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
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark. Appeal from the Patent Trial and Appeal Board....more
Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in...more
Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more
European Commission Orders Unprecedented Unwinding Of Illumina’s Acquisition of GRAIL. For the first time, the European Commission has ordered reversal of a consummated transaction, Illumina Inc.’s 2021 acquisition of GRAIL...more
The FTC’s Amgen/Horizon Lawsuit Ends With a Whimper - We covered the FTC’s investigation into (and litigation challenging) Amgen’s $28.3 billion acquisition of rare disease specialist Horizon Therapeutics in our Q1 and...more
FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an...more
GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO...more
Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
The second quarter saw significant enforcement and dealmaking in the life sciences space. The Federal Trade Commission (FTC) announced its attempt to block Amgen/Horizon, the first such challenge to a life science transaction...more
Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in...more
Our prior updates covered how FTC enforcement activity largely proceeded “as usual” during 2022 in the life sciences industry, with large pharmaceutical players buying or licensing promising, but still risky, assets from...more
Last week, Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus) filed a complaint for patent infringement in the District of New Jersey against Pfizer, Inc. and BioNTech SE....more
M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership...more
Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more
The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays....more
On August 16, 2022, Merck (NYSE: MRK) and Orna Therapeutics each announced that they entered into a collaboration agreement relating to the discovery, development and commercialization of therapeutics and vaccines in the...more
On July 11, 2022, the United States District Court for the District of Kansas approved a $264 million settlement against Mylan and certain of its subsidiaries in the case In Re EpiPen (Epinephrine Injection, USP) Marketing,...more
On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services...more
Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar...more
Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept). Pfizer alleges that the...more
ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more