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 | Collaborations & Alliances | Drug Development
Jacobio Earns $20M AbbVie Milestone
Initiates Phase 1/2a trial of SHP2 inhibitor JAB-3312 in combination with PD-1 antibody Pembrolizumab and MEK inhibitor Binimetinib.06.18.21
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Eisai, BMS Enter Global Anticancer ADC Alliance
BMS to pay as much as $2.45B to co-develop Eisai’s MORAb-20206.18.21
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Breaking News | Collaborations & Alliances | Drug Development | Formulation Development
Lumen Bioscience, Novo Nordisk Enter Metabolic Research Pact
To explore Lumen's drug development and manufacturing platform to deliver oral biologics for cardiometabolic disease.06.16.21
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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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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
iTeos Therapeutics, GSK Enter Monoclonal Antibody Alliance
GSK now has a leading portfolio of antibodies targeting the CD226 axis, a key target for next-gen immuno-oncology therapies06.14.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Development | Industry News
WuXi XDC and LegoChem Ink ADC Agreement
Sign MOU for the development and manufacturing of antibody-drug conjugates.06.11.21
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Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Inspections | Process Validation | Risk Management
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Breaking News | Drug Development
FDA Approves Aducanumab To Treat Alzheimer’s Disease
First novel therapy approved for AD in nearly 20 years was developed by Biogen and its Japanese partner Eisai.Charles Sternberg, Assistant Editor 06.08.21
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Biologics, Proteins, Vaccines | Drug Development
Addressing the Need for Standards in Cell and Gene Therapy
Identifying and understanding the areas with the greatest need for standardization to help the cell and gene industry progress.Robert Shaw, Robert Shaw Executive Director, Standards Coordinating Body for Regenerative Medicine 06.07.21
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APIs | Drug Development
Biocatalysis: An Indispensable Tool for API Synthesis
Biocatalytic processing offers a wealth of advantages and should be evaluated during early-stage drug development.Benzion Dolitzky, VP R&D, Wavelength Pharmaceuticals 06.07.21
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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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Drug Development | Preclinical Outsourcing
Preparing for Preclinical Testing: A Readiness Checklist
As companies prepare for preclinical testing, they can use this checklist to make sure they are ready.Mark Walker, Senior Technical Director of Toxicology, WuXi AppTec Laboratory Testing Division 06.07.21
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Analytical Services | Bioanalytical Services | Drug Development | Laboratory Testing | R&D
CRO Industry Update
Digital modernization, decentralized trials and advanced therapies drive outsourcing.Kristin Brooks, Managing Editor, Contract Pharma 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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Biologics, Proteins, Vaccines | Collaborations & Alliances | Drug Development
Beroni, tella Sign MoU for Cancer Immunotherapy Treatment
Will leverage the resources of each party and their respective affiliates to advance tella’s dendritic cell vaccine therapy.Kristin Brooks 05.28.21
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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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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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Aseptic Processing | Drug Development | Injectables
Bridging Clinical and Commercial Drug Product Manufacturing – Outsourcing Advice from a CDMO
Learn how to mitigate manufacturing capacity issues and ensure your drug product is given the priority it deserves.
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Xeris to Acquire Strongbridge Biopharma
The two businesses will be combined under a new entity called Xeris Biopharma Holdings, specializing in endocrinology and rare diseases.Kristin Brooks 05.24.21
