Novartis is building a facility in Indianapolis that will manufacture Lutathera, a drug that treats neuroendocrine tumors, due to high demand for the radioligand drug. Other radiotherapies will be also made at the plant, which will be the second US facility for Novartis when it opens in 2023.
The FDA plans to move away from multiple PDFs for clinical trial safety data and will begin using digital submissions, says Meredith Chuk, acting associate director for safety at the FDA's Office of Oncologic Diseases. Calling the PDF system "extremely inefficient," Chuk says the new process will give regulators more insight into safety data.
US nonprofits are addressing high drug manufacturing costs and the reliance on Asia for active pharmaceutical ingredients. For example, the Medicines for All Institute developed a manufacturing process based on flow chemistry that can be used to make several medications, including lamivudine, a treatment for HIV/AIDS.
The CDC's COVIDView report showed the percentage of US fatalities attributed to flu, pneumonia or COVID-19 dropped for the ninth consecutive week to 6.9% for the week ending June 20, compared with 9.5% a week earlier. The overall COVID-19 hospitalization rate climbed to 98.4 per 100,000 people, while emergency and outpatient visits for COVID-19 symptoms remained stable in most regions, but rose in the Southeast, Southwest and South Central US.
Drug manufacturers and others in the health care industry and beyond are working together in new ways to support the fight against COVID-19. The US is working with private companies to expedite vaccine development, while some companies are joining together in large consortiums, such as a UK partnership created to manufacture 20,000 ventilators.
A team at Abo Akademi University in Finland used stencil printing to make an orodispersible disc for administration of the antipsychotic haloperidol, and the technique could be used to manufacture other drugs in niche doses or formulations, writes Henrika Wickstrom, a researcher on the project. Stencil printing is similar to the technique used by children in art projects, and while simple, it presents challenges with ink formulations and drying times, Wickstrom writes.
Artificial intelligence has myriad possibilities for pharmaceutical companies, such as predicting drug shortages and managing inventory, writes pharmacist Doug Zurawski, senior vice president of clinical strategy at Kit Check. Manufacturers can also zero in on the source of contamination leading to a drug recall, and they can use AI to locate and pull all recalled packages from the supply chain, Zurawski writes.
The FDA, the European Commission and the European Medicines Agency are working together to identify COVID-19 treatments and vaccines and are extending their collaboration to other regulators around the world through the International Coalition of Medicines Regulatory Authorities. Regulators are jointly determining data requirements for clinical trials by holding virtual meetings to expedite vaccine development.
University of Georgia researchers found warning signs that preceded a 1993 resurgence of malaria in Kenya by about 10 years, according to a study in the Royal Society journal Biology Letters. Researcher Mallory Harris said the tool could be useful for early detection of surges of an illness known to be circulating.
- Page 1