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Top Stories
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
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Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.
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Industry News
More than 120 healthcare organizations plan to bring competition to generic drug market.
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Research from the Perelman School of Medicine at the University of Pennsylvania suggests that a universal flu vaccine that protects people against most influenza strains is one step closer to reality.
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Supplier News
The center will serve manufacturers of specialty medications, biosimilars, and cell and gene therapies.
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Alcami and the University of North Carolina Wilmington received a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to prepare students for careers in pharmaceutical sciences.
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Bio/Pharma News
The collaboration will explore the potential of Dyadic's gene-expression platform to produce multiple biologic vaccines and drugs.
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Emergent BioSolutions is set to acquire Adapt Pharma, a pharmaceutical company focused on addressing the opioid overdose and addiction crisis, in a deal worth up to $735 million.
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Regulatory News
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
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FDA Commissioner Scott Gottlieb, MD, issued a statement regarding new warning letters FDA issued to Chillin Mix Kratom and Mitra Distributing, companies marketing kratom–a potential source of opioids–with unproven medical claims.
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Make Compliance a Competitive Advantage
Are you searching for a CDS software that simplifies meeting the latest demanding regulations? With Thermo Scientific™ Chromeleon™ CDS software, sequence-level data organization and audit trails tracking all actions in the software – including CDS-related external events – you can defend your data with utmost confidence allowing you to focus on the important work of your lab. Visit resource center.  Learn More |
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BIOLOGIC DRUGS
Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at its source.
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ANALYTICS
This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.
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2018 PDA Endotoxins Workshop
October 17-18, 2018 | Bethesda North Marriott Hotel & Conference Center| North Bethesda, MD
At the 2018 PDA Endotoxins Workshop, October 17-18 in North Bethesda, MD, gain valuable insight and learn practical approaches to help you better manage and control endotoxin contamination. Hear the latest in real-world practices for endotoxin testing in bio/pharmaceutical production processes. Topics to be covered will include: low endotoxin recovery, rFC for endotoxin detection, and data integrity.  Learn More |
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UPCOMING WEBCASTS
Sterility Testing: Best Practices and Use of Isolator Technology
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
 Register now
Successfully Navigating the Analytical Environment of Complex Generic APIs
Tuesday, October 16, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Facing Inactive Ingredient Database Challenges? Navigating the Complexity for Successful Regulatory Filings
Tuesday, October 2, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST
 Register now
Moving Beyond the Central Dogma: New Tools and Systems for the Production of Difficult-to-Express Proteins
Wednesday, September 26, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Assessing Product Integrity Risk Profiles and Engineering On-Dose Authentication During Drug Development Process
Thursday, September 20, 2018 at 1pm EDT | 12pm CDT | 10am PDT
 Register now
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.  Learn More |
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As the landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data, it is critical for the biopharmaceutical industry to adhere to new regulatory expectations.
Analytical Procedures & Methods Validation Europe provides a comprehensive understanding of regulatory trends and requirements, "hands-on" training for executing procedures that survive the lifecycle and solutions to challenges within the laboratory.  Learn More |
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Events
September 24–26, 2018
October 9–11, 2018
October 9–11, 2018
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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