Kiromic BioPharma’s Deltacel Receives FDA Fast Track

 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. The designation was awarded for KB-GDT-01 in combination with low-dose radiation therapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on at least two lines of standard of care therapy including platinum-based chemotherapy, immune checkpoint inhibitors and targeted therapy to improve progression-free survival and overall survival. Deltacel is currently being evaluated in the Deltacel-01 Phase 1 study in patients with stage 4 NSCLC who have failed to respond to standard therapies.

Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. The designation allows for more frequent communication with the FDA, potential priority review, and a rolling submission of Biologics License Application or New Drug Application.

"Receipt of Fast Track designation is a significant milestone for Kiromic and underscores the potential of Deltacel to address the urgent needs of patients with advanced solid tumors," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of Deltacel. Fast Track designation will enable us to work more closely with the FDA as we complete Deltacel-01 and advance this promising therapy into later stage studies."

https://finance.yahoo.com/news/kiromic-biopharma-deltacel-receives-fda-120000142.html

Tulsi Gabbard Suing Biden/Harris Admin For Placing Her On Terrorist Watch List

 by Steve Watson via Modernity.news,.

Former Democratic Representative Tulsi Gabbard is taking legal action against the Biden/Harris Administration after she discovered that she has essentially been placed on a terrorist watch list.

Gabbard, a military veteran, had it brought to her attention by Federal Air Marshal whistleblowers that she has been marked under the Quiet Skies program, a TSA scheme that seeks to identify travellers who may pose a risk to aviation security.

Those on this watchlist are not banned from flying, but are subject to enhanced searches and surveillance at airports, including having armed Air Marshals accompanying them on flights.

The whistleblowers have informed Gabbard that she is being monitored by two Explosive Detection Canine Teams, one Transportation Security Specialist specializing in explosives, one plainclothes TSA Supervisor, and three Federal Air Marshals every time she flies.

Kamala Harris is not knowledgeable or strong enough to stand up to potential adversaries, or just as importantly the unelected warmongers — i.e. the Military Industrial Complex which profits from war, and the National Security State which uses these wars as a pretext to further… pic.twitter.com/1uUS6CtGii

— Tulsi Gabbard 🌺 (@TulsiGabbard) July 23, 2024

The whistleblowers have stated that Gabbard became marked on the program on July 23, just one day after she openly criticised Kamala Harris, Joe Biden, and the ‘Deep State’ during a Fox News interview with Laura Ingraham (below).

There is no logical reason why Gabbard should be on the watchlist, unless criticising the regime is a designating factor.

Gabbard posted a video explaining why she is taking legal action, noting “My own government, my president, my commander-in-chief is targeting me as a potential domestic terrorist, the closest word that comes to mind is a complete sense of betrayal.”

“After serving over 21 years and continuing to serve in our nation’s military, my own government has labeled and is targeting me directly now as a domestic terrorist,” she added.

Gabbard further asserted “They’re using people like the air marshals as weapons and pawns to target their political opponents.”

“Of course, there’s no explanation given, which is why we are taking legal recourse,” she emphasised.

“Obviously, I’ve been very outspoken about the dangers of the Biden-Harris administration to our democracy and to our freedom and to our national security. This is what happens as a result,” she concluded.

Tulsi Gabbard will be taking legal action against the Biden/Harris admin over putting her on a terrorist watch list:

“My own government, my president, my commander-in-chief is targeting me as a potential domestic terrorist, the closest word that comes to mind is a complete sense… pic.twitter.com/2Z4gfzHFQv

— End Tribalism in Politics (@EndTribalism) August 11, 2024

Gabbard also went back onto Ingraham’s show to talk about the surveillance.

RETALIATION. A few weeks ago, I had the audacity to tell the truth: that Kamala Harris would essentially be a mouthpiece and puppet of the Military Industrial Complex and National Security State. The next day, July 23, they retaliated. Sadly this is what we can expect from the… pic.twitter.com/nxddO5TGTj

— Tulsi Gabbard 🌺 (@TulsiGabbard) August 10, 2024

I am deeply concerned about reports that @TSA has placed LTC @TulsiGabbard, a decorated military officer and former Congresswoman, on their "Quiet Skies" watch list. I've sent a letter to @TSA_Pekoske requesting detailed information about the process and reasoning behind this… pic.twitter.com/yO9EgIHTV1

— Rep. Doug Lamborn (@RepDLamborn) August 12, 2024

Wow. Just wow. Iraq veteran and former Congresswoman Tulsi Gabbard targeted for TSA harassment as a terror threat. Yet another example of the weaponization of government agencies against political opponents of the administration — or should I call it “the regime”? This is not…

— Robert F. Kennedy Jr (@RobertKennedyJr) August 8, 2024

*  *  *

https://www.zerohedge.com/political/watch-tulsi-gabbard-suing-bidenharris-admin-placing-her-terrorist-watch-list

Otsuka, Click's depression DTx launches in the US

 An FDA-approved digital therapeutic (DTx) that can be used to help people living with major depressive disorder (MDD) has been launched in the US and is available in mobile app stores.

