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Lab Sciences
Top stories summarized by our editors
7/2/2020

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.

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FiercePharma
7/2/2020

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.

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Regulatory Focus
7/2/2020

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.

6/30/2020

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.

6/30/2020

Luminex has submitted its xMAP SARS-CoV-2 Multi-Antigen IgG blood test to the FDA for emergency use authorization.

6/30/2020

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.

6/30/2020

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.

6/30/2020

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.

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Pharmacy Times online
6/30/2020

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.

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PharmExec
6/30/2020

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.

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University of Georgia