Legal

Dr. Jeanne Marrazzo's firing highlights concerns over political interference in health research and vaccine safety advocacy amid whistleblower allegations.

A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.

Ron Lanton, partner, Lanton Law, warns that ongoing lawsuits targeting vaccine policy could create ripple effects across FDA decision-making and reshape how future emergency use authorizations are granted.

Ron Lanton, partner, Lanton Law, warns that recent changes to federal vaccine recommendations could trigger extensive litigation as insurers, providers, and patients face new access and coverage challenges.

The directive calls for building a Strategic Active Pharmaceutical Ingredients Reserve, updating the essential medicines list, and prioritizing US-made APIs.

A new two-phase initiative aims to streamline facility approvals, reduce reliance on foreign pharmaceutical production, and bolster domestic supply chain resilience amid rising tariffs and reshoring investments.

The settlement ends US mRNA patent disputes involving COVID-19 and influenza vaccines, while positioning GSK for additional payments and global royalty benefits if BioNTech’s acquisition of CureVac closes.

The Regeneron litigation highlights that donations routed through independent entities are not immune from challenge, especially if the government believes they are effectively covering a patient’s co-pay for a specific product.

Q&A with Model N's Michael Grosberg drills deeper into the new US drug pricing directives, including challenges in implementation, the potential unintended consequences, and how these actions could spark the shift to outcomes-based contracting in healthcare.

Ron Lanton, Partner, Lanton Law, discusses the constitutional and statutory challenges facing the President’s use of executive orders to implement international drug pricing models such as the Most Favored Nation, highlighting the ongoing debate over separation of powers and congressional authority.

Ron Lanton, Partner, Lanton Law, outlines how the MFN executive order may face significant legal challenges from the pharmaceutical industry, citing concerns over due process, intellectual property, and regulatory overreach.

Armando Castro, partner, emerging companies, venture capital, Lowenstein Sandler, explains how repurposing GLP-1s and psychedelics for addiction treatment introduces unexpected patent challenges, liability concerns, and complex state-by-state regulatory hurdles.

Armando Castro, partner, emerging companies, venture capital, Lowenstein Sandler, explains how regulatory, patent, and reimbursement challenges are slowing venture investment in GLP-1 and psychedelic addiction therapies.

A seminar shares key observations and learnings from the first round of direct price negotiations.

IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.

Matthew Yelovich, partner at Cleary Gottlieb, discusses his transition in late-2024 from working as a federal prosecutor to a role at Cleary Gottlieb, as well as how he sees the intersection of technology and law evolving in the Bay Area.

Matthew Yelovich, partner at Cleary Gottlieb, discusses some of the broader implications for corporate governance and accountability the Theranos case highlights.

Ron Lanton, Partner, Lanton Law, discusses the legal and industry challenges posed by recent National Institute of Health budget cuts, diversity bans in clinical trials, and pharmaceutical supply chain disruptions due to tariffs.

With the Inflation Reduction Act now in flux, how will the government and industry respond?

The proposal aims to reduce out-of-pocket costs for a number of anti-obesity medications by 95%.

Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.

The legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer's drug development, leading to securities litigation over allegedly misleading statements about trial results and commercialization efforts.

Q&A with Evaluate’s Paul Verdin digs deeper into the data-backed drivers likely to sway the future growth and jockeying of biopharma’s top players.

Unlike for individuals or entities providing or receiving services related to in vitro fertilization (IVF), the Alabama IVF Act does not grant immunity to manufacturers, but it limits damages for their violations to the cost of an IVF cycle.

Amid lingering questions and uncertainty, a look at ways pharma companies can prioritize incorporating the Inflation Reduction Act into their strategic planning process—and do it now.