Latest From Biotech Now

What Parallel Review Means for Manufacturers

Drug Manufacturing

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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BIO IP Counsels Conference Agenda Topics

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Join us in Austin for BIO’s Intellectual Property Counsels Committee Conference on April 16-18.  Agenda topics are below. The Decline of Process Patents: This session will examine the enforceability of process claims and how it has led to the recent controversy around divided infringement. Unlike claims to machines, manufactures, and compositions, process claims can be divided up by different actors, or by jurisdiction, and conceivably even by time.  Right now the focus is on different 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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