Hunter Biden Held Previously Undisclosed Meeting With The "F**king Spy Chief Of China"

 First brother Jim Biden told Congress last week that Hunter Biden held a previously undisclosed meeting with Patrick Ho, an executive with Chinese energy conglomerate CEFC China Energy - which, weeks earlier, paid Hunter and Jim Biden $5 million as part of a joint venture to find investments for the Chinese firm, the Washington Free Beacon reports.

Hunter had previously referred to Ho as "the fucking spy chief of China" in an audio recording dated May 11, 2018.

In a congressional deposition last month, Jim Biden said he accompanied Hunter Biden to Hong Kong in September 2017 to meet with Patrick Ho...

...The Biden family’s arrangement with CEFC China Energy has stoked national security concerns because of the Chinese firm’s links to Chinese military intelligence. Middlemen for CEFC China Energy approached Hunter Biden in 2015, when his father was vice president, about potential business deals.

According to Jim Biden, he and Hunter Biden had a "pleasant" lunch in Hong Kong with Ho, who also served as head of the China Energy Fund Committee, a think tank funded by CEFC China Energy. At the end of the meeting, Ho asked to meet alone with Hunter Biden, according to Uncle Jim. -Washington Free Beacon

 According to Jim Biden, "Ho said, ‘Can I borrow Hunter for, you know, a half-hour? We're going to go in the next room.’"

CEFC paid Hunter $1 million to represent Ho, however Hunter does not appear to have done any actual legal work on Ho's behalf. According to court records, the US government was surveilling Ho under a FISA warrant because they suspected that he was a possible agent of a foreign government.

Worming their way in

Jim Biden also described how CEFC entered the Biden orbit - telling congressional investigators that the father of one of Hunter's daughter's classmates contacted Biden about working with CEFC. The man, Scott Oh, gave Hunter a diamond ring after approaching Hunter in October 2015 to discuss "investment opportunities" involving CEFC.

Meanwhile, a former Hunter Biden business associate has revealed in a jailhouse confession that the first son sought roughly $5 million from fugitive Ukrainian oligarch Dmitri Firtash in order to try and quash a US indictment while his father Joe Biden was Vice President, Just the News reports.

Jason Galanis’ jailhouse account of an effort to assist Firtash was recently provided to the House Oversight and Judiciary Committees in President Joe Biden’s impeachment inquiry, and it corroborates a story from Just the News in 2021 in which Firtash’s longtime righthand man Hares Youssef confirmed the future first son was engaged in 2015 to try to help solve Firtash’s legal woes in the United States.

Both Hares in 2021 and Galanis last month said Hunter Biden was unsuccessful – Firtash still faces charges and is fighting extradition to the United States from his safe harbor in Austria – but the efforts ultimately resulted in a $3 million investment in a tech fund called mBloom that Galanis and other Hunter Biden partners had formed.

According to the report, around $300,000 of the $3 million made it into Rosemont Seneca Bohai, one of Hunter Biden's firms - which was also used for payments Hunter received from a second Ukrainian oligarch, Mykola Zlochevsky - president of Burisma Holdings energy firm.

As Just the News reports further, Gelanis told Congressional impeachment investigators:

• Hunter Biden offered to help Firtash try to “influence or attempt to quash” his federal indictment;
• Galanis believed either $5 million or $5.5 million was delivered to Boies, where Hunter worked as a lawyer. The payment was to compensate Hunter Biden for trying to resolve Firtash's U.S. legal issues;
• Youseff became “very unhappy” with Hunter Biden’s work on the matter because of the lack of progress resolving Firtash's criminal case;
• Eventually, the effort ended and Youseff arranged to transfer $3 million of Firtash’s money to a tech startup associated with Galanis and other Hunter Biden business partners called mBloom.
• mBloom then sent about $300,000 of that money to Rosemont Seneca Bohai, a firm where Hunter Biden often got paid for his Burisma work.

Firtash was indicted in 2014 by the Obama-Biden DOJ on allegations of corruption, and has been represented by several powerful American lawyers, including former Clinton White House lawyer Lanny Davis, ex-U.S. Attorney Dan Webb and former DOJ officials Joseph diGenova and Victoria Toensing.

