Morgan Lewis

Life Sciences

Publications of Interest

109 Publications Found
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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

11/15/07 Implications of CMS Clinical Research Policy, presented as a webinar for The Center for Business Intelligence

Presentation | Speech
Andrew Ruskin

11/15/07 The Science of Outsourcing, Legal Week

Outside Publications | Article
Natalie Kingston

11/08/07 How Are New Safety Concerns Affecting FDA Approvals and CMS Reimbursement of Bio/Pharma Products, presented by The Center for Business Intelligence

Presentation | Speech
Stephen Mahinka

10/08/07 Patent Wars: New Landscape, New Strategies, presented at Biotech 2007: A Joint Symposium of the Biotechnology Council of New Jersey and Pennsylvania Bio, Philadelphia

Presentation | Speech
Louis Beardell, Jr.

10/02/07 Regulatory Trends Affecting Product Approvals and Reimbursement of New Drugs and Biologics, presented at the 8th Annual Philadelphia-Japan Health Sciences Dialogue, Philadelphia

Presentation | Speech
Stephen Mahinka

Autumn 2007 Thinking Outside the Box, European Biopharmaceutical Review

Outside Publications | Article
Natalie Kingston

09/13/07 Advancing European Medtech: A Regulatory Perspective, presented at the MedTech Investing Europe 2007 Conference, London

Presentation | Speech
Anthony Warnock-Smith

2007 The Self-Regulation of Medicines in the UK, The International Comparative Legal Guide to: Pharmaceutical Advertising 2007

Outside Publications | Article
Anthony Warnock-Smith, Natalie Kingston

06/29/07 FDA Regulation of Medical Devices, presented at the D.C. Bar Health Law Section and Litigation Section Off-The-Record Luncheon Program, Washington, D.C.

Presentation | Speech
Phoebe Mounts

06/19/07 Proactive Steps Every Provider Should Take to Avoid Government Scrutiny, presented at ACI's Preparing for Government Healthcare Fraud Enforcement Conference, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

06/18/07 New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

05/17/07 Compliant Models for Medical Device Grants, presented at CBI's Premier West Coast Conference on Bio/Pharmaceutical and Medical Device Grants, San Francisco

Presentation | Speech
Kathleen Sanzo

05/17/07 Regulatory and Corporate Considerations in Life Sciences Industry Investments, presented at a Morgan Lewis Seminar, Palo Alto

Presentation | Speech
Kathleen Sanzo, Denis Segota

05/15/07 Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More, presented at ACI's FDA Boot Camp Basic Training for Products Liability and Patent Lawyers

Presentation | Speech
Robin Silva

Spring 2007 The Legal Implications of Phase I Clinical Trials, European BioPharmaceutical Review Spring 07

Outside Publications | Article
Anthony Warnock-Smith

04/26/07 Sailing to FDA Product Approval: Innovations in the Clinical Trial Paradigm, presented at Bay Bio 2007, San Francisco

Presentation | Speech
Phoebe Mounts

04/17/07 Managing Customer Communications in a Post-Neurontin World, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
M. Elizabeth Bierman

04/17/07 The AdvaMed Code of Ethics, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

03/16/07 U.S. Patent and Trademark Office Issues Notice on Patent Applications Containing Nucleotide Sequences

LawFlash/Client Alert | Intellectual Property LawFlash
Intellectual Property

On March 12, 2007, the U.S. Patent and Trademark Office posted a notice on restriction requirements in patent applications containing nucleotide sequences. The 2007 Notice rescinds a 1996 Notice on the subject and is eff... more

03/15/07 The Six Regulatory Issues That MUST Be Addressed in a Life Sciences M&A, presented to the American Conference Institute, New York

Presentation | Speech
Stephen Mahinka

03/14/07 Unique Challenges in Private Versus Public Life Sciences M&A, presented to the American Conference Institute, New York

Presentation | Speech
Randall Sunberg

03/02/07 Potential Challenges to Pricing of Biotech Products: Medicare/Medicaid and Related Pricing Developments, presented at the 2007 BIO General Counsels' Committee Meeting

Presentation | Speech
Stephen Mahinka, Andrew Ruskin

01/22/07 FTC Critical of Recent “Pay-For-Delay” Settlement Tactics in Hatch-Waxman Patent Litigations; Proposed Senate Bill Would Limit Them

LawFlash/Client Alert | Intellectual Property LawFlash
Intellectual Property

The Federal Trade Commission (FTC), in a statement made by Commissioner Jon Leibowitz before the Senate Judiciary Committee on January 17, expressed its concern over recent court decisions allowing cash or other incentive pa... more

2007 Business Process Outsourcing: Process, Strategies, and Contracts (John Wiley)

Outside Publications | Book
Barbara Melby

November/December 2006 Morgan Lewis on Life Sciences
November/December 2006

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • The Next Wave of Wage and Hour Litigation: Pharmaceutical Prod... more

2006/07 Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook 2006/07

Outside Publications | Chapter
Stephen Mahinka, Kathleen Sanzo

November 2006 Bringing a Drug to Market in the European Union

White Paper | Morgan Lewis White Paper
Catherine McLoughlin, Anthony Warnock-Smith, Keith Black

