Pharmaceutical Technology ePT Weekly
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PharmTech
June 1, 2017
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In this issue:

FDA Cites B. Braun Medical

BMS Collaborates with Advaxis; Array

Gottlieb Outlines Opioid Fight

Top Stories

Value-Based Pricing Viewed as Most Potentially Transformative Factor Facing the Industry

In Lazard's Global Healthcare Leaders 2017 survey, most respondents said pricing and reimbursement were the most significant challenge, but nearly half of the pharma executives who responded see value-based pricing as having the greatest impact on the business, potentially even more than scientific breakthroughs.
/ read more /


Janssen Enters License Agreement with Protagonist Therapeutics

The company entered a collaboration with Protagonist to develop, manufacture, and commercialize PTG-200.
/ read more /

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Podcast

Rajesh M. Dave, distinguished professor at the New Jersey Institute of Technology, sat down with Pharmaceutical Technology to discuss polymer thin films for drug delivery.

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Industry News

EMA Builds Collaboration with African Regulators

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.
/ read more /


B. Braun Medical Cited for cGMP Violations

The company was cited for cGMP violations at its Irvine, California facility.
/ read more /


More Industry News

Supplier News

Intertek Expands GMP Pharmaceutical Stability Storage Facility in UK

The company expanded its UK storage facility to meet increasing demand from its growing customer base.
/ read more /


Charles River Laboratories Updates Online Tumor Model Compendium

The compendium provides a resource to identify and locate targeted suitable patient-derived xenografts based on specific histology and molecular properties.
/ read more /


More Supplier News

Bio/Pharma News

FDA Approves Keytruda for Cancers with Specific Biomarker

This marks the first FDA approval of a treatment based on a specific biomarker.
/ read more /


BMS Collaborates with Advaxis and Array

The company entered two separate collaborations with Advaxis and Array Biopharma involving its PD-1 immune checkpoint inhibitor Opdivo.
/ read more /


More Bio/Pharma News

Regulatory News

Gottlieb Outlines Opioid Fight

FDA's new commissioner asks staff for suggestions for fighting the opioid crisis.
/ read more /


CMA Accuses Merck of Restricting Access to Remicade Biosimilars in UK

The Competition and Markets Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.
/ read more /


More Regulatory News

FEATURED TOPICS

MANUFACTURING

Single-Use Bioreactors Have Reached the Big Time

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
/ read more /

QUALITY

Ensuring the Biological Integrity of Raw Materials

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
/ read more /

SUPPLY CHAIN

Getting Biopharmaceutical Tech Transfer Right the First Time

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.
/ read more /

DRUG DELIVERY

Developing an Injectable Compound for a Dual- Chamber Delivery System

Prefilled dual-chamber cartridges offer several advantages. Several steps should be taken to determine if a dual-chamber system is viable for a lyophilized injectable drug product.
/ read more /


UPCOMING WEBCASTS

How to Create Insights from Your Quality Data
Live Webcast: Tuesday, June 13 at 11:00am EDT
Register now


Best Practices for Effective Tablet Lubrication
Live Webcast: Wednesday, June 7 at 11:00am EDT
Register now


ON DEMAND WEBCASTS

Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
On Demand
Learn more


A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Implementing Pharmaceutical Elemental Impurity Sample Preparation and Analysis
On Demand
Learn more


Events

Quality by Design for Biopharmaceuticals

June 12, 2017

BIO International Convention

June 19–22, 2017

Excipientfest Asia

July 13–14, 2017

more events

REFERENCE BOOKS

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Click here /

More Reference Library

eBOOKS

Biologics and Sterile Manufacturing

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.


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