Tag Archives: public policy

A New Addition to Pennsylvania Bio’s Leadership Team

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To effectively achieve our mission as the champion and advocate of biotechnology, BIO works with a broad network of organizations. Foremost among these relationships are the ones we possess with a broad network of state-based organizations known as the Council of State Bioscience Associations (CSBA). Pennsylvania Bio (PA Bio) has been a key ally to BIO and vocal advocate for state and federal public policy in support of the biotechnology industry since our inception. Just Read More >

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FDA Check-Up: Drug Development and Manufacturing Challenges

Paul Hastings

I have over 27 years of experience in the biotechnology and pharmaceutical industry. My current company, OncoMed Pharmaceuticals, is working at the cutting edge of oncology research, focused on antibodies that target a specific set of cells within tumors, known as tumor initiating cells, that drive the growth of the tumor and can differentiate into various cell types within the tumor. Currently, we have five products in clinical development in over 13 completed or ongoing Read More >

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Innovation Act Passed By House

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The Innovation Act (H.R. 3309), which is intended to reduce frivolous patent-related litigation, was passed by the House today. As we’ve noted, BIO does not support the bill in its current form, which would ultimately undermine biotech research and innovation by making it more difficult for patent holders with legitimate claims to protect their intellectual property. A number of Representatives offered amendments to the bill, several of which BIO supported. These amendments address serious shortcomings with the bill, Read More >

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Sequester Threatens FDA Mission

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One aspect of sequestration isn’t doing anything to reduce the deficit, but could be delaying patient access to new drugs and medical devices, according to the FDA’s Janet Woodcock at a House subcommittee hearing on Friday. The FDA is being denied access to some of the user fees paid by the drug and device industries, which are intended to fund FDA’s review and oversight programs and ensure timely patient access to new and effective treatments. 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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