SpaceX Buys $17 Billion In EchoStar Spectrum To Supercharge Starlink Direct-To-Cell

 Elon Musk's SpaceX struck a deal with EchoStar Corporation for 50 MHz of exclusive U.S. spectrum and global MSS licenses, a move that supercharges its Starlink Direct to Cell service worldwide. 

"This agreement will enable us to develop and deploy our next-generation Starlink Direct to Cell constellation, which will be capable of providing broadband service to cell phones globally," SpaceX wrote in a press release on Monday morning. 

Here's the breakdown of the SpaceX–EchoStar spectrum deal:

• SpaceX is acquiring 50 MHz of exclusive U.S. S-band spectrum (AWS-4 and PCS-H) plus global MSS licenses from EchoStar.

• This spectrum will power next-generation Starlink Direct to Cell satellites, enabling higher bandwidth, optimized 5G protocols, and 100x more capacity than the first generation.

• New satellites will be driven by custom SpaceX silicon and phased array antennas, supporting full 5G connectivity comparable to terrestrial LTE.

EchoStar wrote in a press release that SpaceX is paying $8.5 billion in cash and up to $8.5 billion in SpaceX stock for its AWS-4 and H-block spectrum licenses, adding that the proceeds will be used to "retire certain debt obligations and fund EchoStar's continued operations and growth initiatives." 

Shares of EchoStar jumped 24% in premarket trading and are up 193% year-to-date as of Friday's close. Short interest stands at 12.37% of the float, or approximately 16.4 million shares, with a 6.1-day average trading volume to cover.

Additional color on Starlink Direct to Cell service:

• Service began deployment in January 2024, with early texting and video calling demos on unmodified phones.

• Now at 600+ satellites in orbit, the first-gen constellation provides 4G coverage across five continents, serving 6+ million users—the largest 4G footprint on Earth.

• Operates at 360 km altitude, using regenerative architecture and laser links to integrate with the 8,000-satellite Starlink backbone.

Starlink operations:

• Partnered with T-Mobile, Optus, Telstra, Rogers, KDDI, Kyivstar, and others for global coverage.

• Provided life-saving emergency connectivity during U.S. hurricanes, floods, and wildfires, delivering 1.5 million+ connections and hundreds of emergency alerts.

• Enabled rescues in remote areas.

In recent weeks, SpaceX's Starship rocket deployed the first batch of mock Starlink satellites in space and tested new heat shield tiles on its plunge through Earth's atmosphere, achieving new milestones in preparation to launch next-gen Direct to Cell satellites with EchoStar spectrum that will expand service, speeds, eliminate dead zones, and extend broadband and IoT connectivity to phones worldwide. 

Even though Musk has shown little interest in taking SpaceX public, rumors have circulated about a potential Starlink IPO.

Furthermore, whatever happened to Jeff Bezos' rocket company and space internet company? 

https://www.zerohedge.com/technology/spacex-buys-17-billion-echostar-spectrum-supercharge-starlink-direct-cell

Trump Admin Weighs Annual Chip Supply Licenses For Samsung, SK Hynix In China

 The Trump administration has proposed annual approvals for chipmaking supply exports to Samsung Electronics and SK Hynix's factories in China, potentially replacing the Biden-Harris era waivers that it criticized as a "Biden-era loophole."

Bloomberg reports that the U.S. Commerce Department proposed a one-year "site license" model for South Korean chipmakers, rather than the validated end-user (VEU) waivers.

The annual site licenses would provide more predictability for chipmakers compared to the previous model, which required companies to apply for new U.S. approvals on a shipment-by-shipment basis. 

"Bureau of Industry and Security estimates that these new removals of these entities from the Validated End-User program under the Export Administration Regulations will result in the submission of an additional 1,000 license applications annually, which would be an increase of 495 burden hours," the U.S. Commerce Department wrote in a notice.

According to the federal notice, VEUs are set to expire at the end of the year. 

Here's more color on the potential rule change:

The VEU system granted Samsung and SK Hynix perpetual approval to ship estimated quantities of supplies, based on up-front security and monitoring commitments, to factories in China — where the U.S. has broadly curbed shipments of semiconductors and the tools needed to make them. The Trump team's proposal instead requires South Korea's two largest companies to seek Washington's approval for a year's worth of restricted gear, parts and materials at a time, spelled out in exact quantities, the people told Bloomberg.