For businesses in any industry, the European Union (EU) is a market force to be reckoned with. Currently made up of 25 Member States, the EU is the world’s largest economy by gross domestic product, and it is the third l... more

2 November 2006 Defective Defence, Legal Week

Outside Publications | Article
Anthony Warnock-Smith

10/16/06 Mid-Stage Company Exit Strategies: Path to Glory?, presented at Biotech 2006, Philadelphia

Presentation | Speech
Randall Sunberg

10/06/06 Biotechnology Mergers and Acquisitions, presented at Law Seminars International

Presentation | Speech
Andrew Gilbert, Emilio Ragosa

09/13/06 Finance Sector Mini-Plenary Session, presented at the LES Annual Meeting, New York

Presentation | Speech
Randall Sunberg

09/11/06 From Term Sheet to Contract: A Roadmap for Biotech and Pharma Collaborations, presented at the LES Annual Meeting, New York

Presentation | Speech
Randall Sunberg

July/August 2006 Morgan Lewis on Life Sciences
July/August 2006

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • New Developments and Product Liability Implications of FDA Prescription Drug Labeling Rule: <... more

06/30/06 China Revises Its Guidelines for Patent Examination

LawFlash/Client Alert | Intellectual Property LawFlash
Intellectual Property

On May 24, 2005, China’s State Intellectual Property Office (SIPO) promulgated a new version of its Guidelines for Patent Examination. The new Guidelines will be effective as of July 1, 2006. This document highlights som... more

February/March 2006 Morgan Lewis on Life Sciences
February/March 2006

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • The Increasing Role of Congressional and Advocacy Strategies for Life Sciences Products:
    more

October/November 2005 Morgan Lewis on Life Sciences
October/November 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In This Issue:

  • Manufacturing Outsourcing in the Medical Device Industry: An Overview of the Process and Key Legal Issues:more

10/17/05 Case Study: Patent Pools in Biotechnology and Medicine, presented at Law Seminars International, Seminar on Standards Setting and Patent Pools, Washington, D.C.

Presentation | Speech
Willard Tom

October/November 2005 Manufacturing Outsourcing in the Medical Device Industry: An Overview of the Process and Key Legal Issues, Morgan Lewis on Life Sciences
October/November 2005

Newsletter | Article
Barbara Melby

In today’s increasingly competitive global economy, medical device companies are continually seeking ways to drive down production costs while at the same time improve quality and accelerate time-to market. Out... more

August/September 2005 Morgan Lewis on Life Sciences
August/September 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Medicare Amendments Preserve Strategic Obstacles for Generics: In the 2003 Medicare Pres... more

07/30/05 Current Trends and Provisions in Pharma-Biotech Strategic Alliances, presented at the International Forum on Biotech Commercialization in Greater China/Asia Pacific, Rutgers Business School, NJ

Presentation | Speech
Randall Sunberg

06/18/05 Starting or Expanding a Pharma/Biotech Business in the U.S.: New Legal and Regulatory Issues, presented at the 6th Annual Philadelphia-Japan Health Sciences Dialogue, Japan America Society, Philadelphia

Presentation | Speech
Stephen Mahinka

06/08/05 Partnering with Large Pharma, presented at the New Jersey Technology Council Commercialization Center for Innovative Technologies, NJ

Presentation | Speech
Randall Sunberg

05/24/05 Defining the "Market" and Its Effect on Antitrust Analysis of Pharmaceutical Company Conduct and Transactions presented at the American Conference Institute; In-House Consul Forum on Pharmaceutical Antitrust, in Washington, D.C.

Presentation | Speech
Scott Stempel

05/24/05 Pharmaceutical Industry Mergers: Anticipating Antitrust Issues and Surviving the Investigation, presented at the American Conference Institute In-House Counsel Forum on Pharmaceutical Antitrust, Washington, D.C.

Presentation | Speech
Stephen Mahinka

May/June 2005 Morgan Lewis on Life Sciences
May/June 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Life Sciences Mergers and Acquisitions: Potential Intellectual Property Pitfalls: When n... more

03/30/05 Pharma-Biotech Negotiation Workshop, presented at BIOMEDEX 2005, Montreal

Presentation | Speech
Randall Sunberg

March/April 2005 Morgan Lewis on Life Sciences
March/April 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Changing Strategies in Joint Research and Collaboration Agreements: The Impact of the Cooperative Research an... more

2005 Information Technology Outsourcing: Process, Strategies, and Contracts (John Wiley)

Outside Publications | Book
Barbara Melby

January/February 2005 Morgan Lewis on Life Sciences
January/February 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Outsourcing in the Pharmaceutical Industry: Most if not all major pharmaceutical compani... more

January/February 2005 Morgan Lewis on Life Sciences
January/February 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

November 2004 Licensing in the Pharmaceutical Industry: Strategies and Questions Regarding Antitrust Premerger Notification, FDLI Update

Outside Publications | Article
Harry Robins, Stephen Mahinka

10/29/04 Making 50-50 Collaborations Work Effectively, JP Morgan Chase, Newport Conference Center

