Latest From Biotech Now

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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Sen. Bob Menendez & William Waddill on the Therapeutic Discovery Project

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Senator Bob Menendez (D-NJ), at the March 6th Senate Banking, Housing and Urban Affairs hearing, emphasizes the effectiveness of the 2010 Therapeutic Discovery Project, the need to extend the program, and asks William Waddill, CFO/SVP of OncoMed Pharmaceuticals to share his company’s success story as a result of receiving an award. Read testimony from Waddill on the importance of capital formation.

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What Parallel Review Means for Manufacturers

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By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the FDA and CMS consider new medical products in series; after FDA approval or clearance, CMS begins consideration of a National Coverage Determination (NCD), if requested by an interested stakeholder. Any party seeking drug approval (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. In addition, CMS may initiate a request for an Read More >

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Programming Updates to the 2012 BIO International Convention

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With Convention less than four months away, things are quickly falling in to place with several programming updates to note! A total of 115 breakout sessions have been confirmed and scheduled, including 18 international case studies.  Session organizers are currently finalizing speakers.  All session descriptions and confirmed speakers are available on myBIO. Even after all of the session submissions work, we asked for more session ideas! We recently completed a call for “Late-Breaking” sessions in Read More >

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Importance of Reauthorizing Pandemic All-Hazards Preparedness Act

Sen. Casey

Senator Robert P. Casey, Jr. (D-PA) joined with BIO and The Center for Biosecurity of UPMC to co-sponsor a Hill briefing on the reauthorization of the Pandemic All-Hazards Preparedness Act (PAHPA) on March 1st.  Officials from the Food and Drug Administration, Centers for Disease Control and Prevention, the White House, and Department of Health and Human Services as well as experts from the Center for Biosecurity at UPMC and the WMD Center discussed the critical Read More >

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