Morgan Lewis

Life Sciences Publications of Interest

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Firm Events

03/24/10 What You Need to Know About the Current Reevaluation of Chemical Risks by the EPA Webcast
Please see event details for CLE credit information.
05/03/10-05/06/10 2010 BioInternational Convention Chicago
Wendy Pan, chair, "Beyond the Border & Beyond the Boundary"
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Industry Events

Fast Facts

200 partners and counsel focused on the life sciences industry

60 professionals with advanced scientific degrees

800 active life sciences clients

Honors

PLCCross-border Quarterly 2009 Life Sciences Legal Market Review

  • Industry Super League - Ranked 16th among law firms worldwide
  • Regulatory Super League - Ranked 7th among law firms worldwide

PLCCross-border Life Sciences Handbook 2007/2008

  • U.S. - Recognized for commercial/ partnering, competition/ antitrust, corporate, government law enforcement/ investigations, regulatory, regulatory/ medical devices, and patent counseling
  • England - Recognized for regulatory
  • Japan - Recognized for corporate/commercial

Chambers USA 2009: Recommended in Washington, D.C. for healthcare/ pharmaceutical/ medical products regulatory

UK Legal 500 2007/2008: London: Pharmaceuticals and Biotechnology

BioPharm Insight 2009

  • Legal advisers to North American licensing agreements based on both value and volume - Ranked 2nd
  • Legal advisers to European licensing agreements based on volume - Ranked 2nd
  • Legal advisers to global licensing agreements based on both value and volume - Ranked 3rd

Clients

16 of the top 20 pharmaceutical companies

7 of the top 20 biotechnology companies

12 of the top 20 medical device companies

138 Publications Found
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November/December 2009 21st Century Toxicology and its Implications for FDA Regulation of Food-Contact Substances, FDLI Update

Outside Publication | Article
Stephen Mahinka

11/16/09 Battle Weary Life Sciences Industry Put on Notice

LawFlash/Client Alert | Foreign Corrupt Practices Act LawFlash
Amy Conway-Hatcher

On November 12, the Justice Department’s Assistant Attorney General for the Criminal Division, Lanny Breuer, issued a stern warning to the life sciences industry and its executives. As the country wrestles with the challe... more

10/06/09 European Court of Justice Delivers Mixed Message on Parallel Trade

LawFlash/Client Alert | Antitrust LawFlash
Antitrust Practice

The European Court of Justice (ECJ) issued its long-awaited decision in C-501/06 P GlaxoSmithKline Services v. Commission today (October 6, 2009). The ECJ overturned the European Commission’s (EC’s or the Commissi... more

10/01/09 New Trends Affecting Pharmaceutical and Medical Device Life Cycle Risk Management, presented at the Fourth National FDA Regulatory Symposium, Washington, D.C.

Presentation | Speech
Stephen Mahinka

09/28/09 German Federal Cartel Office Imposes €11.5 Million Fine on CIBA Vision for Restricting Online Sales of Contact Lenses and for Resale Price Maintenance

LawFlash/Client Alert | Antitrust LawFlash
Antitrust Practice

The German Federal Cartel Office (FCO) fined U.S.-based international firm CIBA Vision €11.5 million ($16.8 million) for breaking German antitrust law by restricting online trading of its lenses and improperly pressuring on... more

09/11/09 European Court of Justice Confirms Presumption of Parent Company Liability for Subsidiaries' Antitrust Violations in Akzo

LawFlash/Client Alert | Antitrust LawFlash
Antitrust Practice

The European Court of Justice (ECJ) confirmed September 9, 2009, in Akzo Nobel and Others v. Commission (Case C-97/08 P), that parent companies are presumed to be liable for cartel violations committed by their wholly owned su... more

September/October 2009 Chill in the Air – How the Harkonen Decision May Impact Pharmaceutical Company Communications, Journal of Health Care Compliance

Outside Publication | Article
Sun Park

September 2009 The Ever-Widening Legal Morass Around Off-Label Communication, Washington Legal Foundation's Contemporary Legal Note Series, No. 63 (click here to read the article)

Outside Publication | Article
Kathleen Sanzo, Zane Memeger, Sandra Phillips, Sarah Bouchard

07/16/09 Detecting Off-Label Promotion Issues That Can Derail a Life Sciences M&A, presented at ACI's 6th Annual Pharmaceutical Counsel's Guide to Off-Label Communications, Philadelphia

Presentation | Speech
Stephen Mahinka

06/24/09 Anticorruption Compliance for the Life Sciences Industry: Case Studies and Practical Tips Webcast

Presentation | Webcast
Jürgen Beninca, Anthony Warnock-Smith, Eric Sitarchuk, Mark Srere

The life sciences industry has increasingly expanded its manufacturing operations and scientific studies to countries outside of Western Europe and North America. At the same time, enforcement authorities around the globe are inc... more

06/16/09 BioBucks Meets PharmacoEconomics: Who's Got the Negotiating Leverage Now? presented at Allicense Conference, San Francisco

