Pharmaceutical Technology ePT Weekly
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PharmTech
September 29, 2016
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in this issue

HHS Contracts Sanofi Pasteur for Zika Vaccine
Contract Packager Expands Capabilities
FDA Approves Humira Biosimilar

Top Stories

Pfizer Decides to Remain One Company

Pfizer announced its decision to remain one company after debating the possibility of splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies.
/ read more /


Congressional Committee Questions Mylan CEO Over EpiPen Controversy

The House Committee on Oversight and Government Reform questioned Heather Bresch during a hearing on the company's decision to raise the price of EpiPen more than 400%.
/ read more /

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Industry News

HHS Contracts Sanofi Pasteur for Zika Vaccine Development

HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.
/ read more /


US and Europe Collaborate on Treatment of Rare Diseases

FDA and EMA set up new working group on the development of treatments for rare diseases.
/ read more /


More Industry News

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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Supplier News

Dow, Colorcon Add Excipients to Alliance Offerings

Dow and Colorcon extend and broaden the scope of the Controlled Release Alliance.
/ read more /


Contract Packager Expands Serialization and Cold Chain Capabilities

Sharp Packaging Services adds Biotechnology Center of Excellence to its to its Allentown, PA campus.
/ read more /


More Supplier News

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Bio/Pharma News

Cancer Research Technology and SV Life Sciences Launch Company

CRT and SV Life Sciences launched Artios Pharma, a new company formed to develop drugs targeting the DNA damage response to cancer.
/ read more /


Genentech and BioNTech Collaborate on Cancer Therapies

The companies will collaborate on mRNA-based cancer vaccine development.
/ read more /


More Bio/Pharma News
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Regulatory News

FDA Approves Humira Biosimilar

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.
/ read more /


China Facility Receives FDA Warning Letter

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.
/ read more /


More Regulatory News
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FEATURED TOPICS

API SYNTHESIS & MANUFACTURING

The Search for a Greener Fluorination Reaction

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.
/ read more /

MANUFACTURING

Maintaining Hygienic Diaphragm Valves

A process-specific preventative maintenance program improves productivity and reliability.
/ read more /


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Struggling to Maintain Quality Oversight?
Gain greater end-to-end control with harmonized operations. Read the five steps to align quality globally for faster, fact-based decision making and compliance readiness.
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STANDARDS & REGULATIONS

Efforts Accelerate to Streamline Postapproval Change Process

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
/ read more /

OUTSOURCING

Innovation vs. Capacity: How CMOs Compete

The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
/ read more /


AAPS Planning Guide

CordenPharma

CordenPharma is your full-service Contract Development & Manufacturing (CDMO) partner for APIs, Drug Products, and Packaging Services.
AAPS Booth # 1108
/ Learn more /

MPI Research

MPI Research is a high-quality organization that provides discovery, preclinical, and clinical services to the biopharmaceutical, medical device, animal health, and chemical industries.
AAPS Booth # 1249
/ Learn more /

ACG Worldwide

ACG Worldwide is an integrated manufacturing, packaging, and R&D solutions provider for the global pharmaceutical industry.
AAPS Booth # 801
/ Learn more /


UPCOMING WEBCASTS

Biocompatibility Testing of Combination Devices – New Regulatory Guidance
Live Webinar: Thursday, November 3 at 8:00 am PDT
Register now


Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
Live Webinar: Wednesday, October 26 at 11:00 am EDT
Register now


Strategies for IND Filing Success
Live Webinar: Friday, October 21 at 11:00 am EDT
Register now


Implementing On-Dose Anticounterfeiting Technologies for Solid-Dose Drug Products
Live Webinar: Friday, October 14, 11:00 AM EDT
Register now


Don't Let Your Diluent be the Weakest Link in Your Drug Product
Live Webinar: Thursday, October 13, 2016 at 10:00 am EDT
Asia / Pacific Session: Thursday, October 13, 2016 at 3:00 pm SGT (Singapore)/ 4:00 pm JST (Tokyo/Korea)
US/EU Session: Thursday, October 13, 2016 at 10:00 am EDT (New York City)/ 3:00 pm BST (London)/ 4:00pm CEST (Berlin)
Register now


Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
Live Webinar: Tuesday October 11 at 11:00 am EDT
Register now


Events

CPhI Worldwide

October 4–6, 2016

Global Conference on Pharmacy and Pharmaceutical Sciences Education

November 7–8, 2016

AAPS Annual Meeting and Exposition

November 13–17, 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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