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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
  

  Catalent Completes RheinCell Therapeutics Acquisition

  Plans to facilitate accelerated access to high-quality iPSC banks with integrated solutions from plasmid DNA manufacturing to clinical supply.

  08.04.21
  

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• Breaking News | Drug Delivery | Drug Development | Drug Discovery | Industry News
  

  BioMed X, Janssen Begin Autoimmunity and Drug Delivery Research

  New research groups, PTA and TMI, aim to combat chronic inflammatory diseases and develop oral delivery of macromolar therapeutics.

  08.04.21
  

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• Breaking News | cGMP Manufacture | Chemistry | Drug Development | Industry News
  

  BMS Completes Sale of Couvet Site to WuXi STA

  Acquisition significantly enhances WuXi STA's drug product capacity in Europe and enhances capabilities by adding capacity to support global customers.

  08.04.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
  

  Sanofi to Acquire Translate Bio for $3.2B

  Upgrades drug formulation capabilities and accelerates development of licensed programs in vaccines and potential to explore other therapeutic areas.

  08.04.21
  

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• Breaking News | Collaborations & Alliances | Drug Development | Industry News | Preclinical Outsourcing
  

  Nanoform, Boehringer Ingelheim Sign Master Services Agreement

  Will address bioavailability and solubility challenges in the pre-clinical early development stages.

  08.03.21
  

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• Drug Development | Scale-up/Technology Transfer | Validation
  

  Keys to Successful Tech Transfer for Topical Pharmaceuticals

  This whitepaper illustrates the keys to choosing the right manufacturing partner and how to manage a topical drug tech transfer.

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

  Almac, THREAD to Integrate Technologies for Clinical Trials

  Integrating technology platforms aims to provide sponsors and CROs with a full range of tools designed to reduce the risk of trial delays.

  07.28.21
  

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• Breaking News | Drug Development | Industry News
  

  Lantern Pharma Reacquires Irofulven from Allarity Therapeutics

  Based on early Phase II results, Lantern to advance development in bladder and prostate cancer with a key mutation in the ERCC2/3 genes.

  07.28.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
  

  ValenzaBio, ProBioGen Enter Cell Line Pact

  Aims to maximize cell line productivity leveraging ProBioGen's GlymaxX technology for ValenzaBio's clinical-stage antibody.

  07.28.21
  

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• Biologics, Proteins, Vaccines | Drug Development
  

  AAV-Mediated Gene Therapy: Quantifying Viral Titer and Integrity

  Droplet Digital PCR offers precise potency data, critical for the proper dosing of gene therapies.

  Mark White and Marwan Alsarraj , Digital Biology Group at Bio-Rad 07.27.21
  

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• Breaking News | Collaborations & Alliances | CRO News | Drug Delivery | Drug Development | Drug Discovery | Industry News | R&D
  

  Aptamer and WuXi AppTec Form Research Partnership

  Collaborate to identify new Optimer-enabled therapeutics.

  07.22.21
  

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• Biologics, Proteins, Vaccines | Drug Development | Reader Showcase
  

  Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator

  First-in-market CO2 incubator combines optimal cell growth capabilities with certified cleanroom compatibility.

  07.21.21
  

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• Bioanalytical Services | Biologics, Proteins, Vaccines | Filtration & Purification | QA/QC | Reader Showcase
  

  MOBILion Launches MOBIE HRIM for Biotherapeutic Drug Development

  Designed to address characterization challenges during biopharmaceutical drug development and quality monitoring.

  07.21.21
  

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• Drug Development | Trials & Filings
  

  AskBio’s Gene Therapy Gets Fast Track

  LION-101 is a recombinant adeno-associated virus (rAAV) based vector being developed as a one-time treatment for Limb-Girdle Muscular Dystrophy.

  07.21.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
  

  Eisai, Biogen’s Lecanemab Gets Breakthrough Designation in AD

  Based on pre-specified analysis showing consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.

  07.20.21
  

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News
  

  BioNTech to Acquire Kite’s TCR Cell Therapy Platform and Mfg. Facility

  Strengthens cell therapy pipeline with individualized solid tumor Neoantigen TCR cell therapy R&D program and adds manufacturing footprint in North America.

