Publications of Interest > Life Sciences > Practices : Morgan, Lewis & Bockius

05/22/12 Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges, presented at the AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law

Presentation | Speech
Andrew Ruskin

Morgan Lewis partner Andrew Ruskin presented on "Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges" at AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law. more

05/09/12 Eleventh Circuit Rejects FTC Challenge to Reverse Payment Settlement

LawFlash/Client Alert | Antitrust LawFlash
J. Everett, Jr., Sean Duffy, Steven Reed, Scott Stempel

Decision by court of appeals affirms that settlements that do not expand the exclusionary scope of a patent are not subject to antitrust challenge.

05/03/12 HHS Plugs Payment Suspensions as Key Tool in Latest Takedown

LawFlash/Client Alert | Life Sciences & Healthcare LawFlash
Kathleen McDermott, Arianne Callender, Howard Young, Eric Sitarchuk

The Medicare Fraud Strike Force's use of a pivotal ACA regulation to suspend payments during criminal investigations signals a turning point in its prosecution strategy.

04/18/12 Manufacturers Affected by Recent Medicare Part D Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner

CMS formalizes its Medicare Part D Coverage Gap Discount Program rules as part of an omnibus Medicare Part C and Part D rulemaking.

04/10/12 FDA Issued ACA Industry Submission Specifications User Guide for ACA §6004

Marketing Material | Supplemental Info

04/10/12 Health Industry Compliance Brochure

Marketing Material | Brochure

04/03/12 Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

LawFlash/Client Alert | Insurance Recovery LawFlash
Kevin Dreher, Christopher Loeber

State and federal courts reject efforts to categorize salmonella as a "communicable disease."

04/02/12 It’s Not Just Pill Mills The DEA Is After, Law360

Outside Publication | Article
Kathleen Sanzo, Lee Rosebush, Michele Buenafe

03/21/12 Personalized Medicine Patents Rejected by U.S. Supreme Court

LawFlash/Client Alert | Intellectual Property LawFlash
Robert Smyth, Ph.D.

Court ruling applies law of nature; impacts patents directed to personalized medicine.

03/09/12 Pharmacies and Suppliers Beware: It Is Not Just the Pill Mills They Are After

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Lee Rosebush, Michele Buenafe

DEA's recent position against a national pharmacy chain and a wholesale distributor expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly medical necessity reviews.

February 2012 Co-author, Compliance Certifications and the Era of Accountability—A Forecast to Debate, Journal of Health & Life Sciences Law, Vol. 5, p. 158

Outside Publication | Article
Kathleen McDermott, Arianne Callender

02/13/12 2011 Year in Review: Selected Federal Securities Litigation Developments

LawFlash/Client Alert | Securities LawFlash
Anthony Fassano, Laura Hughes, Nicholas Schretzman, Brian Herman, John Vassos

In 2011, the Supreme Court and the federal circuit courts issued a number of important decisions concerning securities fraud class actions. These decisions address pleading standards, statutes of limitations defenses, class certification, and a number of other critical topics.

02/09/12 FDA Issues Three Draft Guidances for Biosimilars

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, Phoebe Mounts, Alexis Miller, Kathleen Sanzo

Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.

02/06/12 CMS Proposes Major Changes to AMP Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner, Stephen Ruscus

The Proposed Rule provides provisions that will significantly impact pharmaceutical manufacturers' rebate liability, price reporting calculations, and possibly their operations.

02/03/12 Class Action Arbitration Waiver Rejected by Federal Appellate Court

LawFlash/Client Alert | Class Actions LawFlash
Litigation Practice

Second Circuit sidesteps Concepcion and holds that the ability to enforce federal statutory rights mandates that a plaintiff be allowed to pursue a class action in court notwithstanding the parties' agreement to mandatory arbitration.

01/25/12 2011 American Health Lawyer’s Association Annual Meeting

Presentation | Speech
Kathleen McDermott

Morgan Lewis's Kathleen McDermott presented "The Era of Individual Accountability-Is A Liability Hailstorm On The Way?" at the 2011 American Health Lawyer's Association Annual Meeting. Ms. McDe... more

01/11/12 FDA Gets (Un)Social

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Alexis Miller

FDA draft guidance on responding to requests for off-label information foreshadows restrictive policies on use of social media.

2011 Co-author, Prescription, Drug Promotions and Marketing, FDLI’s Food and Drug Law Regulation 2011, 2nd edition

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

12/21/11 CMS Issues Transparency Reporting Proposed Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Rebecca Osowski, Kathleen McDermott, Jonathan Havens, Michele Buenafe

The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.

