Search This Blog

Sunday, December 8, 2024

Netanyahu Says Israeli Forces Secured Buffer Zone In Golan Heights After Syria's Assad Fell

 By Jack Phillips of the Epoch Times

Israeli Prime Minister Benjamin Netanyahu said that Israel’s military has taken over a buffer zone in the Golan Heights that was established decades ago, after Syrian opposition fighters ended the rule of President Bashar al-Assad’s decades-long reign.

In a statement released by video on Sunday morning, Netanyahu said that the agreement, hashed out in 1974 by Israel and former leader Hafez al-Assad’s regime, “collapsed” on Saturday night because the “Syrian army abandoned its positions.”

The reason Israel seized the territory is because “we have to take action against possible threats” caused by the power vacuum left by the Assad regime’s collapse, he said.

“We gave the Israeli army the order to take over these positions to ensure that no hostile force embeds itself right next to the border of Israel,” the prime minister added. “This is a temporary defensive position until a suitable arrangement is found.”

Netanyahu said Assad’s downfall is a “historic day” for the region, adding that the the new situation in Syria “offers great opportunity but also is fraught with significant dangers.”

His announcement was delivered in Golan Heights.

Syria’s collapse, he also said, is the result of Israeli action against Iran and the Hezbollah terrorist group, which had been allied with both Iran and Assad for years. Iran and several groups loyal to Tehran had long used military bases in Syria, while Israel at times carried out air strikes against those positions over the years.

“It set off a chain reaction of all those who want to free themselves from this tyranny and its oppression,” Netanyahu said.

Israel is extending “a hand of peace to all those beyond our border in Syria: to the Druze, to the Kurds, to the Christians, and to the Muslims who want to live in peace with Israel,” Netanyahu said. “We’re going to follow events very carefully. If we can establish neighborly relations and peaceful relations with the new forces emerging in Syria, that’s our desire.”

“But if we do not, we will do whatever it takes to defend the State of Israel and the border of Israel.”

Assad has not released a statement on his government’s collapse, and it’s not clear where he currently is. Russian officials have said that he departed Syria before opposition fighters took over the country, seizing the capital of Damascus on Sunday morning.

On Sunday, rebel groups and militias cooperating with terrorist group Hay'at Tahrir al-Sham, said they had entered the capital with no sign of army deployments. Thousands of people in cars and on foot congregated at a main square in Damascus waving and chanting, witnesses said.

Leading rebel commander Abu Mohammed al-Golani, an individual who is currently listed by the U.S. State Department as a terrorist who carried out “multiple terrorist attacks throughout Syria” over the years, said there is no room for turning back.

“The future is ours,” he said in a statement read on Syria’s state TV after his forces took over Damascus.

Underscoring the major changes, Iran’s embassy was stormed by Syrian rebels, Iran’s English-language Press TV reported.

Iran’s foreign ministry said Syria’s fate is the sole responsibility of the Syrian people and should be pursued without foreign imposition or destructive intervention.

https://www.zerohedge.com/markets/netanyahu-says-israeli-forces-secured-buffer-zone-golan-heights-after-syrias-assad-toppled

Insulet wins $452m in trade secrets clash

 Insulet has persuaded a jury that rival South Korean company EOFlow stole trade secrets relating to its wearable insulin pump technology, awarding it a whopping $452 million in damages.

The lawsuit revolved around Insulet's Omnipod tubeless insulin pump – used with continuous glucose monitors (CGMs) to create an artificial pancreas system used by diabetics – and claimed that EOFlow's competing EOPatch device infringed three patents held by Acton, Massachusetts-based Insulet on the technology.

The suit also that EOFlow was originally developing an alternative device, but changed direction after stealing Omnipod intellectual property, and headhunted Insulet staff in order to develop EOPatch.

Insulet said in a statement that, after a four-week trial, the jury found that EOFlow and several other defendants misappropriated Insulet's trade secrets.

It awarded the US company $170 million in compensatory damages from EOFlow and an additional $282 million in exemplary damages from EOFlow for "willfull and malicious misappropriation." EOFlow – which strenuously denied the allegations – has not commented on the outcome of the lawsuit. Its shares fell by nearly 30% after the outcome of the trial was announced.

