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American Pharmaceutical News In Review
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October 08, 2020
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  Different Name. Same Customer Focus

Thomas H. Lee Partners, L.P. (“THL”) and Frazier Healthcare Partners (“Frazier”) announced they have acquired Adare Pharmaceuticals, which will be rebranded Adare Pharma Solutions (“Adare”), a leading specialty contract development and manufacturing organization (CDMO) and global provider of advanced pharmaceutical technologies, from TPG Capital. The acquisition includes Adare’s CDMO, pharmaceutical technology and microbiome businesses, while TPG Capital will retain rights to Adare’s Eosinophilic Esophagitis (EoE) product, which has been spun out into a separate entity.

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» Industry News
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  Marksans Expands Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets
Marksans is voluntarily expanding its earlier initiated recall to include an additional 76 unexpired... read more »
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  Fulcrum to Initiate FTX-6058 Trial for Sickle Cell Disease
Fulcrum announced the IND is now in effect for its Phase 1 trial in healthy adult volunteers with ... read more »
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  FDA Approves Drug Combination for Treating Mesothelioma
The FDA approved Opdivo in combination with Yervoy for the first-line treatment of adults with ... read more »
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  Nephron Receives Warning Letter from FDA
The FDA has issued a warning letter to Nephron due to emails Nephron’s CEO and a sales ... read more »
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  Haemonetics Receives FDA Clearance for NexSys PCS with Persona Technology
Haemonetics has received FDA 510(k) clearance for its NexSys PCS system with Persona technology. read more »
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  Farxiga Granted Breakthrough Therapy Designation for Chronic Kidney Disease
Farxiga has been granted Breakthrough Therapy Designation in the US for patients with chronic kidney... read more »

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» Featured Articles
Opportunities and Pitfalls in the Analysis of Subvisible Particles during Biologics Product Development and Quality Control
Subvisible particulate matter testing in injectable drugs has been required for many parenteral drugs since USP <788> was first implemented in the early ... read more »
QC Corner: Single-Use Systems Underline the Rising Significance of Extractables and Leachables Studies
Examining extractables and leachables is an important safety issue as these substances can adversely impact the health of patients. read more »
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» Featured Announcements
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  Register Now: Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
Join Dr. Kara Norman from Thermo Fisher Scientific on October 13, 2020 as we discuss the development... read more »
» Infographic
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  New Product Filing Strategies: Questions to Ask Your CDMO
Important considerations to minimize the stress caused by the regulatory journey. read more »
» Featured Video
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  Interphex Live 2020-Advancements in Cell and Gene Therapy
Interphex Live 2020-Advancements in Cell and Gene Therapy watch »
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  On-Demand Webinar: A Successful Journey to Cell Therapy Manufacturing: From R&D to Lot-Release
In this webinar you'll learn about regulatory requirements for GMP ancillary materials for cell and gene therapy, closed-system manufacturing and how ... watch »

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» Featured Products
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  MB-Rx Insitu Reaction Monitoring Analyzer
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  CEOLUS UF Grade Microcrystalline Cellulose
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» Featured Whitepaper
Steritest NEO Sterility Testing Devices
Our Steritest™ NEO devices simplify every aspect of testing, from handling to traceability, all within a closed concept system. The ease and convenience of this closed assembly enable you to increase productivity while maintaining the highest levels of quality and reliability. When used with the Steritest™ Symbio pump and Steritest™ culture media and fluids, the Steritest™ system delivers unmatched sterility testing consistency. Since 1974, we have been the market leader in sterility testing. ... read more »
eBook: TOC and Microbial Detection Monitoring
Proper and thorough monitoring of pharmaceutical water systems is imperative to deliver the highest quality products to patients. read more »

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| Events
EVENT
  A Quality Perspective Roundtable Discussion on the Successes and Challenges of Making Changes to Pharma Workflow
Online –  10/15/2020
Join us in an interactive roundtable discussion with real-world pharmaceutical industry professionals.
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EVENT
  Ophthalmic Drugs Conference
Kensington, London –  11/23/2020
SMi proudly presents the 4th Annual Ophthalmic Drugs Conference taking place on the 23rd-24th of November 2020, in London.   The global ophthalmic ...
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