Good morning, everyone, and welcome to a new week of work. We hope you had a restful weekend and are ready to dive back into the routine of online meetings and deadlines. Let’s start the day with a cup of pistachio creme to give us a boost. Here are some interesting updates to kick off your day.
GSK has decided to leave the Biotechnology Innovation Organization, which is the largest trade group in the biotechnology industry, according to STAT. This move by GSK follows the departure of four other companies from BIO in the past year, including Pfizer and UCB. The trade group has faced challenges, including a drop in lobbying spending and a restructuring that led to layoffs of 30 employees. John Crowley, a biotech executive and rare disease advocate, is the current CEO of BIO. Despite leaving BIO, GSK has increased its lobbying spending this year compared to last year, spending $3.87 million in the first three quarters of 2024.
In other news, companies in India, China, and Europe are major players in manufacturing active pharmaceutical ingredients (APIs) used in products for the U.S. market, as reported by Regulatory Focus. Data from the U.S. Pharmacopeia shows that only 4% of active APIs disclosed in Drug Master Files filed with the FDA in 2023 were from U.S. manufacturing facilities. India held 50% of the active APIs, followed by China at 32%, the European Union at 10%, and other countries at 4%. The USP noted that not all drug products are made with APIs referencing DMFs, but this geographical analysis can provide insights into global manufacturing trends. India leads globally in total active DMFs, accounting for 48%, followed by the EU at 17%, China at 16%, and the U.S. at 9%.
As the pharmaceutical industry looks ahead, there may be opportunities to make adjustments to the Medicare drug pricing negotiation law with Republicans now in control of the White House and Senate. This shift in power could lead to changes in drug pricing policies and regulations. Stay tuned for more updates on the evolving landscape of the pharmaceutical industry.
Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades, providing in-depth analysis and insights into the latest developments in the field. Subscribe to STAT+ for exclusive stories, analysis, newsletters, premium events, and news alerts to stay informed about the latest trends and news in the pharmaceutical industry.
