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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
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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 Discovery and Development
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Analytical Services
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Biologics, Proteins, Vaccines
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Breaking News
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R&D
Parexel Announces CEO Transition
Jamie Macdonald will retire and transition his role as CEO to the company’s COO and Growth Officer Peyton Howell.
03.18.24
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
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
|
Breaking News
|
Drug Development
|
Drug Discovery
|
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
|
Drug Development
|
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
Analytical Services
|
Breaking News
Pace Life Sciences Acquires New Jersey Lab
Expands its specialized analytical services.
03.15.24
Biologics, Proteins, Vaccines
|
Breaking News
|
Collaborations & Alliances
Alcami and Tanvex CDMO Partner to Streamline Biologics Development and Manufacturing
Will offer clients a complete solution from bulk drug substance production through to finished drug product.
03.15.24
Biosimilars
Inflation Reduction Act and the Impact on Biosimilars
Exploring the IRA’s provisions and their impact to biosimilars.
Online Exclusives
Dinakaran Balasubramanian, Dr. Reddy’s Laboratories
03.15.24
Drug Development
|
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
|
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
|
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
|
Collaborations & Alliances
|
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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Promotions & Moves
|
R&D
CRS Clinical Research Services Appoints Dr. Elisabeth Lackner as CEO
Dr. Lackner is a highly experienced and well-respected global thought leader with over 20 years of experience in the healthcare industry.
03.15.24
Biologics, Proteins, Vaccines
|
Breaking News
|
Promotions & Moves
Nuclera Welcomes Joseph Bertelsen as Chief Commercial Officer
Bertelsen’s sales record will be instrumental to the commercial launch strategy and adoption of Nuclera’s eProtein Discovery platform.
03.14.24
Biologics, Proteins, Vaccines
|
Breaking News
|
Fill/Finish
Upgraded Syngene Biologics Facility to Be Operational in Second Half of 2024
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day.
03.14.24
Biologics, Proteins, Vaccines
|
Breaking News
|
Collaborations & Alliances
Microbix's Kinlytic Secures Manufacturing Partner for U.S. Market Return
Sequel Pharma executes agreement with CDMO for drug substance production.
03.14.24
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Industry News
GeminiBio Introduces Aseptic Assurance System
Supports closed system manufacturing for cell therapies.
03.14.24
Breaking News
|
Drug Development
|
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
|
Collaborations & Alliances
|
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
|
Breaking News
|
cGMP Manufacture
|
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
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 >