Presentation | Speech
Randall Sunberg

06/12/09 FTC Follow-on Biologics Report Takes Hard Line against Exclusivity Periods and Patent Protection for Pioneer Products

LawFlash/Client Alert | Life Sciences LawFlash
FDA & Healthcare and Antitrust Practices

On June 10, the Federal Trade Commission (FTC) released its report, “Emerging Health Care Issues: Follow-on Biologic Drug Competition” (the Report). On June 11, Commissioner Pamela Jones Harbour testified on behalf ... more

06/11/09 Employers Should Stay the Course as WHO Declares H1N1 Pandemic

LawFlash/Client Alert | Labor and Employment LawFlash
Labor and Employment Practice

The World Health Organization (WHO) today raised its pandemic alert level to its highest level, Phase 6, the pandemic phase, in response to the ongoing global spread of the H1N1 virus. The increased alert level relates only to th... more

05/04/09 Appropriate Employer Responses to Swine Flu Webcast

Presentation | Webcast
Nina Stillman, Jonathan Snare, Andy Anderson

This 90-minute webcast took an in-depth look into how employers can deal with the emergent issues and immediate questions that arise from the swine flu epidemic within the workforce. It also focused on creating long-term emergenc... more

04/30/09 Workplace Challenges of Swine Flu

LawFlash/Client Alert | Labor and Employment LawFlash
Labor and Employment Practice

The reality of swine flu has now reached the American workplace, and employers are struggling to implement responses that protect their healthy employees, guard the privacy of stricken employees, and comply with applicable natio... more

04/29/09 Senate Finance Committee Releases First Healthcare Reform Policy Paper

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

On April 28, Senate Finance Committee Chairman Max Baucus (D-MT) and Ranking Member Chuck Grassley (R-IA) released the first in a series of three healthcare reform policy papers, “Transforming the Health Care Delivery Sys... more

04/23/09 Identifying Litigation Risks for Healthcare and Pharmaceutical Companies, presented for the Delaware Valley Area (DELVACCA) Chapter

Presentation | Speech
Erica Smith-Klocek, Emily Lawrence, Meredith Auten

03/25/09 Regulatory and Litigation Strategies for Life Sciences Companies Post-Wyeth v. Levine, presented as a Morgan Lewis Webcast

Presentation | Webcast
John Lavelle, Jr., Sandra Phillips, Kathleen Sanzo

03/11/09 Tales from the Front: Lessons Learned, Best Practices, and What to Avoid, presented at ACI's Life Sciences M&A Conference, New York

Presentation | Speech
Randall Sunberg

03/05/09 U.S. Supreme Court Ruling in Wyeth v. Levine Rejects Preemption of Failure-to-Warn Claim

LawFlash/Client Alert | Litigation LawFlash
Sandra Phillips, Phoebe Mounts, Emily Lawrence, John Lavelle, Jr., Joan Haratani, James Pagliaro, Brian Shaffer, Kathleen Sanzo, David Schrader

In a highly anticipated decision, the U.S. Supreme Court has rejected a pharmaceutical manufacturer's argument that federal approval preempts state law failure-to-warn claims relating to FDA-approved prescription drugs. By a v... more

01/29/09 Balancing Between the Company's Attorney-Client Privilege and the Need to Disclose Information, presented at the ACI Pharma/Biotech IP Due Diligence Conference, New York

Presentation | Speech
Thomas Duley

01/28/09 California Supreme Court Denies Review of First Appellate District's Decision in Conte v. Wyeth Regarding Liability of Brand-Name Drug Manufacturer for Injuries Experienced by Patient Who Took Generic Drug

LawFlash/Client Alert | Litigation LawFlash
Kathleen Waters, John Lavelle, Jr., Emily Lawrence, David Schrader

On January 21, the California Supreme Court declined to review the decision issued by the California Court of Appeal for the First Appellate District in Conte v. Wyeth (Case Nos. A116707, A117353; California Supreme Court No.... more

12/22/08 FTC Challenges Post-Closing Deal Too Small to Be Subject to the HSR Act

LawFlash/Client Alert | Antitrust LawFlash
Antitrust Practice

The Federal Trade Commission (FTC) has filed a complaint against Ovation Pharmaceuticals, Inc. (Ovation) in connection with its 2006 acquisition of a drug nearing FDA approval (NeoProfen). The FTC alleged that NeoProfen was the... more

11/13/08 Advanced Therapies Regulation Update, presented at a Morgan Lewis Seminar, London

Presentation | Speech
Anthony Warnock-Smith, Natalie Kingston

09/25/08 Spotlight on the EU: Documenting Compliance with Evolving Guidance When Designing Multi-Center/Country Studies and Examining Implementation Issues in Key Member States, presented at ACI's 3rd Legal and Regulatory Forum on Conducting International Clinical Trials, Boston

Presentation | Speech
Anthony Warnock-Smith

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