Justice Department to take abortion pill fight to Supreme Court: Garland

 The Justice Department on Thursday said it would take the fight over an abortion pill to the Supreme Court after an appeals court ruling that would restrict access to the widely-used abortion pill mifepristone.

The appeals court ruling was set to take effect early Saturday morning.

"The Justice Department strongly disagrees with the Fifth Circuit's decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal. We will be seeking emergency relief from the Supreme Court to defend the FDA's scientific judgment and protect Americans' access to safe and effective reproductive care," Attorney General Merrick Garland said in a statement.

The federal appeals court late Wednesday partially blocked an unprecedented ruling by a single federal judge in Texas last week would reverse the Food and Drug Administration's approval of mifepristone.

The appeals court granted the Justice Department's emergency request to put on hold U.S. District Judge Matthew Kacsmaryk's decision to suspend the FDA's initial authorization of mifepristone back in 2000, citing the the statute of limitations.

However, the three-judge panel determined that other parts of Kacsmaryk's ruling, which suspends changes the FDA later made to mifepristone's approved use and halts distribution of the drug by mail, could still go into effect at the end of the day Friday.

The challenge to mifepristone's FDA approval stems from a lawsuit filed in Amarillo, Texas, in November 2022 by Alliance Defending Freedom, an Arizona-based conservative Christian legal advocacy group working to outlaw abortion.

The case was assigned to Kacsmaryk, who was appointed to the federal bench in 2019 under former President Donald Trump and is currently the sole judge seated in the Amarillo division of the U.S. District Court for the Northern District of Texas.

https://www.yahoo.com/gma/justice-department-abortion-pill-fight-155100459.html

Russia's Navalny has mystery ailment which may be slow poisoning

 Alexei Navalny, Russia's most prominent opposition politician, is grappling with severe stomach pain in jail that could be some sort of slow acting poison, his spokeswoman said on Thursday.

An ambulance was called for Navalny overnight on Friday to Saturday to the maximum security IK-6 penal colony at Melekhovo, about 250 km (115 miles) east of Moscow, where he is being held. Kira Yarmysh, his spokeswoman, told Reuters.

Navalny was suffering from severe stomach pain, she said, and could not eat the prison food provided to him because it was making his pain worse and since Monday has has been banned from buying alternative food.

"He doesn’t eat anything because he is prohibited from receiving parcels with food or to buy food in the prison store and the food that is provided by the prison to him actually worsens his stomach pain," Yarmysh said in English.

"His health is not a good condition," she said. "We can't rule out the idea that he is being poisoned, not in a huge dosage as before, but in small ones so that he doesn't die immediately but for him to suffer and to ruin his health."

Yarmysh said there was no definitive proof of the poisoning theory but that he had never had such stomach pains before. She said she was terrified for him because there was almost no contact with him and he was not receiving proper medical care.

When asked about claims that Navalny might be being slowly poisoned, the Kremlin said it was not following the state of his health and that it was a matter for the federal penitentiary service.

The penitentiary service, which has in the past denied allegations that its employees have mistreated Navalny and has said he has always been afforded medical treatment when needed, did not immediately respond to a Reuters request for comment.

Navalny, who is serving combined sentences of 11-1/2 years for fraud and contempt of court on charges he says were trumped up to silence him, said via Twitter on Tuesday that he had been moved back into solitary confinement and forced to endure "extremely hellish" conditions.

https://news.yahoo.com/russias-navalny-mystery-ailment-may-075104411.html

Airlines, repair shops in N. America eye used, generic parts to keep aircraft flying

 Airlines and aircraft repair shops in North America are increasingly relying on used and generic parts to keep jets flying, a symptom of the rising costs and supply-chain shortages plaguing the aerospace industry.

These alternatives to new parts made by the original manufacturer must be certified and deemed safe. While they account for a fraction of the estimated $35 billion spent annually on components for repairs, sales are growing, analysts and executives say.

Driving demand is the struggle aerospace suppliers face to fill new orders as air traffic soars and the supply chain for aircraft parts recovers from the COVID-19 pandemic, when labor shortages and lockdowns slowed production.

Higher costs and a shortage of available new parts are also delaying aircraft repairs, which risk pushing up air fares.

That has spurred demand from airlines and repair shops for alternatives that cost roughly 20% to 40% less than new parts, analysts and executives said. Some makers of brand-name parts like General Electric Co stand to benefit because they also sell used parts, known as used serviceable material.

Some planemakers are also benefitting. Business jet maker Bombardier Inc uses a teardown venture to gain parts for its growing "aftermarket" business that provides maintenance and repairs for planes.

The venture has helped the company source parts for older aircraft models that are harder to find in the current market, or are no longer being produced, a spokesman said.

American Airlines, meanwhile, says it has helped develop certified parts that were not made by the original manufacturer to mitigate "increased costs and other supply chain constraints."

Companies spent $35 billion in 2019 on materials for aviation repairs and overhauls, including $5 billion on used parts and $725 million on generic components, aerospace specialist Naveo Consultancy estimates.