Otsuka Pharma and Click Therapeutics' Rejoyn (formerly CT-152) app – which is used to help people with MDD manage their emotions more effectively – can be unlocked with a prescription from a healthcare provider.

Patients seeking a prescription for the app can ask their current provider or arrange a virtual consultation from online health specialist Wheel Health, a remote healthcare specialist that has partnered with Otsuka and Click to improve access.

Rejoyn became the first prescription DTx to be approved for MDD by the FDA in March, getting the go-ahead for use as an add-on to clinician-managed outpatient care for adults aged 22 and over with MDD who require antidepressant medicines.

Delivered over six weeks, the DTx is designed to help alleviate MDD symptoms using a combination of cognitive emotional training exercises and brief therapeutic lessons.

"In an effort to facilitate broad access, the six-week Rejoyn treatment program is available for a limited time at a discounted price of $50 for patients," said Click and Otsuka Precision Health (OPH) in a joint statement on the launch.

They also said that the launch price of Rejoyn for payors will be $200, adding: "Coverage from health insurers is expected to be forthcoming."

All eyes will be on the commercial success of Rejoyn, given the challenges faced by other companies in building a sustainable business for prescription DTx – mainly due to difficulties in getting reimbursement and encouraging doctors to consider a digital health option for their patients.

Those difficulties resulted in the demise of Pear Therapeutics – a pioneer of the DTx sector – and a change in strategy by another early entrant, Akili Interactive, to focus most of its efforts on direct-to-consumer sales and put its prescription business on the back burner.

Last year, US lawmakers reintroduced the Access to Prescription Digital Therapeutics Act, which would create a dedicated benefit category for these products in Medicare and Medicaid, but that has not yet made it onto the statute, although it was referred to committee. 

Notably, OPH has set pricing for Rejoyn that is a lot lower than has been seen with other prescription DTx products, and is more in line with what Akili is charging for its DTC offering. In the meantime, a lot will depend on OPH and Click convincing doctors that the data for its app is robust.

In the pivotal Mirai study of Rejoyn in 286 people with MDD, patients using the app achieved an average 8.78-point reduction change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score – versus 6.66 points for a sham group – meeting the primary endpoint for efficacy. The full or partial response rate to the app was 48.3%, compared to 37.5% for the sham.

Rejoyn is the first DTx to emerge from a collaboration set up in 2019 between Click and Otsuka, worth $300 million, focusing on the development of DTx software.

"We are proud to bring Rejoyn, the first and only FDA-cleared digital treatment for MDD symptoms, to the market," said Sanket Shah, president of OPH.

The launch is an "important milestone in [OPH's] journey to improving the patient experience through data-backed and digital products and services that meet patients where they are," he added.

Click is also working on DTx candidates for schizophrenia with Boehringer Ingelheim and with Indivior on software to support people with substance use disorders. Its in-house pipeline is led by a DTx candidate for migraine.

https://pharmaphorum.com/news/otsuka-clicks-depression-dtx-launches-us

Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangiti

 – First and Only Treatment to Demonstrate Statistically Significant Reductions Across Key Biomarkers, ALP Normalization and Pruritus Versus Placebo –

https://www.businesswire.com/news/home/20240814469557/en

Crypto Tumbles As 'Harris/Biden' Admin Moves Another 10,000 'Silk Road' Bitcoin To Coinbase

 Bitcoin prices fell this morning in reaction to the lackluster CPI (as rate-cut expectations dipped). That selloff broke through $60,000 and accelerated further as headlines broke that the US government moved 10,000 seized Bitcoin from the Silk Road dark web marketplace to a Coinbase wallet Wednesday.

According to the onchain analytics firm, Arkham Intelligence, the funds were seized during the Silk Road raid and are currently valued at $593.91 million.

It's not immediately clear whether the United States plans to sell or custody the assets.

The transaction follows a previous move of approximately $2 billion worth of Silk Road Bitcoin in late July.