"We are extremely pleased with the jury's verdict, which validates our commitment to protecting our technology and defending our intellectual property against misappropriation and infringement," said Jim Hollingshead, Insulet's president and chief executive.

"We will not only enforce our patents, but also zealously protect our valuable trade secrets, in which we've invested heavily to improve the lives of people with diabetes," he added.

The dispute between the two companies scuppered a $738 million takeover of EOFlow by medical device giant Medtronic, which was first announced in May 2023 before being abandoned a few months later after a federal judge blocked EOFlow from selling its insulin patch pump in the US.

Medtronic said its decision to walk away resulted from "multiple breaches" of the takeover agreement, while EOFlow said efforts to find a solution failed because of "a wide gap between the two companies, given Medtronic's view of uncertainties."

At the time, EOFlow CEO Jesse Kim said: "While the company is facing a legal challenge, the fact that we are one of the only two entirely disposable wearable insulin delivery solutions in the world doesn't change."

EOFlow licensed the EOPatch pump to Menarini in Europe, which was selling it under the GlucoMen Day Pump brand in Germany from August 2022, but withdrew it from sale last year after Insulet was granted a preliminary injunction.

https://pharmaphorum.com/news/insulin-pump-firm-insulet-wins-452m-trade-secrets-clash

'Single mutation could make H5N1 flu a human threat'

 A single mutation in the H5N1 strain of avian influenza that is infecting cattle in the US could make it more likely to infect humans, according to a new scientific paper.

The worrying finding has reinforced the need for close monitoring of H5 flu viruses to try to get ahead of potential mutations that could raise the risk of the emergence of a strain that can be transmitted between humans and cause a major outbreak.

Typically, bird flu viruses require several mutations to adapt and spread among humans, according to the scientists behind the research, led by a group at Scripps Research Institute, which has been published in the journal Science.

The research has focused on a highly pathogenic influenza H5N1 clade 2.3.4.4b virus, which has spread widely in cattle in the US this year and has also caused a few cases in humans, albeit mostly with relatively mild symptoms.

Historically, H5N1 have had mortality rates of up to 30%, according to the authors, but there are currently no documented cases of H5N1 transmitting between people. Cases to date have involved people working closely with animals or consuming contaminated food.

The single mutation discovered by the researchers is in the gene coding for haemagglutinin – the 'H' in flu virus designations – a protein that is used by the virus to bind to glycan receptors on the surface of host cells.

Bird flu viruses like H5N1 mainly infect hosts with sialic acid-containing glycan receptors typically found in birds, and the team is concerned that if they evolve to recognise sialylated glycan receptors found in people, they could gain the ability to infect and possibly transmit between humans.

"Monitoring changes in receptor specificity […] is crucial because receptor binding is a key step toward transmissibility," said Ian Wilson, co-senior author and the Hansen Professor of Structural Biology at Scripps.

Receptor mutations alone don't guarantee that the virus will transmit between humans, he stressed, and other genetic changes would likely be necessary for this to take place.

That said, with cases of H5N1 in humans rising, the discovery highlights the need for proactive surveillance of evolution in H5N1 and similar avian flu strains and that even a single mutation shouldn't be overlooked.

Commenting on the discovery, Professor Ed Hutchinson, of the Medical Research Council-University of Glasgow Centre for Virus Research in the UK, said that the outbreak of bird flu in US dairy herds has provided far more opportunities for the virus to spillover and infect humans.

The new finding is concerning because influenza viruses can acquire mutations and evolve very rapidly.

"Recent studies of the influenza viruses in a Canadian teenager, who has been severely ill for a prolonged period with H5N1 bird flu, implied that the virus had begun to evolve to 'explore' ways of binding more effectively to the cells in their body during the course of an infection," said Prof Hutchinson.

"We do not yet know whether H5N1 influenza viruses will evolve to become a disease of humans," he added. "This study only worked only with purified proteins and did not generate any potentially dangerous viruses, so we also do not know for sure if this mutation has any hidden costs for the virus which might make it harder to acquire."

Nevertheless, he said the research highlights the need for the current outbreak in cattle in the US to be taken extremely seriously and for every effort to be made to monitor the evolution of the virus.

https://pharmaphorum.com/news/single-mutation-could-make-h5n1-flu-human-threat

'Potential of GLP-1s in Alzheimer’s'

 

The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk.

