Category Archives: Inside BIO Industry Analysis

Dealing with Rejection, the Regulatory Kind

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The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days? It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd Read More >

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BIO Europe Spring 2012 – Opening Remarks

For Monday’s Opening Remarks at BIO Europe Spring 2012, I covered the following topics: Public market performance in the US vs other sectors Private funding environment. Drug pipeline deal volume. For a copy of the slides, they can be found here.

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Does Biotech History Repeat?

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According to Mark Twain, “History does not repeat itself, but it does rhyme”. Little did he know that one day that would hold true for something called “Biotech”. Indeed, there seems to be a lot of rhyming going on with Biotech IPOs today with recent history. When we compare the accumulated number of IPOs in the last IPO window (2003-2007) with the current window (2009-now), we see an amazing overlay. Not identical, but not too far from it. Read More >

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Update: Indices, IPOs, and New Drug Approvals

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Here is a look at year to date (YTD) numbers through the end of February for the biotech indices, initial public offerings, and recent FDA Approvals. 1. Indices: The Nasdaq Biotech Index held the January jump through February, settling at + 14% YTD. The concentrated BTK slipped in February, but has outpaced the NBI since January 1st. YTD, both biotech indices have significantly outperformed the broader market. In contrast, the NYSE Pharmaceuticals Index has not Read More >

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Oncology Clinical Trials – Secrets of Success

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At last year’s BIO CEO & Investor Conference, BIO and BioMedTracker presented data showing that drugs in development for oncology indications had the lowest overall clinical trial success rate of all therapeutic areas in development since 2004. We have updated these numbers to include clinical trials through December 2011. Although overall success rates did improve slightly, oncology remained in last place. The chart below illustrates why oncology’s overall success rate is so low relative to Read More >

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