In court, his lawyers have argued that the charges filed in Chicago were unwarranted.

"He didn't pay any bribes. He's not even charged with paying bribes. He's charged with a scheme to bribe, involving a transaction in India, that never happened," Lanny Davis said back in 2021.

According to Hunter's own recent testimony to Congress, Firtash was believed to be aligned with Vladimir Putin.

"There were two gas companies inside of Ukraine at that time. One of them was the state-owned, which was highly corrupt and connected to people like Firtash, which was directly going into Vladimir Putin's pocket," he said, explaining that Firtash's ties to Russia were connected to why he joined the board of Burisma.

"The only independent company was Burisma. And Burisma was supplying 60 percent of all natural gas to power the entire industry in Ukraine, including 78 percent of all steel mills. And so they needed to survive."

https://www.zerohedge.com/political/agent-hunter-ex-partner-says-5-million-sought-quash-ukrainian-indictment-undisclosed

Walgreens CEO says no plans to sell specialty pharmacy unit

 Walgreens Boots Alliance's CEO rejected a media report, saying the company does not plan to sell specialty pharmacy unit Shields Health Solutions at least for now

The pharmacy chain is instead looking for ways to drive "the most value" for the business, CEO Timothy Wentworth said at a conference on Monday.

Bloomberg News reported in January that Walgreens was exploring a sale of the unit.

"Shield is a terrific asset, and I love the fact that we've got it. And so from that standpoint, whatever you may have read, don't believe it. We are not announcing we're selling Shields," Wentworth said.

Shares of the company were down 2% in early trading.

They have fallen 11.4% since Walgreens nearly halved its dividend payout in January in an attempt to conserve cash as it sought to win back market share from rivals and expand beyond pharmacies.

Walgreens bought the remaining stake in Shields for $1.37 billion in 2022, after spending $970 million to increase its stake in the company to 71% in the prior year.

Specialty pharmacies sell medications that require extreme care in handling, storage and distribution, often for patients with complex conditions such as cancer, multiple sclerosis and rheumatoid arthritis.

https://finance.yahoo.com/news/1-walgreens-ceo-says-no-150022752.html

Therapeutic Solutions Patents Commercially Available Nutraceutical to Up Natural Killer Cell Immunity in COVID

 Latest Patent to Complement Issued Claims on Viral Inhibition, Adaptive Immune Stimulation, and Brain Protection/Regeneration

 

Therapeutic Solutions International, Inc. (TSOI), a clinical-stage stem cell and immunotherapy company, announced today the granting of a patent covering the ability of QuadraMune® and similar compositions, to stimulate natural killer (NK) cell activity in patients with COVID-19. NK cells are the first line of defense against viruses and cancers¹.

The Company was previously awarded by the United States Patent and Trademark Office the following QuadraMune® related patents:

1. Patent #11,229,674, covering inhibition of the immune suppressing enzyme indolamine 2,3 dioxygenase². It is published that this enzyme plays a fundamental role in immune suppression by cancer³, as well as numerous viruses including SARS-CoV-2, the causative agent of COVID-19⁴.
2. Patent #11,266,707, “Nutraceuticals for the prevention, inhibition, and treatment of SARS-CoV-2 and associated COVID-19”⁵.
3. Patent #11,504,410, covering use of QuadraMune® and its derivatives for protecting and restoring brain function after neurological damage, including Long COVID⁶.
4. Patent #11759495, covering upregulation of T regulatory cells for suppression of suicidal ideation⁷.

“In addition to this important validation from the USPTO, the fact that the ingredients in QuadraMune® have been reported by institutions such as Johns Hopkins University to suppress SARS-CoV-2 is strongly encouraging,” said Famela Ramos, Vice President of Business Development for the Company.

https://www.biospace.com/article/releases/therapeutic-solutions-international-granted-patent-on-commercially-available-quadramune-nutraceutical-for-increasing-natural-killer-cell-immunity-in-covid-19-patients/

Inspira 'to Report Primary Results for Core Blood Oxygenation Tech Within Days'

 

• The major milestone refers to Inspira's proprietary technology to oxygenate blood for the INSPIRA™ ART (Gen 2). This patented tech is considered by Inspira to be a game-changer and also aims to replace technologies used today by current medical device companies.
• Anticipated U.S. Food and Drug Administration (FDA) Clearance for INSPIRA™ ART100 (Gen 1) in the first half of 2024, to address the $1.16 Billion perfusion systems market.

