Newsletter | July 9, 2014

07.09.14 -- Transcept And Paratek Sign Merger Agreement; FDA Grants Priority Review To Boehringer Ingelheim's Nintedanib NDA

Bioresearch Online Newsletter

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November 10 and 11, 2014 | Hyatt Regency, San Francisco, CA

Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.

Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.

Featured Focus

Digging For Big Data Gold: Data Mining As A Route To Drug Development Success
By Suzanne Elvidge, Contributing Editor
Big Data is becoming a major part of all facets of healthcare as more and more clinical trials results and other drug development and approval documents are being stored electronically. The challenge of Big Data is the number of combinations and factors involved, which is where data mining comes to the rescue.

Featured Content

Poster: Rapid Process Improvement Achieved By Applying A Rational Approach To Culture Media Optimization
By Tom Fletcher, Scott D Storms, and Jenny Y Bang, Irvine Scientific
The challenge of effective cell culture process development often involves how to simultaneously meet two competing needs: the need to maximize improvement of process performance and the need to minimize time spent on process development.


White Paper: The Trend In Global Sourcing
By Brian Kohr, President and CEO, CSafe
Global sourcing is a 'business-essential' that continues to be of increasing importance to life sciences companies. As manufacturers adapt to changing market conditions, consolidate their operations, and focus thought leadership to work as one company across borders, continents, and markets, the drive to make cost and efficiency savings becomes ever more demanding.


White Paper: What Is FDA 21 CFR Part 11, And Are Your Systems Compliant?
By Infitrak, Inc.
21 CFR Part 11 is a federal statutory provision designed to codify specific Best Practices for certain industries. Particularly, it authorizes commercial entities to establish and utilize computerized networks that exponentially enhance individual productivity levels via drastic reduction of manual data entry errors.


Application Note: Syloid FP Silica Improves Flow Properties And Helps Prevent Caking
By Grace
For the proper handling of active ingredients or excipients in powder form, good flow properties are very important. Clumpy or poor flowing powders are difficult to transport and dose.

Industry News

Transcept And Paratek Sign Merger Agreement
Novartis Ally Quark Wraps Up siRNA Lead Phase 2 Trial
FDA Grants Priority Review To Boehringer Ingelheim's Nintedanib NDA In IPF
Agenus' GBM Vaccine Extends Patient Survival In Phase 2 Trial
Galderma Receives Orphan Drug Designation For Skin Disease Therapy
View more headlines

 

Upcoming Training

 


Process Validation Guide: Regulatory Expectations and Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

Monitoring Informed Consent (IC): Frequently Asked Questions
Date: Thursday, July 24, 2014 • Time: 1:00 pm to 2:30 pm EST

Remote Monitoring Of Clinical Source Data: Why Not?
Date: Monday, July 28, 2014 • Time: 1:00 pm to 2:30 pm EST

Featured Downloads

RAP t2: Large Temperature-Controlled Container
The Envirotainer RAP t2 container provides accurate and reliable protection for large shipments of temperature-sensitive products. The RAP is only forkliftable when empty and is most commonly handled with rollerbeds.

Medical Devices And Diagnostic Equipment Logistics Services
Marken has trained professionals on hand with global expertise to protect and manage the logistics of medical devices, diagnostic equipment, and medical components, including sensitive microchips and surgical equipment. Their expertise also extends to ECG/ABM devices, stents, pacemakers, and investigator site specimen separation devices.

Highly Selective y-Glutamyl Transpeptidase (GGT) Inhibitor, GGs Top, For Cell Biology
GGs Top is a highly selective enzyme y-Glutamyl Transpeptidase (GGT) inhibitor for use in cell biology, laboratory research, and early drug discovery.

Take Product Samples With Minimal Effort: Three60 Sampling System
The simple design behind the Three60 Sampling System allows you to take a representative sample of your product with minimal effort.
Browse the download library

Featured Multimedia

Greater Flexibility With Genderless Connectors For Small-Flow Sterile Fluid Transfer
Small-format AseptiQuik S Connectors from Colder Products Company extend the range of sterile fluid connectors to now include 1/8" and 1/4" flow configurations. Proven AseptiQuik technology, combined with an intuitive and robust genderless design, provides biopharmaceutical manufacturers with even greater flexibility in making sterile connections.

Featured Products And Services

MPC Ceramic Hydroxyfluoroapatite Chromatography Media
MPC Ceramic Hydroxyfluoroapatite Chromatography Media

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Bio-Rad Laboratories, Inc.

Swiss World Cargo: Collaborating To Make A Difference
Swiss World Cargo: Collaborating To Make A Difference

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Envirotainer

HPLC Columns
HPLC Columns

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Hamilton Company

Pure Sericin: Silk Protein
Pure Sericin: Silk Protein

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Wako Laboratory Chemicals

Klave-it Bioprocess Containers
Klave-it Bioprocess Containers

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Parker domnick hunter Process Filtration

Crimping System
Crimping System

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ILC Dover

cGMP Biologics Manufacturing Services
cGMP Biologics Manufacturing Services

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Therapure Biopharma Inc.

Biopharmaceutical Films
Biopharmaceutical Films

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Thermo Scientific