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Life Sciences Alerts
Year:
2016
2015
2014
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All
RSS
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FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices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The Name Game – The FDA Issues Draft Guidance of Biologics Naming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