https://www.biospace.com/article/releases/inspira-announces-plans-to-report-the-primary-results-for-a-core-blood-oxygenation-technology-within-days/

BioCardia: Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial

 

• CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared to control patients on guideline-directed heart medications alone
• Large sub-set of treated patients with elevated NTproBNP – a marker of heart distress – showed greater reductions, with 86% relative risk reduction in heart death equivalents and 24% relative risk reduction in non-fatal MACCE
• FDA-approved follow-on Phase III trial of high-responding patient population with elevated NTproBNP (CardiAMP HF II) has launched to validate positive interim results

https://www.biospace.com/article/releases/biocardia-reports-positive-interim-results-from-phase-iii-cardiamp-cell-therapy-heart-failure-trial-with-compelling-data-in-subgroup-with-elevated-ntprobnp-biomarker-for-heart-failure/

New ALS Treatments Face Regulatory Uncertainty

 The past two years have seen a pair of new treatments approved for a particularly intractable neurodegenerative disease—amyotrophic lateral sclerosis. But while Amylyx’s Relyvrio and Biogen’s Qalsody have crossed the FDA finish line, others have stumbled in a regulatory space that experts say is still evolving.

The FDA put out new guidance in 2019 that sought to clarify the clinical outcome measures required for traditional approval of an ALS therapy. But with conflicting data regarding the importance a key biomarker, neurofilament light chain (NfL), and with the disease’s heterogenous nature challenging the interpretation of clinical trial results, a lot is still up in the air.

Merit Cudkowicz, chair of the neurology department at Massachusetts General Hospital who helped run trials for both Relvrio and Qalsody, told BioSpace that the recent leadership changes within the FDA’s neurology division—Billy Dunn stepped down as head of the neuroscience office a year ago—are an opportunity to dialogue with regulators in order to understand the standard for approval of an ALS drug.

What the FDA Is Looking For

The 2019 guidance outlines clinical outcome measures that can be used as endpoints in ALS trials to support traditional approval, with a focus on “measures that assess function in daily activities, muscle strength, respiratory function and mortality,” the neurology division’s new director, Teresa Buracchio, told BioSpace in an email.

Relyvrio was approved in September 2022 after an unprecedented second adcomm. The drug hit its primary outcome measure in the Phase II CENTAUR trial, and long-term survival data from the open-label extension trial also supported its approval, said Cudkowicz, one of the trial’s co-principal investigators. Relyvrio is composed of two repurposed drugs—sodium phenylbutyrate and taurursodiol—with a lot of safety data behind them, she added. Amylyx is expecting topline data from the Phase III PHOENIX trial during or before the second quarter of 2024.

For accelerated approval, Buracchio said, surrogate endpoints or intermediate clinical endpoints that are “determined to be ‘reasonably likely’ to predict clinical benefit” can be used.

Qalsody, approved in April 2023 under the accelerated approval pathway for patients with ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene, capitalized on this provision. Despite missing its primary Phase III endpoint, the antisense therapy “had really outstanding data in the open label extension, with some people stopping progression and getting better,” said Cudkowicz, a co-principal investigator on the trial, adding that there was also a large biomarker effect. Indeed, the approval was based on reductions in plasma levels of NfL, a marker of nerve injury and neurodegeneration—changes that were determined to be reasonably likely to predict clinical benefit.

For ALS therapies still seeking approval, it remains to be seen how to best demonstrate efficacy. “The appropriate design of a clinical trial for ALS will depend on the mechanism of the drug and population of patients that will be enrolled in a trial,” Buracchio said.

Take BrainStorm Cell Therapeutics’ NurOwn, which failed to impress a panel of FDA advisers during a September 2023 adcomm, with panelists citing a “lack of efficacy” in terms of survival and statistical evidence that didn’t meet the regulatory requirement. While acknowledging that a small group of people might have benefited from the treatment, “others did not or may have done worse,” said Cudkowicz, who served as the trial’s principal investigator. “There were many learnings from the trial, and the next step would be to consider a study in the population more likely to respond.”

