Supreme Court Rejects Claim From DaVita Inc. About Low Reimbursement Rates

 The Supreme Court released a decision Tuesday morning that involves Denver-based DaVita Inc., one of the nation’s largest providers of dialysis. It involved a technical dispute about health insurance reimbursements for kidney dialysis.

The court rejected a claim from the company that the insurer’s low reimbursement rates violated federal law.

In a technical dispute about health insurance reimbursements for kidney dialysis, the Supreme Court sides with a health insurer, rejecting a claim from DaVita Inc. (one of the nation's largest providers of dialysis) that the insurer's low reimbursement rates violated federal law.

— SCOTUSblog (@SCOTUSblog) June 21, 2022

The opinion from Brett Kavanaugh in Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita can be read here: https://supremecourt.gov/opinions/21pdf/20-1641_3314.pdf. Justice Kagan, joined by Justice Sotomayor, dissents in part.

https://denver.cbslocal.com/2022/06/21/supreme-court-rejects-davita-health-insurance-reimbursement/

Nuvectis: FDA Clears IND for cancer candidate

 Nuvectis Pharma, Inc. (“Nuvectis”, “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (“FDA”) cleared the Company's Investigational New Drug Application (“IND”) for NXP800, which includes the Phase 1 clinical trial protocol. The NXP800 Phase 1 clinical trial is comprised of two parts, a dose escalation study (“Phase 1a”) to be followed by an expansion study (“Phase 1b”). The Phase 1a is currently ongoing in the United Kingdom (“U.K.”) and, with the IND in effect, U.S. clinical sites will now be included. The Company expects to initiate the Phase 1b study in early 2023.

Nuvectis licensed exclusive world-wide rights to NXP800, a novel, oral Heat Shock Factor 1 (“HSF1”) pathway inhibitor, which was discovered at the Institute of Cancer Research in London, England. The HSF1 pathway is implicated in cancer cell growth, metastasis, and survival across several types of cancer. In preclinical studies, NXP800 demonstrated potent anti-proliferative activity against a variety of cancer cell lines, and inhibited tumor growth in ARID1A-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma human xenograft models. Nuvectis is conducting further in vivo studies to evaluate the potential use of NXP800 in additional tumor types, including gastric, liver and esophageal cancers, with and without mutations in ARID1a and other biomarkers.

https://finance.yahoo.com/news/nuvectis-pharma-announces-fda-clearance-121500155.html

Convey To Be Taken Private By TPG

 Convey Health Solutions Holdings, Inc. (NYSE: CNVY) ("Convey"), a leading healthcare technology and services company, announced today that it has entered into a definitive merger agreement pursuant to which TPG Capital, the private equity platform of global alternative asset management firm TPG ("TPG") and Convey's principal shareholder, will acquire all of the outstanding shares of Convey common stock not currently owned by TPG or certain management and director shareholders for $10.50 per share in cash, representing an enterprise value of approximately $1.1 billion.

The purchase price represents a premium of approximately 99% over Convey's 30-day volume weighted average price per share as of June 17, 2022, and a premium of approximately 143% to the closing price of Convey common stock on June 17, 2022, the last trading day prior to public disclosure of the transaction.

A special committee (the "Special Committee") of the Board of Directors of Convey (the "Board"), comprised solely of independent directors and advised by its own independent legal and financial advisors, unanimously recommended that the Board approve the transaction and determined it was in the best interests of Convey and its shareholders that are not affiliated with TPG or such management and director shareholders. Acting upon the recommendation of the Special Committee, the Board approved the transaction.

"We believe this transaction provides substantial value, liquidity and certainty for our shareholders. Going forward, as a private company and with TPG's support, we will have the ability to continue to make investments in the company and better serve our customers," said Stephen Farrell, CEO of Convey.

