All articles tagged with #drug manufacturing
ProPublica developed Rx Inspector, a tool that links generic drugs to their manufacturing facilities and FDA inspection histories, aiming to improve transparency and inform consumers and healthcare providers about drug safety and manufacturing practices.
President Trump announced new 100% tariffs on branded or patented pharmaceutical imports to the US starting October 2025, with exemptions for generics and companies building US factories. The move aims to boost domestic drug production but could increase costs, disrupt supply chains, and impact global trade, especially for EU and Asian exporters. US consumers are likely to face higher drug prices, and the overall industry may see significant shifts depending on how the exemptions are implemented.
Eli Lilly plans to build a $5 billion drug manufacturing plant near Richmond, Virginia, creating 650 jobs as part of its strategy to expand domestic pharmaceutical production.
The FDA announced the new PreCheck program to enhance U.S. drug manufacturing by streamlining regulatory processes and encouraging domestic production, aiming to reduce reliance on overseas sources for pharmaceuticals and active ingredients, with a public meeting scheduled for September 30, 2025.
AstraZeneca pledges to invest $50 billion in the US by 2030 to expand manufacturing and research, including a major facility in Virginia, as a response to potential US tariffs on pharmaceuticals, aiming to increase its US market share and support job creation.
Researchers developed AshPhos, a cost-effective and efficient ligand that simplifies the formation of carbon-nitrogen bonds crucial for many medicines, potentially reducing drug production costs and environmental impact, with promising applications in pharmaceuticals and clean energy.
A 23-year-old New York scientist, Matthew Leshinsky, has pleaded guilty to charges related to operating a "Breaking Bad"-style meth lab after mistakenly calling the police on himself when he reported a burglary at his business, which led to the discovery of the lab. Police found a clandestine laboratory involved in the production of methamphetamine and other controlled substances, resulting in Leshinsky pleading guilty to 13 charges. Despite his attorney's claim that he was analyzing drug addiction for the public good, Leshinsky is due for sentencing in March.
Varda Space Industries has finally received approval to bring its drug manufacturing spacecraft, Winnebago capsule, back to Earth after being stuck in orbit for months. The capsule contains pharmaceutical crystals of the drug Ritonavir, used to treat HIV/AIDS, manufactured on orbit. The landing attempt is scheduled for February 21 at the Air Force’s Utah Test and Training Range, marking the first time the FAA has licensed a commercial company to land a spacecraft on U.S. soil. Varda aims to exploit microgravity for manufacturing materials and plans to bring spacecraft containing manufactured materials back to Earth monthly by 2026.
The ongoing nationwide shortage of ADHD medications like Vyvanse, Adderall, and Ritalin is causing significant strain on patients and their families. The shortage, which has been ongoing for over a year, has made it difficult for individuals with ADHD to access the medications they rely on to manage their symptoms. The demand for stimulant medications has increased during the pandemic, but manufacturers have not been able to keep up. This shortage has led to disruptions in daily routines, difficulties in focusing and completing tasks, and emotional regulation issues for those affected. The lack of transparency in drug manufacturing and limited visibility into production quantities has made it challenging to address the shortage effectively.
Varda Space, the off-Earth drug manufacturer, has postponed its plans to bring its spacecraft, which is being used to develop pharmaceuticals in space, back to Earth. The US Air Force (USAF) denied Varda's request to land its module on a training area in Utah due to safety concerns, while the Federal Aviation Administration (FAA) rejected Varda's reentry application for failing to comply with regulatory requirements. Varda has requested a reconsideration from the FAA. The spacecraft, which has been in space since June, aims to utilize microgravity to manufacture drugs differently.
Afghanistan has become the world's fastest-growing producer of methamphetamine, according to a report from the United Nations drug agency. Despite the Taliban's ban on narcotics, the country's meth production has surged, posing a significant threat to national and regional health and security. Meth in Afghanistan is primarily made from legally available substances or extracted from the ephedra plant, which grows in the wild. The rise in meth seizures within the country suggests increased production, but the exact value and domestic usage of Afghanistan's meth supply remain unknown. Meth production in Afghanistan offers advantages over heroin or cocaine production, as it does not require land and can be conducted in mobile and hidden labs. The Taliban claims to have taken measures to crack down on drug activities, but the impact on meth supplies is yet to be assessed. The country's economic downturn, along with drought and other hardships, has driven people into poverty, hunger, and addiction.
A survey conducted by the American Society of Health-System Pharmacists (ASHP) reveals that nearly all hospital pharmacists in the United States are experiencing drug shortages, with about a third describing the impact as "critical." The shortages, which are nearing record levels, have led to rationing, delays, and cancellations of treatments or procedures. Chemotherapy drugs are among the most affected, with 57% of pharmacists stating that the shortages have direct effects on patient care. The survey highlights the need for proactive strategies to address the shortage, including penalties for manufacturers without risk strategies and diversifying the manufacturing supply chain. Pharmacists also expressed willingness to spend more on drug products from manufacturers with recognized quality programs.
Most of the damage caused by a tornado at a Pfizer plant in North Carolina was to a warehouse facility, rather than the areas that produce medicines, according to the drug giant. The plant, which supplies 8% of all sterile injectable medicines used in US hospitals, remains closed while damage is assessed. Pfizer is working to restore full function to the site and minimize supply disruptions, with plans to move products to other nearby sites for storage and explore alternative manufacturing locations. The FDA does not expect immediate significant impacts on supply, but experts are concerned about exacerbating the existing crisis in access to medicines in the US.
Pfizer's drug manufacturing plant in Rocky Mount, North Carolina, has reportedly not suffered major damage to its drug manufacturing areas after being hit by a tornado. The facility supplies nearly 8% of all sterile injectable medicines used in U.S. hospitals and manufactures about 25% of Pfizer's sterile injectables. While a warehouse facility storing raw materials and finished medicines was primarily damaged, it is unclear if this will lead to new drug shortages. The plant is currently closed as authorities assess the damage, and Pfizer is working to move medicine products to nearby sites for storage and identify alternative manufacturing locations.
The US Food and Drug Administration (FDA) rejected Regeneron Pharmaceuticals' application for a stronger formulation of its eye medicine Eylea due to ongoing inspection findings at a Catalent Inc. production facility in Bloomington, Indiana. Catalent confirmed that its facility was the one in question and stated that it is taking the observations seriously and working on proposed corrective actions. This is the latest setback for Catalent, which has faced previous inspection-related issues impacting the supply of Moderna's Covid booster shot and Novo Nordisk's weight-loss drug Wegovy. The delay in approval could be costly for Regeneron, as it faces potential competition from cheaper versions of Eylea next year.