Legal

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.

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.

Novartis rescinds rights to to develop and commercialize multi-tyrosine kinase inhibitor dovitinib due to a material breach by Allarity for lack of financial payment.

Best practices for defending against lawsuits based on pharmaceutical labeling, including avenues for early resolution of the case and, as necessary, strategies for developing the best evidence for defense.

Wholesalers claim drugmaker illegally suppressed generic competition for opioid addiction treatment, Suboxone.

Effort aims to protect Americans from potentially harmful ophthalmic products.

Lawsuit comes amid announcement of the first 10 drugs eligible for negotiated prices in 2026.

Delay to allow agency to consider other ways of solving the issue, filing says.

In this exclusive Q&A, Alice Valder Curran, life sciences regulatory expert and partner, Hogan Lovells LLP, shares her perspective on the biggest drug pricing challenges today, current efforts to lower drug pricing, and the Inflation Reduction Act.

While ESG is still in the early stages for pharma, many companies are moving forward with a need for compliance.

Examining efforts to boost women representation on company boards.

The validity of ESG-driven investment and reporting in healthcare.

A prime opportunity for pharma to raise its strategic game in ESG.

U.S. patent law will have to adapt to the use of AI in the life sciences industry.

How principles of both can help companies navigate future storms.

Issue represents a potential threat in fighting future pandemics.

Pharma companies should review their commission-based compensation arrangements with independent contractors to address enforcement risk under the Anti-Kickback Statute, in light of recent Department of Justice enforcement.

Instead, incorporate ESG into your long-term business planning.

Role drift and clinical trials among many areas for compliance professionals to keep an eye on in 2022.

Cross-sector businesses are banding together to protect their intellectual property, but there’s a better way to do it.

Pharma and legal experts weigh in on the rush to secure intellectual property around psychedelic medicines, the value imperative that should govern pricing strategies, and the likely long-haul battle for more widespread decriminalization of these drugs.

New technology serves as reminder for the appropriate uses of CRISPR.

As the pressure on teams reviewing promotional content has increases, both in terms of volumes of content and complexity, Sameer Lal discusses the need for a near-term strategies using artificial intelligence (AI) and machine learning (ML) to decongest bottlenecks of the manual review process.