Morgan Lewis

Life Sciences

Publications of Interest

110 Publications Found
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09/18/08 European Court of Justice Finds Dominant Pharma Companies May Not Prevent Parallel Imports by Refusing to Meet “Ordinary” Orders from Wholesalers

LawFlash/Client Alert | Antitrust LawFlash
Antitrust Practice

The European Court of Justice (ECJ) ruled on September 16 that pharmaceutical companies that occupy a dominant position with respect to a particular drug may not refuse to meet “ordinary” orders from wholesalers in order to sto... more

08/25/08 Request for Comments on the Basic Results Data Entry System for ClinicalTrials.gov to Be Submitted by September 3

LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA-Healthcare Regulation Practice

In preparation for the implementation of the results data entry system mandated by the Federal Food and Drug Administration Amendments Act of 2007 (FDAAA), the National Library of Medicine has modified the Clin... more

July 2008 Advanced Therapies Regulation, European BioPharmaceutical Review

Outside Publications | Article
Anthony Warnock-Smith, Natalie Kingston

06/21/08 Harnessing the Value of Your IP: Partnering Across Borders, presented to the Chinese-American Pharmaceutical Society, Beijing

Presentation | Speech
Thomas Duley

06/14/08 Strategic Alliances, presented at the Business Development Basics Course (sponsored by BIO and LES), San Diego

Presentation | Speech
Thomas Duley

May/June 2008 Computer and Software Devices: FDA Seeks Framework for Regulation, FDLI's Update

Outside Publications | Article
Michele Buenafe, M. Elizabeth Bierman

05/21/08 Harnessing the Value of Your IP: Partnering Across Borders, San Francisco

Presentation | Speech
Thomas Duley

05/08/08 Update on FDA Regulatory/Legislative Issues Impacting Drugs, Biologicals and Medical Devices, presented at the American Health Lawyers Association Life Sciences Law Institute, Bethesda, MD

Presentation | Speech
Phoebe Mounts

04/25/08 Regulatory Process—Navigating the FDA: Moving from Product Concept to Product Clearance/Approval, presented at Morgan Lewis and Pittsburgh Life Sciences' Spring Training Briefing Series, Pittsburgh

Presentation | Speech
M. Elizabeth Bierman

2008 Emerging Life Sciences Companies Deskbook 2008 (second edition)

Book | Morgan Lewis Deskbook
Emerging Growth & Life Sciences Groups

To request a copy, please email deskbook@morganlewis.com with your contact information and with "life sciences" in the subject line.

more

04/17/08 Changing Landscape of the Regulatory Pathway for Follow-on Biologics, presented at BayBio2008: Doing Well by Doing Right, San Francisco

Presentation | Speech
Phoebe Mounts

04/14/08 Dividing the Intellectual Property Pie in the Life Sciences Industry, New Jersey Law Journal

Outside Publications | Article
David Glazer, Alan Leeds

April 2008 An Overview of Pharmaceutical and Medical Device Regulation in Japan, Asian-Counsel

Outside Publications | Article
Benjamin Lang

03/28/08 Effective Patent Strategies—Somewhere Between Prosecution and Litigation: An Introduction to Intellectual Property Diligence, presented at Morgan Lewis and Pittsburgh Life Sciences' Spring Training Briefing Series, Pittsburgh

Presentation | Speech
Christopher Halliday

03/27/08 Solving the Challenges of Regulatory Compliance Through Technology, presented at the 51st Annual Food and Drug Law Institute/FDA Conference, Washington, D.C.

Presentation | Speech
Stephen Mahinka

03/13/08 Critical Regulatory Concerns that Must be Addressed in a Life Sciences M&A, presented at the American Conference Institute, New York

Presentation | Speech
Stephen Mahinka

03/12/08 Getting to the Heart of the Business Reasons Behind the Deal and Finding the Right Partner, presented at ACI's Life Sciences Mergers and Acquisitions Conference, New York

Presentation | Speech
Randall Sunberg

02/29/08 Work Smarter. Stay Informed. Employment Law and Public Policy Affecting HR Practice, presented at the Southern California Biomedical Council Human Resources Conference, Los Angeles

Presentation | Speech
Anne Brafford, A. James Vázquez-Azpiri

02/22/08 U.S. Supreme Court Ruling in Riegel v. Medtronic Confirms Preemption for Medical Devices with FDA Premarket Approval

LawFlash/Client Alert | Life Sciences LawFlash
Life Sciences

On February 20, 2008, the U.S. Supreme Court ruled that the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA) preempt most state tort claims that challenge the safety or... more

02/20/08 Overview of Final 403(b) Regulations - What You Need to Know and Do Before the End of 2008, presented at the 9th Annual Emerging Issues in Healthcare Law Conference, San Francisco

Presentation | Speech
James Wynn, Gregory Needles

02/19/08 Negotiating and Living with Consent Decrees, presented at the 6th Annual Food and Drug Law Institute Enforcement and Litigation Conference, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

01/29/08 State Perspectives on Existing and Future Regulations Surrounding Sales and Marketing, presented at the 5th Annual Pharmaceutical Marketing Compliance Congress, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

2008 The Centrality of Regulatory Due Diligence in Life Sciences M&A (Chapter 2), Life Sciences Mergers and Acquisitions (Aspatore Books)

Outside Publications | Chapter
Stephen Mahinka

2007/08 Risk Management for Drugs and Biologics in the U.S., PLC Cross-border Life Sciences Handbook 2007/08

Outside Publications | Chapter
Stephen Mahinka, Kathleen Sanzo

12/06/07 Assessing and Reducing Risks Associated with Medical Information/Product Information Communications, presented at ACI's 6th Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs Conference, Philadelphia

Presentation | Speech
Kathleen Sanzo

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