Pharmaceutical Technology ePT Weekly
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PharmTech
May 19, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

in this issue

Behind NIH's Quality Problems
AAPS 2016 Award Winners
Clinical Trials Begin with CBG Ointment

Top Stories

Pfizer to Acquire Anacor

Pfizer will acquire Anacor for $5.2 billion and expects the transaction to complete in the third-quarter of 2016.
/ read more /


ISSCR Releases Updated Guidelines on Stem Cell Research

The updated guidelines detail best practices for conducting research with human embryonic stem cells.
/ read more /

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Industry News

What's Behind NIH's Quality Problems?

Drug manufacturing lapses undermine NIH research programs.
/ read more /


GPhA Cites Opportunities for Generic Savings

In a statement, Chip Davis, president and CEO of GPhA offers support of a study published in JAMA identifying opportunity for drug savings.
/ read more /


More Industry News

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Supplier News

AAPS Announces 2016 Award Winners

The awards were presented at the AAPS Biotechnology Conference and included awards for ligand binding, innovation in biotechnology, and graduate student symposiums.
/ read more /

 

Pelican BioThermal Enters Into Partnerships in South America

The company has partnered with NatBio and BioThermal Solutions to offer cold chain logistics support in South America.
/ read more /


More Supplier News
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Bio/Pharma News

Caribou Biosciences Completes Series B Financing Round

Caribou announced the completion of a $30-million Series B financing round, which included the participation of new and current investors.
/ read more /

 

AXIM Begins Clinical Trials with CBG Ointment

The Phase I trials will examine AX-1602's clinical efficacy for the treatment of psoriasis and eczema.
/ read more /


More Bio/Pharma News
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UV spectroscopy for analyzing dissolution test samples: When established technology works better, faster and more cost effectively
Keith Moore examines why analytical chemists use UV spectroscopy for analyzing dissolution test samples, rather than high-performance liquid chromatography (HPLC) — and how they're delivering accurate lab results more quickly and cost effectively as a result. Read the article at metricsinc.com.



Regulatory News

Any Chance for “Cures” Legislation This Year?

Biomedical innovation legislation may stall in 2016.
/ read more /

 

FDA Warns of Serious Side Effects Associated with Fluoroquinolone Drugs

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.
/ read more /


More Regulatory News

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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
LIVE WEBCAST: Thursday, June 23, 2016 at 11:00 am EDT
Free registration



FEATURED TOPICS

SCALE-UP

Practical Approaches to Tech Transfer and Scale-up of Lyophilization Processes

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.
/ read more /

STANDARDS & REGULATIONS

Significant Revisions and Updates to the European Pharmacopoeia

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.
/ read more /

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Bio/Pharma in China
New Initiatives, New Opportunities

TWO LIVE EVENTS - Part 1: Wednesday, May 18, 2016, and Part 2: Thursday, May 19, 2016 at 8:00am PDT | 11:00am EDT | 4:00pm BST | 5:00pm CEST
Free registration



FORMULATION

A QbD Method Development Approach for a Generic pMDI

Application for sirdupla uniformity of delivered dose methodology.
/ read more /

API SYNTHESIS & MANUFACTURING

Upstream and Downstream Operations Can Impact Biologic API Uniformity

Bioprocess operations—from cell line selection to final filtration—can influence the consistency and purity of biologic drug substances.
/ read more /

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Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder

On Demand
Learn more



Webcasts

The Importance of Data Integrity in a GXP Regulated Laboratory

On Demand

With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by Mettler Toledo

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The Top 4 Most Expensive Encapsulation Mistakes and How to Avoid Them
On Demand
Learn more



Stability Assessment for Shipment of API and Drug Products

On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.

Sponsored by Patheon

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Ensuring Effective Drug Stability Studies
Drug Stability Testing from Development to Shipping

On Demand
Learn more



Events

The Role of Microstructure in Topical Semi-solid Product Performance and Functionality

May 24, 2016

Quality Manufacturing Conference

June 6-8, 2016

BIO International Convention

June 6-9, 2016

more events

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Continuous Manufacturing of Pharmaceuticals: Scale-up of a Hot Melt Extrusion Process
On Demand
Learn more


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