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Thursday, June 1, 2023

Wearable Devices Commences Commercial Manufacturing of the Mudra Band for Apple Watch

 he Company Incorporates Innovative Design To Optimize Mudra Band’s Manufacturability

 Wearable Devices Ltd. (Nasdaq: WLDS, WLDSW) (“Wearable Devices” or the “Company”), a technology growth company specializing in AI-powered touchless sensing wearables, is pleased to announce that it has commenced commercial manufacturing of its anticipated Mudra Band for Apple Watch.

Wearable Devices has witnessed a growing demand from customers worldwide, with thousands of preorders already received so far.

In the development of the Mudra Band, Wearable Devices utilized an innovative manufacturing technique which combines the advantages of a flex-rigid printed circuit board with enhanced durability and flexibility, to ensure a sleek and seamless integration with the Apple Watch.

The Mudra Band, initially developed for touchless operation of the Apple Watch using neural signals, has now expanded its product features with Air-Touch. This groundbreaking addition allows users to seamlessly control Apple's entire ecosystem of devices using subtle finger movements and hand gestures without the need for physical touch. With the latest enhancements, users can effortlessly toggle and switch between connected devices, including iPhone, iPad, Mac computer, Apple TV devices, smart glasses, and various mobile gaming devices, creating an immersive and intuitive user experience.

https://finance.yahoo.com/news/wearable-devices-commences-commercial-manufacturing-110000684.html

Cheapest Humira Alternative to Be Sold via Mark Cuban’s Drug Company

 

  • Yusimry to launch in July, cost $995 for two autoinjectors
  • Biosimilar to be sold via Mark Cuban’s Cost Plus Drugs Company

AbbVie Inc.’s blockbuster drug Humira costs the US health system $90,000 per patient each year. Now, an emerging competitor plans to sell an alternative at an 85% discount. 

Coherus BioSciences Inc. will launch the cheapest-ever Humira copycat, Yusimry, in July, with a list price of $995 for two autoinjectors, the company said Thursday. That’s far below the $6,922 AbbVie charges for the same supply of its drug used to treat rheumatoid arthritis, plaque psoriasis and other autoimmune conditions.

https://www.bloomberg.com/news/articles/2023-06-01/cheapest-humira-alternative-to-be-sold-by-mark-cuban-s-cost-plus-drugs

McCarthy Reportedly Gave Dems Secret Concessions In Exchange For Debt Ceiling Votes

 Update (2300ET): Hours after the House passed the debt ceiling bill, Axios reports that House Speaker Kevin McCarthy (R-CA) gave Minority Leader Hakeem Jeffries (D-NY) secret concessions to boost spending on Democratic districts in the form of "community project funding" in exchange for their votes earlier this evening, according to two senior lawmakers.

McCarthy has told reporters that he didn't cut any deals to supply the Democratic votes.

When asked if he cut a deal, Jeffries said "House Democrats to the rescue to avoid a dangerous default and help House Republicans get legislation over the finish line that they negotiated themselves."

More via Axios;

The backdrop: Rep. Rosa DeLauro (D-Conn.), ranking member of the Appropriations Committee, previously had told Democrats that they would receive significantly reduced funding for projects in their districts this year, according to Politico.

What we're watching: The deal could further inflame far-right lawmakers already incensed about the compromise bill that McCarthy cut with Biden. They've accused the speaker of caving to most of Democrats’ demands and not cutting enough government spending.

  • Rep. Chip Roy (R-Texas), reacting to news that Democrats might have squeezed McCarthy on earmarks, tweeted derisively: "Earmarks! Sell! Sell! Sell! #NoDeal[.]"

*  *  *

Update (2115ET): The House has successfully voted to raise the debt limit. The legislation now heads to the Senate, where it will need (and undoubtedly receive) at least 60 votes to proceed to President Biden's desk for his signature ahead of a June 5 deadline to avert a national default.

