Category Archives: Inside BIO Industry Analysis

Breakthrough Designations Reach 13

One of the outcomes of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) was the creation of the “Breakthrough Therapy” designation.  The new law allows FDA to grant a Breakthrough Therapy designation to drugs showing early clinical promise for serious or life-threatening conditions, thereby expediting both the development and the review of these drugs. As of today, 13 designations have been granted according to a search of the BioMedTracker database (see table Read More >

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Results from the BIO Convention 2013 Meeting Analysis of Therapeutic In/Out Licensors

BIO’s results from the BIO 2013 Convention 1×1 meeting analysis conducted to identify trends and intentions of therapeutic in-licensors and out-licensors were released today. The analysis looked at the meeting activity of 180 in-licensors attending the Chicago conference in terms of what therapeutic areas and stages of development were in highest demand. Of the 804 drug R&D companies, companies in Phase I/Rare Disease came out ahead as a group, with an average of >17 meetings/company. This was followed by Phase Read More >

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BIO-Europe Spring Opening Remarks

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BIO’s own David Thomas, Director of Industry Research, delivered opening remarks at the BIO-Europe Spring conference in Barcelona yesterday. His slides provide a snapshot of the biotech industry’s performance and highlight emerging trends in venture exits: IPOs and M&A. Takeaways from his talk include breakouts on multiple fronts for the industry: FDA approvals at highs not seen since the 1990s Orphan designation approvals at all-time highs IPOs starting to show signs of life in 2012 Read More >

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A Bright Future for Orphan Disease Indications

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In celebration of National Rare Disease Day BIO’s Industry Analysis team took a look at recently-approved drugs in the BioMedTracker database with an orphan indication designation. Our research found that 2012 saw the greatest number of approvals of therapies for orphan indications going back all the way to 2000 (This count includes previously approved drugs with new, orphan indication approvals).   Overall, 24 therapies were approved in orphan indications last year, including drugs for Anthrax, Gaucher’s Read More >

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The IPO Road Less Traveled: Form 10

When investors talk about alternate exits for private companies beyond the traditional IPO they are usually referring to reverse mergers, if not outright acquisitions. However, another route is gaining some traction with sophisticated biotech investors – the so-called Form-10 pathway. Although it can be used in combination with reverse mergers, recent SEC rules applied to reverse mergers have shifted interest towards a more direct Form-10 approach to public markets. At last week’s BIO CEO & Read More >

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