Data from two recent studies showed that Novo Nordisk’s GLP-1 drugs semaglutide (marketed as Ozempic and Wegovy) and liraglutide could help protect against Alzheimer’s disease or cognitive decline in Alzheimer’s, sparking hope that the trendy therapeutic class could offer a new weapon in medicine’s arsenal against the memory-robbing disorder.

The more recent paper, published in Alzheimer’s and Dementia in October, described a real-world study showing that patients with type 2 diabetes taking semaglutide had a 40% to 70% reduction in the risk of Alzheimer’s disease diagnosis. This followed results from a Phase II trial of liraglutide, Novo’s older GLP-1 (sold as Saxenda in obesity and Victoza in type 2 diabetes), demonstrating slower decline in cognitive function among patients on the drug compared with placebo. These data were announced at the Alzheimer’s Association International Conference in July.

“I think we are at the verge of a revolution,” said Christian Hölscher, co-founder and chief scientific officer at neurodegeneration-focused Kariya Pharmaceuticals, which is developing GLP-1 treatments.

Neuroscientist George Perry of the University of Texas at San Antonio was more cautious in his evaluation of the drug class for Alzheimer’s, speculating that if there is a role for GLP-1s in this space, it would be preventative, though he didn’t rule out the idea that GLP-1s could be disease-modifying. “I think there’s some evidence . . . that there’s really a profound metabolic change in the person during Alzheimer’s disease,” he said. If GLP-1s could reverse this, “that would be really exceptional, but I don’t think there’s any evidence for that.”

While preclinical studies have shown benefits of GLP-1 receptor agonists in targeting the core pathology of Alzheimer’s disease, data from clinical studies are limited, according to an article recently published in the Journal of Alzheimer’s Disease Reports. That’s set to change next year, however, when Novo is expecting readouts from two large Phase III trials, EVOKE and EVOKE Plus, testing semaglutide in patients with Alzheimer’s. Both trials are expected to be completed in September 2025.

“I’m confident that we will see some effects in the Novo Nordisk trials . . . because everything we’ve seen so far supports this concept,” Hölscher told BioSpace. “We know this is a worthwhile target and it definitely should be pursued.”

The Diabetes-Alzheimer’s Connection

The idea of using GLP-1s for Alzheimer’s isn’t out of left field, noted Graig Suvannevejh, senior biopharmaceuticals and biotechnology equity research analyst at Mizuho Americas. There has always been an interest in whether drugs that are used for diabetes and targeting metabolic disease and endocrine disease pathways could have an impact on Alzheimer’s disease, he told BioSpace.

While there is much debate about what actually causes the disorder, Perry said there is an “intersection of diabetes and midlife obesity with Alzheimer’s disease.”

Indeed, several studies have suggested the connection between insulin resistance and Alzheimer’s. The hypothesis has even led to Alzheimer’s disease being dubbed “type 3 diabetes.” Multiple observational studies and meta-analyses have also linked type 2 diabetes to an increased risk of Alzheimer’s.

“There’s no doubt there’s increasing insulin resistance with aging across the whole body,” meaning that cells fail to take up glucose in response to the hormone, Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation (ADDF), previously told BioSpace. “When there’s sub-optimal glucose and highly active neurons have limited access to energy, they dysfunction and ultimately die on a chronic basis.”

If insulin resistance is indeed a contributor to Alzheimer’s, it stands to reason that GLP-1s, which work by stimulating insulin secretion and slowing glucagon release, could help to stave off the disease.

Growing Body of Evidence

While researchers await the results of Novo’s EVOKE and EVOKE Plus studies, the body of evidence for GLP-1s’ potential role in preventing and treating Alzheimer’s is growing.

Perry, who served as an advisor on the October study of semaglutide, urged caution in interpreting the results of the retrospective analysis but said that it “pinpoints the real, clear metabolic dimension to Alzheimer’s disease.”

The results from the Phase II liraglutide trial supported the same hypothesis. With 204 people at multiple sites in the UK randomized to receive placebo or Novo’s drug, the study found that cognitive function in the liraglutide cohort declined 18% slower than in the placebo arm over one year of treatment.

