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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
  

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• Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
  

  Precirix, Evergreen Ink Clinical Supply Deal

  Evergreen will provide U.S.-based manufacturing for Precirix's lead product candidate, CAM-H2.

  Tim Wright, Editor, Contract Pharma 04.29.21
  

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• Breaking News | Clinical Trials | Drug Development | Industry News
  

  Pfizer Acquires Amplyx Pharmaceuticals

  Deal expands anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix (APX001).

  Tim Wright, Editor, Contract Pharma 04.29.21
  

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• Breaking News | cGMP Manufacture | Clinical Trial Materials
  

  Precirix Partners with Evergreen Theragnostics

  Evergreen will provide US-based manufacturing for Precirix's lead product candidate, CAM-H2.

  Charles Sternberg, Assistant Editor 04.28.21
  

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• Clinical Trials | CRO News | Information Technology
  

  PPD, Science 37 Partner to Advance Decentralized Trials

  PPD will leverage Science 37's DCT SaaS-based technology platform to design, build, test, implement and execute digital trials.

  Kristin Brooks 04.28.21
  

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• Clinical Trials | CRO News | Information Technology
  

  Syneos, Medable Partner for New Decentralized Capabilities

  Aims to increase clinical trial diversity and improve patient access and experiences with fit-for-purpose decentralized digital solution.

  Kristin Brooks 04.22.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings
  

  Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data

  VLA2001 was highly immunogenic with more than 90% of study participants developing significant levels of antibodies to SARS-CoV-2 virus spike protein.

  Kristin Brooks 04.22.21
  

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• Clinical Trials | R&D | Regulatory Affairs
  

  Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance

  Learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance in this webinar on May 13.

  04.22.21
  

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• Clinical Trials
  

  Decentralized Clinical Trials: The 101 on Digital Health Technologies (DHTs)

  The huge uptick in decentralized trials this past year has greatly increased the use of digital health technologies (DHTs).

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• Breaking News | Clinical Trial Materials | Cold Chain Management | Facilities | Industry News | Lyophilization
  

  Catalent Adds Cryogenic Capabilities at Philadelphia Facility

  Bolsters clinical supply services at site to meet growing demand for cell and gene therapy development.

  Tim Wright, Editor, Contract Pharma 04.15.21
  

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• Breaking News | Clinical Trial Materials | Industry News | Promotions & Moves | Solid Dosage/Creams/Ointments
  

  Metrics Names Stephanie Emory Associate Director of Pharma Development

  Will direct team of formulation scientists who develop oral solid dose formulations for Phase I through Phase III clinical trials.

  Tim Wright, Editor, Contract Pharma 04.15.21
  

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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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• Analytical Services | Drug Delivery | Lyophilization | Process Development | Validation
  

  Vetter Development Service

  With Vetter, you have a partner you can trust to support you throughout drug product development, clinical manufacturing and regulatory approval.

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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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• Analytical Services | Breaking News | Clinical Trial Materials | Drug Development | Industry News
  

  Ascendia Pharmaceuticals Poised for Expansion

  CDMO secures growth equity investment from Signet Healthcare Partners.

  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 Trial Materials | Drug Development | Formulation Development
  

  On-Demand Webinar: Accelerated Timelines for Clinical Supply Manufacture

  Watch this on-demand webinar to gain a deeper understanding of the value of adaptive processes at this critical early stage of drug development.

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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 Trial Materials | Cold Chain Management | Industry News
  

  PCI Pharma Services Expands Cold Chain Clinical Supply Storage

  Adds significant capacity and several new cold chain storage conditions, which now include temperatures from controlled room temperature to -80°C.

  Kristin Brooks 03.16.21
  

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• Breaking News | Clinical Trial Materials | CRO News
  

  LabConnect Expands Johnson City Facility

  Central lab to add 20,000 sq.-ft., tripling kit building capacity for complex clinical studies along with other planned operational improvements.

  Kristin Brooks 03.16.21
  

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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 | cGMP Manufacture | Clinical Trial Materials | Industry News
  

  Tevogen Bio, BioCentriq Partner for COVID T-cell Therapy

  NJ-based cell and gene therapy development and manufacturing center to support clinical manufacturing of Tevogen’s investigational COVID-19 treatment.

  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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• Bio News | Breaking News | Industry News
  

  NMPA Accepts Application for Clinical Trial of Bifunctional Fusion Protein

  JS201, developed by Junshi Biosciences, can simultaneously target PD-1 and TGF-β.

  Charles Sternberg, Assistant Editor 03.09.21
  

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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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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Scale-up/Technology Transfer
  

  MaxiVAX, Minaris Enter Cell Therapy Mfg. Agreement

  Minaris will provide GMP manufacturing, freezing and shipping of the MVX-ONCO-2 capsules from its site near Munich, Germany.

  Kristin Brooks 02.22.21
  

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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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• APIs | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
  

  Cascade Chemistry Begins $14M cGMP Mfg. Capacity Expansion

  Will triple floor space and increase manufacturing capacity for APIs for clinical trial materials and ultimately commercial production.

  Kristin Brooks 02.18.21
  

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• Clinical Trial Start-Up: Effective Planning for Sponsors, CROs, and Sponsor-Investigators

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  02.17.21
  

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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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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
  

  Recipharm Bolsters Biologics Offering

  Extends manufacturing license to include immunology products at clinical and commercial scales, in both freeze-dried and liquid forms.

  Kristin Brooks 02.11.21
  

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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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• Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News
  

  Thermo Fisher, JW Therapeutics Form CAR-T Partnership in China

  Companies join forces in cell therapy applications and commercial-scale manufacturing.

  Tim Wright, Editor, Contract Pharma 02.08.21
  

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