Life Sciences Alerts

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Mar.12.2021	President Biden Signs American Rescue Plan Act of 2021, sets in motion historic expansions of the ACA, Medicaid and other important health policy related changes among sweeping pandemic relief provisions
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Feb.01.2016	FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices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Aug.28.2015	The Name Game – The FDA Issues Draft Guidance of Biologics Naming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.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

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