Two Labs celebrates a special milestone on July 1st – its 20th anniversary! In the two decades since its founding, the company has enjoyed significant growth in both size and services, and continues to drive innovation in the pursuit of improving the lives of others.
With the industry changing so rapidly – along with patient expectations and prescriber priorities – we felt there was an unmet need to shine a light on programs that are leading the way. Transactional features are now table stakes, and going above and beyond with patient services is how you can help differentiate your product.
Tracing is essentially an extension of what companies should already have in place in their suspect drug investigation procedures. The tracing request should not be looked at in a vacuum but as another component of a robust suspect drug investigation.
While Tracing hasn’t gotten much airtime outside the tight circle of DSCSA experts – those of us who live and breathe this – the new Tracing requirement is a fundamental process that will become the norm in the pharmaceutical industry.
Today’s drug pipeline is in an interesting spot. In 2022, there were only 44 novel new drugs approved, down from 58 in 2020 and 60 in 2021. The decrease is due to several reasons beyond a regulatory COVID lag: a constricted approval pathway, the natural ebb and flow of the industry, and manufacturer funding issues. As the industry grows, it’s becoming harder for companies to go public and raise money like they once could.
In 2015, the U.S. government passed the 21st Century Cures Act. In it was a provision called the ‘Open Act,’ designed to increase drug pricing transparency by requiring manufacturers to submit clinical trial results and detailed information on production and R&D costs.
Two Labs is officially unveiling its State Drug Price Transparency (DPT) managed service offerings to help emerging pharmaceutical manufacturers navigate the evolving regulatory landscape imposed by each state's own independent reporting requirements. Read the press release.
Based on Two Labs’ experience supporting 280+ pharmaceutical new product launches, our experts will walk you through the most critical questions to answer when planning a pharma launch strategy.
We’ve entered a new era in the U.S. healthcare system with the passage of the Inflation Reduction Act’s (IRA) landmark policy changes. And whether you are an emerging manufacturer bringing your first drug to market or more seasoned about the whole launch process, it’s important to make sure that your strategy includes a focused public policy element.
REMS are FDA-mandated, post-marketing safety programs that can be required to appropriately balance a drug's benefits and risks to support safe use. These safety programs are most often required during the NDA or biologics license application (BLA) process to address risks identified in development.
