Latest From Biotech Now

Report Shows World’s Weakest IP Environments

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There is clear link between a country’s rate of economic development and the strength of its intellectual property laws. This is particularly true in knowledge-intensive sectors such as biopharmaceuticals. The good news is that some mature and emerging economies are making growing use of patent systems to facilitate biotechnology research and commercialization. The bad news is that a number of countries, including India, China, Brazil and Canada, have established bureaucratic and burdensome hurdles to patentability. 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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BIO CEO Company Snapshot: Tetraphase Pharmaceuticals

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The BIO CEO & Investor Conference is now just a week away, and buzz for the event has never been greater. Tomorrow, Inside BIO is hosting its first ever twitter chat to discuss the annual buyside survey, which has been getting great responses from the investor community. Presentation spots are still sold out as well, and we’re continuing to highlight those companies slated to present. One such company is Tetraphase Pharmaceuticals, who went public this Read More >

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Life Science Leader on TransCelerate’s Efforts to Modernize Drug Development

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Life Science Leader’s Rob Wright has a great profile on TransCelerate BioPharma and their efforts to modernize the drug development and clinical trial landscape. TransCelerate is a nonprofit organization made up of 18 innovate biopharmaceutical companies dedicated to collaborating across the industry to find ways to simplify and accelerate the discovery of new medicines. As the article notes, the challenge involved is enormous: With combined annual revenues in excess of $300 billion and nearly 800,000 employees 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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