False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more
Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later - February 2025 - and...more
In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging...more
In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...more
The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases. The Justice Department is executing on that promise and doing so with great success. Week after week, we read about...more
Commercial transactions often involve parties from different states. When a dispute arises between diverse parties, the question of whether a party can obtain personal jurisdiction over a defendant becomes critical. This...more
Recent notable industry transactions. The Alan Turing Institute, the Royal Statistical Society and the UK Department of Health and Social Care's Joint Biosecurity Centre finalised a partnership agreement in relation to the...more
A state appeals court in California has preempted Uber and Lyft’s threatened state-wide shutdown over a new state law ordering them to reclassify their drivers as employees by “allowing them to continue operating [under their...more
Welcome to 2020's second edition of Product Lines, our e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal issues. As you will...more
Contraceptive Is Linked to Injuries and Deaths and Now Is the Subject of Lawsuits - Bayer, the company that manufactured and marketed the dangerous birth-control device Essure, is looking more and more like a bad actor as...more
Although Covid-19 is disastrous for people around the globe, Big Pharma is finding advantage in the infection: Bayer, a pharmaceutical and agricultural products’ giant, is on the brink of what would be an $8 billion-plus...more
DUSTING SPRAY DEATHS AND INJURIES - Robins Kaplan LLP is investigating and litigating “dusting” cases, which arise when someone inhales—or “huffs”—compressed gas dusting spray for its intoxicating effects while driving and...more
While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more
Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million. The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more
On March 13, 2018, China’s Ministry of Commerce (“MOFCOM”)announced its Conditional Approval following antitrust review of a concentration of undertakings relating to Bayer’s proposed merger with Monsanto (“Merger”) (Bayer...more
Case Name: Bayer Intellectual Prop. GmbH v. Aurobindo Pharma Ltd., No. 15-902, 2018 U.S. Dist. LEXIS 116931 (D. Del. July 13, 2018) (Stengel, C.J.)....more
Miles Laboratories pioneered the concept of daily dosing of multivitamins and minerals in the 1940s with the introduction of its One A Day brand. Now owned by Bayer AG, the brand encompasses a suite of vitamins for targeted...more
Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants. Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its...more
Case Name: Bayer Pharma AG v. Watson Labs., Inc., 874 F.3d 1316, No. 2016-2169, 2017 U.S. App. LEXIS 21705 (Fed. Cir. Nov. 1, 2017) (Circuit Judges Lourie, Moore, and O’Malley presiding; Opinion by Moore, J.) (Appeal from D....more
On Tuesday, a jury entered a verdict of $27.8 million against Johnson & Johnson’s Janssen Pharmaceuticals, Inc. and Bayer AG’s Bayer Pharmaceuticals Inc. in the first state court trial out of the Philadelphia County Court of...more
The Federal Circuit reversed a finding of non-obviousness on Friday based on clear error by the District Court on factual underpinnings of its obviousness determination, in Bayer Pharma AG v. Watson Laboratories, Inc. Such...more
HSBC’s making good on its plans to shift to a focus on Asia by naming John Flint—who spent his first 14 years at the bank in Asia—as its new CEO. Flint will take over from Stuart Gulliver in February....more
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more
The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more
Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more