71 Republicans opposed the measure, as did 46 Democrats, while 149 Republicans and 165 Democrats voted to back the plan.

As we noted earlier, the bill - which as discussed here does not cut real Federal spending even in year one despite widespread propaganda that In exchange for Republican votes for the suspension, Democrats agreed to cap federal spending for the next two years - would set the course for federal spending for the next two years and suspend the debt ceiling until Jan. 1, 2025 — postponing another clash over borrowing until after the presidential election. By then total US debt will be $35 trillion and well on its way to unsustainability.

Of note, in order to try and convince hardline conservatives to vote yes, House Speaker Kevin McCarthy had proposed a bipartisan commission, at an expected cost upwards of $100 million, to outline future budget cuts.

"After today, I’m going to put a commission together to look at the entire budget. This debt is too large," said McCarthy. "We can be very serious about looking long term to solve this problem."

*  *  *

Update (2115ET): The full House vote has started on the debt ceiling deal.

Watch live:

*  *  *

Shortly after 4pm ET, the debt-limit deal cleared a major hurdle in the House despite growing opposition, setting up the legislation for a vote around 8:15pm on Wednesday night, a vote which despite vocal showboating opposition from various republicans appears destined to pass.

While the House voted 241-187 to take a procedural step needed to consider the measure, McCarthy needed votes from Democrats to offset 29 Republican “no” votes, underscoring the divide within his own party over the legislation as such votes setting the rules for debate are nearly always decided along party lines.  The final vote tally suggests that the Speaker's position is becoming increasingly vulnerable... if only there was someone willing to submit a motion to vacate.

Here are the 29 Republicans that voted no on the rule for the debt ceiling:

A) 29 GOPers voted no on rule for debt ceiling.

  1. Biggs
  2. Bishop
  3. Boebert
  4. Brecheen
  5. Burlison
  6. Buck
  7. Cline
  8. Burchett
  9. Cloud
  10. Clyde
  11. Crane
  12. Gaetz
  13. Gosar
  14. Good
  15. Griffith
  16. Higgins
  17. Harris
  18. Harshberger
  19. Luna
  20. Miller
  21. Moore
  22. Norman
  23. Perry
  24. Posey
  25. Rosendale
  26. Roy
  27. Self
  28. Spartz
  29. Tiffany

“I think things are going as planned,” Biden told reporters at the White House, before he was due to leave for Colorado. “God willing, by the time I land, Congress will have acted, the House will have acted, and we’ll be one step closer.”

House Majority Whip Tom Emmer, a Minnesota Republican, said early Wednesday that he’s sure the votes are in hand. “It’s going to pass,” he said even though he will need Democrat vote for the final passage.

If it passes, the bill will next go to the Senate, where objections from conservatives could force days of debate. But John Thune, the Senate’s No. 2 Republican, said Wednesday that there could be a deal to pass the bill by Friday night, days ahead of the June 5 default deadline.

The bill - which as discussed here does not cut real Federal spending even in year one despite widespread propaganda that In exchange for Republican votes for the suspension, Democrats agreed to cap federal spending for the next two years - would set the course for federal spending for the next two years and suspend the debt ceiling until Jan. 1, 2025 — postponing another clash over borrowing until after the presidential election. By then total US debt will be $35 trillion and well on its way to unsustainability.

* * *

As the deal to raise the debt ceiling works its way through the House, Senate Republican leader Mitch McConnell (KY) is preparing for battle with Senate conservatives who are calling for amendments to the bill and threatening to delay the legislation until changes are made.

As The Hill reports, the bill is likely to get over 40 Senate Democratic votes, meaning it will likely need at least 10-20 "yes" votes from Senate Republicans in order for it to move to President Biden's desk before the June 5 "X-date" deadline set by Treasury Secretary Janet Yellen for the US to run out of funds.