12/05/11 Comparative Effectiveness Research: Impact on Pharmaceutical Pricing and Marketing, presented at the QI Productions Conference on Integrating Comparative Effectiveness Research, Philadelphia

Presentation | Speech
Stephen Mahinka

Topics presented include: Structural Changes in Pharmaceutical Industry Stimulating Focus on Comparative Effectiveness Research Potential Changes by Healthcare Reform Law Affecting Demand Levels and Prices/Payments ... more

12/02/11 Spotlight On Physician Owned Distributors: Stay Tuned For Agency Guidance, Health Lawyers Weekly

Outside Publication | Article
Arianne Callender, Howard Young

Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers. more

12/01/11 Government Program Integrity Enforcement and Child Behavioral Provider Focus Areas, presented at the National Association for Children’s Behavioral Health 2011 Technical Meeting, Orlando, FL

Presentation | Speech
Howard Young

10/31/11 FTC/DOJ Final Policy on Accountable Care Organizations: Important Antitrust Issues Remain Uncertain for Healthcare Collaborations

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, J. Everett, Jr., David Brenneman, Albert Shay

The Federal Trade Commission (FTC) and Department of Justice (DOJ) (together, the Agencies) issued their final "Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Sha... more

October 2011 Where Will Biosimilars Fit in Federal Drug Pricing Programs?, BNA's Pharmaceutical Law & Industry Report

Outside Publication | Article
Donna Lee Yesner

10/06/11 Physician-Owned Distributors and Agency Guidance: Still Waiting

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young

Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers.

09/23/11 The Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at American Conference Institute’s FDA Boot Camp, Boston

Presentation | Speech
Stephen Mahinka

08/09/11 FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Phoebe Mounts, M. Elizabeth Bierman, Michele Buenafe

On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device."[1] Once ... more

07/28/11 New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
M. Elizabeth Bierman, Michele Buenafe

On July 19, the Food and Drug Administration (FDA) issued a new draft guidance document, titled Mobile Medical Applications , describing FDA's position on the regulation of mobile applications, i.e., software applications inten... more

07/13/11 Supreme Court Strikes Vermont Data Mining Law and Protects Pharmaceutical Marketing

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Life Sciences and Healthcare Practice

On June 23, the U.S. Supreme Court issued a 6–3 decision in Sorrell v. IMS Health Inc., declaring a Vermont law designed to prevent data mining unconstitutional. The Vermont Prescription Confidentiality Law at issue restr... more

07/12/11 Third Party Reimbursement of Covered Entities: Manufacturers' Perspective, presented at the 15th Annual 340B Coalition Summer Conference, Washington, DC

Presentation | Speech
Donna Lee Yesner

06/30/11 Physician-Owned Distributors in the Crosshairs: Senate Committees Call on OIG and CMS to Take Action

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young

In a strong signal that physician-owned distributors (PODs) may be in the line of enforcement fire, on June 9, five senators, representing the Committees on Finance, Aging, and Judiciary (Committees), signed joint letters to the... more

06/29/11 The Compliance Revolution Will Be Televised: OIG Videos Offer Practical Compliance Pointers, BNA's Health Law Reporter

Outside Publication | Article
Kathleen McDermott, Arianne Callender

06/16/11 HHS Proposed Rule Creates New Access Report Obligations And Amends Existing Accounting of Disclosures Provisions, BNA's Health Law Reporter

Outside Publication | Article
Heather Deixler, W. Reece Hirsch

06/14/11 HHS Issues Proposed Rule; Creates New Access Report Obligations and Amends Existing Accounting of Disclosures Provisions

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
FDA & Healthcare, Life Sciences, and Employee Benefits Practices

On May 31, the U.S. Department of Health and Human Services (HHS) released a notice of proposed rulemaking (Proposed Rule) creating a new requirement that covered entities produce an "access report" informing individuals of all ... more

06/13/11 Seventh Circuit Embraces Use of “One Purpose” Standard Under Anti-Kickback Statute

LawFlash/Client Alert | FDA and Healthcare LawFlash
Howard Young, Daniele Capasso, Albert Shay

Recently, in United States v. Borrasi ,[1] the Seventh Circuit aligned with the Third, Fifth, Ninth, and Tenth Circuits in determining that the Anti-Kickback Statute (AKS)more

