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Latest From Biotech Now
Managed Entry Trumps Risk Sharing
Since 2000, pharmaceu-tical and biotech companies have engaged in agreements with government and private payers across the world to gain market access for their innovative drugs despite struggles to qualify for formal reimbursement criteria, such as the cost effectiveness threshold from NICE in the UK. These agreements, usually referred to as “risk sharing” agreements, have had a wide variety of structures but usually do not involve any sharing of risk, as the name misleadingly suggests. Read More >
Ernst & Young’s Beyond Borders: Matters of Evidence
Hundreds of attendees turned out to glean insights from findings outlined in Ernst & Young LLP’s (EY) 27th annual report on the biotechnology industry – Beyond borders: matters of evidence – officially launched at Tuesday morning’s Super Session at the 2013 BIO International Convention. The report was presented by Glen Giovannetti and Gautam Jaggi of EY’s Global Life Sciences Center, and the Super Session featured a panel of industry leaders, including: Brian Edelman, VP, Corporate Read More >
The Justness of Gene Patents
Most of the biotechnology world awaits the U.S. Supreme Court’s answer to the Question Presented, “Are human genes patentable,” in the Association of Molecular Pathologists et al. v. Myriad Genetics case. Claims to “human genes” have a canonical form that has been developed over the thirty years during which “genes” (human or otherwise) have been patented under U.S. law: An isolated nucleic acid having a nucleotide sequence that encodes a protein having an amino acid Read More >
Governors Share Best Practices on Bringing Biotech Jobs to their States
With the state competition for biotech jobs in full force at the BIO International Convention, BIO released its Bioscience Economic Development report yesterday to a standing room only crowd that came to hear Texas Gov. Rick Perry, Pennsylvania Gov. Tom Corbett, Missouri Gov. Jay Nixon and Director of Illinois Department of Commerce and Economic Opportunity Jack Lavin share their insights on attracting and growing the biotech industry within their states. Common themes quickly emerged around Read More >
AquAdvantage Salmon: A Regulatory Odyssey
At BIO 2012, an article was published on AquaBounty Technologies which told the tale of the Company’s New Animal Drug Application (NADA) for AquAdvantage Salmon. At that time, the Company had completed all the required major elements for an FDA approval and FDA had held a thorough public airing before its Veterinary Medicine Advisory Committee (VMAC) of the results of the agency’s Center for Veterinary Medicine’s (CVM) review of AquaBounty’s application. Following the meeting of Read More >
