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Latest From Biotech Now
Sen. Bob Menendez & William Waddill on the Therapeutic Discovery Project
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.
What Parallel Review Means for Manufacturers
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 >
Programming Updates to the 2012 BIO International Convention
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 >
Importance of Reauthorizing Pandemic All-Hazards Preparedness Act
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 >
BIO IP Counsels Conference Agenda Topics
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 >
