Latest From Biotech Now

2013 Novel Drug Approvals

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The FDA approved 24 novel drugs last year by our count, in line with average approvals for the last ten years but down from the decade-high approvals seen in 2012. Our count is a bit lower than the FDA’s count of 27 new approvals, because we did not include imaging agents like Navidea’s Lymphoseek, or reformulations like J&J’s Simponi Aria. 2013 was the first year the breakthrough-designated therapies were approved, with three breakthrough therapies approved: Gilead’s Read More >

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BIO Submits Comments to the EPA’s 2014 RVO Proposed Rule

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The public comment period for the Environmental Protection Agency’s (EPA) 2014 proposal on the Renewable Volume Obligations (RVO) closed Tuesday January 28, 2014, with the agency receiving 16,575 comments.  On behalf of its members, BIO submitted over fifty pages of comments, stressing that the proposed changes to the RFS would be detrimental to the cellulosic and advanced biofuels industry. In a recent press release, Brent Erickson, executive vice president of BIO’s Industrial & Environmental Section, stated Read More >

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IPAB: Bad Medicine for Patient Care

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The Independent Payment Advisory Board is bad medicine for patient care, deficit reduction and containing Medicare costs. This board, consisting of 15 bureaucrats appointed by the President, has been given the power to make decisions affecting patients’ quality of care, with almost no oversight and no means for challenging its decisions. IPAB must be repealed. There is widespread support among patient advocacy groups and members of Congress on both sides of the aisle for full Read More >

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Triumph of the anti-GMO movement would be a disaster

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In Discover magazine’s Collide-a-Scape blog, Keith Kloor writes about Why GMOs Matter. Kloor reflects on the debate around GMOs and the various positions articulated by others such as University of Wyoming’s Andrew Kniss, Berkley’s Michael Eisen and Author Ramez Naam. Kniss believes that the GMO debate is overlooking an essential voice: “While activist groups, scientists, and journalists yell past each other in this debate, the people who are actually using and benefiting from the technology are largely ignored. So too are Read More >

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More than a Quarter of 2013 US-Based Biotech IPOs Call California Home

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And of those 39 US-based biotech companies, five of them are from San Diego, highlighting the region’s growing importance as hub for the biotech and life science industries. According to a recently authored BIO article in the Union Tribune San Diego, there are several reasons at play for the strong public offerings – enactment of the JOBS Act, an eager investor market and increasing regulatory transparency resulting from PDUFA V. As powerful as the JOBS Read More >

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