Stephen Paul Mahinka


Stephen Paul Mahinka counsels clients on antitrust and Federal Trade Commission (FTC) issues, US Food and Drug Administration (FDA) regulatory, transactional, and compliance matters throughout the product life cycle, and Committee on Foreign Investment in the United States (CFIUS) matters. Steve founded the firm’s FDA practice, previously led its antitrust practice, and co-founded and chaired its life sciences industry practice. He is a frequent speaker and has written more than 70 articles and co-authored several books on antitrust, FDA, and CFIUS topics.


5/31/2019 - Supplement Firms Work on Mitigating Import Tariff Costs Before Raising Prices, HBW Insight

11/21/2018 - FDA Finally Hitting Sweet Spot with Off-Label Oversight, Law360

10/10/2018 - US to Scrutinize Foreign Biotech Investments, BioCentury

10/30/2017 - Par Pharma Suit Tests FDA's Drug Pricing Pushback, Law360

11/9/2016 - Morgan Lewis Represents China Life in $940M Investment in Platform to Acquire Hotel Portfolio

2/16/2016 - Fairchild Sides with ON Semiconductor, Citing Regulatory Concerns, The Deal

12/2/2015 - Treasury Faces Lawsuit for Clinton-related CFIUS Documents, The Deal

11/9/2015 - 3 Key Issues To Watch As Pricing Probes Swamp Big Pharma, Law360

10/15/2015 - Morgan Lewis Life Sciences Capabilities Recognized in 2015 LMG Life Sciences Guides

7/14/2015 - Tsinghua’s Bid for Micron Would get a Long U.S. Review, The Deal Pipeline

5/26/2015 - Bolder Cures Act Could Ease Limits On Drug Cost Claims, Law360

3/11/2015 - NXP Semiconductor hopes Freescale purchase will bypass CFIUS, The Deal Pipeline

3/10/2015 - Law360 Life Sciences Editorial Advisory Board, Law360

1/14/2015 - Life Sciences Group Of The Year: Morgan Lewis, Law360

1/2/2015 - Life Sciences Cases To Watch In 2015, Law360

10/16/2014 - White House Holds Back on Ralls Appeal, The Deal Pipeline (read the article)

10/10/2014 - Rules of the Road: Ralls Battle Heads for Supreme Court, The Deal Pipeline (read the article)

9/29/2014 - LMG Life Sciences Praises Morgan Lewis’s Life Sciences Capabilities

9/24/2014 - Morgan Lewis Advises Total E&P in $400M Sale of Midstream Oil and Gas Assets to Korean Companies

8/25/2014 - Morgan Lewis Represents APM Terminals North America in Sale of Pioneer U.S. Container Terminal

7/24/2014 - Biosimilars Clarity Coming as FDA Eyes Sandoz Application, Law360

7/15/2014 - DC Circuit Rebuke Could Shake Up CFIUS Review Process, Law360

5/13/2014 - FDA Sheds New Light On Biosimilars Approval Pathway

2/21/2014 - Law360 Invites Nine Morgan Lewis Partners to Serve on its 2014 Editorial Advisory Boards

2/4/2014 - Morgan Lewis Advises Chiesi on Completed Cornerstone Acquisition

1/1/2014 - Life Sciences Cases To Watch In 2014, Law360

10/11/2013 - No Letup In US Scrutiny Of Foreign-Backed Energy Projects, Law360

10/3/2013 - Morgan Lewis Receives 2013 LMG Life Sciences Awards

9/27/2013 - Drug Comparison Suits May Drive Shift In Pharma Ads, Law360

9/16/2013 - Morgan Lewis Advises Chiesi Farmaceutici on Merger Agreement with Cornerstone Therapeutics

9/5/2013 - 3 Must-Watch Issues For Drug Cos. In 2013's Final Stretch, Law360

5/31/2013 - D.C. Hurdles Likely to be Minor for Smithfield Deal, The Deal Pipeline (read the article)

5/15/2013 - Pharma Cos. Smell Victory In Push For Drug-Tracking System, Law360

3/29/2013 - 6 Health Policies A Gridlocked Congress Can Get Behind, Law360

3/25/2013 - Latest FDA User Fee Bill Unlikely To Include Major Reforms, Law360

3/15/2013 - FDA’s Risk-Benefit Plan May Drive More Drug Approvals, Law360

2/28/2013 - Judge tosses out Chinese effort to overturn Obama on Ralls, The Deal Pipeline (read the article)

2/19/2013 - FTC Opinion Draws New Roadmap For Health Care Tie-Ups, Law360

1/29/2013 - Deadline Extension Indicates Nexen-Cnooc Deal on Track , The Deal Pipeline (read the article)

1/7/2013 - Foreign Energy Deals Have a Little-known Watchdog, Platts’ Inside Energy

11/2/2012 - Politics Aside, A123 Bankruptcy Loan Warrants Security Review, The Deal Pipeline (read the article)

10/15/2012 - Meningitis Outbreak Exposes FDA's Oversight Failures, Law360

10/2/2012 - Ralls Whistles in the Wind with Suit Against CFIUS, The Deal Pipeline (read the article)

9/20/2012 - US lawsuit reveals Cfius review defencts, ChinaCo fears International Financial Law Review

9/20/2012 - How Cnooc’s bid was structured for foreign investment approval, International Financial Law Review

9/14/2012 - FDA Budget To Plunge By $319M If Sequester Takes Effect, Law360

9/11/2012 - New FTC Pick Could Bring Economic Focus to Privacy Cases, Law360

8/14/2012 - Sequester Could Gum Up FDA Drug, Device Reviews, Law360

8/10/2012 - K-V Bankruptcy May Hurt FDA's Unapproved Drug Initiative

7/6/2012 - DOJ Has No Current Plan to Challenge Nuclear Power Plant Operators' Proposal, BNA's Antitrust & Trade Regulation Report

6/21/2012 - House Approves FDA Legislation On User Fees; Senate Vote Upcoming, BNA's Daily Report for Executives

6/19/2012 - Drugmakers Find Much To Love In Final FDA Reform Bill, Law360

6/11/2012 - Center for Biologics Evaluation and Research, FDLI Update

6/6/2012 - Q&A With Morgan Lewis' Steve Mahinka, Law360

5/4/2012 - Regulatory Policy: CBER Importance Boosted With Attention To Biologic Drugs, Biosimilars, Speakers Say

4/5/2012 - Biosimilars Naming and Labeling: An FDLI Dialogue, Update Magazine

8/12/2011 - Q&A With Morgan Lewis' Steve Mahinka

7/15/2011 - Morgan Lewis Serves as Co-Counsel to BHP Billiton on $12.1 Billion Acquisition of Petrohawk

7/13/2011 - Morgan Lewis Team Advises Kinetic Concepts on Company’s $6.3 Billion Acquisition by Apax

6/1/2010 - Changing Spaces, ABA Journal

5/21/2010 - Planned Life Sciences Company Purchases Require Enhanced Due Diligence Under Health Care Reform Law, Life Sciences Law & Industry Report

1/18/2010 - The Life Sciences Industry: Trends and Predictions, PLC Life Science Cross-Border Handbook

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