06/11/11 2011 Health Law Institute: Federal Fraud & Abuse Update, presented for the 2011 Health Law Institute

Presentation | Speech
Howard Young

06/08/11 Transparency Update: Vermont Revises Disclosure Form and Seeks Comment on 2011 Draft Consolidated Disclosure Guide

LawFlash/Client Alert | FDA and Healthcare LawFlash
Lee Rosebush, Kathleen McDermott, Michele Buenafe

The State of Vermont regulates expenditures and gifts to healthcare professionals and entities by manufacturers of prescribed products (medical device, pharmaceutical, and biological products entities). Such entities with repor... more

06/07/11 The Compliance Revolution Will Be Televised: As Government Turns Up Heat on Healthcare Fraud, OIG Videos Offer Practical Compliance Pointers

LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen McDermott, Arianne Callender

The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Health Care Fraud Prevention and Enforcement Action Team (HEAT) has garnered headlines for its coordinated Medicare fraud criminal swee... more

06/06/11 New Government Healthcare Policies - Impact on Growth and Investment in the Biopharma Industry, presented at the US – Japan Health Sciences Dialogue 11th Annual Meeting, Philadelphia

Presentation | Speech
Stephen Mahinka

05/24/11 Medicare ACOs: Details From the Fraud and Abuse Perspective (an American Health Lawyers Association webinar)

Presentation | Webinar
Kathleen McDermott

Morgan Lewis partner Katie McDermott participated in AHLA's hosted webinar on "Medicare ACOs: Details From the Fraud and Abuse Perspective" on May 24, 2011. The much-anticipated proposed regulations regarding the Medicare Shared ... more

05/23/11 FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Phoebe Mounts, Lee Rosebush, Stephen Mahinka

On May 10, the Food and Drug Administration (FDA) issued a Federal Register notice requesting comments relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitt... more

04/14/11 FDA Proposes to Expand the Scope of Clinical Investigator Disqualifications

LawFlash/Client Alert | FDA and Healthcare LawFlash
Phoebe Mounts, Jacqueline Berman

The Food and Drug Administration (FDA) has issued a proposed rule which, if finalized, will expand the scope and consequences of clinical investigator disqualifications. [1] Under the propose... more

12/07/10 Bioequivalence and the "Same Active Ingredient" vis-à-vis Patentability, presented at the Paragraph IV Disputes West conference, San Francisco

Presentation | Speech
Robin Silva

10/28/10 Preparing for a Biotechnology M&A – Corporate and Regulatory Insight to Keep Ahead of the Competition

Presentation | Speech
Stephen Mahinka, Richard Aldridge

07/06/10 Price Reporting and Governmental Rebate Issues Arising from the Healthcare Reform Law—an Early Assessment

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Andrew Ruskin

With the passage of the Patient Protection and Affordable Care Act (the Healthcare Reform Law) three months ago, pharmaceutical manufacturers are continuing to assess how the changes to their price-reporting responsibilities are... more

05/24/10 Treasury Issues Guidance for 50% Tax Credit/Cash Grant for Life Sciences Companies

LawFlash/Client Alert | Tax LawFlash
Gary Wilcox

On May 21, 2010, the U.S. Department of the Treasury (Treasury) issued Notice 2010-45 (the Guidance), [1] which outlines the procedures for obtaining a valuable new 50% tax credit or equival... more

05/11/10 Life Sciences Mergers and Acquisitions: How Healthcare Reform Will Change Your Partnership Strategy, presented at a Elsevier Business Intelligence Webinar

Presentation | Speech
Stephen Mahinka, Joyce Cowan

05/11/10 Life Sciences Real Estate in New Jersey Webinar

Presentation | Webinar
John McAleese, III, J.J. Broderick

04/27/10 Healthcare Reform Law and Mandatory Compliance Programs

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Scott Memmott, Howard Young

With the passage of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care Education Reconciliation Act of 2010 (the Healthcare Reform Law), Congress for the first time has mandated that a broad ra... more

04/21/10 New 50% Tax Credit/Cash Grant for Life Science Companies Requires Timely Determination of Eligibility and Application

LawFlash/Client Alert | Tax LawFlash
Gary Wilcox

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), provides for a valuable new 50% tax credit or equivalent cash grant, for... more

04/19/10 Healthcare Reform Law: Comparative Effectiveness Provisions Concerning Healthcare Products and Services

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Stephen Mahinka

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), contains provisions supporting the development of comparative effectiven... more