“The slower loss of brain volume suggests liraglutide protects the brain, much like statins protect the heart,” Paul Edison, an Imperial College London professor of science who led the study, said in a statement. While noting the need for further research, Edison said liraglutide may reduce brain inflammation, lower insulin resistance, improve nerve cell communication and limit the harm of amyloid-beta and tau.

Meanwhile, Kariya is developing KP405, a first-in-class, dual GLP-1/GIP receptor agonist, initially for Parkinson’s disease with plans for a study in Alzheimer’s. Hölscher previously told BioSpace that drugs like liraglutide and semaglutide have limitations when it comes to treating diseases of the brain. “They’re actually designed to stay in the blood, which is good for diabetes but bad for Alzheimer’s because a drug that stays in the blood doesn’t get into the brain.” The key, therefore, to applying GLP-1s to dementia is getting the drug where it’s needed.

Kariya has removed “add-ons” such as fatty acids that keep GLP-1s in the blood, allowing its drugs to enter the brain at a higher rate, Hölscher explained. The addition of a TAT sequence that is recognized by cell membrane receptors further enable the drug to reach the brain faster, according to Kariya.

Hölscher credited these modifications for helping KP405 to avoid certain side effects linked to GLP-1s in the Phase I Parkinson’s study. “The GLP-1s, the ones designed to treat diabetes, they can cause nausea and stomach upset and all kinds of side effects,” he said. Because KP405 doesn’t stay in the bloodstream, “the peripheral effects are very little.”

As for Novo’s top GLP-1 competitor Eli Lilly, while there are no studies of tirzepatide in Alzheimer’s listed on the ClinicalTrials.gov database, Suvannevejh said it would be a natural fit for a company “whose entire existence is focused on neurology and neuroscience and Alzheimer’s disease.” Lilly’s monoclonal antibody Kisunla was approved in July, becoming the third disease-modifying treatment for the condition and the second actively on the market.

Eli Lilly did not respond to BioSpace‘s request for comment.

Still To Prove

Despite the positive signs in certain studies, experts agree that GLP-1s still have a ways to go to prove their worth in Alzheimer’s.

Perry said the class will need to show that it can really make a difference in lowering the incidence of the disease—something that requires analyzing large populations in random, controlled trials with patients—but that’s easier said than done. “The cost and even the practicality of doing the trial really becomes difficult . . . because how do you follow a bunch of 60-year-old people that have really a low chance of transitioning to Alzheimer’s disease?”

Another potential hurdle is safety. “One of the things [GLP-1s] need to show is if they’re safe for chronic use,” Perry said. “To be effective for Alzheimer’s disease, at least the paradigm I would imagine is that people would take this drug continuously . . . therefore you have to worry about side effects.”

But Hölscher also expressed concern with anti-amyloid antibodies like Kisunla and Biogen/Eisai’s Leqembi. “The antibodies are too toxic, and the effect in patients is so small that it is unlikely that patients even notice a difference.”

He made a bold prediction regarding Novo’s EVOKE and EVOKE Plus studies: “If those trials show even a small effect, the amyloid strategy will be dead in the water.”

https://www.biospace.com/drug-development/evidence-mounts-for-potential-of-glp-1s-in-alzheimers-disease

FDA Action Alert: Ionis, Lexicon, AstraZeneca/Daiichi Sankyo

 

The FDA’s year-end rush includes ten target action dates, mostly for rare disease and cancer therapies.

The FDA is ending 2024 with a bang. In the coming weeks, the regulator is set to decide on ten drug applications, many of them for rare and genetic diseases. The regulator will also release verdicts on a couple of notable cancer therapies.

Read below for more.

Ionis Awaits Verdict for RNA Medicine in Familial Chylomicronemia Syndrome

Ionis Pharmaceuticals is advancing the investigational RNA-targeted therapy olezarsen for the treatment of familial chylomicronemia syndrome (FCS). The FDA’s decision is due on December 19.

Diagnosed in between 1 and 13 per million people in the U.S., FCS is a rare, genetic disease involving elevated concentrations of triglycerides. People with FCS have a dysfunctional lipoprotein lipase enzyme and are unable to break down a specific form of lipoprotein, in turn suffering from a heightened risk of acute pancreatitis. Olezarsen addresses a core cause of FCS by decreasing the production of the apoC-III protein, which is involved in triglyceride metabolism.

