Latest From Biotech Now

Fresenius v. Baxter: BIO files Amicus Brief in Federal Circuit

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The Biotechnology Industry Organization filed an amicus brief at the Federal Circuit in the case of Fresenius v. Baxter: BIO is concerned that the panel decision could have a number of unintended consequences, such as incentivizing defendants (or declaratory judgment plaintiffs) to employ dilatory tactics in the federal courts while re-arguing already-decided issues under claim construction more favorable to the patent challenger and lower burden-of-proof standards in the PTO.  Courts and parties may be forced Read More >

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BIO Investor Forum Company Snapshot: MAX BioPharma

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Earlier this week, we featured a presenting company for our upcoming BIO Investor Forum event in San Francisco in our ‘company snapshot‘ feature. For our next post, we spoke to MAX BioPharma, who will be giving a presentation in our Discovery Company presentation track, which features companies in their Seed or Series A financing rounds, with under 25 million raised to date. Read on to learn more about this Discovery Company.   Company Snapshot What Read More >

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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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