Identify REMS Risk Before It Impacts Your Launch.
Failure to evaluate REMS risk early can create avoidable launch risks, including compressed implementation timelines, increased costs, and delayed market entry.
By Melissa Landers, Founder and Vice President, Shepherd Safety Services at Two Labs
Here is a situation that plays
Louisiana’s New Prescription Drug Affordability Board: What Manufacturers Should Be Monitoring
Louisiana’s recent enactment of Senate Bill 401 is another step forward in the evolution of state-level oversight of prescription drug pricing. Effective January 1, 2027, this legislation establishes a Prescription Drug Affordability Board (PDAB) within the Louisiana Department of Insurance
What Accelerated FDA Review Means for Psychedelic Therapy Safety and Patient Access
Recent news highlights a new federal directive aimed at accelerating FDA review and research pathways for certain psychedelic therapies being explored for serious mental health conditions, including treatment‑resistant depression and PTSD.
While faster review timelines may help advance innovation in
Pre-Launch Specialty Pharmacy Selection & Implementation: A Defining Commercial Decision
Pre-Launch Specialty Pharmacy Selection is one of the most important commercial decisions you will make. This decision will determine how quickly patients access therapy, how smoothly prescribers navigate reimbursement, how much visibility you have into your own data, and how
Connecting Strategy to Performance in the Post-Launch Phase
Bringing a drug to market is a significant milestone, marking the culmination of years of clinical development, regulatory planning, and cross-functional coordination, all converging in a single moment: launch day.
While launch is a significant achievement, it does not guarantee
Beyond the Prescription: Why Patient Support Is a Commercial Imperative in Specialty Pharma
A breakthrough therapy delivers results only if patients can access and maintain it. Across all therapeutic areas, the path from prescription to getting on and staying on therapy involves steps like reimbursement review, prior authorizations, financial navigation, and patient education.
Strategic decisions in days, not months: the simulated advisory board breakthrough
In life sciences today, time is the biggest barrier between strategic questions and meaningful answers. Whether launching a new therapy, preparing for label expansion, or navigating market access challenges, medical affairs and commercial teams must quickly understand and navigate how
DSCSA Exception Handling: Preparing for Full Compliance by 2026
As the pharmaceutical supply chain transitions into full compliance with the Drug Supply Chain Security Act (DSCSA), one issue that has been simmering below the surface for years is now starting to boil over: exception handling. While much of the
Case Study: Rapid Trade Support for Urgent Patient Needs
How a proactive trade response ensured same-day access to a critical rescue medication
The Challenge
While on vacation, the caregivers of a young child had just stepped off a ride at a theme park when the child suffered their first
Whitepaper: Dates associated with pharmaceutical products – National Council for Prescription drug programs
Navigating product discontinuation has long been a complex and often confusing challenge for pharmaceutical manufacturers. What might seem like a simple step—removing a product from the market—quickly becomes complicated by varying requirements from the FDA, CMS, and major compendia organizations.