  07.19.21
  

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• Breaking News | Drug Development | Industry News
  

  Novo Nordisk Acquires Prothena’s ATTR Program in $1.2B Deal

  To develop the Phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy.

  07.13.21
  

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• APIs | Cytotoxics and High Potency Manufacturing | Drug Development
  

  Leverage the Benefits of Biocatalysis with the Right API CDMO

  A powerful tool for organic synthesis, enzymatic chemistry has become an established methodology for manufacturing APIs.

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• Breaking News | cGMP Manufacture | Drug Development | Formulation Development | Industry News
  

  Recro Pharma Inks Development and Mfg. Pact

  To support a client’s ongoing clinical development of an orally administered, minimally-absorbed investigational compound.

  07.13.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery | Information Technology
  

  I-Mab Expands Next-Gen Novel Oncology Portfolio

  Expands pipeline of antibody assets leveraging cutting-edge mRNA and AI technology platforms.

  07.09.21
  

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• Breaking News | Drug Development | Drug Discovery | Industry News | Information Technology
  

  SRI, Sanofi Enter Drug Discovery Collaboration

  Will leverage SynFini, SRI’s artificial intelligence and automation platform to accelerate development of small-molecule drug targets.

  07.07.21
  

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• Collaborations & Alliances | Drug Development
  

  Y-Biologics, Pierre Fabre Enter Immuno-oncology Alliance

  Aims to develop and commercialize a family of human antibodies to inhibit the growth of tumor cells.

  07.07.21
  

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  Mimetas, Roche to Develop Human Disease Models for Drug Development

  Will focus on tailor-made phenotypic models for IBD and HBV.

  07.06.21
  

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• Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News | R&D
  

  BioMed X Expands Collaboration with Merck

  Launches a new joint research program in oncology.

  07.06.21
  

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• Breaking News | cGMP Manufacture | Drug Development | Industry News
  

  Hermes Pharma Announces Spin-out from Hermes Arzneimittel

  CDMO specializes in the development and manufacture of user-friendly oral dosage forms for healthcare companies around the world.

  07.02.21
  

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• Breaking News | CRO News | Drug Development | Drug Discovery | Industry News
  

  Frontage to Acquire Quintara Discovery

  Quintara provides in vitro ADME profiling, bioanalytical services, and dedicated assay development and compound screening.

  07.01.21
  

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• Breaking News | Drug Development
  

  CureVac Appoints Dr. Malte Greune as COO

  Dr. Florian von der Mülbe will shift focus exclusively toward the expansion and accelerated development of The RNA Printer.

  06.30.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
  

  AskBio’s Gene Therapy Program Gets Fast Track Designation

  LION-101 is a recombinant adeno-associated virus based vector being developed as a one-time intravenous infusion for Limb-Girdle Muscular Dystrophy Type 2I/R9.

  06.28.21
  

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• APIs | Drug Development | Formulation Development
  

  QBD Addresses API Supply in Orphan Drug Formulation

  Due to the high costs and low demands of the drug product, it is important to efficiently use API supply during the formulation process.

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• Analytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Drug Development
  

  Host Cell Impurities, Bioassays, Micro-Flow Imaging

  WHO, FDA and the European Pharmacopoeia have established strict regulatory guidelines to guarantee product quality in biologics.

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• Aseptic Processing | Drug Development | Injectables
  

  Clinical to Commercial Manufacturing: Selecting the Right CDMO for Your Sterile Drug Product

  Finding an appropriately-sized CDMO to help you go to market can be difficult. To find the right partner, you must know what to look for.

  06.25.21
  

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• Collaborations & Alliances | Drug Development
  

  ProBioGen, LAVA to Develop Cell Lines for Bispecific Candidate

  ProBioGen will conduct cell line development of a novel gamma-delta bsTCE using its CHO.RiGHT expression platform.

  06.22.21
  

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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-202

  06.18.21
  

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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 therapies

  06.14.21
  

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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
  

  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 | 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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