Tag Archives: regulation

Is Regulatory Transformation for Alzheimer’s Therapies Needed?

Mary Canady

BIO 2014′s  session titled ” Regulatory Transformation: As Alzheimer’s Disease Science, Research and Advocacy Move Toward Earlier Detection and Intervention, How Will Researchers Adapt to this Evolution?” discussed progress and challenges facing researchers and the collaborative efforts between the Food and Drug Administration (FDA) and patient advocacy groups to help them find a cure. The discussion centered on recent FDA Draft Guidance for Early Stage Alzheimer’s Disease Drug Development which allows for an accelerated approval Read More >

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JOBS Act Deconstructed: Confidential Filing

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More than 40 biotech companies have gone public using provisions made available to emerging growth companies through the JOBS Act. BIOtechNOW’s JOBS Act Deconstructed series will explore why it has had such an impact on biotech offerings and how emerging companies can leverage the new law to their best advantage. Any company conducting a public offering must file a registration statement, called an S-1, with the SEC.  The purpose of this document is to inform investors Read More >

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JOBS Act Deconstructed: Testing-the-Waters

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More than 40 biotech companies have gone public using provisions made available to emerging growth companies through the JOBS Act. BIOtechNOW’s JOBS Act Deconstructed series will explore why it has had such an impact on biotech offerings and how emerging companies can leverage the new law to their best advantage. The JOBS Act enables companies to promote themselves to potential investors in advance of their IPO. Prior to the JOBS Act, companies conducting a public offering Read More >

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JOBS Act Deconstructed: Regulatory Relief

Capitol

More than 40 biotech companies have gone public using provisions made available to emerging growth companies through the JOBS Act. BIOtechNOW’s JOBS Act Deconstructed series will explore why it has had such an impact on biotech offerings and how emerging companies can leverage the new law to their best advantage. The JOBS Act marks a key departure from the previous one-size-fits-all regulatory approach for companies conducting a public offering.  Emerging growth companies (EGCs) are now subject Read More >

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Ag Biotech: Going on the Offense

Ag Biotech: Going on the Offense

On Wednesday at the BIO International Convention a panel called “Going on the Offense: Proactive Strategies to Reduce Uncertainty” focused on challenges facing agricultural biotech in the social media and regulatory worlds. Moderated by Peter Whitfield of Baker Hostetler, the panelists included David Bartlett of Levick and Geri Edens and Christopher Marraro, both of Baker Hostetler. Peter opened up the discussion by involving the audience in an interactive poll to determine their willingness to eat Read More >

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