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 Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more
Previous editions of Re:Torts (It’s (Still) Important Enough to Get It Right; Opioid Public Nuisance Question) have covered decisions that addressed whether various states permit public nuisance claims in connection with the...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
The Supreme Court issued a number of headline-grabbing decisions this term on topics like religious accommodation, LGBTQ protections, and consideration of race in college admissions. These decisions are wide-reaching and...more
Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION] (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more
Precedential Federal Circuit Opinions: In Re NITRO FLUIDS L.L.C. [ORDER] (2020-0142, 10/28/28) (REYNA, WALLACH, and CHEN) - Reyna, J. The Court considered a petition for a writ of mandamus seeking transfer from the...more
Judges presiding over multidistrict litigations, known as MDLs, must walk a tightrope between individual and collective needs. ...more
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more
On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more
Summer is winding down, and Fall texted to say she is on her way. This means that Pro Te: Solutio is returning for its third edition of 2019. As always, our authors have taken the time to research and address current issues...more
In late June, thirty-nine cities and counties advancing claims in the opioid multidistrict litigation moved to certify a “negotiating class” solely for the purpose of reaching a settlement....more
We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware. Earlier this month, Judge Lloret issued an order on additional...more
In an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues are...more
Last week the Supreme Court of the United States rejected a petition for a writ of certiorari in Medical Device Business Services, Inc. et al. v. United States ex rel. Nagrol et al. In this case, the petitioner asked the...more
On November 1, 2017, CMS issued a final rule that became effective January 1, 2018, under which hospitals serving a disproportionate share of low-income patients (DSH hospitals) will receive nearly 27 percent less in...more
The US District Court for the District of New Jersey awarded Luitpold more than $210,000 in fees and costs under 35 USC § 285 after granting its motion for judgment on the pleading under Fed. R. Civ. P. 12(c) (ANDA Update,...more
The Sixth Circuit's recent decision in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co. reinforced Federal Rule of Civil Procedure 9(b)'s requirement that plaintiffs plead fraud "with particularity" in False Claims Act cases....more
As we previously reported, on September 22, 2017, a Delaware federal jury awarded Amgen $70 million in damages after finding that Hospira infringed one of Amgen’s Epogen® (EPO) patents (the ’298 patent). Five days later,...more
Perhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure. Particularly when the professor is bold enough to engage students on the intricacies...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more
In a 7–2 decision penned by Justice Breyer, the Supreme Court of the United States overturned the de novo standard as the sole standard of review issues arising in claim construction. Teva Pharmaceuticals USA v. Sandoz,...more
The Supreme Court recently handed down its 7-2 opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The case involved a Federal Circuit review of a district court’s determination that Teva’s patent claims were not...more
On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA,...more