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Top Stories
The acquisition will give Gilead access to Forty Seven’s investigational lead product candidate, magrolimab, a monoclonal antibody in clinical development for the treatment of numerous cancers.
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Under the agreement, Takeda will divest the rights, title, and interest to 18 over-the-counter and prescription products sold in Brazil, Mexico, Argentina, Colombia, Ecuador, Panama, and Peru.
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Industry News
With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.
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ABPI has issued a statement noting that it shares the ambition of the United Kingdom’s government, as set out in its published approach to the negotiations for the future relationship with the European Union (EU).
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Supplier News
The partners will use ProBioGen’s DirectedLuck transposase technology to support development and large-scale manufacturing of ImmunOs’ biologics.
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German-based company, Insilico Biotechnology, has announced that it has opened its first subsidiary in the United States, specifically in Boston, MA, which is a biopharmaceutical hub in the country.
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Bio/Pharma News
Takeda announced the acquisition after the conclusion of a Phase 1 study of the investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.
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The companies are entering into a development and manufacturing collaboration for the advancement and production of human monoclonal antibodies for the potential treatment of novel coronavirus.
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Regulatory News
If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.
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Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).
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Featured Topics |
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MANUFACTURING
Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.
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QUALITY/REGULATIONS
Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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PEER-REVIEWED RESEARCH
Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.
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ANALYTICS
In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
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WEBCASTS
Complex Liquid Formulations: Solutions for Scale-Up Challenges
Tuesday, March 17, 2020 at 1pm EDT | 12pm CDT | 10am PDT
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Introducing the New Portable XRF Analyzer for Identity Testing of Pharmaceutical Ionic Salts
Wednesday, March 11, 2020 at 10am EDT | 9am CDT | 2pm GMT | 3pm CET
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Lonza Capsugel® - The Right Partner for Your Next Drug Development Project
Thursday, March 12, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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Sterile Filling Challenges for Early-Phase Product Development
Thursday, March 19, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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How to Perform Ignition and Drying Methods Such as USP <281> and USP <731> Safely Without Sacrificing Performance
Thursday, March 26, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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