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

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.

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.

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

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.

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.

Omics & Systems Biology

Catalyst for metagenomics

Catalyst for metagenomics

Almac lands new metagenomics and enzyme discovery program with University College London

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

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

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
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