Tag Archives: FDA

U.S. Rep. Charlie Dent Discusses PDUFA and NIH Funding at #BIOCEO14

Dent

During the 16th Annual BIO CEO & Investor Conference, U.S. Representative Charlie Dent of Pennsylvania, co- chair of the Congressional Biomedical Research Caucus, joined BIO’s Fritz Bittenbender to discuss the biotech industry in Pennsylvania as well as recent legislative developments affecting the industry. Dent points to the recent omnibus spending agreement which allowed the Food and Drug Administration (FDA) to access user $85 million in user fees sequestered in 2013. These fees are paid to Read More >

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4 Tips for Building a Successful Biotech: Richard Pops of Alkermes at #BIOCEO14

Pops

The 16th Annual BIO CEO & Investor Conference opened with a fireside chat between Richard F. Pops, Chairman & Chief Executive Officer of Alkermes, and David Gluckman of Lazard. The candid discussion gave biotech CEOs a peek in to the story of Alkermes, yielding useful guidance on building a successful, agile company ready for a changing marketplace. Here are some of the highlights: Be world class in a specific area of science. “In our company, Read More >

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BIO Responds to GPhA Citizen Petition on Biosimilars Naming

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Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting the FDA to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition). Today, BIO submitted our response. Contrary to the GPhA Petition, BIO believes that the legal, regulatory, and scientific principles related to biologics and biosimilarity Read More >

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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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Congress Passes Omnibus Spending Agreement

Jim Greenwood

This week, BIO President and CEO Jim Greenwood praised the Congress for passing the fundingbill for fiscal 2014, which would, among other things, allow the Food and Drug Administration (FDA) to access $85 million in user fees sequestered in 2013. In addition, BIO supports the agreement’s overall funding for: FDA, NIH, the biodefense enterprise; and improved program oversight of the important 340B program.  BIO also strongly supports the language in the bill providing the Department Read More >

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