Pharmaceutical Technology ePT Weekly
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PharmTech
April 12, 2018
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In this issue:

Fujifilm Expands Bioprocessing Scope

FDA Releases Resources Planning Report

Unlocking the Best Solution for API Sourcing


Top Stories

Roche Completes $1.9-Billion Acquisition of Flatiron Health

The acquisition is expected to accelerate progress towards personalized cancer healthcare.
/ read more /


FDA Issues CRLs to Celltrion for Two Biosimilars

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
/ read more /


INTERPHEX 2018 Keynote Series

Blockchain and Serialization
Experts will discuss information technology including the internet of things, blockchain technology, and serialization.


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Industry News

NIH Reports that Squamous Cell Carcinoma Differs from Other Cancers

National Institutes of Health researchers use genomics to show that squamous cell carcinomas differ from other cancers, which could advance treatments for head and neck and other cancers.
/ read more /


New Practical Guide Published for Measuring Elemental Impurities in Pharmaceuticals

A new book published in response to new USP chapters and ICH Q3D guidelines on measuring elemental impurities provides a practical guide for using plasma spectrochemistry for pharmaceutical analysis.
/ read more /


More Industry News

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Supplier News

Fujifilm Expands Bioprocessing Scope

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.
/ read more /


CordenPharma Facility Passes FDA Inspection

The company’s facility in Boulder, CO, has passed general inspection from FDA.
/ read more /


More Supplier News

Bio/Pharma News

Lilly, Sigilon Partner on Encapsulated Cell Therapies for Diabetes

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.
/ read more /


Boehringer Ingelheim and OSE in Immuno-Oncology Deal Worth $1.7 Billion

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.
/ read more /


More Bio/Pharma News
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From May 14-15, 2018, sterile product experts at the 2018 PDA Sterile Products Manufacturing Conference will cover QRM principles in modern facilities, environmental monitoring, how to meet the demands of new therapies, and PDA's response to the proposed revision to Annex 1. Learn more and register today


Regulatory News

European Pharmacopoeia Gets Updated

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.
/ read more /


 

FDA Releases Resources Planning Report

The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
/ read more /


More Regulatory News
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FEATURED TOPICS

ANALYTICS

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 1

In this three-part podcast series, Rob Thomas, principal consultant at Scientific Solutions, discusses the impetus behind his new book, Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb. 2, 2018.
/ read more /

APIs & EXCIPIENTS

Unlocking the Best Solution for API Sourcing

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.
/ read more /

PEER-REVIEWED RESEARCH

Evaluating the Impact of Sterilization on Gel Formulations

Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
/ read more /

STANDARDS & REGULATIONS

ICH Q12 Guidelines Spark Controversies

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
/ read more /


UPCOMING WEBCASTS

Improve Data Transparency and Collaboration Across your Manufacturing Network
Wednesday, April 25 at 10:00am EDT
Register now


Dose Design: Bridging Early- and Late-Phase Development
Live Webcast: Tuesday, April 24 at 11:00am EDT
Register now

ON DEMAND WEBCASTS

Streamlined Manufacture of Modified Release Matrix Tablets via Direct Compression
On Demand
Learn more


Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
On Demand
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Real-Time Process Control for Healthy, High-Purity Water Systems
On Demand
Learn more


Successfully Progressing Therapeutic Candidates from Discovery to Development Using Early Developability Assessment Tools
On Demand
Learn more

Events

INTERPHEX

April 17–19, 2018

CPhI North America

April 24–26, 2018

BIO International Convention

June 4–7, 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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