Pharmaceutical Technology ePT Weekly
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PharmTech
September 1, 2016
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in this issue

Takeda Launches Medicines Access Strategy
AMRI Licenses CRISPR from Broad Institute
FDA Publishes ANDA Submission Guidance

Top Stories

When Marketing and Medicine Collide

Steep price increases for a popular drug have created patient and Congressional backlash.
/ read more /


Mylan to Launch Generic Version of EpiPen

The company will launch a generic version of EpiPen at the price of $300 for a two-pack.
/ read more /


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Industry News

Compounding Pharmacy Warned Over a Variety of Violations

FDA issued a warning letter to College Pharmacy for multiple violations.
/ read more /


CPhI's Pre-Connect Congress Outlines Pharma Trends

CPhI Worldwide's Pre-Connect Congress will discuss current trends in the pharmaceutical industry.
/ read more /


More Industry News

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Supplier News

Metrics Invests in New Stability Storage Facility

The company will be investing $3.5 million in a 15,00-square-foot facility in Greenville, North Carolina.
/ read more /


Recipharm Expands Lyophilization Capacity in Italy

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.
/ read more /


More Supplier News
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EXPERT INTERVIEW

Francis Flanagan, associate principal scientist at Merck, sat down with Pharmaceutical Technology to discuss using minitablets in pharmaceutical manufacturing.

WATCH NOW



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New Trends in Hygienic Diaphragm Valves that Improve Reliability
LIVE WEBCAST: Thursday, September 22, 2016 at 11:00 am EDT.
Free registration



Bio/Pharma News

Takeda Launches Medicines Access Strategy in Regions with High Unmet Medical Needs

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.
/ read more /


AMRI Licenses CRISPR from the Broad Institute

AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.
/ read more /


More Bio/Pharma News
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Best Practices for Effective Excipient Sourcing and Testing
LIVE WEBCAST: Tuesday, September 20, 2016 at 11:00am EDT.
Register now



Regulatory News

FDA Finds Microbial Contamination at Drug Compounder

The agency sent a warning letter to Cape Apothecary for adulterated drugs.
/ read more /

 

FDA Publishes ANDA Submission Guidance

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.
/ read more /


More Regulatory News


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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
LIVE WEBCAST: Tuesday, September 13, 2016 | 11 am EDT | 10 am CDT | 8 am PDT.
Free registration



FEATURED TOPICS

FACILITIES

One Strategy for Updating an Aging Facility

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.
/ read more /

STANDARDS & REGULATIONS

All Buzz, No Bite

Congressional partisanship creates noise, but no funding for Zika virus research.
/ read more /


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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
LIVE WEBCAST: Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT.
Free registration



GMPs

GMPs Creep into GDPs

Recent revisions to the European Union's good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.
/ read more /

OUTSOURCING

What's Next for the CMO Industry?

CMOs that offer an innovative service-oriented model will dominate the industry.
/ read more /


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Amorphous Dispersion Drug Formulations: A Modern Simulation-Based Approach
LIVE WEBCAST: Wednesday, Sept. 07, 2016 at 11:00 AM EDT.
Free registration



Events

PDA/FDA Joint Regulatory Conference

September 12-14, 2016

ISPE Annual Meeting

September 18-21, 2016

13th Confocal Raman Imaging Symposium

September 26–28, 2016

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

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.


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