Pharmaceutical Technology ePT Weekly
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PharmTech
March 14, 2019
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In this issue:

Florida Facility Receives FDA Warning Letter

Latest ARB Recall Triggered by New Impurity

Advances in Engineering of Protein-Based APIs


Top Stories

Administration Acts Fast to Smooth Transition to New FDA Commissioner

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
/ read more /


Fujifilm to Acquire Large-Scale Biologics Manufacturing Site from Biogen in $890-Million Deal

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm's capacity and capabilities.
/ read more /

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INTERPHEX 2019 KEYNOTE SERIES

Continuous Manufacturing and 3D Printing
At INTERPHEX 2019, experts will share strategies for bringing continuous manufacturing to commercial scale. Plus, learn how 3D printing technology is being used in bio/pharma applications.

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Industry News

Latest ARB Recall Triggered by New Impurity

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.
/ read more /


FDA Takes Steps to Refine Biosimilar Naming Convention

FDA Commissioner Gottlieb released a statement on the agency's efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.
/ read more /


More Industry News
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Supplier News

GE Healthcare Announces Digital Collaboration with Amgen

The collaboration's enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.
/ read more /


Oxford Biomedica, Microsoft Announce R&D Collaboration

The companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.
/ read more /


More Supplier News
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Bio/Pharma News

Biogen to Acquire Gene-Therapy Company Nightstar in $800-Million Deal

Biogen will acquire a clinical pipeline of gene-therapy candidates in ophthalmology.
/ read more /


Krystal Biotech Opens Gene-Therapy Manufacturing Facility

The new facility, located at the company's headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company's lead gene therapy program.
/ read more /


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Webinar: Inhalation Performance Testing Webinar
Join Eurofins BioPharma Product Testing as we discuss requirements and common challenges in inhalation performance testing for drug/device combination products, such as pMDI and DPI. This webinar will include case studies; an overview of testing requirements, including extractables and leachables testing; guidelines for developing robust quality control testing methods; and more.
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Regulatory News

Florida Facility Receives FDA Warning Letter

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company's cleaning and stability testing procedures were inadequate.
/ read more /

FDA Approves New Generic Valsartan

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.
/ read more /


More Regulatory News
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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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FEATURED TOPICS

REGULATORY/GMP COMPLIANCE

A Week is a Long Time

Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.
/ read more /

MANUFACTURING

Changing Perceptions: An Understanding of Lyophilization Advancements

Technical advances in process understanding and control must be accompanied by a change in mindset.
/ read more /


APIs AND EXCIPIENTS

Advances in Engineering of Protein-Based APIs

New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
/ read more /

ANALYTICS

Paradigm Shift for Data Analysis and Interpretation

Leveraging vast quantities of analytical data requires digitalization and platform integration.
/ read more /


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UPCOMING WEBCASTs

Formulation Development for Scalability: Manufacturing Strategies for Bioavailability-Enhancing Technologies
Wednesday, April 3, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Capsugel® Vcaps® Plus: The New Standard in HPMC Capsules
Thursday, March 28, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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Ensuring Integrity of Drug Formulation from Development to QC
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Events

Pittcon 2019

March 17–21, 2019

DCAT Week '19

March 18–21, 2019

INTERPHEX

April 2–4, 2019

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eBOOKS

Laboratory Best Practices 2018 eBook

The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.


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