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Life Sciences Alert

Mar.26.2010 Finally—A Regulatory Pathway for Biosimilars in the United States
Feb.01.2010 USPTO Announces Interim Recalculation of Patent Term Adjustment in view of Wyeth
Nov.18.2009 Pharmaceutical and Medical Device Industries are The Top Targets for Foreign Corrupt Practices Act ("FCPA") Enforcement
Apr.01.2009 The Generic Biologics Debate Moves to the Senate
Mar.24.2009 The Generic Biologics Debate Heats Up With Introduction of Rival House Bill
Mar.13.2009 Massachusetts Finalizes Regulations and Code of Conduct for Medical Device and Pharmaceutical Relationships with Health Care Practitioners
Mar.12.2009 House Introduces Legislation On Generic Biologics Approval Process
Mar.06.2009 In Wake of Wyeth Pharma Decision, Congressional Democrats Introduce Bills to Nullify Supreme Court's Riegel Medical Device Preemption Ruling
Mar.04.2009 The Obama Administration Stakes Out Positions on Generic Biologics, Hatch-Waxman Settlements and Evergreening in Its First Budget
Mar.04.2009 Wyeth v. Levine: U.S. Supreme Court Rules FDA Approval of Label Does Not Provide Pharmaceutical Manufacturer with Complete Preemption Defense to State Failure-to-Warn Claims
Nov.11.2008 Recent California Appeals Court Ruling May Lead To Direct Liability For Pioneer Manufacturers In Suits Involving Generic Drugs: Conte v. Wyeth, Inc., et al.
Nov.05.2008 Supreme Court Asked To Consider Congressional Staff Report on Eve of Oral Argument in Wyeth v. Levine
Feb.21.2008 U.S. Supreme Court Limits Lawsuits Against Medical Device Manufacturers – Products Approved Under FDA’s PMA Process Exempt From State Tort Law Claims
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