GSK leaves BIO; A schizophrenia drug from AbbVie failed in two studies

Good morning everyone and welcome to another week of work. We hope that the weekend break was relaxing and invigorating, because the oh-so-familiar routine of online meetings, calls and deadlines has returned. But what can you do? The world, as it is, keeps turning. So why not give it a push in a better direction with a cup of stimulation? Our choice today is pistachio cream. In the meantime, here are some interesting things to get you started. We hope that today is manageable and productive. Good luck and stay in touch. …

GSK plans to exit the biotechnology industry’s largest trade group, the Biotechnology Innovation Organizationwrites STAT. GSK is the fifth company to leave BIO in about a year, a group that includes Pfizer and UCB. The departures coincided with a decline in the group’s lobbying spending and other challenges. The retail group laid off 30 employees, including several senior executives, as part of a restructuring earlier this year and has had four chief executives in the last four years. The current leader, John Crowley, a biotech executive and rare disease advocate, took over in March. GSK spent slightly more on lobbying this year compared to 2023. The company spent $3.87 million in the first three quarters of 2024, compared to $3.63 million in the same period in 2023. The pharmaceutical industry faces an opportunity to tweak parts of this price negotiation law for Medicare drugs after Republicans took control of the White House and Senate.

Companies in India, China and Europe continue to play an outsized role in the production of active pharmaceutical ingredients used in products for the U.S. marketRegulatory Focus tells us, citing data from the US Pharmacopeia. Only 4% of active APIs disclosed in Drug Master Files filed with the U.S. Food and Drug Administration in 2023 relate to U.S. manufacturing facilities. However, 50% was held by India, followed by China with 32%, the European Union with 10% and other countries with 4%. DMFs are submitted to the FDA by companies that supply drug ingredients to another company. They are confidential and do not contain any proprietary information. The USP cautioned that not all drugs are made with APIs that reference DMFs and that the proportion of DMFs is not necessarily indicative of a country or region’s total production. However, USP claimed that geographical analysis of DMFs could shed light on global manufacturing trends. Looking at total active DMFs, India remains the global leader at 48%, followed by the EU at 17%, China at 16% and the US at 9%.