Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings, calls, and deadlines has, once again, returned. But what can you do? The world, such as it is, continues to spin. So why not give it a nudge in a better direction with a cup of stimulation. Our choice today is pistachio creme. Meanwhile, here are a few items of interest to help get you on your way. We hope today is manageable and productive. Best of luck, and keep in touch. …
GSK plans to depart the biotechnology industry’s largest trade group, the Biotechnology Innovation Organization, STAT writes. GSK is the fifth company to leave BIO in roughly a year, a group that includes Pfizer and UCB. The departures coincided with a drop in lobbying spending from the group and other challenges. The trade group laid off 30 employees, including several senior leaders, in a restructuring earlier this year and has had four chief executive officers over the past four years. The current head, John Crowley, a biotech executive and rare disease advocate, took over in March. GSK has spent slightly more on lobbying this year compared with 2023. The company spent $3.87 million in the first three quarters of 2024, compared with $3.63 million over the same period in 2023. The pharmaceutical industry is poised for an opportunity to tweak parts of the Medicare drug pricing negotiation law, after Republicans took control of the White House and Senate.
Companies in India, China, and Europe continue to play an outsized role in manufacturing active pharmaceutical ingredients used in products destined for the U.S. market, Regulatory Focus tells us, citing data from U.S. Pharmacopeia. Only 4% of the active APIs disclosed in Drug Master Files filed with the U.S. Food and Drug Administration in 2023 cited U.S. manufacturing facilities. However 50% were held by India, followed by China at 32%, the European Union at 10% and other countries at 4%. DMFs are submitted to the FDA by companies supplying drug ingredients to another company and are confidential and stripped of proprietary information. The USP cautioned that not all drug products are made with APIs referencing DMFs, and that the proportion of DMFs is not necessarily indicative of total output by a country or region. But USP maintained the geographical analysis of DMFs can shed light on global manufacturing trends. When looking at total active DMFs, India remains in the lead globally, with 48%, followed by the EU with 17%, China with 16%, and the U.S. with 9%.
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