To support its New Drug Application (NDA), Ionis filed data from the Phase III Balance study, which in April demonstrated a 44% placebo-adjusted drop in triglyceride levels after 6 months. This effect was statistically significant, with a p-value of less than 0.001.

Lexicon Eyes Type 1 Diabetes Approval for Sotagliflizon

After an overwhelming advisory committee meeting loss, Lexicon Pharmaceuticals now awaits the FDA’s verdict on its proposal to use sotagliflozin as an adjunct therapy to insulin for type 1 diabetes. The regulator’s deadline is December 20.

Sotagliflizon blocks the SGLT2 and SGLT1 proteins, both of which play central roles in the absorption of sugar in the kidney and gut. In three Phase III trials, add-on sotagliflozin elicited A1C reductions between 0.35% and 0.46% versus placebo—effects that Lexicon in a briefing document in October called “statistically significant benefits.

However, external experts on the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee flagged uncertainties regarding sotagliflozin’s risk-benefit profile in this indication, and wanted to see more data for the drug, particularly in patients with mild or earlier-stage kidney damage.

Zynquista had previously been approved in Europe for type 1 diabetes, but Guidehouse Germany GmbH, which holds rights to the drug in the region, withdrew its marketing authorization in 2022.

AstraZeneca, Daiichi Sankyo Propose Dato-DXd for Non-Squamous NSCLC

By December 20, the FDA is scheduled to release its verdict on AstraZeneca and Daiichi Sankyo’s investigational anti-TROP2 antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd), which the partners are proposing for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

The companies are backing their application with data from the Phase III TROPION-Lung01 study, which in October 2023 demonstrated a 37% reduction in the risk of disease progression or death in the non-squamous NSCLC population, as compared with docetaxel. A follow-up readout in September, however, showed that Dato-DXd’s overall survival (OS) benefit of 16% fell short of statistical significance.

Despite the OS miss, Jefferies analysts in a September note expressed their belief that Dato-DXd’s chances of approval “remain high,” given the significant progression-free survival benefit.

Zealand Eyes Short Bowel Syndrome Nod for GLP-2 Analog

Zealand Pharma is proposing its investigational GLP-2 analog glepaglutide for the treatment of short bowel syndrome (SBS) in patients on parenteral support. The FDA’s decision is due on December 22.

SBS is characterized by a shortened or damaged small intestine, rendering patients unable to absorb enough nutrients from their food. According to Zealand, there are around 7,500 SBS patients in the U.S. who are dependent on parenteral support and typically suffer from symptoms such as diarrhea, weight loss and fatigue. If left unchecked, SBS can also lead to intestinal failure, which is associated with other severe complications, including liver and kidney failure.

Zealand’s glepaglutide is a long-acting GLP-2 analog that aims to eliminate the need for parenteral support in SBS patients. In the Phase III EASE-1 study, twice-weekly glepaglutide significantly lowered the total weekly volume of parenteral support at 24 weeks, as compared with placebo. Nine patients on glepaglutide were able to completely wean off parenteral support.

Rhythm Seeks Label Expansion for Genetic Obesity Injection

Rhythm Pharmaceuticals is proposing to expand the label for its injection Imcivree (setmelanotide) to children as young as 2 years with certain genetic forms of obesity. The FDA is expected to release its verdict by December 26.

Imcivree is a melanocortin-4 receptor agonist that won FDA approval in 2020 for chronic weight management in patients aged 6 years and up who have monogenic or syndromic obesity due to a deficiency in the pro-opiomelanocortin (POMC) peptide, the proprotein convertase subtilisin/kexin type 1 (PCSK1) enzyme or the leptin receptor (LEPR). In June 2022, Rhythm secured another FDA approval for Imcivree, this time in Bardet-Biedl Syndrome (BBS), a genetic disorder also characterized by obesity.

Currently, however, Imcivree is only indicated for patients aged 6 years and up. Rhythm’s expansion bid is supported by data from a multicenter, open-label Phase III study in 12 pediatric patients with obesity due to biallelic POMC/PCSK1 or LEPR deficiency, or a clinical diagnosis of BBS. Data showed that Imcivree lowered body mass index by an average of 18.4% in these patients.

