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...the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody...Although the FDA has previously issued EUAs to more than 50 antibody tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells...READ MORE

Despite APhA’s concerns that compliance with certain Drug Supply Chain Security Act requirements undermines pandemic response efforts, FDA has confirmed that “dispensers,” including pharmacies, must meet a requirement that goes into effect on November 27, 2020. APhA and pharmacy partners had requested that FDA delay enforcement of certain portions of the DSCSA—also known as “track and trace”—mandate...READ MORE

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies. The list will provide a basis for bolstering biopharmaceutical production at home of essential medicines and medical products and for addressing supply chain vulnerabilities...READ MORE

...the FBI and two federal agencies said they had credible information of “an increased and imminent cybercrime threat” to U.S. hospitals and health care providers. The alert said malicious groups are targeting the sector with attacks aiming for “data theft and disruption of healthcare services.”...It involves a particular strain of ransomware, which scrambles a target’s data into gibberish until they pay up. Previous such attacks on health care facilities have impeded care and, in one case in Germany, led to the death of a patient..Independent security experts say the ransomware, called Ryuk, has already impacted at least five U.S. hospitals this week and could potentially affect hundreds more. Four health care institutions have been reported hit by ransomware so far this week, three belonging to the St. Lawrence Health System in upstate New York and the Sky Lakes Medical Center in Klamath Falls, Oregon...READ MORE

Police in Oakland and other East Bay cities have been dealing with a rash of brazen robberies and other incidents since Tuesday night...Among those businesses hit, was Oakland's longtime High Street Pharmacy...It started with a blow torch at the back door of the 73-year-old pharmacy, as seen on the store's surveillance cameras. Several men show up just after 10:30 p.m., cut their way through a metal back door and then the marathon begins...For five hours, until after 3:30 in the morning, dozens of people run into the pharmacy, smashing computers, wrecking displays, stealing drugs and other merchandise and ransacking a business that..."We feel like we deserve a little bit better," said owner Gareen Avakian, who told us she's heard from neighbors who called 911 almost as soon as the brazen break-in began. An alarm company also apparently tried to call, but Oakland police didn't respond for five hours...READ MORE

...uninsured Nevadans can enroll for health coverage on the state-operated exchange, which this year features more carriers and plans...Insurance plans are available through online marketplace Nevada Health Link to those who don’t qualify for Medicaid or Medicare or don’t have insurance through an employer...“I don’t think that it comes as any surprise to anybody during this COVID era, there’s never been a more important time to connect to comprehensive health care,” Heather Korbulic, executive director of the Silver State Health Insurance Exchange, said...The 50 plans on the exchange, nearly twice as many as last year, cover COVID-19-related testing and diagnosis, she said. They are all so-called qualified health plans that encompass the 10 essential health benefits, including coverage of pre-existing conditions, mandated by the Affordable Care Act. Dental and vision plans also are available...READ MORE

Deaths after flu vaccination keep rising in South Korea. But as local health authorities work to calm concerned citizens by refuting a connection between the two, a fellow Asian country has taken the precautionary measure of suspending two shots given to people who later died...Singapore has temporarily pulled its backing for SK Bioscience’s SKYCellflu Quadrivalent and Sanofi Pasteur’s VaxigripTetra, the Ministry of Health said...READ MORE

In a first in the nation, Oregon has rejected charging drug users with criminal offenses, with voters passing a ballot measure that decriminalizes possession of heroin, methamphetamine, LSD, oxycodone and other hard drugs...“Today’s victory is a landmark declaration that the time has come to stop criminalizing people for drug use,” said Kassandra Frederique, executive director of the Drug Policy Alliance, which was behind the measure. “Measure 110 is arguably the biggest blow to the war on drugs to date.”...The measure completely changes how Oregon’s justice system treats those who are found with personal-use amounts of the hard drugs...READ MORE

The U.S. Department of Health and Human Services' Office for Civil Rights leveraged $1,000,000 in fines against Aetna Life Insurance Company and $202,400 against the city of New Haven, Connecticut, to settle potential HIPAA violations...The fines are just the latest moves on the part of OCR to enforce HIPAA regulations around protected health information..."When individuals contract for health insurance, they expect plans to keep their medical information safe from public exposure. Unfortunately, Aetna's failure to follow the HIPAA Rules resulted in three breaches in a six-month period, leading to this million dollar settlement," said OCR Director Roger Severino in a statement...READ MORE

Washington, Oregon and Nevada will join California to independently review any coronavirus vaccine before distributing it to the public...Gov. Gavin Newsom said Tuesday that the three states would identify their own public health experts to participate in the scientific review committee he announced last week, which was charged with ensuring that any vaccine approved by the U.S. Food and Drug Administration is safe and effective...California has also formed a second committee to develop guidelines for the ethical distribution of vaccines, Newsom said, addressing questions about who should receive the first doses and how to allocate potentially limited supplies...READ MORE