As a reminder, the price action (dowwward) in various cryptocurrencies is front-running expectations of the creditors getting their hands back on these assets and selling them...

...the only problem with that argument is, as we detailed here, the creditors are not selling, they're HODLing...

“Now, seeing the continued growth and acceptance of their industry, many Mt. Gox creditors may have become even stronger believers in Bitcoin and its future potential, choosing to hodl further.”

So, its really only the algos, reacting to the headlines, that is driving any dips.

“This resilience suggests that while short-term volatility is possible, the long-term impact on Bitcoin’s market dynamics will likely be minimal.”

The US government currently holds roughly 203,000 BTC valued at approximately $12 billion at the time of this writing.

The decision by the Biden/Harris administration in the last few weeks to seemingly accelerate the dumping of their 'seized' Bitcoin comes right as former President Trump outlined his Bitcoin strategy (including creating a Strategic Bitcoin Reserve).

The Harris campaign continues to desperately try and placate the crypto community - despite almost four years of nothing but hate for the sovereign currency and its heretical holders. Let's see how Crypto-Kamala's aides explain the ongoing dumping of assets.

https://www.zerohedge.com/crypto/crypto-tumbles-harrisbiden-admin-moves-another-10000-silk-road-bitcoin-coinbase

Where Harris May Have Last Stood on Healthcare Issues

 Abortion

Harris' Stance:

• Harris supported abortion rights throughout her Senate career; preserving those rights is expected to be a central part of her campaign.
• She is believed to be the first vice president ever to visit an abortion clinic -- a Planned Parenthood facility in Minnesota in March.
• Two months earlier, in Wisconsin, she kicked off her "Fight for Reproductive Freedoms" tour, highlighting the harms of extreme abortion bans.
• In July, Harris pledged that if Congress passed a law to preserve the right to abortion nationwide, she would sign it.
• Abortion-rights groups were quick to endorse Harris after Biden ended his campaign; anti-abortion groups seem alarmed by her unflinching commitment to the issue.

Healthcare Reform

Harris' Stance:

• In 2019, during her first presidential campaign, Harris voiced support for Medicare for All, then appeared to waver on that approach.
• Soon afterwards, she introduced "KamalaCare," a more moderate proposal that preserved a role for private health plans and suggested a 10-year glide path to a single-payer system. However, in late July, a Harris spokesperson said that Harris "will not push single payer as president."
• As California's Attorney General, Harris defended the Affordable Care Act's (ACA) constitutionality in multiple amicus briefs.
• She is expected to extend the enhanced ACA subsidies, which will otherwise sunset at the end of 2025. These subsidies help Americans afford health insurance on the exchanges by capping premiums at a percentage of their income on a sliding scale.
• Harris is also expected to work to expand Medicaid coverage in the 10 remaining non-expansion states.
• As for Medicare, she previously supported President's Biden's plan to increase taxes for Americans who earn more than $400,000 annually to help keep the program solvent.

Healthcare Costs, Drug Prices

Harris' Stance:

• During her first presidential campaign in 2019, Harris proposed granting the HHS secretary the authority to set a fair price for all drugs sold nationally based on prices in other developed countries.
• Harris supported "march-in rights," a provision of the Bayh-Dole Act that allows the government to seize control of patents for high-priced drugs under certain circumstances. She also supported drug importation for high-priced drugs.
• As California's attorney general, she took on healthcare consolidation and anti-competitive pricing among insurers, hospital chains, and drug companies, laying the groundwork for a landmark lawsuit against Sutter Health.
• Harris is expected to continue to defend the Inflation Reduction Act (IRA), which, for the first time ever, allowed the HHS secretary to negotiate the prices of 10 select drugs. Multiple drug companies and other stakeholders have sued the government over the negotiation process, but, to date, the government has won every case.
• For Medicare beneficiaries, the IRA also capped insulin prices at $35 per month and will cap out-of-pocket costs at $2,000 annually for Part D prescription drugs beginning in 2025.
• Harris has said she would support extending the IRA's cost protections to Americans who are not Medicare enrollees.

Maternal Health

Harris' Stance:

• As a senator, Harris was one of the leading co-sponsors of the "Momnibus," a package of more than a dozen bills that addressed drivers of maternal mortality and morbidity, with a focus on Black women.
• In December 2021, she led the White House's first Maternal Health Day of Action Summit.
• In June 2022, the Biden administration released a blueprint for addressing the maternal health crisis, which included plans to expand and diversify the perinatal workforce, increase access to behavioral healthcare, and encourage states to apply for waivers to expand Medicaid coverage from 60 days postpartum to 12 months. As of May, 46 states and the District of Columbia have adopted such policies.

