoperability.Andres Garcia, Co-founder and CTO Florence 02.08.21
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Biologics, Proteins, Vaccines | Clinical Trials
Inside a COVID Vaccine Trial
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.Online Exclusives Kristin Brooks, Managing Editor 02.05.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
Catalent, Decibel Team Up for Hearing Loss Treatment
Enter development and manufacturing agreement for dual-vector gene therapy for the treatment of congenital hearing loss.Tim Wright, Editor, Contract Pharma 02.04.21
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Breaking News | Clinical Trials | Drug Development | Industry News
Affimed, Roche Explore AFM24, Tecentriq Combo
To investigate the combination for the treatment of advanced solid epidermal growth factor receptor (EGFR) expressing malignancies.Kristin Brooks 02.03.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Clinical Trials | Drug Development | Industry News
Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement
Abzena will work with Immunome to produce the antibody cocktail for clinical testing.Kristin Brooks 02.03.21
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Bio News | Breaking News | cGMP Manufacture | Clinical Trials | Collaborations & Alliances | Industry News
RedHill and Cosmo Expand Opaganib Manufacturing Deal
New agreement expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study.Tim Wright, Editor, Contract Pharma 02.02.21
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Breaking News | Clinical Trials | Drug Development | Industry News
DoD Awards Rigel $16.5M to Support Fostamatinib COVID Trials
Will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure.Kristin Brooks 02.01.21
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Clinical Trials | Information Technology
The State of Clinical Trial Technology
Blake Adams of Florence discusses key report findings and the clinical trial software used to support Pfizer’s global COVID-19 vaccine study.Online Exclusives Kristin Brooks, Contract Pharma 01.26.21
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Clinical Trials
The Future of Clinical Trials Series: Part II
Greater awareness will ensure diversity is no longer an afterthought and patients will be at the center of every aspect of clinical research.Jena Daniels, Rasmus Hogreffe, Ingrid Oakley-Girvan, Dr. Michelle Longmire, Medable 01.26.21
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Breaking News | Clinical Trials | Industry News
Care Access Research, AstraZeneca Partner on COVID-19 Antibody Trial
Care Access to provide decentralized, mobile research site operations for AstraZeneca’s AZD7442 Phase III trial in the U.S.Kristin Brooks 01.26.21
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Breaking News | Clinical Trials | Drug Development | Industry News | Laboratory Testing
Caprion-HistoGeneX Rebrands as CellCarta
Recently expanded its scientific capabilities and geographic presence with the acquisitions of Clinical Logistics Inc. and Mosaic Laboratories.Kristin Brooks 01.26.21
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Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
Humanigen, Emergent Enter Covid-19 Partnership
Sign contract development and manufacturing agreement for Phase 3 COVID-19 therapeutic candidate lenzilumab.Tim Wright, Editor, Contract Pharma 01.25.21
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Clinical Trials
The Future of Clinical Trials Series: Part I
What will 2021 have in store for an industry in flux?Alison Holland, Head of Decentralized Trials, Medable, Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health 01.19.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
Intravacc Completes Project for Provention Bio’s Vax Candidate
Potentially the first preventive vaccine for coxsackievirus B, a risk factor associated with type 1 diabetes and celiac disease.Contract Pharma Staff 01.19.21
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Breaking News | Clinical Trials | Industry News
Grifols Begins COVID-19 Plasma Treatment Trial
Treatment could be used for people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease, complementing the vaccine.Contract Pharma Staff 01.18.21
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Clinical Trials | Drug Development | Information Technology
Virtual Clinical Trials: The Future of Dermatology Studies
COVID-19 has created lasting impacts for clinical trials and a host of benefits have arisen from the adoption of virtual and hybrid models.Sonja VanWye, RN, MSN, Director, Dermatology Strategy, IQVIA Biotech 01.15.21
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Breaking News | Clinical Trials | CRO News | Industry News
Frontage Bolsters Clinical Services Capabilities
Unveils plans to provide full service human radiolabeled absorption, metabolism, and excretion study capabilities.Contract Pharma Staff 01.15.21
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Breaking News | Clinical Trials | CRO News
Parexel Completes Strategic Separation
Aims to simplify and streamline business strategy and customer relationships while positioning both organizations for long-term growth.Contract Pharma Staff 01.12.21
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Clinical Trials | CRO News
Caprion-HistoGeneX Acquires Clinical Logistics
Expands its support of clinical trials specimen logistics.Contract Pharma Staff 01.08.21
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Clinical Trials | Drug Development
The Slow – But Desperately Needed – Evolution of Oncology Clinical Development Designs
Appropriate adaptive designs in early stages of development can accelerate timelines and reduce costs, and help focus on the most promising agents.Jürgen Hummel, MSc, Senior Director, Statistical Science, PPD, and Lead of PPD’s Adaptive Design Working Group 01.07.21
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Breaking News | Clinical Trials | Promotions & Moves
Parexel Appoints Chief Patient Officer
Demonstrates the company’s commitment to elevating the patient perspective.Contract Pharma Staff 01.06.21
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Breaking News | Clinical Trials | CRO News
Genesis Biotechnology Acquires STATKING Clinical Services
Expands its presence in the clinical space.Contract Pharma Staff 01.06.21
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Clinical Trials
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
Akston Biosciences and LakePharma Enter Covid-19 Partnership
Will manufacture second-generation COVID-19 vaccine, AKS-452.Contract Pharma Staff 01.05.21
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Clinical Trials | Drug Development
Impact of Decentralized Trials in Oncology Drug Development
Join us on 2/9 as clinical, regulatory and real-world evidence experts discuss the impact of decentralized trials on the evolution of drug dev in oncology.01.04.21
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Breaking News | Clinical Trials | CRO News | Drug Development
Ergomed Acquires MedSource
Specialist oncology and rare disease CRO further expands Ergomed’s presence in the U.S. market.Contract Pharma Staff 12.15.20
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Clinical Trials | Drug Development | Information Technology
Advancing Digital Endpoints in Clinical Trials
An end-to-end approach to managing wearable devices through clinical development.Online Exclusives Kristin Brooks, Contract Pharma 12.14.20
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Clinical Trials | Information Technology
Life Sciences Strive for Greater Agility
Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.Ronan Brown, SVP of Integrated Technology & Compliance, and Joe Rymsza, VP, Global PV & Regulatory Technology Solutions, IQVIA 12.14.20
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Clinical Trials | Drug Development | Information Technology
Advances in Intelligent Automation
The future of medicine relies on further digital transformation and automation-enabling solutions to improve drug development and monitoring.Updesh Dosanjh, Practice Leader, Technology Solutions, IQVIA 12.14.20
