Home / Archive / July 2013

July 2013 Volume 9, Issue 7

Volume 9, Issue 7 | July 2013

In this Issue

Government Watch

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

Companies challenge EMA’s three-year-old access-to-documents policy

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FDA issues draft guidance on contract manufacturing arrangements

Agency seeks comments on roadmap for quality agreement preparation

FDA releases biosimilar meeting guidance

Industry commenters request greater clarification of timelines, data requirements

Patent Docs: U.S. Supreme Court rules ‘reverse payment’ settlements in ANDA litigation not unlawful

Payments must be assessed using ‘rule of reason’

Global News

Scoping the pipeline

Thomson Reuters offers quarterly analysis of promising drugs to watch

All eyes on Europe

Consortia set sights on moving European biomedical research forward

A joint venture in Japan

Amgen, Astellas initiate strategic alliance for joint venture, pipeline medicines

Drug discovery with strong inflection

Ireland’s Inflection Biosciences licenses preclinical oncology programs from Spanish National Cancer Research Centre

The Russian connection

Alethia announces licensing and research deal with IBC Generium for one of its therapeutic monoclonal antibody inhibitors

Research & Development

Portfolio versus pathogens

GlaxoSmithKline gets $40 million from U.S. government to develop new antibiotics; could see additional $160 million

AstraZeneca acquires Omthera Pharmaceuticals

Omthera’s NDA-ready novel dyslipidemia treatment will complement AZ’s cardiovascular portfolio

States get serious about science

Indiana and Oregon launch bioscience incubators

A gut check for Big Pharma

Major biotech-pharma agreement demonstrates potential value of microbiome research

A robust innovation alliance in oncology

Public-private alliance will create efficient partnership opportunities in oncology drug development and pathway discovery

Commentary

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

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.