That introduces newfound complexity to the process, but also a way for South Korea's top chipmakers to keep operating giant factories in China that churn out components used in everything from smartphones to data centers. U.S. officials have said they don't want to disrupt operations at those facilities, but also won't approve shipments of gear that could be used to upgrade or expand them.

South Korean officials and industry insiders are relieved that a framework exists, but they are frustrated by the added administrative hurdles. Lingering concerns include difficulty in forecasting spare parts needs and the mounting risk of delays if emergency approvals are required.

The takeaway is that the Trump administration seeks a more in-depth understanding of the supply chains of South Korean chipmakers' plants in China amid a multi-front tech war with the world's second-largest economy. 

This revelation comes weeks after South Korea's President Lee Jae Myung visited the White House to meet with Trump, focused on deepening economic ties.

https://www.zerohedge.com/ai/trump-admin-weighs-annual-chip-supply-licenses-samsung-sk-hynix-china

Trial Of Trump Assassination Attempt Suspect Routh Begins

 by Jacob Burg via The Epoch Times,

Ryan Routh, the man accused of trying to assassinate President Donald Trump last year at his South Florida golf course, is set to go on trial in federal court on Sept. 8.

In September 2024, Routh, 59, allegedly entered the grounds of Trump International Golf Club in West Palm Beach, Florida, armed with a semiautomatic rifle. Prosecutors allege that Routh pointed the rifle barrel at a U.S. Secret Service agent while targeting Trump, who was then the Republican presidential candidate.

Routh has pleaded not guilty to multiple charges, including attempting to assassinate a major presidential candidate, assaulting a federal officer, and multiple firearm violations.

Here’s what to know about the trial of the suspect in the second Trump assassination attempt, set to begin on Sept. 8.

Routh Will Represent Himself

U.S. District Judge Aileen Cannon, the same judge who presided over and tossed out Trump’s classified documents case last year, is also handling Routh’s case in Fort Pierce, Florida.

Cannon approved Routh’s request to represent himself at trial during a hearing in July.

Routh requested to represent himself at trial in a June 29 letter to Cannon, claiming that he and his lawyers are “a million miles apart” and that they refused to answer his questions.

He also floated the idea of being used in a prisoner exchange with Iran, China, North Korea, or Russia.

“I could die being of some use and save all this court mess, but no one acts; perhaps you have the power to trade me away,” Routh wrote.

The suspect’s defense counsel, including attorney Kristy Militello, filed a motion on July 23 to terminate representation, saying her “attorney-client relationship” with Routh was “irreconcilably broken.”

Cannon told the defense attorneys that they must remain as standby counsel.

Routh Given Clear Instructions on Court Conduct

During a hearing on Sept. 2, Cannon told Routh that he cannot make any sudden movements while representing himself at trial. While he will be allowed to use a podium while questioning witnesses or speaking to the jury, he will not have free rein in the courtroom, Cannon said.

“If you make any sudden movements, marshals will take decisive and quick action to respond,” Cannon said.

The judge also said that Routh will be dressed in professional business attire for the duration of the trial.

Week one of the trial will begin with jury selection, which is expected to last three days, during which attorneys will question three sets of 60 prospective jurors. Twelve jurors and four alternates must be found before the trial begins. Opening statements will begin on Sept. 11, with prosecutors slated to start presenting their evidence afterward.

While the court has designated four weeks for the trial, attorneys expect it to end sooner.

Defense, Prosecution Plans for Trial

In a court filing ahead of a Sept. 2 hearing, Routh said he wanted to subpoena Trump himself, while suggesting a “beatdown session would be more fun and entertaining for everyone.” He also used a list of insults for Trump, calling the president a “baboon.”

Routh requested Cannon subpoena “every single person that had something negative to say about Ryan Routh” in another filing on the same day.

“Please put them on the stand under oath and lets see who lies, themor [sic] the FBI,” Routh wrote.

In response, Cannon denied Routh’s new witness requests after approving four previously, and said nothing the defendant has written suggests a “subpoena to President Trump would be relevant or necessary to prepare an adequate defense.” Routh also tried to subpoena a former lover, alleging her romantic experience with him “evidences his purported peacefulness, gentleness, and nonviolence.”