"Convey is a leading, integrated payor technology platform that enables efficiency and improves clinical and financial outcomes across the healthcare system. We look forward to continuing our partnership in its next chapter as a private company," said Katherine Wood, Partner at TPG.

https://finance.yahoo.com/news/convey-taken-private-tpg-110000829.html

Midatech Announces MTX110 Development for Treatment of Glioma

 Midatech Pharma PLC (AIM:MTPH.L)(Nasdaq:MTP), an R&D biotechnology company focused on improving the bio-delivery and biodistribution of medicines, is pleased to announce that following the submission of an application to the European Medicines Agency ("EMA"), its development programme of MTX110 for the treatment of glioma has been granted Orphan Medicinal Product designation by the agency.

Midatech has been developing MTX110 for the treatment of recurrent glioblastoma ("rGBM") in adult patients and diffuse intrinsic pontine glioma ("DIPG") and medulloblastoma in paediatric patients.

Orphan designation is granted by the EMA to medicines that meet pre-specified criteria, including treatment of a life-threatening condition and prevalence of no more than 5 in 10,000 in the EU. The designation is intended to offer a range of incentives that facilitate development of the medicine, such as protocol development assistance, reduction in fees and market exclusivity upon successful approval of the drug.

https://www.biospace.com/article/releases/midatech-pharma-plc-announces-mtx110-development-for-the-treatment-of-glioma/

AstraZeneca, Ionis eye U.S. approval after positive trial data

  interim analysis of AstraZeneca and partner Ionis Pharmaceuticals' eplontersen showed the experimental drug met the main goals in a late-stage trial in patients with a rare, fatal disease, the Anglo-Swedish drugmaker said on Tuesday.

Based on the results, the companies plan to file an application to market the therapy in the United States later this year in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN).

The disease - which affects an estimated 40,000 patients globally - leads to peripheral nerve damage with motor disability within five years of diagnosis and, without treatment, is generally fatal within a decade, according to AstraZeneca.

The drug is designed to reduce the production of transthyretin, or TTR protein. Curbing TTR limits the accumulation of amyloid deposits in peripheral nerves and various organs that causes them to function abnormally.

In a separate late-stage study, eplontersen also being tested for use in amyloid transthyretin cardiomyopathy (ATTR-CM), which is a progressive condition that leads to progressive heart failure and death within four years from diagnosis.

There are an estimated 300,000 to 500,000 patients with the condition worldwide, AstraZeneca said.

The Cambridge, UK-based company agreed to pay California-based Ionis $200 million up front, with up to $485 million in conditional payments following regulatory approvals as well as up to $2.9 billion in sales-related milestone payments in a deal to jointly develop and commercialise the drug last year.

A handful of companies are focused on the lucrative field of ATTR. Alnylam Pharmaceuticals secured the first U.S. approval for an ATTR therapy when it brought Onpattro to the market in 2018.

Pfizer also has a pair of ATTR cardiomyopathy therapies - branded Vyndaqel and Vyndamax - that raked in more than $2 billion in total sales last year, including $909 million generated in the United States.

In 2021, Novo Nordisk also agreed to acquire Prothena Corp's experimental ATTR cardiomyopathy drug in a deal that could be worth up to $1.23 billion.

https://finance.yahoo.com/news/1-astrazeneca-ionis-eye-u-090249684.html

WHO's Tedros Privately Admits Lab Leak 'Most Likely Explanation' For COVID-19

 The head of the World Health Organization, Tedros Adhanom Ghebreyesus, who spent the early months of the pandemic publicly kowtowing to China, has privately admitted that he thinks Covid-19 escaped from a Chinese laboratory in a "catastrophic accident," according to the Daily Mail, citing a senior Government source.

Tedros Adhanom Ghebreyesus, director-general of the World Health Organisation (WHO), had recently confided to a senior European politician that the most likely explanation was a catastrophic accident at a laboratory in Wuhan, where infections first spread during late 2019.

The Mail on Sunday first revealed concerns within Western intelligence services about the Wuhan Institute of Virology, where scientists were manipulating coronaviruses sampled from bats in caves nearly 1,000 miles away – the same caves where Covid-19 is suspected to have originated – in April 2020. The worldwide death toll from the Covid pandemic is now estimated to have hit more than 18 million. -Daily Mail

The WHO came under heavy fire early into the pandemic for praising China's "transparent" response to the pandemic, repeating misinformation from Beijing about human-to-human transmission, and bowing to pressure from Chinese President Xi Jinping not to declare the Covid-19 outbreak an emergency.

