Pharmaceutical Technology ePT Weekly
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PharmTech
March 16, 2017
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD
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In this issue:

Trump Nominates Scott Gottlieb to Lead FDA

Allergan and Editas Partner on CRISPR

FDA Warns Illinois Manufacturer

Top Stories

Gottlieb to Face User Fees, De-Regulation Pressures

Trump's choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.
/ read more /


Past, Present, and Future Trends Affecting the Bio/Pharmaceutical Industry

The trends in the year 2017 will present the industry with new challenges, and companies will be able to meet them successfully if they focus on the issues at hand.
/ read more /


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INTERPHEX 2017 Keynote Series

Automating Continuous Manufacturing
This presentation will dive into the mechanism of continuous manufacturing, leaving the isolated 'islands of automation' and working towards a fully integrated approach. Real, established use cases will demonstrate how a process analytical technology (PAT) approach can be established in a continuous manufacturing area.

LEARN MORE
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Industry News

Trump Nominates Scott Gottlieb to Lead FDA

The White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.
/ read more /


Global Regulators Collaborate to Improve Access to Safe Drugs

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.
/ read more /


More Industry News

Supplier News

Gerresheimer Adds Ready-to-Fill Vials to Primary Packaging Portfolio

The ready-to-fill packaging solutions for vials are based on Ompi EZ-fill packaging design.
/ read more /


Shimadzu Launches European Innovation Center

The innovations-oriented Think Tank combines academic-scientific and technical expertise to use Shimadzu's expertise to provide even more customer-focused service.
/ read more /


More Supplier News

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The Future of Monitoring is Now!

Newly launched, the Rotronic Monitoring System is the future of environmental monitoring. Fully browser based, access from any place, any time, on any device. See a live joint demo with Germfree Laboratories at Interphex 2017.
/ Learn more /


Bio/Pharma News

Allergan Enters into CRISPR Territory with Editas Partnership

Under the agreement, Allergan will receive exclusive access to five of Editas' ocular programs.
/ read more /


FDA Grants Clearance for Clinical Development of UCART19

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Sends Warning Letter to Illinois Manufacturer

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.
/ read more /


Chairman of Senate Judiciary Committee Raises Questions Over Auvi-Q Price Tag

Senator Chuck Grassley sent a letter to Kaléo questioning the drugs high listing price.
/ read more /


More Regulatory News

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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
Check it out today!


FEATURED TOPICS

MANUFACTURING

Achieving Manufacturing Excellence

Moving to the next level of productive, reliable performance in bio/pharmaceutical manufacturing requires a willingness to make changes and create a quality culture.
/ read more /

QUALITY

Risk-Based Predictive Stability–An Industry Perspective

A survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
/ read more /

PEER-REVIEWED RESEARCH

An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress Conditions

This study investigated the stability of solid lactose stored under high temperature and humidity conditions.
/ read more /

FACILITIES

GMP Facility Modernization: Opportunities for Successful Implementation

The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
/ read more /


NEW PRODUCTS AND SERVICES

Eurofins Lancaster Laboratories

Eurofins Lancaster Laboratories delivers fast results with a methodical quality approach for your Biopharmaceutical Products. Contact us to get timely results without sacrificing quality.
/ Learn more /

Mikart, Inc.

Mikart specializes in the development, manufacturing, and packaging of solid-dose and liquid-oral dose products.
/ Learn more /

MPI Research

You deserve a strategic, responsive, and efficient partner for your early-stage drug development.
/ Learn more /

PYRAMID Laboratories, Inc.

PYRAMID Laboratories, Inc. is located in Southern California, United States.
/ Learn more /

Suheung Capsule

Widely recognized global supplier of two piece capsules, Suheung Capsule has solely focused on manufacturing the highest quality Capsules.
/ Learn more /


UPCOMING WEBCAST

Titration in Early Drug Discovery and Development
Live Webinar: Thursday, March 16 at 10am EDT
Register now


On Demand WEBCASTS

Around the World in Clinical Trials: New Regulations and Country Specific Challenges
On Demand
Learn more


Accelerate Bioprocess Development Using the Modular Automated Sampling Technology (MAST) Platform
On Demand
Learn more


Events

DCAT Week

March 20–23, 2017

Interphex

March 21–23, 2017

3rd FDA/PQRI Conference on Advancing Product Quality

March 22–24, 2017

more events

REFERENCE BOOKS

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ Click here /

More Reference Library

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.


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