July 2013- Volume 9, Issue 7
July 2013
In this Issue
Government Watch
FDA releases biosimilar meeting guidance
FDA releases biosimilar meeting guidance
Industry commenters request greater clarification of timelines, data requirements
Sequester hits U.S. researchers hard
Sequester hits U.S. researchers hard
With 5 percent of its budget gone, NIH outlines grim state of U.S. biomedical research funding
FDA issues draft guidance on contract manufacturing arrangements
FDA issues draft guidance on contract manufacturing arrangements
Agency seeks comments on roadmap for quality agreement preparation
Thumbs up, thumbs down
Thumbs up, thumbs down
U.S. Supreme Court rules in Myriad case that naturally occurring DNA is not patent-eligible, but cDNA is
The pursuit of pharma data transparency
The pursuit of pharma data transparency
Companies challenge EMA’s three-year-old access-to-documents policy
Products & Services
ELISA automation: IVD and non-IVD labs now have an affordable solution to ease their workflow
ELISA automation: IVD and non-IVD labs now have an affordable solution to ease their workflow
Hamilton Robotics has launched a new module for the Microlab STAR workstation that automates enzyme-linked immunoabsorbant assays (ELISAs).
Capsugel launches LIPIDEX technology platform
Capsugel launches LIPIDEX technology platform
Capsugel’s new LIPIDEX technology platform addresses formulation, technology and manufacturing challenges.
Thermo Fisher Scientific expands stem cell media offerings with HyCell-STEM and HyCell-STEM-FF systems
Thermo Fisher Scientific expands stem cell media offerings with HyCell-STEM and HyCell-STEM-FF systems
Thermo Scientific HyCell-STEM and HyCell-STEM-FF stem cell culture media are designed to optimize the expansion rate of human embryonic stem cells and induced pluripotent stem cells per passage for cell culture applications.
The Pistoia Alliance releases HELM biomolecular representation standard open-source tools
The Pistoia Alliance releases HELM biomolecular representation standard open-source tools
HELM software toolkit and editor now available under open source license.
Optibrium introduces StarDrop 5.4 to target novel, safe and efficacious drugs
Optibrium introduces StarDrop 5.4 to target novel, safe and efficacious drugs
Optibrium, a developer of software for drug discovery, today announced the release of version 5.4 of its StarDrop software platform.
Accelrys releases industry-first informatics system for R&D: The Accelrys Experiment Knowledge Base (EKB)
Accelrys releases industry-first informatics system for R&D: The Accelrys Experiment Knowledge Base (EKB)
Accelrys EKB is an industry-first laboratory informatics system that raises the bar for experimentation management.
Tools & Technology
Going with the flow
Going with the flow
Microfluidic device market expected to grow to $5.7 billion by 2018
On cloud nine
On cloud nine
BT, Accelrys combine big data platforms for better data mining
Giving it the old college try
Giving it the old college try
Agilent instrumentation goes into new UC Berkeley chemistry lab so that next-gen scientists can receive real-world training
Striving for a seamless workload
Striving for a seamless workload
OpGen and Applied Maths team up to do efficient strain typing for public health
Commentary
Out of Order: Success-story succession
Out of Order: Success-story succession
I’m not suggesting we can’t take inspiration from success stories, but I think we need to temper that inspiration with a reminder that success can be measured in several different ways. One such way is longevity, and that is where most of the sexiest success stories tend to fall apart.
Finding the right balance
Finding the right balance
If you’ve ever met with a financial planner or investment advisor, then you know that one of the first rules of investing is diversification, an important risk management technique that ensures there are a variety of assets within a portfolio. As biopharmaceutical organizations, it is important that we recognize the dire consequences that may result if we ignore this proven strategy.
Research & Development
AstraZeneca acquires Omthera Pharmaceuticals
AstraZeneca acquires Omthera Pharmaceuticals
Omthera’s NDA-ready novel dyslipidemia treatment will complement AZ’s cardiovascular portfolio
States get serious about science
States get serious about science
Indiana and Oregon launch bioscience incubators
A gut check for Big Pharma
A gut check for Big Pharma
Major biotech-pharma agreement demonstrates potential value of microbiome research
A robust innovation alliance in oncology
A robust innovation alliance in oncology
Public-private alliance will create efficient partnership opportunities in oncology drug development and pathway discovery
Portfolio versus pathogens
Portfolio versus pathogens
GlaxoSmithKline gets $40 million from U.S. government to develop new antibiotics; could see additional $160 million
Editor's Focus
First in Science: Fighting for research, funding and the American way
First in Science: Fighting for research, funding and the American way
Look up in the sky! It’s a bird! It’s a plane! No—it’s … a biomedical research Super PAC!
Diagnostics
Two ways about it
Two ways about it
Pair of new deals helps QIAGEN expand pipeline of promising biomarkers for personalized healthcare CDx
Eager for early detection
Eager for early detection
Cancer Research UK, CRT, Abcodia to seek biomarkers for early cancer detection
APRs in CTCs
APRs in CTCs
Arno Therapeutics to collaborate with J&J’s Veridex to develop diagnostic test
IVD is a rising oncology star
IVD is a rising oncology star
Cancer testing is maturing from personalized medicine to precision medicine, Kalorama says
Global News
All eyes on Europe
All eyes on Europe
Consortia set sights on moving European biomedical research forward
A joint venture in Japan
A joint venture in Japan
Amgen, Astellas initiate strategic alliance for joint venture, pipeline medicines
Drug discovery with strong inflection
Drug discovery with strong inflection
Ireland’s Inflection Biosciences licenses preclinical oncology programs from Spanish National Cancer Research Centre
The Russian connection
The Russian connection
Alethia announces licensing and research deal with IBC Generium for one of its therapeutic monoclonal antibody inhibitors
Scoping the pipeline
Scoping the pipeline
Thomson Reuters offers quarterly analysis of promising drugs to watch
Omics & Systems Biology
Introducing OncoSpire Genomics
Introducing OncoSpire Genomics
Joint venture between Mayo Clinic and Cancer Genetics will focus on rapid advances in oncology
Sharing is caring
Sharing is caring
Global alliance unites multiple organizations to revolutionize data sharing
Predictive and preclinical partnership
Predictive and preclinical partnership
Cenix BioScience and Debiopharm Group launch predictive biomarker collaboration
Catalyst for metagenomics
Catalyst for metagenomics
Almac lands new metagenomics and enzyme discovery program with University College London
Special Reports
A place for my cells
A place for my cells
As collections expand, biorepositories are bursting at the seams
A place for my cells (continued)
A place for my cells (continued)
As collections expand, biorepositories are bursting at the seams