Presentation | Speech
Randall Sunberg

10/28/04 Protecting the Product Life Cycle - Patent Law for Chemists

Presentation | Speech
Jeffry Mann

10/17/04 Biotech and Pharma M&A and Collaborations: Protecting the Deal and Preserving Your Upside, LES Annual Meeting, Boston

Presentation | Speech
Randall Sunberg

10/13/04 Outline of Issues for a Biotech Company to Consider in Preparing for an IPO

Presentation | Speech
Andrew Gilbert, Steven Cohen

September/October 2004 Morgan Lewis on Life Sciences
September/October 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • OIG Crosshairs Shift to Medical Device Manufacturers: Aggressive federal and state scrut... more

10/05/04 Biotech and Pharma M&A and Collaborations: Protecting the Deal and Preserving Your Upside, presented at Biotech 2004, Philadelphia

Presentation | Speech
Randall Sunberg

July/August 2004 New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

July/August 2004 Morgan Lewis on Life Sciences
July/August 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • FDA Issues Draft Guidances on Advertising and Promotion: The Food and Drug Administrati... more

07/24/04 Strategic Alliances and Business Development, presented at the BioForum 2004, Shanghai

Presentation | Speech
Randall Sunberg

April/May 2004 Morgan Lewis on Life Sciences
April/May 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Protective Provisions in Pharmaceutical/Biotech Strategic Alliances: Strategic alliances... more

March/April 2004 Strategic Implications of FDA’s Proposed Safety Reporting Requirements, On Drugs: Legislation, Litigation, and Policy Proposals

Outside Publications | Article
Michele Buenafe

02/13/04 Protecting Your Downside While Maximizing Your Upside: Protective Provisions in Biotech Deals, presented at the LES Winter Meeting, San Francisco

Presentation | Speech
Randall Sunberg

February 2004 Morgan Lewis on Life Sciences
February 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Congress gave fi... more

September/October 2003 Morgan Lewis on Life Sciences
September/October 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Ensuring That Communications on Product Development Are Not Misleading for Investors: Wh... more

09/09/03 Pharma and Biotech Collaborations, PA Biotech, 3 Rivers Venture Fair

Presentation | Speech
Randall Sunberg

July/August 2003 Morgan Lewis on Life Sciences
July/August 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Policy Shifts for Accelerated Approval of Oncologics: Because of ongoing scrutiny by pat... more

06/24/03 Getting from Biotech to BIG Biotech, BIO 2003, Washington, DC

Presentation | Speech
Randall Sunberg

May/June 2003 Morgan Lewis on Life Sciences
May/June 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • How Life Sciences Companies Can Respond to Sarbanes-Oxley: The Sarbanes-Oxley Act of 200... more

04/30/03 Closing Plenary Session: Facilitating Global Reach in the Life Sciences Industry, BIOTechnica America, Monterey, CA

Presentation | Speech
Randall Sunberg

March/April 2003 Morgan Lewis on Life Sciences
March/April 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Biotech Companies Raise Capital Without Diluting Equity Structure by Monetizing IP Licenses: more

02/28/03 FDA Must Clarify Drug Makers' Ability to Publicly Defend Products, Litigation Legal Foundation Legal Update, Vol. 13, No. 7

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

01/31/03 Issues to Consider in a New Venture Spin-Out

Presentation | Speech
Steven Cohen

January/February 2003 Morgan Lewis on Life Sciences
January/February 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • A Shift in the Hatch-Waxman Balance: FDA's Proposed Rule: The Hatch-Waxman Act, which cr... more

01/31/03 Realizing Value from New Venture Spin-Outs as an Alternative to an M&A Transaction

Presentation | Speech
Steven Cohen

November/December 2002 Morgan Lewis on Life Sciences
November/December 2002

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Pharmaceutical cGMP Regulation - Increasing, Consistent, Decisive: Since the beginning o... more

10/22/02 Promotion and Development Collaborations Between Established Players, American Conference Institute, New York

Presentation | Speech
Randall Sunberg

September 2002 Morgan Lewis on Life Sciences
September 2002

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • How Biotech Companies Can Avoid Accounting Meltdowns: Volatile financial markets and inv... more

July 2002 Morgan Lewis on Life Sciences
July 2002

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue:

  • Welcome and Introduction
  • more

04/30/02 Issues to Consider in a New Venture Spinout

Presentation | Speech
Steven Cohen

March 2002 Pharmaceutical Pricing: System Changes And Global Effects, Metropolitan Corporate Counsel

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

2003 Consumer Products Regulation (Chapter 13), Developments in Administrative Law and Regulatory Practice 2002-2003 (ABA Section on Administrative Law)

Outside Publications | Chapter
Kathleen Sanzo

August 2001 U.S. Pharmaceutical Pricing: System Changes and Global Effects, Life Sciences Industry Report

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

09/04/00 Expect Big Change in Drug Pricing System, The National Law Journal

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

03/29/00 Breakthrough: Management Issues Facing a Growing Biotechnology Company, presented at BIO 2000, Boston

Presentation | Speech
Randall Sunberg

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