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Tuesday, January 4, 2022

Biden: 'Schools should stay open despite omicron wave'


President Biden on Tuesday reiterated his belief that schools in the United States should remain physically open despite the wave of coronavirus cases driven largely by the omicron variant.

Biden noted during remarks at the White House that his $1.9 trillion coronavirus relief plan included billions of dollars to help support school reopenings during the coronavirus pandemic.

“We have no reason to think at this point that omicron is worse for children than previous variants. We know that our kids can be safe when in school by the way. That’s why I believe schools should remain open. They have what they need,” Biden said before a briefing with his COVID-19 response team.

Biden said that $130 billion from the coronavirus relief law passed in March went toward reopening schools and an additional $10 billion was allotted for COVID-19 testing in schools. 

“That money went out to the states and the states and the school districts have spent this money well, many of them, but unfortunately some of them haven’t,” Biden said. “So, I encourage the states and school districts to use the funding that you still have to protect your children and keep the schools open.” 

Biden’s remarks were consistent with his past statements that schools should remain open. The White House has touted the progress on school reopenings in Biden’s first year, distributing a memo to Democrats at the end of last year noting that 99 percent of schools were open compared with 46 percent when Biden took office. 

Republicans have tried to make school reopenings a political issue, arguing that Democrats are siding with teachers unions and support closing schools during the pandemic. 

Some schools have decided to revert to remote learning for periods of time as cases surge around the country, including districts in Wisconsin, Michigan and Ohio. 

Meanwhile, New York City Mayor Eric Adams (D) stood firm in plans to reopen schools in the new year, rejecting a bid from the city’s biggest teacher union to change temporarily to virtual learning.

White House press secretary Jen Psaki similarly highlighted the funding in Biden’s coronavirus relief law for school reopenings and urged schools and states that have not yet tapped into that funding to do so immediately. 

“Ninety-seven percent of schools are open across the country and the president wants schools to be open,” Psaki told reporters at a briefing following Biden’s remarks.  “If states have not used it, and some have not, and if school districts have not used it, now is the time to use it.”

https://thehill.com/homenews/administration/588237-biden-schools-should-stay-open

CDC doubles down on isolation guidance, rejects more testing

 The Centers for Disease Control and Prevention (CDC) on Tuesday did not formally recommend a negative COVID-19 test for a person to leave isolation after being infected and instead merely clarified that for anyone who has access to a test and wants to take it, a rapid antigen test at the end of the isolation period is best.

The agency essentially doubled down on its earlier guidance, released last week, that said people infected with COVID-19 can leave isolation and go back to work after five days if they are asymptomatic or if their symptoms are improving and they wear a mask for five days.

The CDC also recommended that anyone who is not fully vaccinated and boosted should quarantine for 10 days if exposed to someone who was infected. 

After the guidelines were released, the CDC faced a wave of criticism from health experts who said they were concerned that without a testing aspect, people would leave isolation while still contagious.

Top administration health officials, including White House chief medical adviser Anthony Fauci, have hinted in recent days that the guidance could be updated to include a testing component. 

But on Tuesday, the CDC said a test was merely an option if someone wanted to take one, as the value of a test toward the end of the five-day period is uncertain.

"Accumulating evidence demonstrates the majority of transmission occurs during the early periods of infection," the CDC said, adding that coronavirus tests are not authorized by the Food and Drug Administration to evaluate the duration of infectiousness. 

"A negative antigen test does not necessarily indicate the absence of transmissible virus," the CDC said, which is why people should continue to wear masks even after leaving isolation.

"If your test result is positive, you should continue to isolate until day 10. If your test result is negative, you can end isolation, but continue to wear a well-fitting mask around others at home and in public until day 10," the agency said. 

Some experts have speculated that the CDC didn’t include a testing requirement because of the current shortage of rapid tests. In many places, at-home tests are difficult or impossible to find, and even if they are available, the prices are high. 

The CDC did not officially address the availability of tests. But in explaining why officials decided to shorten the isolation period, the agency said it took into account the "societal impact" from a large number of cases. 

"Spread of the Omicron variant has the potential to worsen staffing shortages and increase supply chain challenges, which jeopardize industry, education and other systems that are essential to maintain a functioning society and economy," the CDC said.

Additionally, the agency cited challenges in people staying self-isolated and quarantined for the full period. 

"Studies suggest that only a small percentage of people (25-30%) isolate for a full 10 days," the CDC said.

https://thehill.com/policy/healthcare/588260-cdc-doubles-down-on-isolation-guidance-rejects-more-testing

Shares in COVID-19 vaccine developer Valneva drop sharply

 Shares in biotech company Valneva VLS.PA were suspended briefly on the Paris stock market on Tuesday after dropping sharply.

