Pharmaceutical Technology ePT Weekly
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PharmTech
April 26, 2018
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In this issue:

Pharma 4.0

FDA Publishes Q&A on GMPs for APIs

J&J, BMS Team Up on Cardiovascular Therapies


Top Stories

Sanofi to Divest European Generics Business in Deal Worth $2.4 Billion

Global investment firm Advent to acquire and invest in Sanofi's European generics business, Zentiva, to boost its position in European market.
/ read more /


Merck KGaA to Sell Consumer Health Biz to Procter & Gamble for $4.2 Billion

The transaction is part of Merck KGaA's strategy to actively shape its product portfolio and focus on innovation-driven business.
/ read more /


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Industry News

CDER Publishes Drug Safety Report

FDA's Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
/ read more /


Federal Judge Enters Consent Decree With Drug Compounder

A United States federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.
/ read more /


More Industry News

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Supplier News

AMRI Wins NIH Contract Renewal for Neurotherapeutics

The contract renewal allows AMRI to continue to provide medicinal chemistry and ADME services for advancing drug discovery programs in neurotherapeutics.
/ read more /


Sanofi Buys Berkeley Lights' Cell Line Platform

The new platform is expected to speed up cell line development.
/ read more /


More Supplier News
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Bio/Pharma News

J&J, BMS Team Up on Cardiovascular Therapies

Johnson & Johnson's Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.
/ read more /


FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug

The agency has granted breakthrough therapy designation to Roche's hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
/ read more /


More Bio/Pharma News
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Regulatory News

FDA Seeks to Advance Treatments for Opioid Use Disorder

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
/ read more /


 

FDA Publishes Q&A on GMPs for APIs

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
/ read more /


More Regulatory News

FEATURED TOPICS

FORMULATION

Delivering High-Concentration Protein Formulations

The high viscosity of highly concentrated monoclonal antibody formulations not only presents processing and storage difficulties, but also formulation and delivery challenges.
/ read more /

MANUFACTURING

Pharma 4.0

Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.
/ read more /

EXCIPIENTS

The Real Complexity of Excipient Composition

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.
/ read more /

SUPPLY CHAIN

Managing Pharmaceutical Recalls with Automation

How warehouse execution systems can help in case of a drug recall.
/ read more /


ON DEMAND WEBCASTS

Improve Data Transparency and Collaboration Across your Manufacturing Network
On Demand
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Dose Design: Bridging Early- and Late-Phase Development
On Demand
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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
Learn more


Events

Pharmacopoeia Conference

May 29–30, 2018

BIO International Convention

June 4–7, 2018

American Biomanufacturing Summit 2018

June 14–15, 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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