October 25th 2024
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.
Drug Pricing from a Legal Perspective & IRA Predictions
July 28th 2023In 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.
In DOJ Crosshairs: Rethinking Commission-Based Deals With Independent Contractors
July 8th 2022Pharma 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.
A Complex Patent & Pricing Picture: Regulating Psychedelics More of a Journey Than a Trip
March 8th 2022Pharma 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.
Optimizing the Review Process for Promotional Content
January 10th 2022As 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.
Why Pharma’s Approach to IDMP Today Will Matter to Patients & Physicians Tomorrow
November 15th 2021The Identification of Medicinal Products (IDMP) software industry has talked up the broader potential of data-driven processes. Pharma companies and their software providers have an important role to play in realizing these processes. Frits Stulp discusses the foundations that need to be laid for lasting transformation of pharma information access in the real world.
The American Rescue Plan Act of 2021: Pharmaceutical Industry Impact
March 23rd 2021Assessing the implications for the pharma industry of the America Rescue Plan Act of 2021, which provides nearly two trillion dollars in funding for various government programs, including many related to public health.