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Life Sciences Alert
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Jul.12.2016 CellZDirect: Hope for Life Science Patents
Mar.31.2016 Don’t Hold Back: The FTC Attacks Endo for Agreeing to Delay Launch of an Authorized Generic
Feb.24.2016 First Circuit Joins Third Circuit in Holding That FTC v. Actavis Applies to Non-Cash Payments
Feb.01.2016 FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Dec.03.2015 Four Takeaways for In-House Counsel from the Dec. 1 Amendments to the Federal Rules
Sep.04.2015 Sandoz Launches First U.S. Biosimilar
Aug.28.2015 The Name Game – The FDA Issues Draft Guidance of Biologics Naming
Jul.23.2015 Biosimilars: If You Don’t Dance the Patent Dance, You Have to Wait Until the FDA Approves Your Moves
Jul.02.2015 Third Circuit Rules That FTC v. Actavis Covers More Than Cash
Jun.23.2015 VIDEO: Alternative Fees in Law
May.12.2015 CA Supreme Court Fashions 'Structural' Rule of Reason Analysis for Pay-for-Delay Settlement Agreements
May.08.2015 Federal Circuit Stops the Launch of the First U.S. Biosimilar Pending Appeal
Apr.16.2015 VIDEO: Crisis Management for Government Contractors
Mar.31.2015 VIDEO: Supreme Court to Decide Lawfulness of Receiving Post-Expiration Royalties on Licensed Patents
Mar.23.2015 District Court's Decision Paves the Way for the First U.S. Biosimilar
Mar.11.2015 Three Take-Aways from Novartis' Historic First U.S. Biosimilar Approval
Jan.30.2015 Will the CJEU Uncap the Recovery of IP Litigator Fees?
Nov.12.2014 Pharmaceutical Take-Back Program Deadlines Are Here
Jan.29.2014 NJ Federal Court Says Pharmaceutical Manufacturers Can Agree to Keep Generics Off The Market Without Antitrust Scrutiny If No Cash Changes Hands
Jun.21.2013 What Does FTC v. Actavis Inc. Mean for Hatch-Waxman Litigation?
Mar.28.2013 Virginia Becomes First State to Limit Substitution of Biosimilar Drugs
Jun.20.2012 Congressional Report Critical of FDA Enforcement Protocol
Jun.13.2012 Texas Supreme Court Recognizes "Learned Intermediary" Prescription Drug Defense
Mar.26.2010 Finally—A Regulatory Pathway for Biosimilars in the United States
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