04/15/10 Healthcare Reform Law: A New Regulatory Pathway for Biosimilar Biological Products

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Kathleen Sanzo, Phoebe Mounts

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), establishes an abbreviated licensure pathway for biosimilar biological p... more

04/15/10 Healthcare Reform Law: Impact on Pharmaceutical Manufacturers

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Kathleen Sanzo

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law, or Law), will have a number of direct and indirect effects on pharmaceuti... more

04/14/10 Healthcare Reform Law Leads to Significant Changes to the 340B Program

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Washington Government Relations and Public Policy Practice

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law, or Law), provides for a number of significant revisions to the existing 3... more

04/14/10 Immediate Healthcare Reform Law Issues for Group Health Plans Come Into Sharper Focus

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Saghi Fattahian, Andy Anderson

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), creates a number of immediate issues for employer group health plans. Some o... more

04/13/10 Healthcare Reform Law Imposes New Tax and Other Requirements for Device Manufacturers

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
M. Elizabeth Bierman, Michele Buenafe

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), presents a number of new issues for medical device manufacturers. Devic... more

04/13/10 Healthcare Reform Law: Issues Affecting Hospitals and Health Systems

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Andrew Ruskin, Albert Shay

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), includes substantial changes that will affect how hospitals of all types... more

04/09/10 Healthcare Reform Law Cuts Medicare Advantage Payments and (Mostly) Increases Prescription Drug Program Payments

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Joyce Cowan

The Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010 (Healthcare Reform Law) makes substantial changes to the Medicare Part C Medicare Advantage (MA) and M... more

04/07/10 Healthcare Reform Law Requires Reasonable Break Times and Locations for Nursing Mothers

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Michael Ossip

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), includes a provision that requires employers to provide covered employee... more

04/01/10 FDA Proposed Rule Requires Reporting Suspected Falsification of Data in Studies with Human or Animal Subjects

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

The U.S. Food and Drug Administration (FDA or the Agency) recently announced a Proposed Rule titled “Reporting Information Regarding Falsification of Data” in a February 19 Federal Register Notice (75 Fed. Reg. 7,41... more

03/31/10 Healthcare Reform Law: Healthcare Fraud and Abuse and Program Integrity Provisions

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Kathleen McDermott, Meredith Auten

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), contains more than 32 sections related to healthcare fraud and abuse and... more

03/31/10 U.S. District Court Invalidates Patents Claiming BRCA Genes

LawFlash/Client Alert | Intellectual Property LawFlash
Intellectual Property Practice

On March 29, a U.S. District Court sided with the American Civil Liberties Union (ACLU) and other plaintiffs in an ongoing lawsuit, declaring Myriad Genetics' patents directed toward nucleotides encoding BRCA genes as invalid. ... more

03/29/10 Healthcare Reform Law Delivers New Transparency Requirements for the Health Industry

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Kathleen McDermott

The Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law) provides for a number of new transparency requirements for several health ... more

03/25/10 Healthcare Reform Law and Its Impact on Business: Ongoing Information and Analysis from Morgan Lewis

LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Washington Government Relations and Public Policy Practice

The Patient Protection and Affordable Care Act (the Healthcare Reform Law) that President Obama signed intlaw on March 23 contains a large number of provisions that will significantly affect businesses in the coming months and y... more

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
Litigation Practice

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 challenges o... more

10/27/09 Funding Healthcare and IT Media, presented at the 2009 New York Life Sciences & Healthcare Venture Summit

Presentation | Speech
Emilio Ragosa

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 Commission's) decisi... 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 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, 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 Webinar

Presentation | Webinar
Jürgen Beninca, Anthony Warnock-Smith, Eric Sitarchuk

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 and Healthcare 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 of the FTC... 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 ... more

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

Presentation | Webinar
Nina Stillman, Jonathan Snare, Andy Anderson

This 90-minute webinar 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, Meredith Auten

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

Presentation | Webinar
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
Brian Shaffer, Phoebe Mounts, David Schrader, John Lavelle, Jr., Sandra Phillips, Joan Haratani, James Pagliaro, Kathleen Sanzo

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

01/28/09 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., 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

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

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 o... 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 and Healthcare LawFlash
FDA and Healthcare 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 ClinicalTrials.gov Pr... more

July 2008 Advanced Therapies Regulation, European BioPharmaceutical Review

Outside Publication | Article
Anthony Warnock-Smith

06/29/08 Off-Label Use of Drugs and Devices, presented at the American Health Lawyers Association's 2008 In-House Counsel Program & Annual Meeting, San Francisco