On Sunday, McConnell came out in favor of the deal negotiated between House Speaker Kevin McCarthy (R-CA) and President Biden's team, however he faces strong opposition from actual conservatives. Chief among them, Sen. Mike Lee (R-UT), who has threatened to use "every procedural tool at my disposal" to slow down the bill. Sen. Rand Paul (R-KY) has similarly thrown a wrench in the gears - demanding a vote on his "conservative alternative" that would cut total federal spending by $545 billion over two years.

"It’s time to go back to the drawing board or, even better, go back to what the House already passed," said Lee on Tuesday - referring to the Limit, Save, Grow Act, which would cut $4.8 trillion from the future deficit. According to Lee, the current bill "simply does not do what its proponents claim it does — not even close."

Last week, Lee said that if the bill doesn't include substantial budgetary and spending reforms, it "will not face smooth sailing in the Senate."

McConnell has pledged the nation will not default on its debts but he also has a responsibility as leader to help Republican colleagues who want to amend the legislation, which could delay it past the June 5 “X-date.”   

The Senate must act swiftly and pass this agreement without unnecessary delay,” he said in a statement Sunday. -The Hill

Rand Paul, meanwhile, says he won't vote for any bill to raise the debt ceiling that doesn't balance the federal budget in five years - which would require over $500 billion in future cuts.

"To us, it doesn’t look like cuts at all. In fact, spending will go up every year under that debt plan," he said of the Biden-McCarthy deal, adding "Mandatory spending is enormous; it’s over half of the spending every year. It’s going up at five percent a year."

That said, Paul says he won't use procedural amendments to slow down passage of the debt bill, which caps federal spending for two years, and allows Congress to decide how to meet those targets at a later date.

Also opposing the current deal are Sens. Rick Scott (R-FL) and Mike Braun (R-IN).

"This bill leaves us with trillions more in debt & no clear path to less inflation or a balanced budget. I appreciate the work @SpeakerMcCarthy did to try & negotiate a good deal when @JoeBiden refused to engage, but I cannot support this bill," Scott tweeted Tuesday.

Braun, meanwhile, told reporters that he wouldn't vote for the bill unless it similarly contains major changes and amendments, adding that he won't object to speeding up the debate on the legislation if he and his GOP colleagues can submit amendments - even if they're unlikely to pass.

"You want amendments because you know they’re not going to pass, let’s be real here. The Democrats and the neo-cons in our party are going to get this thing across the finish line, but I want the process of being able to amend it. To me, that is a step in the right direction, because this all gives information to the public in terms of what could be done, even though it doesn’t get incorporated," said Braun.

Other GOP Senators on the fence include John Cornyn, John Kennedy and Mike Rounds.

"From my perspective, there’s not really anything to support until the House passes the bill. I’m waiting to see what the House sends us," said Cornyn.

https://www.zerohedge.com/political/debt-deal-inches-towards-senate-mcconnell-prepares-battle-conservative-holdouts

Ionis: late-stage clinical progress in hereditary angioedema

 

  • Two-year treatment with donidalorsen in the Phase 2 open label study resulted in consistent, sustained protection from HAE attacks
  • Completed enrollment in the Phase 3 OASIS-HAE study
  • Topline Phase 3 results expected in H1 2024

Aviceda starts Phase 2 for macular degeneration therapy

 Aviceda Therapeutics, a private clinical-stage biotech company focused on developing next generation immuno-modulators by harnessing the power of glycobiology to alleviate chronic, non-resolving inflammation, announced the dosing of its first patient with AVD-104 in its Phase 2 SIGLEC Trial today by Ashkan Abbey, MD of Texas Retina Associates in Dallas. This lead intravitreal asset is a novel glycan-coated nanoparticle, supported by a uniquely strong pre-clinical in vivo efficacy and safety profile, used for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). “I am honored to be the first to dose a new agent that we hope will usher in a generation of safe treatments for GA with better outcomes than were ever possible before,” said Dr. Abbey.

https://www.biospace.com/article/releases/aviceda-announces-dosing-of-first-patient-with-avd-104-a-novel-glyco-mimetic-nanoparticle-for-the-treatment-of-geographic-atrophy-from-macular-degeneration-in-the-phase-2-siglec-trial/

Arcturus fast tracked for liver enzyme deficiency treatment

 Arcturus Therapeutics, Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company’s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency.

