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FOB Guidances From FDA Could Be Issued By End Of 2010, Hospira Says

Executive Summary

FDA could issue guidance on how to develop applications for follow-on biologics in three product categories by the end of the year, Hospira Chief Scientific Officer Sumant Ramachandra believes

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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

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

Biosimilars Pathway Has Blind Spots As FDA And Firms Begin Roadwork

Now that a pathway for approval of biosimilars has been laid out in the health care reform law, a slew of questions remain to be answered, from how FDA will implement the legislation to how the process for resolving patent disputes will play out

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