| November 17, 2022 |
Unveiling the Complexity of the Belgian MedTech Legal Landscape |
| March 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 |
| July 12, 2016 |
CellZDirect: Hope for Life Science Patents |
| March 31, 2016 |
Don’t Hold Back: The FTC Attacks Endo for Agreeing to Delay Launch of an Authorized Generic |
| February 24, 2016 |
First Circuit Joins Third Circuit in Holding That FTC v. Actavis Applies to Non-Cash Payments |
| February 1, 2016 |
FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices |
| December 3, 2015 |
Four Takeaways for In-House Counsel from the Dec. 1 Amendments to the Federal Rules |
| September 4, 2015 |
Sandoz Launches First U.S. Biosimilar |
| August 28, 2015 |
The Name Game – The FDA Issues Draft Guidance of Biologics Naming |
| July 23, 2015 |
Biosimilars: If You Don’t Dance the Patent Dance, You Have to Wait Until the FDA Approves Your Moves |
| July 2, 2015 |
Third Circuit Rules That FTC v. Actavis Covers More Than Cash |
| June 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 8, 2015 |
Federal Circuit Stops the Launch of the First U.S. Biosimilar Pending Appeal |
| April 16, 2015 |
VIDEO: Crisis Management for Government Contractors |
| March 23, 2015 |
District Court's Decision Paves the Way for the First U.S. Biosimilar |
| March 11, 2015 |
Three Take-Aways from Novartis' Historic First U.S. Biosimilar Approval |
| January 30, 2015 |
Will the CJEU Uncap the Recovery of IP Litigator Fees? |
| November 12, 2014 |
Pharmaceutical Take-Back Program Deadlines Are Here |
| January 29, 2014 |
NJ Federal Court Says Pharmaceutical Manufacturers Can Agree to Keep Generics Off The Market Without Antitrust Scrutiny If No Cash Changes Hands |
| June 21, 2013 |
What Does FTC v. Actavis Inc. Mean for Hatch-Waxman Litigation? |
| March 28, 2013 |
Virginia Becomes First State to Limit Substitution of Biosimilar Drugs |
| June 20, 2012 |
Congressional Report Critical of FDA Enforcement Protocol |
| June 13, 2012 |
Texas Supreme Court Recognizes "Learned Intermediary" Prescription Drug Defense |
| March 26, 2010 |
Finally—A Regulatory Pathway for Biosimilars in the United States |
| November 18, 2009 |
Pharmaceutical and Medical Device Industries are The Top Targets for Foreign Corrupt Practices Act ("FCPA") Enforcement |
| April 1, 2009 |
The Generic Biologics Debate Moves to the Senate |
| March 24, 2009 |
The Generic Biologics Debate Heats Up With Introduction of Rival House Bill |
| March 13, 2009 |
Massachusetts Finalizes Regulations and Code of Conduct for Medical Device and Pharmaceutical Relationships with Health Care Practitioners |
| March 12, 2009 |
House Introduces Legislation On Generic Biologics Approval Process |
| March 6, 2009 |
In Wake of Wyeth Pharma Decision, Congressional Democrats Introduce Bills to Nullify Supreme Court's Riegel Medical Device Preemption Ruling |
| March 4, 2009 |
The Obama Administration Stakes Out Positions on Generic Biologics, Hatch-Waxman Settlements and Evergreening in Its First Budget |
| March 4, 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 |
| November 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. |
| November 5, 2008 |
Supreme Court Asked To Consider Congressional Staff Report on Eve of Oral Argument in Wyeth v. Levine |
| February 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 |