Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 248: Fighting Addiction and Expanding Access to Treatment with Sara Howe and Morgan Coyner of APNC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
Early Returns Podcast with Jan Baran - Josh Gerstein: SCOTUS, the Presidential Immunity Case Fallout, and the Dobbs Case Leak Investigation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 189: Student Mental Health with Dr. Stephanie Irby Coard, UNC Professor
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim Dall, Healthcare Economist
Podcast: Post-Dobbs - One Year Later - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
In the Boardroom With Resnick and Fuller - Episode 2
Let's Talk About the Constitutional Aspects of the Dobbs Decision
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Compliance Perspectives: Providing Patient Access to Personal Health Data
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab)....more
President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more
President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more
For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more
The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more
On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with misoprostol, was used in nearly two-thirds of all U.S. abortion and miscarriage treatments...more
On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more
On March 26, 2024, the Supreme Court heard arguments in the two consolidated cases concerning access to mifepristone pending before the Court, FDA v. Alliance for Hippocratic Medicine, Case No. 23-235 and Danco Laboratories,...more
Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of...more
The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more
On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more
The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more
On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the requirement that mifepristone...more
The federal government started 2023 by clarifying important legal issues surrounding the use of medications for abortions. These changes come after much uncertainty—and controversy—around the availability of medication...more
On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to...more
On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more
In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more
This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request...more
On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain...more
How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal "Right to Try" - As discussed in our Alert of June 4, "Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers,...more