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4/3/2020

Julia Schaletzky, head of the Center for Emerging and Neglected Diseases at the University of California, Berkeley, was pushing the federal government to let academic research centers use the equipment they already have on hand to process COVID-19 tests at the same time CRISPR pioneer Jennifer Doudna was rallying her colleagues at Innovative Genomics Institute to take on the pandemic. IGI dismantled their lab, set up a COVID-19 testing lab, and established rapid-response research teams, and Berkeley's student health center extended its lab certification to a lab at IGI, which is scaling up to handle 3,000 tests a day.

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University of California
4/3/2020

Medical anthropologist Theresa MacPhail began displaying COVID-19 symptoms in early March and still has not recovered, but she has been unable to get tested. She became aware of the novel coronavirus in January and was confident that both the Chinese and US governments could contain the outbreak. MacPhail was in Hong Kong in 2009 during the H1N1 influenza epidemic, and she talks about what's different with the COVID-19 response.

4/3/2020

The guideline to stay at least six feet away from other people might not be enough to stop spreading SARS-CoV-2, says Lydia Bourouiba, an associate professor at the Massachusetts Institute of Technology, whose previous research on pathogen transmission found a sneeze can send droplets 23 to 27 feet through the air. Maintaining a distance greater than six feet would be wise in confined spaces, Bourouiba says.

4/3/2020

March 31 was Equal Pay Day, the day marking how many more days women have to work this year to make the income men made last year, writes Lilly Ledbetter, the plaintiff in a Supreme Court discrimination case 13 years ago. "The Covid-19 pandemic has suddenly exposed the brutal economic reality of low-paid women workers who are on the frontlines of this crisis -- and I feel an increased sense of urgency to close the wage gap that continues to shortchange them when they can least afford it," Ledbetter writes.

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CNN
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Supreme Court
4/3/2020

Physician and pharmacy advocates sent a letter to the the Drug Enforcement Administration urging the agency to increase production limits of injectable fentanyl, hydromorphone, morphine and other narcotics used for COVID-19 patients on ventilators to ensure hospitals have enough supplies during the pandemic. A senior DEA official said the agency is closely monitoring the situation and has been discussing measures it could implement to accelerate a quota increase if necessary, though the agency believes the current limit is high enough for companies to meet the surge in demand.

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Reuters
4/3/2020

Pfizer has received a warning letter from the FDA for its sterile injectables plant in Visakhapatnam, India. The facility's quality system does not ensure the "safety, effectiveness and quality of the sterile drugs" being shipped to the US, the letter states.

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FiercePharma
4/3/2020

The FDA is advising that it has not issued an emergency use authorization to a company called Bodysphere for a COVID-19 test despite false statements from the company that were distributed in the media. The agency is also warning people to be cautious of false coronavirus tests, drugs and devices.

4/3/2020

An FDA official said the agency will now permit imports of KN95 masks, described as the Chinese version of an N95 mask, due to the scarce supply of personal protective equipment in the US. The FDA said it's "ready and available to engage with importers to minimize disruptions during the importing process," but it noted importers may want to verify the authenticity of the masks.

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The Hill
4/3/2020

The FDA has given emergency use authorization to Cellex's SARS-CoV-2 serology test, which can deliver results within 15 minutes.

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Regulatory Focus
4/3/2020

ApiFix has been acquired by OrthoPediatrics, expanding the latter's spinal deformity portfolio with ApiFix's Minimally Invasive Deformity Correction System, a non-fusion treatment for idiopathic scoliosis in adolescents. The deal's terms include a cash payment of $2 million at closing, 934,768 OrthoPediatrics common stock shares, an earnout over four years and milestone payments.

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Becker's Spine Review