Checkpoint Tries Again for Cosibelimab Approval in Skin Cancer

Following a previous rejection, Checkpoint Therapeutics is again seeking approval of its PD-L1 blocker cosibelimab, which it is developing for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). The FDA has until December 28 to release its decision.

Checkpoint is backing cosibelimab with data from a pivotal trial, which in January 2022 demonstrated a 47.4% confirmed objective response rate (ORR) in patients with metastatic cSCC. Interim data from the patients with locally advanced disease showed an ORR of 54.8%. Checkpoint used these data to file its first Biologics License Application for cosibelimab, which the FDA accepted in March 2023.

In December 2023, however, the regulator handed Checkpoint a Complete Response Letter, citing concerns around a third-party contract manufacturing organization. Importantly, the FDA did not identify issues with the biotech’s data package, nor did it flag problems with cosibelimab’s safety.

Mirum Awaits Approval in Rare Metabolic Disease

By December 28, the FDA is expected to release its decision on Mirum Pharmaceuticals’ oral drug candidate chenodiol for the treatment of the rare metabolic disease cerebrotendinous xanthomatosis (CTX).

Caused by mutations in the CYP27A1 gene, CTX is a progressive and underdiagnosed condition of impaired cholesterol metabolism that affects various organs. It is characterized by a dysfunctional sterol 27-hydroxylase enzyme, which leads to the pathologic accumulation of toxic byproducts such as cholestanol and bile alcohols. Common signs of CTX include chronic diarrhea, jaundice or bile flow interruption in newborns and neurological problems.

Mirum’s chenodiol, designed to be administered orally in tablet form, works by dissolving the buildup of toxic cholesterol. Its regulatory application is backed by data from the Phase III RESTORE trial, which found that chenodiol can significantly reduce bile alcohol levels in patients while also improving serum cholestanol concentrations.

BMS Eyes First Subcutaneous PD-1 Therapy With Opdivo Expansion

Bristol Myers Squibb is proposing a subcutaneous formulation of its PD-1 blocker Opdivo (nivolumab), for which the FDA is expected to announce its verdict by December 29.

Opdivo is currently approved for intravenous administration and is indicated for several cancers, including melanoma, non-small cell lung cancer and renal cell carcinoma. BMS is seeking to have a below-the-skin injection of Opdivo cleared for all previously approved adult solid tumor indications of its intravenous version.

To support its application, BMS filed data from the Phase III CheckMate-67T, which in October 2023 found the subcutaneous therapy to be non-inferior to the intravenous formulation in terms of time-averaged and trough serum concentrations at steady state, as assessed in patients with advanced or metastatic clear cell renal cell carcinoma. Subcutaneous Opdivo also achieved non-inferiority for overall response rate.

If approved, Opdivo would be the first subcutaneous PD-1 therapy on the market, giving it an important edge over its biggest competitor, Merck’s Keytruda (pembrolizumab), which is currently approved only as an intravenous therapy.

Neurocrine Seeks First New Congenital Adrenal Hyperplasia Approval in 70 Years

Neurocrine is proposing crinecerfont, an investigational CRF1 antagonist, for congenital adrenal hyperplasia in adults and children. The FDA is scheduled to release its decision on crincerfont’s capsule formulation on December 29 and oral solution formulation on December 30.

CAH is a rare, genetic condition that disrupts the balance of certain crucial adrenal hormones, including the adrenocorticotropic hormone (ACTH). CAH is currently managed using glucocorticoids, which at high doses can result in complications such as steroid excess, osteoporosis and diabetes. Crinecerfont is a selective blocker of the CRF1 receptor, allowing it to help prevent excess ACTH levels and control other adrenal androgens without the need for glucocorticoids.

In the Phase III CAHtalyst study, crinecerfont treatment led to significant reductions in androstenedione levels in both the adult and pediatric cohorts. In turn, patients were able to taper their glucocorticoid doses without compromising androstenedione control.

https://www.biospace.com/fda/fda-action-alert-ionis-lexicon-astrazeneca-daiichi-sankyo-and-more

Rand Paul Warns Musk & Ramaswamy About The Swamp's Upcoming DOGE Dodge

 Sen. Rand Paul (R-KY) warned Department of Department of Government Efficiency (DOGE) co-heads Elon Musk and Vivek Ramaswamy that Senate Republicans are moving to allow the Department of Defense, which has failed seven audits in a row, to exceed its spending limits. The Kentucky Republican highlighted the issue this week on Fox News’s 'The Ingraham Angle.’

