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Breaking News | Clinical Trials | Industry News | Information Technology
WCG Acquires eClinical Provider VeraSci
Aims to address growing demand for scientific and technology solutions for remote data capture, hybrid virtual studies and decentralized clinical trials.07.26.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
Catalent Plans $100M Expansion of Biologics Mfg. Capabilities in Italy
Initial phase includes installation of two 2,000-liter single-use bioreactors and associated investments to support early-and late-phase clinical development.07.21.21
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Fill/Finish | Industry News | Lyophilization
Vetter’s New Clinical Mfg. Site Now Fully Integrated
Expands clinical capacity to address growing market demand.07.21.21
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Facilities | Industry News
ImmVira Launches Pilot-scale Production Line
To expedite the advancement of next-generation oncolytic virus clinical trials.07.20.21
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Bio News | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News
Samsung Biologics, Kineta Enter Development and Manufacturing Agreement
Samsung's San Francisco R&D center and South Korea headquarters to offer end-to-end CDMO service for anti-VISTA antibody immunotherapy.07.20.21
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Clinical Trial Supply Services
The constant drive for efficiency has become an essential element of any business process, across all industries.07.19.21
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Clinical Trials | CRO News | Information Technology | Reader Showcase
Quanticate Launches Updated Remote Source Data Verification Platform
Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location07.19.21
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Breaking News | Clinical Trials | Industry News | Information Technology
Calyx Opens U.S. HQ Near Research Triangle Park
RTP-based headquarters established to meet growing needs for eClinical and regulatory services.07.19.21
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Clinical Trials | Information Technology | Reader Showcase
Almac Offers Expedited IRT Solutions for COVID-19 Trials
Launches the expedited deployment and support of multiple Interactive Response Technology (IRT) solutions in support of COVID-19 treatments07.16.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News
GentiBio, Forge Biologics Ink Development and Manufacturing Agreement
Partnership to support GentiBio’s cell therapy pipeline with AAV process development, scale up and GMP manufacturing services.07.16.21
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Bio News | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News
Curtana and Catalent Enter Brain Cancer Drug Partnership
Sign development and manufacturing agreement for brain cancer drug CT-179.07.16.21
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Breaking News | Clinical Trials | Industry News | Information Technology | Logistics
UPS Healthcare, THREAD Partner on Decentralized Clinical Trial Platform
Brings together THREAD's digital platform and Marken's clinical trial logistics services to create a single seamless workflow for clients and patients.07.15.21
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Breaking News | Clinical Trials | Industry News | Information Technology
Medable Opens EMEA HQ in Dublin
Expands European presence to grow market for decentralized clinical trials.07.15.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News | Parenterals
Batavia Manufactures IAVI’s Lassa Fever Vax Candidate
Uses innovative 'scale-X' bioreactor to support Phase I clinical trials.07.14.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
Batavia to Develop Clinical Process for RocketVax’s COVID-19 Vaccine
After successful completion, Batavia will continue to scale-up and optimize the process for commercial scale.07.08.21
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Breaking News | Clinical Trials | Collaborations & Alliances | Industry News | Information Technology
CMIC and Lokavant Partner to Deploy Clinical Trial Intelligence Platform
Enter first phase of multi-year partnership to deploy predictive analytics platform for monitoring and management of clinical trials in Asia-Pacific.06.29.21
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Clinical Trials | Information Technology
The Power and Promise of Decentralized Trials
Clinical researchers turned to a range of digital solutions to address the effects of the COVID-19 pandemic on trials.Derk Arts, CEO, Castor 06.25.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News
Cobra Biologics, CombiGene Ready to Start GMP Production of Epilepsy Drug Candidate
Complete production and quality assurance of the plasmids to be used in the GMP production of CG01.06.25.21
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Breaking News | Clinical Trial Materials
Chemomab and AGC Biologics Partner to Manufacture CM-101 for Phase II/III
AGC Biologics will manufacture the clinical trial materials at its site in Copenhagen to support clinical testing and launch readiness.06.24.21
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Breaking News | Clinical Trial Materials | Industry News
CaroGen, BioCentriq Enter Clinical Manufacturing Pact
BioCentriq to provide clinical manufacturing to support Phase 1 clinical trials of CaroGen's lead immunotherapy candidate, CARG-201.06.22.21
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Breaking News | Clinical Trials | CRO News
Syneos Expands Decentralized Trial Capabilities
Aims to accelerate decentralized clinical trial delivery through collaboration with site sponsors.06.22.21
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Clinical Trial Materials | Cold Chain Management | Logistics | Supply Chain
Mitigating the Logistical Challenges Associated with Clinical Studies of Investigational Drugs
How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more.Contract Pharma Staff
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development | Trials & Filings
Novavax COVID-19 Vax is 90% Effective in Phase 3 Trial
NVX-CoV2373 demonstrates 100% protection against moderate and severe disease, 90% efficacy overall, and met the primary endpoint.06.14.21
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Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Drug Delivery | Industry News | Solid Dosage/Creams/Ointments
Enteris BioPharma Receives $10M Milestone from Cara Therapeutics
Third milestone payment related to the development of Oral KORSUVA.06.11.21
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Bio News | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News
Revolo and Northway Biotech Enter Manufacturing Partnership
To manufacture novel binding immunoglobulin protein, ‘1805, to support phase 2 trials in rheumatoid arthritis and uveitis.06.11.21
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Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Inspections | Process Validation | Risk Management
Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates
Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.