Neurofilament as an ALS Biomarker

While much attention has been given to NfL as an important biomarker for neurodegenerative diseases, Cudkowicz said she wouldn’t yet consider it a standard requirement in ALS. “I think it’s helpful when it changes, but we don’t know if it doesn’t change what that means.” Three of the ALS drugs currently on the market, Riluzole, Relyvrio and Radacava, “did not change neurofilament but had a clinical effect,” she said.

Cudkowicz added that the upcoming PHOENIX trial readout for Relyvrio will be informative. “If it’s positive and still doesn’t have an effect on NfL, that really tells us that it’s good when it changes but it doesn’t mean that a drug isn’t effective when it doesn’t change.”

Amylyx co-CEO and co-founder Josh Cohen said the company will be more focused on the clinical evidence from the PHOENIX trial but will look at NfL as well. “I think the ALS field is really eager for a biomarker,” he told BioSpace. “Personally, I think the jury’s very much out [on] whether neurofilament is a helpful tool or is more than that.”

Asked what a win would be when the PHOENIX topline data read out, Justin Klee, the company’s other co-CEO and co-founder, said, “ALS is largely looked at still as an untreatable disease, so showing twice with a treatment that you can fundamentally impact the progression of the disease, I think would be an enormous milestone.”

Meanwhile, Salt Lake City–based Clene received FDA feedback in December 2023 that initial biomarker data from the Phase II trials of its investigational gold nanocrystal suspension CNM-Au8 were “insufficient to support accelerated approval.” CNM-Au8, which is part of the Healey ALS Platform trial on which Cudkowicz is a sponsor and principal investigator, elicited a “statistically significant” reduction in NfL levels compared to placebo after 24 weeks of treatment. On average, patients treated with CNM-Au8 saw a 10% decline from baseline in NfL over the 24-week double-blind treatment period of the HEALEY trial compared to placebo and a 16% decline from baseline versus placebo in the OLE through 76 weeks, Clene reported in December 2023. But Cudkowicz said the effect was “small [and] nothing like Qalsody,” which lowered NfL levels by more than 50% in participants on active treatment. 

She added that it was a very good study “that identified the right dose and had a clinically important signal” and noted that a larger Phase III trial is a critical next step. Clene anticipates launching a Phase III trial in 2024, CEO Rob Etherington said in a press release announcing the meeting’s outcome.

Patient Heterogeneity Challenges NurOwn’s Path to Market

For Bob Hebron, co-head of the I AM ALS Clinical Trials committee whose daughter was diagnosed with ALS more than a decade ago, much of the challenge lays in the heterogeneity of the disease. “No two patients progress at the same rate, and progression even within a single patient changes over time,” he told BioSpace. Thus, a treatment can appear to work for some patients but not in others. “It’s very hard with certain patients to discern progression,” he said, pointing to NurOwn as an example.

BrainStorm reported in November 2020 that the Phase III trial of NurOwn failed to meet statistical significance in the primary efficacy endpoint. The 34.7% response rate was only a little better than the 27.7% placebo response, which exceeded others observed in contemporary ALS trials. However, in a pre-specified subgroup of patients with early-stage disease, the difference was much larger, with 34.6% of NurOwn recipients having a clinically significant response compared with 15.6% in the placebo group.

BrainStorm executives have consistently pointed to a “floor effect,” which occurs when the scale of measurement is unable to capture the patient’s progression at the bottom end of the scale, to explain the overall result. Essentially, patients declining more rapidly reach the end of the scale’s ability to measure progression. If such rapidly declining patients are unevenly distributed between the treatment and placebo groups, this could skew the results.

BrainStorm co-CEO Stacy Lindborg confirmed that this challenge would be addressed in the company’s second Phase III trial, for which it submitted a Special Protocol Assessment request to the FDA on February 23. “One of the most critical aspects that any sponsor has to think about is inclusion criteria,” she told BioSpace. “That is an important learning and is central to how we’re designing the trial, to ensure we have the right patients.”

