Week of Jan. 8, 2024

This week we highlight the integration of artificial intelligence in regulatory compliance for software as a medical device (SaMD), alongside a surge in health care mergers and acquisitions totaling over $6.4 billion. We also examine the U.S. Food and Drug Administration’s approval of Florida’s drug import plan from Canada and the halted merger between IQVIA and DeepIntent due to Federal Trade Commission scrutiny. Additionally, we look at one of the many hot topics at the J.P. Morgan Healthcare Conference.

Each week we highlight five things affecting the life sciences industry. Here’s the latest.

Per Med-Tech News, the article discusses the increasing complexities in global medical device regulations, especially for SaMD. With the SaMD market expected to grow significantly, there’s a pressing need for regulatory professionals to navigate diverse frameworks and ensure safety and efficacy in global markets. AI-driven regulatory tools are becoming essential, offering real-time updates and strategic insights to streamline compliance processes. These tools assist in areas like quality management, documentation requirements, and clinical trial strategies, adapting to the varying regulations in different countries. The article emphasizes the crucial role of AI in supporting regulatory professionals, ensuring compliance and facilitating global market access for SaMD products.

Yahoo Finance reports on a significant surge in health care deals, totaling over $6.4 billion, announced at the J.P. Morgan Healthcare Conference this week. Many of the acquisitions reflect the pharmaceutical industry’s strategy to rejuvenate their portfolios as patents expire and the demand for COVID-19 vaccines and treatments declines. The industry is also adapting to the U.S. government’s price negotiations under the Inflation Reduction Act. The deals indicate a shift from the previous year’s cost-cutting measures with companies now investing heavily in promising therapies, particularly in cancer treatment and targeted drug delivery technologies.

The FDA has granted Florida the approval to import prescription drugs from Canada, as reported by AARP. This decision is a significant step in addressing the high costs of life-sustaining medications in the United States. Florida’s health agency can now initiate a drug importation process for certain state health programs. Since 2019, several states, including Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas and Vermont, have passed laws for drug importation to combat soaring prescription drug prices. Despite a 2003 federal law permitting foreign-drug importation, implementation was stalled due to safety concerns.

The proposed merger between IQVIA, a leading biopharma data provider, and DeepIntent, a pharma advertising specialist, has been abandoned due to ongoing scrutiny from the U.S. government, as reported by Fierce Pharma. Initially, IQVIA sought to acquire Propel, the parent company of DeepIntent, but the FTC intervened last summer, blocking the transaction. The FTC’s concern was that the merger would give IQVIA a dominant position in health care product advertising, particularly in prescription drug advertising aimed at doctors and health care professionals. Consequently, both companies, facing a lengthy and resource-intensive administrative court trial, mutually agreed to abandon the proposed merger.

One of the hottest topics at the J.P. Morgan Healthcare Conference this week is antibody-drug conjugates (ADCs), which drove a spike in licensing deal proceeds during the fourth quarter of 2023 and are expected to continue to be attractive to large pharmaceutical companies in 2024, according to Fierce Pharma. J.P. Morgan’s annual Biopharma Licensing and Venture Report, released this week, revealed that despite a challenging year, biopharma licensing partnerships accounted for $63 billion in total value, with one significant deal amounting to $22 billion. The report also highlighted a decline in the number of licensing deals and initial public offerings, a surge in M&A activity in December, and a notable focus on ADCs, with fewer but substantial deals in 2023 compared to the previous year.

For more insights in life sciences, check out RSM’s industry outlook.


Source link: https://realeconomy.rsmus.com/5-things-to-know-in-life-sciences-week-of-jan-8-2024/ by Justin Culbertson at realeconomy.rsmus.com