Pharmaceutical Technology ePT Weekly
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PharmTech
March 9, 2017
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In this issue:

Study Dismantles Argument on Drug Pricing

CDER Director Details Priorities for 2017

MedImmune and Sanofi Pasteur Strike Deal

Top Stories

EU and US Pledge to Recognize Each Other’s GMP Inspections

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
/ read more /


Trump Blasts FDA “Restraints,” High Drug Prices

President Trump calls for faster FDA approvals and lower drug prices.
/ read more /


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INTERPHEX 2017 Keynote Series

Moving from Compliance to Value: A State of the
Industry Report

This session will examine results of an extensive industry survey and focus on areas where serialization and traceability projects can bring significant business value.

LEARN MORE
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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 /


Industry News

CPhI North America Releases Conference Program Lineup

The conference will include 55 speakers at more than 44 sessions.
/ read more /




Study Dismantles PhRMA’s Long-Standing Argument on Drug Pricing

Premium pricing in the US produces excess revenue for pharma companies. According to a new assessment, only 66% of those excess funds go to R&D.
/ read more /


More Industry News

Supplier News

PharmaCord Launches in Louisville

The new company links and manages aspects of treatment delivery, facilitating access for patients to treatments by serving as a connector between manufacturers, patients, physicians, and payors.
/ read more /


Allergopharma Begins Production at Reinbek Biopharmaceutical Facility

The company made a €42 million investment in a new building at its Reinbek site to support the production of biopharmaceuticals.
/ read more /


More Supplier News

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Attend the 2017 PDA Annual Meeting (Apr. 3-5) to take a forward look into the future of bio/pharmaceutical science and technology! This hallmark meeting will explore cell and gene technologies for personalized medicine, next-generation manufacturing, immunotherapy, “big data” applications for process design and optimization and accelerating product development. Stay for the 2017 PDA Cell and Gene Therapy Workshop (Apr. 5-6) and the PDA Annual Meeting Course Series (Apr. 6-7).
Learn more


Bio/Pharma News

BeiGene and GDD Build Biologics Facility in China

BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.
/ read more /


MedImmune and Sanofi Pasteur Strike Deal

The companies have entered into an agreement to develop and commercialize a mAb for the prevention of lower respiratory tract illness in young children.
/ read more /


More Bio/Pharma News

Regulatory News

China API Facility Receives FDA Warning Letter

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
/ read more /


CDER Director Details Priorities for 2017

Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.
/ 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

Ensuring Sterility in Small-Scale Production

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
/ read more /

STANDARDS & REGULATIONS

Regulatory Reform Is Not That Simple

Reducing regulatory roadblocks requires more than the stroke of a pen.
/ read more /

FILL/FINISH

Taking a Closer Look at Parenteral Contaminants

Visual inspection of parenteral vials is the first step in a root cause investigation.
/ read more /

GMPs

The Transition to Electronic Records

A four-stage process to successfully make the switch from paper to electronic batch records is presented.
/ read more /


NEW PRODUCTS AND SERVICES

Patheon

Patheon, a business unit of DPx Holdings B.V., is a leading provider of contract development and commercial manufacturing services to the pharmaceutical and biotechnology sectors.
/ Learn more /

AbbVie Contract Manufacturing

AbbVie’s Contract Manufacturing business has been serving our partners for over 35 years.
/ Learn more /

Ashland Inc.

Delivering pharmaceutical and nutraceutical performance, Ashland provides solutions for applications in tablet binding, film coating and disintegration, controlled release formulation and drug solubilization.
/ Learn more /

Coating Place, Inc.

Coating Place develops and manufactures modified release oral products. We are the leading provider of Wurster microencapsulation.
/ Learn more /

CordenPharma

CordenPharma is your full-service Contract Development & Manufacturing (CDMO) partner for APIs, Drug Products, and Packaging Services.
/ 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 Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
/ 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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