Ultimately, Lindborg said that with a number of ALS products having now gone through the regulatory process, questions about how to best measure functional benefit in ALS have begun to be answered. “There is more and more of a standard,” she said. However, because biomarkers and clinical trial design continue to be the subject of much discussion, the path to bringing new ALS therapies to market is still uncertain.

https://www.biospace.com/article/new-als-treatments-face-regulatory-uncertainty-/

FDA Action Alert: Vanda, Eyenovia and Viatris/Mapi

 March is shaping up to be a busy month for the FDA, beginning with three target action dates for an insomnia therapy, an injectable multiple sclerosis medication and a topical steroid for pain and inflammation following eye surgery.

Read below for more.

Vanda Awaits Verdict on Insomnia Drug

By March 4, the FDA is scheduled to release its decision on Vanda Pharmaceuticals’ supplemental New Drug Application (sNDA) proposing its oral drug Hetlioz (tasimelteon) for the treatment of insomnia, as characterized by difficulties in initiating sleep.

Hetlioz is an orally available agonist of the melatonin MT1 and MT2 receptors, which are crucial to the control of circadian rhythms. It is currently approved for non-24-hour sleep-wake disorder. The exact mechanism of action of Hetlioz is still unknown, according to its label.

In February 2024, the FDA informed Vanda it had identified “deficiencies” in the sNDA that “preclude discussion of labeling and postmarketing requirements/commitments.”

While the FDA indicated that the communication did not reflect its final decision on the sNDA, Vanda stated in a press release that it believes that the regulator’s notice is “part of an ongoing violation of the Federal Food Drug and Cosmetic Act,” which requires the FDA to give applicants the opportunity of a hearing within 180 days of their filing.

Vanda’s sNDA was filed on May 4, 2023, which meant the FDA would have had a deadline of October 31, 2023, to provide a decision or a hearing.

Vanda is backing Hetlioz’s sNDA with data from a Phase III, placebo-controlled, four-week study, along with two transient insomnia studies.

Eyenovia Hopes to Join $1.3B Market with Ophthalmic Steroid

Also on March 4, the FDA is expected to issue a verdict on Eyenovia’s investigational APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for the treatment of pain and inflammation after ocular surgery.

Initially developed by Taiwan-based Formosa Pharmaceuticals, APP13007 is a topical ophthalmic steroid. Its active ingredient is clobetasol propionate, which is a super-potent steroid that elicits rapid and sustained relief of both pain and inflammation, allowing a twice-daily dosing schedule every two weeks.

Eyenovia acquired the U.S. commercial rights to APP13007 in August 2023 for single-digit million-dollar commitments in cash and shares, payable upon the signing of the agreement, the FDA approval of the candidate, the transfer of its NDA to Eyenovia and the first commercial sale of APP13007. Formosa will also be eligible for various sales milestones for the candidate.

If approved, APPI13007 will join the $1.3 billion market of ocular steroid and steroid combinations, which sees around 7 million eye surgeries in the U.S. every year. APP13007 will complement Eyenovia’s FDA-approved mydriasis product Mydcombi and could provide the company with additional near-term revenue.

Viatris, Mapi’s MS Candidate Faces March 8 Verdict

By March 8, Viatris and Israel-based partner Mapi Pharma expect a decision on the NDA for their investigational version of glatiramer acetate GA Depot for relapsing forms of multiple sclerosis (MS).

Glatiramer acetate, sold by Teva under the brand name Copaxone, is an immunomodulating therapy that works by tempering the inflammatory response, an underlying pathologic driver of MS. The drug cannot cross the blood-brain barrier, and its exact mechanism of action is still unknown, but it is believed to enhance peripheral helper T cells and help them move into the brain to dampen inflammation in the central nervous system.

Viatris’ and Mapi’s GA Depot is a long-acting formulation of glatiramer acetate designed to be administered through an intramuscular injection every four weeks.

The partners are backing their application with data from a double-blinded, placebo-controlled Phase III trial that enrolled 1,016 patients who were given either 40 mg of GA Depot or placebo for a total of 13 doses. Study results showed that GA Depot could significantly reduce annualized relapse rate by 30.1% while also decreasing injection site reactions.

If approved, Viatris believes GA Depot could “improve patient experience through fewer injections, greater tolerability and increased compliance,” Rajiv Malik, the company’s president, said in a statement alongside the NDA’s acceptance.

https://www.biospace.com/article/fda-action-alert-vanda-eyenovia-and-viatris-mapi/