Yet, while initially promoting the natural origin theory, Tedros and the WHO have become far more 'open' to the lab leak theory - despite officially being on the fence, unlike Tedros.

"We do not yet have the answers as to where it came from or how it entered the human population," Tedros told EU member states this month, adding "Understanding the origins of the virus is very important scientifically to prevent future epidemics and pandemics."

"But morally, we also owe it to all those who have suffered and died and their families. The longer it takes, the harder it becomes. We need to speed up and act with a sense of urgency."

"All hypotheses must remain on the table until we have evidence that enables us to rule certain hypotheses in or out. This makes it all the more urgent that this scientific work be kept separate from politics. The way to prevent politicisation is for countries to share data and samples with transparency and without interference from any government. The only way this scientific work can progress successfully is with full collaboration from all countries, including China, where the first cases of SARS-CoV-2 were reported." -Tedros Adhanom Ghebreyesus

Notably, China initially resisted a WHO probe into the origins of SARS-CoV-2 - however highly conflicted point-man and Wuhan collaborator Peter Daszak spearheaded a Beijing-friendly report that concluded the virus was likely passed to humans through animal intermediaries.

Yet, after 14 nations criticized the report, including the UK, US, and Australia, Tedros admitted the report was flawed and ordered another investigation, sans Daszak, which the NIH funded to literally enhance bat covid to be more transmissible to humans, in the town where Covid first appeared, working with China's "bat lady" who was doing the same types of risky experiments.

https://www.zerohedge.com/covid-19/who-tedros-privately-admits-lab-leak-most-likely-explanation-covid-19

Hospitals implore Congress to punt Medicare payment cut slated for July

 The American Hospital Association (AHA) penned a last-ditch letter to congressional leaders pleading for Medicare sequester cuts slated to take effect July 1 to be halted in light of the financial strain many of the nation’s hospitals are expected to face throughout 2022.

Congress had initially paused the 2% payment cut as part of the CARES Act when the COVID-19 pandemic began to threaten providers’ bottom lines. Sequestration cuts were continually punted downfield until last December, when a bill was signed to resume a 1% cut in April and the full 2% in July.

With half a month to go, AHA Executive Vice President Stacey Hughes warned majority and minority leaders Tuesday that financial relief from the pending cut is necessary for hospitals “to maintain access to care for the patients and communities they serve.”

Providers are still under the pressure of COVID-19 with higher expenses tied to labor costs and supply chain issues, Hughes wrote. Hospitals are also unable to absorb or deflect “historic inflation levels” as most of their payments come from Medicare and Medicaid’s nonnegotiable, fixed reimbursement rates, she said.

“All these factors have led to a historically poor first quarter financially for hospitals and health systems this year,” Hughes wrote. “And as recently as April, operating margins were down nearly 40% from the prior month.

“Without immediate action, the AHA estimates hospitals will lose at least $3 billion by the end of the year,” she wrote.

Hospital industry groups had hoped that another delay to the sequestration cuts could be included alongside other health priorities in omnibus spending bills passed earlier this year. In particular, the groups had noted that the decision to end the cuts came before hospitals faced their worst COVID-19 surge of the pandemic.

“When that passed [I am] not sure there was the first case of omicron, and the landscape has entirely changed,” Jonathan Jagoda, senior vice president of legislative affairs for the Federation of American Hospitals, said in January.

Hospital groups have previously proposed tying the cuts to the flexibilities of the public health emergency, which has also been on many lawmakers’ cutting blocks the past several months. The public health emergency is slated to run until July 16, although no word of a 60-day warning from the Department of Health and Human Services means that it is likely to be extended until at least the fall.

https://www.fiercehealthcare.com/providers/hospitals-implore-congress-punt-medicare-payment-cut-slated-july