Fast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs. Programs granted Fast Track Designation may receive important benefits including more frequent interactions with FDA review teams and the ability to obtain rolling review of a Biologics License Application (BLA). In addition, BLA applications may receive a priority review, with the FDA aiming to complete its review within six months, instead of the standard ten months review timeline.

https://www.biospace.com/article/releases/arcturus-therapeutics-receives-u-s-fda-fast-track-designation-for-arct-810-mrna-therapeutic-candidate-for-ornithine-transcarbamylase-deficiency/

More Oath Keepers convicted of sedition in US Capitol attack face sentencing

 Two more members of the far-right Oath Keepers militant group are set to be sentenced on Thursday for seditious conspiracy and other crimes arising from the Jan. 6, 2021, attack on the U.S. Capitol by then-President Donald Trump's supporters.

Federal prosecutors are asking U.S. District Judge Amit Mehta to sentence Roberto Minuta and Edward Vallejo to 17 years in prison each after they were convicted in January alongside two other Oath Keepers members.

If the judge follows that recommendation, those would be the second-longest sentences for any of the 1,000-plus people charged in the Capitol attack that was intended to block Congress from certifying Democrat Joe Biden's November 2020 election victory over the Republican Trump.

Oath Keepers founder Stewart Rhodes, convicted in November of seditious conspiracy and other charges, was sentenced by Mehta last week to 18 years in prison, the longest of any of the sentences. Three co-defendants of Rhodes were given between four and 12 years in prison. Two of those three were acquitted of seditious conspiracy - is a felony charge involving attempting "to overthrow, put down or to destroy by force the government of the United States" - but convicted on other felony counts.

Minuta, who provided a security detail to Trump ally Roger Stone during political rallies on the day of the attack, entered the Capitol with other Oath Keepers and, according to prosecutors, pushed past police officers while screaming obscene language.

In their sentencing memo, prosecutors said Minuta has failed to accept responsibility and has "continued to spread lies and sow distrust in the criminal investigation" by referring to himself and other Jan. 6 defendants as "political prisoners."

Vallejo was not at the Capitol on the day of the attack. Prosecutors said he stayed at a suburban Virginia hotel where the Oath Keepers had staged a "quick reaction force" and stashed firearms to be quickly ferried into Washington if needed.

Attorneys for Minuta and Vallejo are expected to tell the judge on Thursday that the evidence against their clients was thin and did not justify the stiff sentences the prosecution is recommending.

"The government's sentencing statement is a farce," Minuta's attorney William Shipley wrote in his sentencing memo to the judge.

Matthew Peed, Vallejo's attorney, intends to ask the judge to give his client no more time incarcerated beyond the amount he already has served.

Peed sought to shift blame to Trump, who during a speech to supporters shortly before the riot repeated his false claims that the election had been stolen from him through widespread voting fraud and urged them to march on the Capitol and "fight like hell."

"The tragedy of January 6 is that hundreds of lifelong law-abiding people like Edward Vallejo were lied to by the sitting president and told that the certification was an orchestrated assault on our democracy," Peed wrote.

"The people who broke the law that day were not al Qaeda members bombing the World Trade Center or even 'traitors' who consciously chose to attack democracy rather than accept that they validly lost. They were patriotic Americans who believed wrongly - very wrongly - that they were defending democracy against corrupt officials," Peed added.

Joseph Hackett and David Moerschel, co-defendants in the trial in which Minuta and Vallejo were convicted - are due to be sentenced on Friday. They too were convicted of seditious conspiracy and other crimes. The prosecution has recommended a sentence of 12 years in prison for Hackett and 10 for Moerschel.

https://sports.yahoo.com/more-oath-keepers-convicted-sedition-102243131.html