Presentation | Speech
Andrew Ruskin

06/19/08 From Europe and Japan to the U.S.: Build or Buy?, presented at the 2008 BIO International Convention, San Diego, CA

Presentation | Speech
Randall Sunberg

06/19/08 Regulatory and Legal Developments Concerning Clinical Trials, presented at the 2008 BIO International Convention, San Diego, CA

Presentation | Speech
Kathleen Sanzo

June 2008 Co-author, Quelles limites à la brevetabilité du vivant? (What Are the Limits of Living Organisms’ Patentability?), La Gazette du Palais

Outside Publication | Article
Virginie Desmoulin

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

Outside Publication | Article
M. Elizabeth Bierman, Michele Buenafe

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)

Morgan Lewis Title | Deskbook
Emerging Growth & Life Sciences Groups

Request a copy of the deskbook here. 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 Publication | Article
Alan Leeds, David Glazer

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

Outside Publication | 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
A. James Vázquez-Azpiri, Anne Brafford

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 and Healthcare 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 effectiveness of... 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
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 Publication | Chapter
Stephen Mahinka

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

11/08/07 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

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

Presentation | Speech
Anthony Warnock-Smith

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 Publication | 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 Publication | 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 effective ... 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 paymen... more

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

Outside Publication | 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 Product Representatives Seek Overtime: In recent years, class and collective actions filed under the Fair Labor Standards Act (FLSA) and... more

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

Outside Publication | Chapter
Stephen Mahinka, Kathleen Sanzo

2 November 2006 Defective Defence, Legal Week

Outside Publication | 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
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: The January 2006 Food and Drug Administration (FDA) final rule on prescription drug labeling, with its sign... 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 some major... 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: In view of recent widely publicized issues regarding lobbyists' activities and ethics, many life sciences comp... 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: In today’s increasingly competitive global economy, medical device companies are continually ... more

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. Outsourcing the manu... 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 Prescription Drug, Improvement and Modernization Act (the “Medicare Amendments”), Congress addressed a “critical” is... 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 negotiating a life sciences merger or acquisition agreement, the merged or acquired entity must fully understand ... 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 and Technology Enhancement Act: Under U.S. patent law, publications that describe (either alo... more

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

Outside Publication | 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 companies have outsourced, or are evaluating the benefits of outsourcing, one or more of their non-core business functi... 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 Publication | Article
Stephen Mahinka, Harry Robins

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

Presentation | Speech
Randall Sunberg

10/28/04 Protecting the Product Life Cycle - Patent Law for Chemists, presented at the American Chemical Society Western Regional Meeting, Sacramento, CA

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
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 scrutiny of and enforcement against pharmaceutical companies and providers for anti-kickback violations and healthcar... 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 Publication | Article
Kathleen Sanzo, Stephen Mahinka

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 Administration released three new draft guidance documents regarding direct–to–consumer (DTC) advertisements of drugs, biolo... 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 continue to be an important component of the product development and commercialization process in the life scie... more

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

Outside Publication | 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 final approval on November 25, 2003 to a bill that represents the broadest changes in the Medicare Program since i... 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: When publicly disclosing progress on product development, publicly traded life sciences companies, including biote... 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 patient groups and Congress of the benefits and progress of FDA’s program for accelerated approval of drugs and bio... 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 2002 represented a sweeping revision of the federal securities laws, affecting virtually every public company (and ... 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: Independent auditors have occasionally used the term “pipe dream” to describe the operation of companies in... more

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

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

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 created today’s generic drug system, was premised on balancing two divergent interests — facilitating the approval... 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 of 2002, FDA has sought to ensure more consistent enforcement of current good manufacturing practice (cGMP) requi... more

10/22/02 Promotion and Development Collaborations Between Established Players, presented at the 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 investor skepticism following recent accounting meltdowns have raised new challenges for public companies. Ine... more

July 2002 Morgan Lewis on Life Sciences
July 2002

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Welcome and Introduction BuSpar® and Tiazac® Antitrust Cases Leave Unanswered Questions: Over the last few years, an increasing number of antitrust cases have challenged various action... 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 Publication | Article
Kathleen Sanzo, Stephen Mahinka

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

Outside Publication | Chapter
Kathleen Sanzo

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

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

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

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

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

Presentation | Speech
Randall Sunberg