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Gemzar "Double-Patenting" Case Has Broad Implications For Industry Pipeline

Executive Summary

Eli Lilly & Co. has the backing of the pharmaceutical and biotech industries in its effort to get an appeals court to reverse its ruling that the company’s Gemzar (gemcitabine) patent is invalid.

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Regulatory Updates, In Brief

If at first you don't succeed: The specter of legislation to end "pay-for-delay" patent settlements continues to haunt the pharmaceutical industry. Wisconsin Sen. Herb Kohl's S. 369, as reported by the Judiciary Committee in 2009, is in the financial services appropriation bill approved by the Senate Appropriations Committee July 29. The Kohl provision would bar generic companies from receiving anything of value and limiting drug development or sales in return for ending patent litigation unless the firms can prove by clear and convincing evidence that the deal will not harm competition. Sen. Arlen Specter, R-Pa., tried to strip S. 369 from the appropriations bill, but failed on a 15-15 vote. The measure is not in the financial services appropriations bill approved by a House subcommittee July 29, but it was in the war supplemental appropriations package approved by the full House (1"The Pink Sheet," July 19, 2010). The war supplemental sent to President Obama for his signature was the Senate version, which did not contain S. 369. Further action on the financial services bills has not yet been scheduled on either side of Capitol Hill

Social Media Data Gains Prominence In Patient-Focused Drug Development

FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.

Missing Data Hinders Inclusion Of Patient Experience In Drug Labeling, US FDA Says

Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.


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