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Top Stories
The transaction gives Alexion access to Achillion’s portfolio of oral small-molecule Factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases.
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The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology.
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PYRAMID Laboratories, Inc. is a CMO focused on injectables, established in 1988 in Southern California, we offer aseptic vial and syringe filling, as well as lyophilization, for both Clinical and Commercial products. Our laboratory offers development and analytical capabilities in a cGMP/GLP setting. For 30 years, we have provided clients with Top Quality services assuring that their critically important parenteral products reach patients in need.
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Industry News
Enterprise Therapeutics is the recipient of funding worth up to £5.7 million (US $7 million) from the Cystic Fibrosis Foundation.
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GammaDelta Therapeutics has unveiled the formation of a new spin-out company, Adaptate Biotherapeutics, aimed at developing antibody-based therapies that modulate gamma delta T-cells.
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Supplier News
Nonacus has revealed the launch of its new capture kit, ExomeCG, which has been designed to simplify molecular and cytogenomics data generation and interpretation.
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Orgenesis has signed a co-development agreement with Accelix to integrate advanced optic technologies, cartridges, and software onto POCare platform.
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Attending CPhI Worldwide? Don’t Miss Out!
The increasing use of and interest in innovative combination products – products combining a drug & device – is raising significant challenges both for regulators and the industries they regulate. Join Nelson Labs Speaker Lise Vanderkelen, PhD during her ICSE Theater presentation at CPhI Worldwide on 6 November from 16:30-17:00.
Visit the Nelson Labs website for more information.
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Bio/Pharma NewS
The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.
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Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.
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Regulatory News
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
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The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
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PEER-REVIEWED RESEARCH
Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
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FORMULATION
As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.
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MANUFACTURING
Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.
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UPCOMING WEBCASTS
Replacing Settle Plates with Active Air Sampling
Wednesday, November 13, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET
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How to Approach Preparative LC for Compound Purification in the Research and Development Laboratory
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Choosing The Right CDMO For Late-Phase Clinical Trials
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New Research Revealed on a Promising Functional Alternative to Surfactants within Biologic Formulations
Tuesday October 29, 2019 at 10am EDT | 9am CDT | 2pm GMT | 3pm CET
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Data Integrity and the Next Level of Connectivity in a Modern Lab
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A Roadmap for Early Development to Commercial Manufacturing
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The editors explore novel technologies for the formulation, manufacture,
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