Newsletters

03.03.24

February 29, 2024: The “Rarest Day of the Year”

Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare disease community around the goal of achieving ...


02.27.24

The FDA and the Future of AI Oversight

In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging ...


01.29.24

Lykos MDMA Submission Series A

On December 11, 2023, following positive results from two published Phase 3 studies, MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the Federal Drug Administration (FDA) for an investigational MDMA-assisted therapy for persons suffering from post-traumatic ...


06.05.23

Prenatal Vaccines in Medicaid and CHIP: Coverage, Reimbursement and State Policy Solutions

In a new white paper funded by Pfizer, Inc., Manatt Health discusses the current landscape of Medicaid and Children’s Health Insurance Program coverage and reimbursement for prenatal vaccines, informed by a recent assessment of relevant policies in all 50 states, plus Washington, D.C., and ...


02.07.23

Appeals Court Finds for Manufacturers in 340B Dispute; Additional Manufacturers Impose Restrictions

On January 31, the U.S. Court of Appeals for the Third Circuit found in favor of pharmaceutical manufacturers in the ongoing dispute over whether manufacturers may restrict the shipment of reduced-price drugs to contract pharmacies of health care entities that participate in the prescription drug ...


01.30.23

FDA Stands By Long-standing Interpretation of the Orphan Drug Act…For Now

On January 24, the Food and Drug Administration made a long-awaited announcement with major implications for how the agency awards exclusivity for rare disease drugs under the Orphan Drug Act.


11.01.22

340B Anti-Discrimination Provisions: A Review of Proposed and Enacted Legislation by State

The 340B Drug Pricing Program, which was enacted in 1992 by Section 340B of the federal Public Health Services Act, requires pharmaceutical manufacturers that participate in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care providers and ...