LAURA INGRAHAM: I know you have been constantly focused on this, and you have been with Vivek this week. What ideas have you given him because he is looking to you for ideas, other than, of course, as we were saying, getting the federal workers.

SEN. RAND PAUL: One of my favorite examples of federal workers not showing up is from a few years ago. We had an assistant to the head of the EPA, and he told his boss that he also worked for the CIA. He said he would be gone for six months at a time. Finally, during a government shutdown, someone said, "Hey, Mr. Smith, we understand this guy works for you. We haven’t seen him in six months." They replied, "Who?" They had never heard of the guy.

The man completely made up a story about working for the CIA, and for nearly a decade, millions of dollars were paid to him while he didn’t show up. He’d be lounging around saying, "I’m on a secret mission to the Middle East, can’t talk." That kind of stuff runs rampant throughout government.

People say you can’t balance a budget by making people go back to work, but you certainly can start. When Elon Musk told Twitter employees to go back to work, a third of them quit—they weren’t used to working. Then, when he told them they’d have to do overtime, another third quit. You can get rid of a lot of people, and that saves a lot of money.

There are many rules that protect federal workers, but some of these need to change, and we need to outsource certain things. I had it out with the Postmaster General the other day. Two years ago, the Postal Service lost $6.5 billion. Last year, they lost $9.5 billion. The only way to fix this is to implement better rules that require accountability. You can’t keep hiring more government employees. You have to make them nongovernmental employees.

LAURA INGRAHAM: How difficult is that process? Everybody knows that Elon Musk and Vivek Ramaswamy are both brilliant individuals. They are extremely capable—obviously, Elon is the richest person in the world. Washington, however, is its own beast. As smart as they are, getting stuff done will be a challenge. A lot will rest with you in Congress.

SEN. RAND PAUL: One of the big things Elon did with SpaceX to reduce costs was to move away from cost-plus contracts to competitive contracts. I think that can be done by the executive branch. They can lay off people, downsize, and switch to competitive contracts. Is that going to balance the budget? Not alone.

I’m for getting rid of all this waste. When the federal and state governments cut welfare, aid, and food stamps, the states need to take on more responsibility. Because the Federal Reserve and our debt are financing the federal portion, states will have to become more fiscally responsible. They’ll either need to raise taxes to fund benefits or be more conservative about who qualifies.

To be clear, I’m for looking at entitlements, waste—everything—because it’s such an enormous problem. If you put the military off the table and entitlements off the table, you’re left with only 16% of the budget. Even if you eliminate that, you don’t get anywhere close to balancing the budget. So, while I’m for eliminating waste, I’m also for reviewing all spending.

LAURA INGRAHAM: The Pentagon, which I mentioned, has so much waste and so many duplicative initiatives inside the Defense Department. They fail the audits year after year. Have you been on top of this? Republicans, frankly, have been rubber-stamping the Pentagon budget for decades. That has to change.

SEN. RAND PAUL: It's worse than that, Laura. Right now, the first budget reconciliation that the Republicans are proposing is to bust the Pentagon caps. We have military spending caps, but spending is still going upwards. All the old guardrails in the Senate—you know who they are—are going to bust the military caps with their first budget reconciliation. Same as the first budget.

https://www.zerohedge.com/political/rand-paul-warns-musk-ramaswamy-about-swamps-next-outrageous-spending-spree

WuXi Companies Surge on Slimmer Chances of US Biosecure Passage

 

Shares of WuXi AppTec Co. and WuXi Biologics Cayman Inc. surged Monday, after a draft US legislation targeting the Chinese biotechnology service firms was left out of a key defense bill.

WuXi AppTec’s shares rose as much as 12% in early trading in Hong Kong on Monday, lifting the stock to the highest level in two months. WuXi Biologics gained as much as 13%, while MGI Tech Co. climbed 4.3% in Shanghai.

https://www.bloomberg.com/news/articles/2024-12-09/wuxi-companies-surge-on-slimmer-chances-of-us-biosecure-passage