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7/20/2021

The International Society for Pharmaceutical Engineering's UK affiliate is working with volunteer members of the IChemE COVID-19 Response Team on methods for reducing the risk of infection in workplace settings. A recent report highlighted the importance of adequate ventilation in buildings, transport systems and public spaces in controlling COVID-19.

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The Chemical Engineer
7/20/2021

The government of Alberta has promised around $14.6 million over three years to build a $39.3 million cyclotron and radiopharmaceuticals facility at the Foothills Medical Centre. Calgary Radiopharmaceutical Centre Director Ingrid Koslowsky says a local facility will reduce delays in patient care, and provincial leaders say it will also encourage research.

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CTV (Canada)
7/20/2021

Regeneron Pharmaceuticals is planning to invest about $1.8 billion at its Tarrytown, N.Y., campus to add up to eight buildings housing preclinical manufacturing and process development suites, laboratories and office space, along with parking garages and a utility plant. Regeneron expects to add 1,000 full-time employees over the next five years, and the two-phase project is slated for completion in 2027.

7/20/2021

The Coalition for Epidemic Preparedness Innovations will lead a new marketplace to match buyers and sellers of supplies for COVID-19 vaccine production, such as filters, bioreactor bags, lipids and vials. "What we're actually seeing is manufacturers unable to deliver the vaccines that they were promising just because of one small thing like a filter," said CEPI Director of Vaccine Research and Development Melanie Saville.

7/20/2021

The Pharmaceutical Inspection Co-operation Scheme's updated guidance on risk-based change management for pharmaceutical quality systems includes a checklist of life cycle stages where change can be expected, and adherence to the guidance "should provide sufficient evidence of an effective science and risk-based change management system," according to the organization. A COVID-19 risk assessment guidance document for on-site inspections says risk assessments should be performed while planning for the inspection and urges inspectors to follow protocols for reducing exposure.

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Regulatory Focus
7/20/2021

Innoveix Pharmaceuticals voluntarily recalled compounded injectable sermorelin/ipamorelin 3 mg and injectable AOD-9604 3 mg because they might not be sterile. The drugs were distributed in glass vials to customers and medical facilities nationwide.

7/20/2021

The AACC, together with laboratory professionals, has released a document on the clinical recommendations and interpretation of emergency-use authorization and laboratory developed test serologic testing for COVID-19, which is available in Clinical Chemistry with a more in-depth version on the AACC website. The published document includes information on different assays and verification and validation of EUA tests and LDTs and will serve as a reference "to appropriately implement these assays in the clinical laboratory and interpret the results to serve their patient needs during this pandemic," said lead author Y. Victoria Zhang.

7/20/2021

Scientists from Flinders University in Australia have developed a genetics-based blood test that can identify individuals who are at high risk of developing glaucoma.

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Daily Mail (London)
7/20/2021

By 2030, CMS plans to end coinsurance for Medicare beneficiaries who undergo a colorectal cancer screening that becomes a diagnostic test. CRC screenings become diagnostic tests when a gastroenterologist identifies a polyp for removal.

7/19/2021

The FDA could grant emergency use authorization for COVID-19 vaccines among children younger than 12 by early to midwinter, according to an agency official. The agency is requiring four to six months of follow-up safety data for the age group, compared with two months of follow-up data for adults, the source said.

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NBC News