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Trending ..... Myriad: SCOTUS Rules on Gene Patentability ..... Oxford Health Plans: SCOTUS Backs Arbitrator on Class Call ..... Bowman v. Monsanto: SCOTUS on Self-Replicating Technologies (eg Seeds) ..... SEC Proposes Money Market Reforms ..... Wellness Program Guidance ..... Equator Principles ..... Broker-Dealer Faces FCPA, Travel Act and Securities Fraud Charges for Venezuelan Payments ..... NLRB's Employee Rights Poster Comes Down ..... Ralph Lauren Settles FCPA Charges ..... Kiobel: SCOTUS Sends Alien Tort Statute Packing ..... DoJ Cuts Corporate Plea Agreement Carve-Out ..... How Bad Will it Be? That is Sequestration ..... HIPAA Omnibus Rule ..... Final FATCA Regs ..... PPACA: Play or Pay ..... DOJ/SEC Issue FCPA Guidance .....

Latest News For Pharma & Life Sciences Sectors

Kaye Scholer: Supreme Court Requires Full Rule of Reason Analysis in So-Called “Reverse Payment” Settlements of Patent Litigation

June 20, 2013 Pharma Reverse Payment Settlements

Hogan Lovells: Supreme Court overturns Eleventh Circuit in Reverse Payment Case

June 20, 2013 Pharma Reverse Payment Settlements

Dechert: Myriad's Possible Impact on Patent Eligibility of Isolated Non-DNA Chemical Substances

June 20, 2013 Association for Molecular Pathology v. Myriad Genetics: SCOTUS Holds Isolated Genes Not Patentable

HHS OIG Provides Guidance on Use of Permissive Exclusion Authority

Bass Berry Sims: Know Your People! OIG Issues New Special Advisory Bulletin on Excluded Persons

McGuireWoods: OIG Issues Updated Bulletin on Effect of Exclusion

Alston & Bird: Updated OIG Guidance on Health Care Program Exclusions – More Trouble for Health Care Entities Owned or Controlled by Excluded Persons?

Pharma & Device Sectors Face FCPA Scrutiny

Arnold & Porter: Pfizer's FCPA Settlement Provides Important Lessons for the Medical Products Industry on Compliance Program Expectations

Vinson & Elkins: A Prescription for Trouble: Pfizer Hit with FCPA Charges as Focus on Foreign Corruption in the Pharmaceutical Industry Continues

Fulbright & Jaworski: Orthofix Makes Latest Medical Device FCPA Settlement

CMS Implements PPACA Fraud and Abuse Controls

Mintz Levin: CMS Final Rule Strengthens Framework to Prevent Health Care Fraud

Mintz Levin: CMS Finalizes Regulations Intended to Strengthen Program Integrity

ReedSmith: CMS Final Rule Expands Medicare/Medicaid/CHIP Provider and Supplier Screening Requirements Under Affordable Care Act Authority

PLIVA v. Mensing: Generic Drug Makers Protected from Failure to Warn Claims

Bingham: The Federal Preemption Defense for Generic Drug Manufacturers May Be Short Lived

Haynes and Boone: Contemplating Pliva V. Mensing

ReedSmith: PLIVA Inc. v. Mensing: The U.S. Supreme Court Muddles Through Another One

Stanford v Roche & University Ownership of Federally Funded Patents

Baker Botts: Does Your Employment Agreement Contain A Time Bomb? 5 Minutes That Can Save A Lawsuit

Greenberg Traurig: U.S. Supreme Court: Bayh-Dole Act Does Not Supersede Inventors' Rights in Federally Funded Inventions

K&L Gates: Bayh-Dole Act Turned On Its Head?

Association for Molecular Pathology v. Myriad Genetics: SCOTUS Holds Isolated Genes Not Patentable

Dechert: Myriad's Possible Impact on Patent Eligibility of Isolated Non-DNA Chemical Substances

Dentons: DNA and Genetics Patents: What Impact Will the Myriad Decision Have?

Haynes and Boone: Not a Biotech Company? What Myriad Might Mean For You

Matrixx v Siracusano & Disclosure/Materiality of Adverse Event Reports

McCarter & English: Matrixx and Recent Lower Court Decisions

Pepper Hamilton: Lower Courts Follow Matrixx's Guidance on Motions to Dismiss

Akin Gump: Supreme Court Gives Guidance On Materiality Standard

Statutory Pathway for Biosimilar Biologics

McDermott Will & Emery: Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

Latham & Watkins: FDA Provides Draft Guidance on Meetings with Biosimilar Product Sponsors

Duane Morris: Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

Clinical Trials

K&L Gates: FTC Rules that “Randomized Clinical Trial” Evidence is Necessary to Support Advertising Claims for Juice Beverage and Related Products

Holland & Knight: Controversial U.S. Medical Study Raises Informed Consent Questions

Sidley Austin: Draft Guidance on Dual Function Molecular Diagnostic Instruments Could Broaden FDA Reach into Non-Devices

Stem Cell Research

K&L Gates: Cultured Stem Cells—Court Rules on the Regenexx Case

Sidley Austin: Stem Cell Warning Letter Reflects FDA Focus on Medical Procedures

Eversheds: A New Way to be Human? [Oliver Brüstle v Greenpeace]

Stark Anti-Kickback Laws

Haynes and Boone: Appeals Court Overturns $44 Million Judgment Against Tuomey Hospital in Important Stark Law Case

Foley & Lardner: Hospital - DMEPOS supplier arrangements and the Anti-kickback Statute

Foley & Lardner: First Circuit Rejects False Claims Act Analysis and Rescues Anti-Kickback Claims Against Medical Device Company

Health Care Reform & Stark Law

Mintz Levin: Federal District Court Upholds Stark Regulation Ban on Physician-Owned Under Arrangement Service Providers

Arent Fox: Intermountain Healthcare Settlement of $25.5 Million Stems from Stark Law Violations

Greenberg Traurig: Stark Law Violations Costly To Intermountain Health Care Inc.