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Practice Highlights
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
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.
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.
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.
Marketing Material | Supplemental Info
LawFlash/Client Alert | Insurance Recovery LawFlash
Kevin Dreher, Christopher Loeber
State and federal courts reject efforts to categorize salmonella as a "communicable disease."
Outside Publication | Article
Kathleen Sanzo, Lee Rosebush, Michele Buenafe
LawFlash/Client Alert | Intellectual Property LawFlash
Robert Smyth, Ph.D.
Court ruling applies law of nature; impacts patents directed to personalized medicine.
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.
Outside Publication | Article
Kathleen McDermott, Arianne Callender
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.
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.
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.
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.
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
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.
Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka
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.
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
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
Presentation | Speech
Howard Young
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
Outside Publication | Article
Donna Lee Yesner
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.
Presentation | Speech
Stephen Mahinka
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
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
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
Presentation | Speech
Donna Lee Yesner
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
Outside Publication | Article
Kathleen McDermott, Arianne Callender
Outside Publication | Article
Heather Deixler, W. Reece Hirsch
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
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
Presentation | Speech
Howard Young
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
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
Presentation | Speech
Stephen Mahinka
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
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
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
Presentation | Speech
Robin Silva
Presentation | Speech
Stephen Mahinka, Richard Aldridge
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
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
Presentation | Speech
Stephen Mahinka, Joyce Cowan
Presentation | Webinar
John McAleese, III, J.J. Broderick
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Outside Publication | Article
Stephen Mahinka
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
Presentation | Speech
Emilio Ragosa
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
Presentation | Speech
Stephen Mahinka
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
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
Outside Publication | Article
Kathleen Sanzo, Sandra Phillips, Sarah Bouchard
Presentation | Speech
Stephen Mahinka
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
Presentation | Speech
Randall Sunberg
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
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
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
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
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
Presentation | Speech
Erica Smith-Klocek, Meredith Auten
Presentation | Webinar
John Lavelle, Jr., Sandra Phillips, Kathleen Sanzo
Presentation | Speech
Randall Sunberg
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
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
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
Presentation | Speech
Anthony Warnock-Smith
Presentation | Speech
Anthony Warnock-Smith
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
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
Outside Publication | Article
Anthony Warnock-Smith
Presentation | Speech
Andrew Ruskin
Presentation | Speech
Randall Sunberg
Presentation | Speech
Kathleen Sanzo
Outside Publication | Article
Virginie Desmoulin
Outside Publication | Article
M. Elizabeth Bierman, Michele Buenafe
Presentation | Speech
Phoebe Mounts
Presentation | Speech
M. Elizabeth Bierman
Morgan Lewis Title | Deskbook
Emerging Growth & Life Sciences Groups
Presentation | Speech
Phoebe Mounts
Outside Publication | Article
Alan Leeds, David Glazer
Outside Publication | Article
Benjamin Lang
Presentation | Speech
Christopher Halliday
Presentation | Speech
Stephen Mahinka
Presentation | Speech
Stephen Mahinka
Presentation | Speech
Randall Sunberg
Presentation | Speech
A. James Vázquez-Azpiri, Anne Brafford
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
Presentation | Speech
Gregory Needles
Presentation | Speech
Kathleen Sanzo
Presentation | Speech
Kathleen Sanzo
Outside Publication | Chapter
Stephen Mahinka
Presentation | Speech
Kathleen Sanzo
Presentation | Speech
Andrew Ruskin
Presentation | Speech
Stephen Mahinka
Presentation | Speech
Louis Beardell, Jr.
Presentation | Speech
Stephen Mahinka
Presentation | Speech
Anthony Warnock-Smith
Presentation | Speech
Phoebe Mounts
Presentation | Speech
Kathleen Sanzo
Outside Publication | Article
Stephen Mahinka, Kathleen Sanzo
Presentation | Speech
Kathleen Sanzo
Presentation | Speech
Kathleen Sanzo, Denis Segota
Presentation | Speech
Robin Silva
Outside Publication | Article
Anthony Warnock-Smith
Presentation | Speech
Phoebe Mounts
Presentation | Speech
M. Elizabeth Bierman
Presentation | Speech
Kathleen Sanzo
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
Presentation | Speech
Stephen Mahinka
Presentation | Speech
Randall Sunberg
Presentation | Speech
Stephen Mahinka, Andrew Ruskin
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
Outside Publication | Book
Barbara Melby
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
Outside Publication | Chapter
Stephen Mahinka, Kathleen Sanzo
Presentation | Speech
Randall Sunberg
Presentation | Speech
Emilio Ragosa
Presentation | Speech
Randall Sunberg
Presentation | Speech
Randall Sunberg
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
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
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
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
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
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
Presentation | Speech
Randall Sunberg
Presentation | Speech
Stephen Mahinka
Presentation | Speech
Randall Sunberg
Presentation | Speech
Scott Stempel
Presentation | Speech
Stephen Mahinka
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
Presentation | Speech
Randall Sunberg
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
Outside Publication | Book
Barbara Melby
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
Newsletter | Morgan Lewis on Life Sciences
Life Sciences
Outside Publication | Article
Stephen Mahinka, Harry Robins
Presentation | Speech
Randall Sunberg
Presentation | Speech
Jeffry Mann
Presentation | Speech
Randall Sunberg
Presentation | Speech
Steven Cohen
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
Presentation | Speech
Randall Sunberg
Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka
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
Presentation | Speech
Randall Sunberg
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
Outside Publication | Article
Michele Buenafe
Presentation | Speech
Randall Sunberg
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
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
Presentation | Speech
Randall Sunberg
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
Presentation | Speech
Randall Sunberg
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
Presentation | Speech
Randall Sunberg
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
Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka
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
Presentation | Speech
Steven Cohen
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
Presentation | Speech
Randall Sunberg
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
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
Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka
Outside Publication | Chapter
Kathleen Sanzo
Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka
Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka
Presentation | Speech
Randall Sunberg