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The oral arguments about the patentability of human genes indicate the Supreme Court could be heading to a middle ground in which isolated DNA would not be patentable but cDNA would.
Published on 4/22/2013
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Myriad middle ground Of genes and baseball bats Question: What do a gene, a baseball bat and a cookie have in common? A. All of them are man-made. B. None of them are man-made. C. Nothing. D. All of the above. …
Published on 4/22/2013
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Rather than clarify FDA's autonomy to make science-based decisions, a federal judge's rebuke of HHS on emergency contraceptives might open the door to more challenges to agency decisions via the courts.
Published on 4/8/2013
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Although FDA doesn't plan to furlough staff, uncertainty over the agency's budget for the rest of fiscal 2013 is likely to delay drug reviews, according to Commissioner Margaret Hamburg.
Published on 3/11/2013
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Sequester slowdown Instituting sequestration It will be up to the leaders of each of NIH's 27 institutes and centers to implement the total $1.6 billion in budget sequestration that must be cut by Sept. 30. "Each …
Published on 3/11/2013
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Bowman v. Monsanto could solidify IP protections on 'self-replicating' inventions such as GMO seeds, stem cells and other biomedical inventions that are easily reproducible.
Published on 2/25/2013
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A U.S. appeals court decision to overturn a pharma sales rep's conviction will not unleash a flood of off-label promotion. But FDA and Congress may have to accept less FDA regulation of speech.
Published on 12/10/2012
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NIH must face the music as the fiscal cliff emergency takes center stage, while bigger pharma rebates and biosimilars exclusivity will be back on the table in the rush to implement the Affordable Care Act.
Published on 11/12/2012
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Members of Congress want to stem the brain drain of foreign-born graduates in science, technology, engineering and math. But in a colossally wrong-headed move, life science graduates would be excluded.
Published on 11/5/2012
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In its report to the White House, PCAST is calling for a public-private partnership to reverse declining productivity in drug development.
Published on 10/8/2012
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Sequestration, coupled to peculiar decisions by the House and White House, is creating a budgetary noose that would block FDA's access to user fees and potentially force a decade of downsizing at the agency.
Published on 9/17/2012
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Unless Congress acts, NIH's budget will be cut $2.5B in 2013, and over the next decade the agency will be forced to decide between funding new science or scaling back existing commitments to researchers.
Published on 9/17/2012
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A week after tens of thousands of sensitive FDA documents were pulled off the Internet, logs cataloging their contents remained visible.
Published on 7/23/2012
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FDA reviewers trying to persuade the agency to withdraw approval of digital mammography and CT colonoscopy devices also sought financial rewards from a secret suit against the manufacturers.
Published on 7/23/2012
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Although a trove of sensitive FDA documents have been pulled from view on the Internet, publicly available government documents and letters, court records and interviews document the poisonous atmosphere that developed …
Published on 7/23/2012
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While patient groups and industry hailed the bipartisan effort by Congress to reauthorize PDUFA, the White House ranked the news on a par with efforts to redevelop Washington's fish market.
Published on 7/16/2012
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The Supreme Court's decision on the Affordable Care Act assures key elements fought for by PhRMA and BIO will stand, at least until year end.
Published on 7/2/2012
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PCORI says it will issue new conflict of interest standards before it begins to award contracts for primary research into comparative effectiveness this month.
Published on 5/7/2012
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Biopharma companies have been making business plans on the presumption that the Affordable Care Act would survive. But the Supreme Court's review leaves the future of biosimilars, Part D drugs and IPAB up in the air.
Published on 4/2/2012
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The Supreme Court ruling in Prometheus did little to remove uncertainty about MDx patents, and raised worries the decision could be extended to drugs. The next shoe will drop when PTO issues guidance.
Published on 3/26/2012
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FDA officials are supporting the principle behind IDSA's proposal for a staged approval pathway to shorten development of therapies for well-defined populations with serious unmet medical need.
Published on 3/19/2012
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Both the House and Senate have drafted PDUFA legislation that includes the GAIN Act, which would add market exclusivity and other incentives for developing antibiotics.
Published on 3/19/2012
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Oral arguments before the U.S. Supreme Court suggest MDx companies may not get the guidance they were hoping for from the high court's decision in Mayo v. Prometheus.
Published on 12/12/2011
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The scientific complexity of hESC-derived products should provide a high barrier to entry despite a European Court of Justice ruling that deems such products unpatentable.
Published on 10/31/2011
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Biodefense report card BARDA bioterror pipeline The Biomedical Advanced Research and Development Authority (BARDA) is responsible for the U.S. government's procurement and advanced development of medical …
Published on 9/12/2011