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
The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi. ...more
The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more
On November 4, 2022, the Supreme Court granted certiorari in Amgen v. Sanofi, No. 21-757, agreeing to review, “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art...more
Last week, the Supreme Court granted Amgen’s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. Sanofi improperly...more
The Supreme Court has granted Amgen’s Petition for a Writ of Certiorari, agreeing to address what it means to provide an enabling disclosure. In particular, Amgen asked the Court to address...more
High Court Will Tackle Proper Enablement Standard - Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its...more
In a rare action by the Supreme Court of the United States, Chief Justice Roberts granted Novartis’s emergency request for a stay of a mandate from the US Court of Appeals for the Federal Circuit, which had found a Novartis...more
Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more
Welcome - Welcome to the fourth 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal...more
A last-minute deal between defendants McKesson, Cardinal Health, AmerisourceBergen, and Teva and plaintiffs’ attorneys means that multidistrict opioid epidemic litigation set to kick off in Ohio federal court today will not...more
The Supreme Court of the United States issued the following decision this morning: Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229: Every patent statute over the past two centuries has included an...more
An amicus brief in an FCA suit indicates that the government is serious about applying the Granston Memo and invoking its statutory authority to dismiss cases. Our White Collar, Government & Internal Investigations and Health...more
The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question...more
On June 25, 2018, the Supreme Court granted certiorari on Helsinn Healthcare's petition to overturn the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals that its patents were invalid by application of...more
On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
Nation’s highest court agrees to hear appeal of a California Supreme Court case with far-reaching implications for personal jurisdiction. In the recently published opinion in Bristol-Myers Squibb Co. v. Superior Court...more
On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more
The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more
On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more
Responding to the Supreme Court’s request for its views, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195)....more
The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...more
On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more