Pharmaceutical Technology ePT Weekly
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PharmTech
May 11, 2017
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In this issue:

Sartorius Stedim's New Testing Services

PhRMA Changes Membership Criteria

FDA Moves Forward on Mutual Inspections

Top Stories

Gottlieb Faces Multiple Challenges at FDA

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
/ read more /


US Prescription Drug Spending to Hit $610 billion in 2021, according to Quintiles/IMS

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.
/ read more /


WHO Launches Biosimilar Pilot Program

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.
/ read more /

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CPhI NORTH AMERICA SESSION

The Contract Services Market: Status and Strategies
Industry expert Jim Miller, president of PharmSource Information Services, will share his perspective on the contract services landscape and suggest strategies for outsourcing companies looking to grow in this sector.

Learn More

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5 cGMP Mapping Resources to Make Your Next Project Easier

Get these 5 mapping resources that will make your next mapping project easier and more efficient. Learn about the proper number of sensors, calibration recommendations, warehouse mapping, regulations and guidelines, and choosing the best sensor.
/ Download these 5 great resources! /

Industry News

EMA Promotes Understanding and Use of Biosimilars

EMA and the European Commission released a biosimilars information guide for health professionals during the EC's biosimilars conference.
/ read more /


PhRMA Increases R&D Criteria for Member Companies

More stringent R&D investment requirements for PhRMA membership reduces the association ranks by 22 associate and member companies.
/ read more /


More Industry News

Supplier News

Croda Completes Global EXCiPACT Accreditation

The company is the first multi-site excipient supplier to achieve accreditation across production facilities.
/ read more /


Sartorius Stedim's New Testing Services to Focus on mAbs and Biosimilars

Operated by BioOutsource, Sartorius' subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.
/ read more /


More Supplier News

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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
Check it out today!

Bio/Pharma News

Novartis Licenses CAR-T Patents in Separate Deals

Novartis entered separate license agreements with bluebird bio and Celyad for patents related to the manufacture of CAR-T cells.
/ read more /


Oxford Genetics Licenses CRISPR Gene Editing Technology from ERS Genomics

Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Moves Forward on Mutual GMP Inspections with Europe

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
/ read more /


API from Unregistered Companies Entered US, According to FDA

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
/ read more /


More Regulatory News

FEATURED TOPICS

MANUFACTURING

Innovating in a Value-Based World

Value-based medicine is putting patients at the center of pharmaceutical R&D and forcing the industry to move from treatment to prevention.
/ read more /

API SYNTHESIS & MANUFACTURING

Catalysis, Flow Chemistry Impact API Manufacturing

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
/ read more /

FILL/FINISH

Impact of PFS and Filling Process Selection on Biologic Product Stability

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
/ read more /

QUALITY

Keeping an Eye on Quality

New study will reveal bio/pharma practices and performance on quality issues.
/ read more /


UPCOMING WEBCASTS

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


Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
Live Webcast: Wednesday, May 24 at 11:00am EDT and Wednesday, May 31 at 11:00am CEST
Register now


ON DEMAND WEBCASTS

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


Events

CPhI North America

May 16–18, 2017

Pharmaceutical Sciences World Congress

May 21–24, 2017

Excipientfest Asia

June 7–8, 2017

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

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.


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