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Breaking News | Clinical Trial Materials | Cold Chain Management | Industry News | Logistics | Packaging & Tracking | Supply Chain
Yourway Breaks Ground on Major Expansion at Pennsylvania HQ
The project includes a new Phase I clinical trials unit.06.09.21
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Clinical Trials | CRO News | Industry News | Information Technology
Bioclinica Adds eConsent to EDC Platform
New electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote interactions.Kristin Brooks 06.08.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
INOVIO, Advaccine Expand COVID Vax Alliance
To jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 INNOVATE trial evaluating INO-4800 in a two-dose regimen.Kristin Brooks 06.08.21
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Clinical Trial Materials | Drug Development | Preclinical Outsourcing
Strategies for Entering Phase 1 Clinical Development with Limited API
Removing API supply as a criterion in the “Go/No-Go” decision tree and enhancing the opportunity to successfully navigate the pharmaceutical “Valley of Death.”Thomas Daggs and Angelo Consalvo, Enteris BioPharma 06.07.21
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Biologics, Proteins, Vaccines | Clinical Trials
Gene Therapy Trials
Answering critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.April Marquick, Cell and Gene Therapy Expert, Premier Research 06.07.21
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Clinical Trials
Waving Goodbye to Human Clinical Trials in a Post-COVID Landscape
Exploring the untapped potential presented by current biowaiver regulations.Jaleel Shujath and Rao Mukkavilli, Absorption Systems 06.07.21
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Clinical Trials | CRO News | Drug Development | Information Technology
Driving Efficiencies in Today’s Complex Trials
Murray Aitken of IQVIA discusses CRO market trends, post-pandemic opportunities, and leveraging tech-enabled services and capabilities.Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 06.03.21
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Clinical Trials | Drug Development
The Future is Decentralized: What This Means for Clinical Trial Sites
Benefits for research sites and how to prepare for decentralized trials.Marc Leighton, Vice President of Product at Florence Healthcare 06.02.21
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Breaking News | Industry News
RECRO Expands Capabilities for Clinical Trial Services
Adds clinical-scale sachet and blister packaging servicesKristin Brooks 06.02.21
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Biologics, Proteins, Vaccines | Clinical Trials | Drug Development
Gene Therapy Trials
Critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.April Marquick, Cell and Gene Therapy Expert, Premier Research 05.26.21
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
Cambrex Adds Kilogram-Scale Mfg. Capabilities at Estonia
Building work and installation of the new reactor and supporting equipment is now complete, and preparation for GMP qualification is underway.Kristin Brooks 05.26.21
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Clinical Trials | Drug Development | Information Technology
Clinical Development Trends
Digital modernization, decentralized trials, and advanced therapies drive outsourcing of clinical trials.Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 05.25.21
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Breaking News | Clinical Trial Materials | Industry News | Promotions & Moves
Sharp Appoints Robert O’Beirn to Its Global Clinical Services Business
Names O’Beirn as SVP and managing director.Charles Sternberg, Assistant Editor 05.19.21
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Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News | R&D
R&D Alliance for Eye Disease Cell Therapies
BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases.Tim Wright, Editor, Contract Pharma 05.17.21
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
Northwest Bio Seeks GMP Certification of Sawston Mfg. Facility
Upon initial license, production of GMP DCVax-L products in the Sawston facility may begin by the end of Q3.Kristin Brooks 05.12.21
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Breaking News | Clinical Trials | CRO News
Emmes Acquires Orphan Reach
Establishes Emmes as an industry leader in clinical research for orphan and rare diseases.Kristin Brooks 05.12.21
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
OncoTEX, Sterling Pharma Sign Clinical Mfg. Pact
Sterling will produce clinical material for OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.Kristin Brooks 05.10.21
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Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings
INOVIO’s DNA COVID Vax Achieves Positive Results
Phase 2 clinical trial shows INO-4800 was generally safe, well-tolerated and immunogenic in all studied age groups.Kristin Brooks 05.10.21
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Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
AGC Biologics and Oculis Enter Manufacturing Deal
AGC to manufacture Oculis’ OCS-02 at its Heidelberg facility.Tim Wright, Editor, Contract Pharma 05.07.21
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Clinical Trials | Logistics | Supply Chain
LabConnect, Cryoport Partner to Support Triumvira Trial Logistics
Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.Kristin Brooks, Contract Pharma 05.06.21
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Clinical Trial Materials | Cold Chain Management | Facilities | Logistics | Supply Chain
Expediting Clinical Trials
Mitigate potential delays while awaiting IND approval with a Pre-IND strategy.Contract Pharma Staff
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Analytical Services | Clinical Trials | Information Technology
Implications of COVID-19 on Statistical Design and Analyses of Clinical Studies
A look at the challenges and risks to statistical integrity and how they can be mitigated.Tim Victor, Head of Biostatistics, Clinical Research Services, ICON plc 05.05.21
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Breaking News | Clinical Trials | CRO News | Information Technology
Syneos, Komodo Health Expand Data App Alliance
Leveraging Komodo’s Healthcare Map, Syneos aims to better analyze clinical, real-world, and commercial data.Kristin Brooks 05.04.21
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Clinical Trials | Information Technology | Promotions & Moves
Clinical Ink Adds Executives
CCO Chris Crucitti, COO Brian Donahue, and VP Project Operations Bill Barrasso to manage eSource platforms.Kristin Brooks 05.04.21
