Legal

FDA Commissioner Marty Makary’s warning against mass-marketed copycat drugs escalated the regulatory and legal clash over compounded oral GLP-1 products.

Public Citizen’s lawsuit highlights broader concerns over government transparency and oversight in pharmaceutical policy.

The Trump administration has announced new negotiated Medicare prices for a second wave of blockbuster treatments, yielding an estimated $12 billion in savings for 2027, when compared to Medicare’s 2024 net spending.

Tesaro and AnaptysBio engage in legal battles over alleged breaches of their 2014 partnership agreement regarding Jemperli.

Following Pfizer's lawsuits, Novo Nordisk enhanced its acquisition offer for Metsera, resulting in Pfizer also sending an enhanced offer.

Pfizer's lawsuits come after Novo Nordisk proposed an unsolicited acquisition proposal to Metsera.

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 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.

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.

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%.

Ron Lanton, Partner, Lanton Law, discusses why the regulatory body made the decision to place restrictions on PD-1 inhibitors for gastric cancers.

Ron Lanton, Partner, Lanton Law, discusses the legal implications of the FDA’s broad label challenge to PD-1 inhibitors for gastric cancers.

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.

In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses best-case scenarios for health policy amid the 2024 presidential election.

In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses the upcoming United States presidential election and the potential impact that it could have on the pharma industry.