Author: Peter

Pfizer announced positive early results from its coronavirus vaccine trial, cementing the lead in a frenzied global race that has unfolded at record-breaking speed...Pfizer, which developed the vaccine with the German drugmaker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts...The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said...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

Development on the new UNLV Medical School building officially began...months ahead of schedule and still without originally earmarked monies from the state pulled due to budget cuts driven by the coronavirus pandemic...Maureen Schafer, the CEO of Nevada Health and Bioscience Corporation, said the developers are still in conversation with the governor’s office and the Legislature about making up the funding stream...“The way we look at this is, we as a development corporation made a commitment to the community, so we’re breaking ground, we’re going to move forward, because the care can’t stop,” Schafer said...READ MORE

...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

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

GlaxoSmithKline is committing to a new environmental plan with two ambitions: eliminate its impact on climate change and neutralize its impact on nature by 2030...In environmental parlance, the goal is a net zero impact on climate change and a net positive impact on nature by the end of the decade...The twofold approach means GSK will reduce its environmental footprint as much as possible—and where it can’t reduce, implement restoration programs—while also contributing more to nature than it takes out...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