Latest From Biotech Now

FDA Issues Final Guidance on Clinical Trial Oversight

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The FDA released its final guidance governing clinical trial oversight and urges a risk-based approach to monitoring. The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods. The guidance provides various risk-based monitoring strategies and clarifies that while the Sponsor can transfer monitoring responsibilities to contract research organizations (CROs), the CROs Read More >

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BIO Investor Forum Company Snapshot: AM-Pharma

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The BIO Investor Forum will be taking place this October in San Francisco for its 12th annual event. So far this year, the hot topic is, of course, the hot market. Out of all the therapeutic US companies that have had an IPO in 2013, 71% of them have attended the BIO Investor Forum. The program for the event will thus feature two great panels about the recent IPO activity, in addition to other therapeutic workshops Read More >

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Back to School: Time for Immunization Check-In

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Preparing for school means gathering supplies and backpacks. It is also the perfect time to make sure children are up-to-date on their vaccines. Getting all of the recommended vaccines is one of the most important things parents can do to protect their children’s health. Vaccines are among the safest and most effective ways to prevent disease. Protecting your child from preventable diseases will help keep them healthy and in school. But vaccines don’t just protect Read More >

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Propel Small Business Innovation through Tax Reform

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As CEO of an emerging clinical-stage biotech company, I lose over $10 million each year. Over the lifetime of my company, I have lost over $100 million. But constantly losing money in an effort to advance discoveries should not overshadow the real lifeblood of biotechnology, which is the reward of seeing patients treated, lives saved, and families healed. Some of the biggest challenges companies like mine face include high research and production costs, coupled with Read More >

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Bayh-Dole and Technology Transfer Continue to Deliver

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The Association of University Technology Managers released the 2012 AUTM U.S. Licensing Activity Survey Highlights which provides data on respondents from “161 universities, 32 hospitals and research institutes, and one third-party technology investment firm” (a response rate of 65%).  Here are some of the highlights: Start-Ups and Products: • 705 startup companies formed (+5.1% [over last year]), 554 of which had their primary place of business in the licensing institution’s home state (+13.8% [over last Read More >

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