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Implementing an Automated DOE in Twin Screw Wet Granulation
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Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
Quotient Sciences Makes Executive Leadership Team Appointments
Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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Drug Development
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Analytical Services
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Biologics, Proteins, Vaccines
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Breaking News
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cGMP Manufacture
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Drug Development
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Industry News
Samsung Life Science Fund Invests in BrickBio
Samsung affiliates will work with BrickBio to evaluate, manufacture, and develop therapies using BrickBio's protein engineering technology.
03.18.24
Biologics, Proteins, Vaccines
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Breaking News
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Drug Development
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Drug Discovery
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Industry News
Selvita Adds Antibody Discovery and Development Capabilities
Will open a new research site in Wroclaw, Poland, with over 400 square meters of state-of-the-art labs along with all necessary infrastructure.
03.18.24
Clinical Trials
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Drug Development
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Regulatory Affairs
The High Five: Key Regulatory Topics for Drug Development in 2024
Master protocols in clinical trial design, patient outcomes in oncology, advancements of new modalities, use of AI/ML and digitizing clinical trials.
Patrick Brady, PharmD, Global Head, Therapeutic Innovation & Regulatory Science, IQVIA
03.18.24
Drug Development
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Trials & Filings
FDA Filings Roundup
FDA approves first and only medication to treat NASH, grants accelerated approval for Breyanzi in CLL, SLL, and TEVIMBRA approved in esophageal cancer.
Online Exclusives
03.15.24
Breaking News
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Drug Development
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Trials & Filings
FDA Approves BeiGene's TEVIMBRA in Esophageal Cancer
Phase 3 trial showed prolonged the survival of patients who received prior systemic treatment compared to chemotherapy.
03.15.24
Breaking News
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Drug Development
|
Trials & Filings
FDA Grants Accelerated Approval for BMS’ Breyanzi in CLL, SLL
Complete response rate associated with Breyanzi treatment was 20% with median duration of response 35.3 months.
03.15.24
Breaking News
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Collaborations & Alliances
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Drug Development
Biotheus and Hansoh Pharma Expand Collaboration for Novel Cancer Treatment
Biotheus grants Hansoh Pharma a license to use PM1080/HS-20117 for the development of antibody-drug conjugates.
03.15.24
Breaking News
|
Drug Development
|
Trials & Filings
Madrigal Wins Accelerated Approval for NASH Drug Rezdiffra
Becomes the first and only medication approved by the FDA for the treatment of nonalcoholic steatohepatitis.
03.15.24
Breaking News
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Drug Development
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Industry News
AstraZeneca to Acquire Amolyt Pharma in Potential $1.05B Deal
Further expands rare disease pipeline with Phase III therapeutic peptide designed to meet key therapeutic goals for hypoparathyroidism.
03.14.24
Breaking News
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Collaborations & Alliances
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Drug Development
Anocca & EmendoBio Team Up for Next-Gen Cell Therapy
Anocca to integrate EmendoBio’s nuclease into its manufacturing process to accelerate the manufacture and development of TCR-T cell therapies.
03.14.24
Biologics, Proteins, Vaccines
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Breaking News
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cGMP Manufacture
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Drug Development
|
Industry News
Charles River, Navega Therapeutics Enter Gene Therapy Mfg. Pact
Will leverage Charles River’s off-the-shelf plasmid products, custom plasmid capabilities, and GMP-grade AAV production.
03.14.24
Breaking News
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Clinical Trials
|
Collaborations & Alliances
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Drug Development
PluriCDMO to Support Remedy Cell in the Manufacture of RC-0315
Will assist with manufacturing of a clinical-grade Working Cell Bank (WCB) and GMP batches.
03.14.24
Breaking News
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Collaborations & Alliances
|
Drug Development
Bayer and Aignostics Partner to Co-Create a Novel Target Identification Platform
Aim to identify novel cancer targets through AI models applied to multimodal patient data and to accelerate clinical development of oncology programs.
03.14.24
cGMP Manufacture
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Drug Development
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Drug Discovery
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Preclinical Outsourcing
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Process Development
Anitbody Discovery and Engineering
From DNA to Drug Product
Breaking News
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Collaborations & Alliances
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Drug Development
Ricoh Licenses CRISPR/Cas9 Tech to ERS Genomics for Drug Discovery
CRISPR/Cas9 genome editing technology contributes to the expansion of the creation of novel disease model.
03.13.24
Bioanalytical Services
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Breaking News
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Collaborations & Alliances
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Drug Development
|
Drug Discovery
Allumiqs, Prolytix Enter Strategic Discovery and Development Pact
To provide interconnected bioanalytical services to advance drug candidates from the early R&D phases through to lot release.
03.13.24
Biologics, Proteins, Vaccines
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Breaking News
|
Collaborations & Alliances
|
Drug Development
ProteoNic Biosciences Partners with Ginkgo Bioworks to Support Clients
Grants Ginkgo Bioworks’ customers access to ProteoNic's vector technology.
03.13.24
Biologics, Proteins, Vaccines
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Breaking News
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Collaborations & Alliances
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Drug Development
Almirall and Eloxx Pharmaceuticals Enter Exclusive License agreement for ZKN-013
Almirall obtains global rights to develop and commercialize ZKN-013, including for the use in orphan dermatological diseases.
03.13.24
Breaking News
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Drug Development
|
Industry News
Novartis to Acquire IFM Due in Potential $835M Deal
Gains rights to IFM Due's portfolio of STING antagonists, which have the potential to treat an array of serious inflammation-driven diseases.
03.13.24
Breaking News
|
Drug Development
|
Scale-up/Technology Transfer
Quantoom Biosciences Introduces New mRNA Kit
Ntensify mano is a cost-effective solution for mRNA production, combining convenience, efficiency, and control.
03.13.24
Breaking News
Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
Quotient Sciences Makes Executive Leadership Team Appointments
Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
View Breaking News >
CURRENT ISSUE
March 2024
Implementing an Automated DOE in Twin Screw Wet Granulation
Sustainable Pharmaceutical Packaging
Pre-filled Syringe Packaging Trends
Liquid Pharmaceutical Filling: Small, Smaller, Micro Batches
Newsmakers Q&A: BioVectra
Multi-particulate Formulations – Tablets or Capsules?
Manufacturing Equipment Trends
OSD Outsourcing: Savvy CMOs Hone Skills as Complex APIs Fuel Demand
Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)
The Road Ahead for CDMOs in 2024
View More >