It declined to disclose figures for the following years, but analysts at Naveo and others say demand for alternatives to new parts is rising.

https://finance.yahoo.com/news/airlines-repair-shops-n-america-100854899.html

Intellia started at Buy by Canaccord

 Target $66

https://finviz.com/quote.ashx?t=NTLA&ty=c&ta=1&p=d

Lantern Gets Notice of Allowance for Composition of Matter Patent for Blood Cancer Med

 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for U.S. patent application no. 17/192,838 directed to Lantern Pharma’s drug candidate LP-284 ((+)N-hydroxy-N-(methylacylfulvene)urea). The allowed application entitled "Illudin Analogs, Uses Thereof, and Methods for Synthesizing the same" covers the molecule LP-284, including claims covering the new molecular entity itself. A notice of allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed and grants the patent upon payment of the patent issuance fee.

https://finance.yahoo.com/news/lantern-pharma-receives-notice-allowance-113000082.html

Biden Says Feds 'Getting Close' To Finding Leaker As "Young Gamers" On Discord Theory Emerges

 President Biden announced Thursday while speaking to reporters that US authorities are "getting close" to uncovering the source of the leak of a trove of sensitive Pentagon documents which defense officials say contain "sensitive and highly-classified material." They been subject of widespread reporting over the past days, despite the White House urging media not to publish their contents.

"I can’t right now [give an update]. There is a full-blown investigation going on with the intelligence community and Justice Department and they are getting close," Biden said during his trip to Ireland. "I don’t have an answer for you." 

The president added: "I’m concerned that it happened but there is nothing contemporaneous that I’m aware of that is of great consequence." 

Separately a White House official said the administration has "taken steps to further restrict access to sensitive information" as Pentagon chief Lloyd Austin stressed he'll 'turn over every rock' to find the leaker.

All of this comes as The Washington Post has published a report claiming that a young man in his 20s who worked on a military base posted the classified reports in a Discord chat room. But the report presents little in the way of evidence, only a teenage source who is said to be a friend of the leaker. However the teenage source has reportedly refused to disclose the identity or location of the alleged leaker: 

The man behind a massive leak of U.S. government secrets that has exposed spying on allies, revealed the grim prospects for Ukraine’s war with Russia and ignited diplomatic fires for the White House is a young, charismatic gun enthusiast who shared highly classified documents with a group of far-flung acquaintances searching for companionship amid the isolation of the pandemic.

United by their mutual love of guns, military gear and God, the group of roughly two dozen — mostly men and boys — formed an invitation-only clubhouse in 2020 on Discord, an online platform popular with gamers. But they paid little attention last year when the man some call "OG" posted a message laden with strange acronyms and jargon. The words were unfamiliar, and few people read the long note, one of the members explained. But he revered OG, the elder leader of their tiny tribe, who claimed to know secrets that the government withheld from ordinary people.

Some reports suggest the documents then gained wider circulation on the internet in the context of intense debates over the Ukraine war, as users in the Discord group utilized classified docs during online arguments.

According to more from WaPo:

The young member read OG’s message closely, and the hundreds more that he said followed on a regular basis for months. They were, he recalled, what appeared to be near-verbatim transcripts of classified intelligence documents that OG indicated he had brought home from his job on a "military base," which the member declined to identify. OG claimed he spent at least some of his day inside a secure facility that prohibited cellphones and other electronic devices, which could be used to document the secret information housed on government computer networks or spooling out from printers. He annotated some of the hand-typed documents, the member said, translating arcane intel-speak for the uninitiated, such as explaining that “NOFORN” meant the information in the document was so sensitive it must not be shared with foreign nationals.

On the question of whether US authorities believe a foreign government might be behind the leaks, the report has this to offer: 

The source told the Post he believed "OG" only shared the documents to keep members of the group "in the loop" and was not hostile to he U.S. government nor was he working to help another country. 

"He is not a Russian operative. He is not a Ukrainian operative," the source told the Post. 

And yet, again given the sparsity of actual evidence presented - and given this is all coming from a single source based on one particular theory - it's hard to assess whether or not this in fact points to the true leaker. Very likely, the Pentagon and DOJ could be investigating a number of different leads based on multiple working hypotheses.

https://www.zerohedge.com/political/biden-says-feds-getting-close-finding-leaker-young-gamers-discord-theory-emerges

Tenax Prioritizes Development Of TNX-103 For Heart Failure

 

• Tenax Therapeutics Inc 
  TENX-1.59%+ Free Alerts
   has decided to prioritize the Phase 3 testing of TNX-103 (oral levosimendan), with plans to commence a levosimendan Phase 3 study in 2023.
• The move is based on a strategic review process that began in September 2022.
• The decision to prioritize the clinical development of TNX-103 ahead of imatinib is based on several factors, including a growing intellectual property estate that encompasses the use of levosimendan to treat PH-HFpEF in the U.S.
• In March, the United States Patent and Trademark Office (USPTO) granted Tenax a patent for intravenous (IV) levosimendan in patients with PH-HFpEF. 
• This is the second levosimendan patent granted to the company since early 2022 and provides a strong basis for a potentially successful review of a third patent that will specifically cover claims related to TNX-103 (oral levosimendan), which could be granted in 2023.
• Based on an end-of-Phase 2 meeting with the FDA, the agency agreed that one or two Phase 3 clinical studies (depending on the size) with a primary endpoint of change in a 6-minute walk distance over 12 weeks or a single Phase 3 trial with clinical worsening over 24 weeks would be sufficient to demonstrate the effectiveness of levosimendan in PH-HFpEF. 
• The FDA also agreed to a plan to replace weekly intravenous levosimendan dosing with daily TNX-103 (oral) doses in Phase 3 clinical study. 
• Concerning imatinib, the decision to prioritize the Phase 3 testing of levosimendan places the start of a Phase 3 imatinib trial likely outside the 2023 timeframe, pending fundraising to support that trial and other strategic considerations.

https://www.benzinga.com/general/biotech/23/04/31773053/tenax-therapeutics-prioritizes-development-of-tnx-103-for-heart-failure