Valneva's share price has fluctuated in the past few weeks on news about the company's COVID-19 vaccine candidate. It is awaiting regulatory approval of the shot in the European Union and Britain.

Valneva shares recorded a drop of 23% on Tuesday afternoon before trading was suspended. Trading resumed later and by 1620 GMT the stock was down 23.4%.

At their lowest point on Tuesday, Valneva shares were trading at 17.17 euros ($19.38), the lowest since October last year.

It was not immediately clear what caused the stock to fall on Tuesday. Shares in COVID-19 vaccine makers Moderna MRNA.O, Pfizer PFE.N and GlaxoSmithKline GSK.L also fell on Tuesday, but those drops were in low single figures.

https://www.nasdaq.com/articles/shares-in-covid-19-vaccine-developer-valneva-drop-sharply

Plus Hits Two Milestones To Manufacture Its Lead Radiotherapeutic

 Plus Therapeutics Inc (NASDAQ: PSTV) has met two significant milestones as it progresses toward cGMP manufacture of Rhenium-186 NanoLiposome (186RNL).

  • The Company has entered into a master services agreement (MSA) with IsoTherapeutics Group LLC to develop, manufacture, and supply Rhenium-186 isotope for its 186RNL investigational radiotherapeutic.

  • The agreement will help ensure Rhenium-186 meets FDA requirements for use in late-stage clinical trials.

  • Under the MSA, IsoTherapeutics will develop a synthesis process and in-process manufacturing controls, test method development and validation, stability studies, and manufacture Rhenium-186.

  • Additionally, Plus Therapeutics completed the technology transfer of analytical test methods with Piramal Pharma Solutions (PPS) for 186RNL drug product intermediate.

  • As previously disclosed, Plus Therapeutics entered into an MSA with PPS in early 2021 to develop, manufacture, and supply Plus Therapeutics' 186RNL intermediate drug product.

NLS Pharma Gets US Patent for ADHD Med Extended-Release Formulation

 

  • Key patent now granted in major markets including the U.S., Europe, Canada & South Korea

  • Patent claims cover use of the Company's lead product candidate, Quilience® (mazindol ER) in both attention deficit hyperactivity disorder (ADHD) & narcolepsy

Hoth: Candidate Shows Positive Results - Reduce Amyloid β in Alzheimer's Disease

 Significant decrease in Aβ seen in an Alzheimer's disease mouse model after acute treatment with HT-ALZ, supporting that HT-ALZ has the potential to modify Aβ plaque formation in the brain

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced proof-of-concept data generated using an Alzheimer's disease mouse model, supporting the therapeutic potential of HT-ALZ. The research was conducted as part of the company's Sponsored Research Agreement with Washington University in St. LouisHT-ALZ is a therapeutic in development under the 505(b)(2) regulatory pathway for the treatment of dementia related to Alzheimer's disease (AD).

AD is a neurodegenerative disease that is characterized by aggregates of amyloid β (Aβ) plaques and neurofibrillary tangles of Tau protein in the brain, which contribute to the clinical symptoms of the disease such as dementia. The initial experiments, conducted by Carla Yuede, PhD, Associate Professor of Psychiatry, and John Cirrito, PhD, Associate Professor of Neurology, at Washington University School of Medicine, focused on investigating the effect of orally administered HT-ALZ to reduce the concentration of Aβ in the brain interstitial fluid, using an established Alzheimer's Disease mouse model (aged APP/PS1+/- mice). The initial data from these studies shows a significant decrease in Aβ in both male and female APP/PS1+/- mice after acute treatment with HT-ALZ, compared to placebo-treated animals and baseline Aβ levels, supporting that HT-ALZ has the potential to modify Aβ plaque formation in the brain and be developed as an AD therapeutic.

"The overall positive result from these studies is a first step but a big one in the development of HT-ALZ as an Alzheimer's therapeutic," said Stefanie Johns, Chief Scientific Officer of Hoth Therapeutics, Inc. "HT-ALZ is a unique therapeutic in the AD development space because it is eligible for streamlined development under the 505(b)(2) pathway, including available safety data. This allows Hoth to reach efficacy clinical trials faster and bring a new potential treatment for patients with Alzheimer's disease."

Nevro: UnitedHealthcare to Cover Diabetic Neuropathy Treatment

 Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that UnitedHealthcare, the largest private health insurance company in the United States, will provide coverage for the company's high-frequency 10 kHz Therapy for the treatment of PDN (Painful Diabetic Neuropathy) for dates of service on or after March 1, 2022. UnitedHealthcare is one of the businesses of UnitedHealth Group, a diversified health care company that provides coverage for more than 39 million commercial health care members.

https://finance.yahoo.com/news/nevro-announces-unitedhealthcare-coverage-high-120000359.html