Pandemic Response

Harris' Stance:

• In 2020, then-vice presidential nominee Harris said she would not trust a COVID-19 vaccine that Trump distributed before the election, unless a "credible" source could ensure its safety.
• Harris, however, did receive a COVID vaccine in December 2020 on live television.
• She also publicly supported vaccines, boosters, and masks, casting them as tools to help schools and businesses reopen.
• In July 2023, the Biden-Harris administration, responding to congressional legislation, launched a new Office of Pandemic Preparedness and Response Policy.

https://www.medpagetoday.com/washington-watch/electioncoverage/111499

Steward Health Care Reaches Deal to Sell Its Nationwide Physicians Network

 Steward Health Care said it has reached an agreement to sell its nationwide physicians network to a private equity firm.

The deal comes as Steward is scheduled to go before a bankruptcy court judge Friday on its plan to sell six hospitals in Massachusetts. The Dallas-based company announced its bankruptcyopens in a new tab or window May 6.

In a statement released Monday, Steward said it has entered into a "definitive agreement" to sell its Stewardship Health business -- which includes about 5,000 physicians in Massachusetts and nine other states treating about 400,000 patients -- to Rural Healthcare Group, an affiliate of Kinderhook Industries LLC, a private equity firm.

Steward said the deal, which is subject to regulators' review, will result in strong patient and physician outcomes. "Stewardship Health will continue to serve its loyal patient following in the commonwealth of Massachusetts under new ownership," the company said in a statement Monday.

Mark Rich, president of Steward Health Care, said Kinderhook has "over 20 years of experience investing in mid-sized healthcare businesses that serve the nation's most vulnerable populations."

Steward had previously announced a deal to sell its physicians network. In March, the company said that it had signed a letter of intent to sell Stewardship to the Optum unit of health insurer UnitedHealth. That deal was never finalized.

Steward and its CEO Ralph de la Torre, MD, have come under intense criticism for a series of decisions that critics -- including Massachusetts Gov. Maura Healey (D) -- say led to the bankruptcy. Healey said she has focused on trying to save the remaining Steward hospitals, which have found qualified bidders.

"I have spoken repeatedly about my disgust of Ralph de la Torre, disgust of Steward management," the former attorney general said Monday. "I hope the feds go hard after him and he ends up in jail."

Steward announced its bankruptcy May 6opens in a new tab or window and 2 days later said it planned to sell off the 30 hospitals it operatesopens in a new tab or window nationwide.

A bankruptcy judge last month allowed Steward's decision to close two Massachusetts hospitals. Steward announced July 26 its plan to close the hospitalsopens in a new tab or window -- Carney Hospital in Boston and Nashoba Valley Medical Center in Ayer -- on or around August 31 because it had received no qualified bids for either facility.

Boston Mayor Michelle Wu (D) said Tuesday that she will use the city's planning, zoning, and permitting process to push to keep some kind of healthcare resource on the Carney Hospital property -- and out of the hands of luxury developers.

"We wanted to be very clear that the zoning here, although it is zoned still as multifamily residential, that does not mean that they would be able to, without going through any process, all of a sudden build a gigantic luxury condo complex that could make them a lot of money," Wu said on WBUR radio station. "So they should not see that as an option on the table."

Steward owes lease payments after selling their hospitals' physical properties -- including land and buildings -- to another company. Both Steward and the state have argued that requiring potential buyers to assume those payments instead of negotiating their own leases -- or buying the hospitals' properties outright -- was making it hard to transfer ownership of the hospitals.

Judge Christopher Lopez of the U.S. Bankruptcy Court in Houston late last month approved a motion by Steward to toss out the master lease binding the Massachusetts hospitals.

Massachusetts has also agreed to provide about $30 millionopens in a new tab or window to help support the operations of six hospitals that Steward Health Care is trying to turn over to new owners. The payments are advances on Medicaid funds that the state owes Steward.

A U.S. Senate committee voted last month to authorize an investigationopens in a new tab or window into Steward's bankruptcy and to subpoena de la Torre.

Steward currently operates more than 30 hospitals across Arizona, Ohio, Pennsylvania, Arkansas, Florida, Louisiana, Texas, and Massachusetts.

https://www.medpagetoday.com/hospitalbasedmedicine/generalhospitalpractice/111505