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Tuesday, January 4, 2022

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

Kroger and Walmart hike the price of COVID-19 home tests

 Not only are home coronavirus test kits increasingly hard to find, they're also becoming more expensive. 

Retailers Kroger and Walmart are raising prices on scarce over-the-counter rapid COVID-19 tests after both companies fulfilled pledges to offer Abbott Laboratories' kits to consumers at cost for 100 days, forgoing any profits during the initial sales period.

In 2021, Kroger, Walmart and Amazon agreed to sell the tests at cost or at a discount of up to 35% for three months in an effort to expand testing options for Americans. Without the retailer markups, the kits sold through select retail outlets and containing two tests cost consumers $14.

But that deal, which had been trumpeted by the White House, is now over. A spokesperson for Kroger told CBS MoneyWatch that the supermarket chain had fulfilled its commitment to the Biden administration to make home COVID-19 tests available at cost. saying that the "pricing program has now phased out and retail pricing has been reinstated." 

Abbott's Binax Now at-home COVID-19 test kit, one of the most popular varieties, is now available in Kroger stores with pharmacies for $23.99. It is out of stock on Kroger's website amid surging demand for rapid, or antigen, self-test kits. Kroger sells Quidel's QuickVue test in the supermarket chain's nonpharmacy stores,, according to the company spokesperson. 

Walmart did not immediately reply to CBS MoneyWatch's request for comment. The retail giant's Binax Now test kits, which are also sold out online, are listed for sale on its website for $19.88. 

Other retailers had already been selling the kits at higher prices, never having struck deals with the White House. Despite those costs, many consumers are buying the kits amid record numbers of COVID-19 cases driven by the Omicron variant

Pharmacy chain CVS Health, for example, has been selling the tests for $23.99 a box and is also sold out online. Customers have come up empty-handed in stores, as well. 

NowInstock.net, a service that tracks the availability of products, indicates that at-home rapid COVID-19 tests are nearly completely sold out online. In some cases, kits are available for pre-order.

One bright spot: Intrivo Diagnostics' On/Go rapid self-test kit, which works similarly to the BinaxNow product, is in stock at Walmart.com. It retails for $29.99 for a box of two kits. It's also available from a less obvious source — health care company Ro, which is better known for solving mens' health care needs like hair loss and erectile dysfunction. 

Ro co-founder and CEO Zachariah Reitano said the test kits were among the company's three most sought after products over the holidays. 

"Our patients kept asking for tests, and we partnered with the makers of the On/Go test to provide them," he told CBS MoneyWatch this week. "They have been investing tremendously in manufacturing capacity even as cases have ebbed and flowed in the potential case where there was a far more contagious variant that spread quickly."

https://www.cbsnews.com/news/kroger-walmart-hike-prices-on-covid-19-home-tests/

HCA Buys MD Now Urgent Care With 59 Locations in Florida

 HCA Healthcare, Inc. (NYSE: HCA), one of the nation’s leading healthcare providers, today announced it has purchased MD Now Urgent Care, a network of 59 urgent care centers in Florida.

The transaction significantly expands HCA Healthcare’s reach as one of the nation’s leading providers of urgent care, currently operating more than 170 clinics across 19 markets. MD Now is the largest urgent care provider in Florida.

"The addition of MD Now Urgent Care in Florida enhances our already strong capabilities in a rapidly growing state by providing convenient outpatient care options for our patients," said Sam Hazen, HCA Healthcare’s chief executive officer. "It also connects MD Now patients to a comprehensive statewide network of care, including acute care and specialty services should they be needed."

The acquisition of these MD Now centers, combined with the November announcement of HCA Healthcare’s plans to build three additional hospitals in the state, will enhance HCA Florida Healthcare’s ability to offer patient-centered, high-quality care to more Floridians and meet the growing need for healthcare services in the state. HCA Florida Healthcare currently serves 6.4 million patients each year at more than 400 affiliated sites of care across Florida.

HCA Florida Healthcare has a long history of investing in Florida, including a major capital investment initiative of approximately $3 billion spent over the last three years. This includes the $360 million HCA Florida University Hospital and existing facility renovations across the state to accommodate new, advanced equipment. As a tax-paying entity, HCA Florida Healthcare has also supported local communities with more than $957 million in state taxes over the past three years.

The transaction was completed at the end of 2021. The terms of the transaction were not disclosed.

https://finance.yahoo.com/news/hca-healthcare-purchases-md-now-133000569.html

Inspire Medical cut to Neutral by B of A

 From Buy

https://finviz.com/quote.ashx?t=insp