Monthly Archives: August 2013

TTIP: Global Regulatory Cooperation and Convergence

Moving Inside the Beltway: Brief Health Roundup

The Transatlantic Trade and Investment Partnership (TTIP) initiative holds tremendous promise for the long-term competitiveness of the Transatlantic economy by supporting research and development of innovative technologies. A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy can help bring innovative products to consumers, create jobs, and improve economic prospects on both sides of the Atlantic. The recent (TTIP) negotiations focus on several principles that BIO promotes to boost Read More >

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CSBI: New Study Outlines Potential Impact of Three Promising Tax Proposals

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Ernst & Young recently released a study to determine the potential impact of three tax proposals to help innovative small companies secure sustained private investment. The study models the direct, indirect, and induced impact that the three legislative proposals would have on investment and employment in small, R&D-intensive companies. Below is a summary of the proposals, as well as the potential impact if enacted: Proposal 1:  Section 469 R&D Partnership Structures. Reforming the passive activity Read More >

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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 The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods.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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