DIANT Pharma's continuous nanoparticle manufacturing technology, licensed from the University of Connecticut, creates uniform nanoparticles, and the technology can reduce the size of the clean room substantially from what's needed for batch manufacturing. The modular process makes it easy for manufacturers to move production elsewhere if problems occur, and it could be useful for manufacturing COVID-19 vaccines and others based on emerging mRNA lipid nanoparticle technology.
Leaders who took part in the G20 summit last week promised to make sure that COVID-19 drugs, vaccines and tests are fairly distributed and made affordable for low-income countries. They also said in a statement that they would support the Access to COVID-19 Tools Accelerator as well as its COVAX facility for the distribution of vaccines.
Increased antimicrobial resistance is "one of the greatest health threats of our time," according to World Health Organization Director-General Tedros Adhanom Ghebreyesus. A group to be known as the One Health Global Leaders Group on Antimicrobial Resistance has been established to bring together government heads, CEOs and civil leaders to address antimicrobial resistance.
The FDA's decision to no longer require premarket review for laboratory developed tests has raised concerns regarding oversight of all LDTs in the future. "The notice doesn't say FDA can't regulate LDTs; it just says the agency can't do it without formal rulemaking. It gives labs a bit of a breather," said Patricia Jones, chair of AACC's Policy and External Affairs Committee and clinical director of the chemistry and metabolic disease lab at Children's Medical Center of Dallas.
Moncef Slaoui, chief scientific adviser for the administration's Operation Warp Speed initiative, expects the FDA to grant emergency use approval to Pfizer and BioNTech's COVID-19 vaccine after advisers meet to look at the data on Dec. 10, and he said vaccine shipments to states would start within 24 hours, allowing the first doses to be administered within days. The CDC and a panel of advisers will recommend who should get the initial doses -- likely health care workers and individuals at highest risk of serious illness and death, Slaoui said.
The FDA has granted emergency use authorization to Regeneron Pharmaceuticals' antibody cocktail composed of casirivimab and imdevimab to be used as treatment for mild to moderate COVID-19 in adults, as well as for children at least 12 years old who are at increased risk of progressing to severe forms of the disease. Regeneron expects to have sufficient doses for about 80,000 patients by the end of this month, and enough for 300,000 patients by the end of January.
ViiV Healthcare, a GlaxoSmithKline subsidiary, announced that the FDA has granted its injectable cabotegravir breakthrough therapy designation to prevent HIV. The status was granted based on data from a Phase IIb/III trial that showed cabotegravir being 66% more effective than the oral combo of emtricitabine, tenofovir disoproxil fumarate for HIV prevention.
NASA is exploring ways to manufacture medicines on demand for astronauts on lengthy missions to the moon and Mars, and early research is using the soil bacterium Bacillus subtilis, whose spores can survive for up to six years in a space environment, as a platform. Pharmaceutical manufacturers looking for ways to develop orphan drugs and personalized medicines see an opportunity to learn from NASA's research, which also focuses on producing agents in small quantities on demand, says Lynn Rothschild, senior research scientist at NASA's Ames Research Center.
COVID-19 vaccine manufacturers are outsourcing to contract and development manufacturing organizations at an "unprecedented rate" according to a report by Fiona Barry of PharmSource. The trend is reflected in other reports, but many drug approvals in 2019 were initiated by companies valued at more than $200 billion, and most of those companies use in-house manufacturing rather than outsourcing, according to the Convention on Pharmaceutical Ingredients Annual Report.
Cybercriminals are targeting mobile devices as more employees of pharmaceutical companies are working from home during the pandemic, according to a study by mobile cybersecurity specialists Lookout. The attackers are delivering malware through phishing links and have the most success when spyware and surveillance are added to a device.
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