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The drug reorganization act in Germany known as AMNOG places new requirements on pharmaceutical companies to provide justification for their pricing. The new value assessment process is already causing companies to reconsider whether or not to launch new products in what is the largest pharmaceutical market in Europe. We spoke to Achim Diedenhofen, founder and partner of the consulting firm Executive Insight, about the new law, what it means to pharmaceutical revenues, and how companies will need to think about rolling out their drugs in Europe going forward.
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Former Cougar Biotechnology CEO Seeks to Repeat Success with Puma 
With $55 million from former investors, Auerbach licenses Pfizer cancer drug.
Alan Auerbach is vying for a repeat success. The former Cougar Biotechnology founder and CEO says his newest venture, Puma Biotechnology, has acquired the rights to Pfizer’s late-stage cancer drug, neratinib, completed a reverse merger, and raised $55 million. Read More Here

Avastin Loses Insurer Support in California
Blue Shield of California follows FDA’s lead in questioning drug’s value. 
Blue Shield of California will require all new requests to treat breast cancer with Genentech’s Avastin to be reviewed and found medically necessary by a panel of oncology experts before covering the therapy. Read More Here

Sing for Your Supper
NIH chief tries to inspire a chorus. 
Francis Collins has been known to sing. There are various YouTube videos of him with guitar in hand belting out a tune. But the other day Collins was hoping to get others to sing, as it were, in unison. 
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Thriving in the Data Deluge
New infrastructure, standardization, and technical literacy key elements for finding meaning in genomics revolution. 
During a recent bit of home computer maintenance I moved several gigabytes of family photos from one hard drive to another. I know there are some wonderful snapshots hidden among the seemingly infinite 0’s and 1’s encoding my memories. But given the volume of data, it will undoubtedly take me hours to find them. Even once I’ve identified the good stuff, I’m haunted by knowing that my wife has captured gigabytes of her own photos of many of the same events and people from different angles, named them different things, and filed them away with different organizational schemes on her own drives and social networks. Read More Here

Illumina Falls on Disappointing Sales
The weekly round-up of failed trials, missed targets, and other business mishaps.
Illumina shares sank nearly 35 percent to $27.01 Friday morning on news that the company’s forecasted third-quarter revenue of about $235 million fell short of consensus estimates of $278.3 million. The maker of tools for genetic analysis said the uncertainty related to unknown levels of research funding has resulted in purchasing delays for both instruments and consumables, particularly among large-volume sequencing centers. Read More Here

FDA Outlines Innovation Plan
Agency seeks to accelerate personalized medicine drive, improve service to small business.
The U.S. Food and Drug Administration has unveiled a new plan to address the most pressing concerns of industry and patient advocates, highlighting its plans to build a better agency as it makes its case to Congress for a bigger budget. Read More Here

Blame it on the FDA
VCs attribute decreased investment in medical innovation to regulatory hurdles.
A new report blasts the U.S. Food and Drug Administration for putting the United States at risk of losing its leading position as a home of biomedical innovation. The report, based on a survey of venture capitalists, says regulatory challenges posed by the agency are the main factor for declining investment in experimental drug and device startups in the United States and a shift toward investment in Europe and Asia. Read More Here

Commentary : Et tu, Pharma?
Like Gogol says, "It is no use to blame the looking glass if your face is awry." 
According to a survey by the National Venture Capital Association’s Medical Innovation & Competitiveness Coalition, VC firms are decreasing their investments in biopharmaceutical and medical device companies and shifting investment away from the U.S. towards Europe and Asia. The statements came as part of a survey of 156 of NVCA’s member firms. Of the respondents, 39% of firms decreased investment in life sciences companies over the last three years and the same percentage expect to further decrease investment over the next three years. Read More Here