Cannon referred to the request as a “farce to bring about obviously ludicrous and absurd results in a court proceeding.”

The judge on Sept. 2 also unsealed the prosecution’s 33-page list of exhibits, which may be introduced as evidence during Routh’s trial. The list says that prosecutors possess photos of Routh holding the same model of semiautomatic rifle that was found at Trump’s golf club in September 2024, when the assassination attempt occurred.

The list also contains electronic messages sent from a cellphone that law enforcement found in Routh’s car on the day of the attempt. In one that was dated two months prior to his arrest, Routh allegedly requests a “missile launcher.” The document also accuses Routh of sending a message in August 2024 seeking “help ensuring that [Trump] does not get elected.”

In that message, Routh allegedly offered to pay an unnamed person to track the location of Trump’s airplane with flight tracking apps.

The exhibit list also references a message about an electronic “chat about sniper concealment” during the assassination of President John F. Kennedy, and internet searches for how long gunpowder sticks to clothing and for responses by the U.S. Secret Service to assassination plots.

https://www.zerohedge.com/political/trial-trump-assassination-attempt-suspect-begins-what-know

'WHO Adds GLP-1s to List of Essential Medicines'

 

The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries.

The World Health Organization has placed GLP-1 therapies for diabetes and obesity on its Model Lists of Essential Medicines and Essential Medicines for Children, highlighting the importance of maintaining access to such treatments.

The WHO’s updated model list now includes Novo Nordisk’s semaglutide, dulaglutide and liraglutide, alongside Eli Lilly’s tirzepatide. Model lists, according to the agency’s news release on Friday, serve to “promote better access to medicines in developing countries.” More than 150 countries use these lists to guide procurement, insurance coverage and other policies.

Obesity and diabetes, according to the WHO, are “two of the most urgent” public health problems today, with more than 1 billion people worldwide affected by obesity. Both conditions are also linked to other health problems, including cardiovascular and kidney diseases. Recognizing this, the WHO, in remarks made in the Journal of the American Medical Association in December 2024, acknowledged the potentially “transformative” impacts of GLP-1 therapies for obesity care, while warning at the time that their rapidly rising use could lead to “distorted” care.

By May this year, the agency was already having internal discussions on whether to include GLP-1 drugs in its Essential Medicines list, according to reporting from Reuters at the time. A key issue the WHO raised was pricing—branded versions of both semaglutide and tirzepatide can cost upwards of $1,000 per month—which keeps these GLP-1 therapies out of reach for many patients in poorer countries.

The WHO revisited these concerns in its news announcement on Friday, arguing that the “high prices of medicines like semaglutide and tirzepatide are limiting access to these medicines.” Strategies to improve access, the agency continued, include making these drugs available in the primary care setting and encouraging generic competition.

There may be progress on the latter front. Late last month, Teva Pharmaceuticals won the FDA’s approval for the first GLP-1 generic for obesity. The drug, which is a copycat version of Novo’s liraglutide, has already been launched in the U.S. Like its branded reference product, it is indicated for patients 12 years and up. Teva in December 2024 also won an approval for a liraglutide generic for type 2 diabetes.

Aside from GLP-1 drugs, the WHO’s updated Essential Medicines list also includes cancer therapies, a disease that, according to the agency, claims 10 million lives annually. Merck’s Keytruda, Roche’s Tecentriq and Regeneron’s Libtayo were added to the model list.

https://www.biospace.com/policy/who-adds-glp-1s-to-list-of-essential-medicines

Alkermes One Ups Takeda in Narcolepsy, Clearing Cognitive Impairments in Mid-Stage

 

Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.

Alkermes’ mid-stage narcolepsy type 1 drug alixorexton improved wakefulness, cognition and fatigue over six weeks, setting up a potential showdown with Takeda in the sleep disturbance space.

Presenting at the World Sleep Congress 2025, the company announced that patients in the Phase II Vibrance-1 trial got statistically significant and “clinically meaningful” improvements in the three key narcolepsy endpoints over a six-week treatment period.

Patients going into the study had mean sleep latency (MSL)—the time from being completely awake to being asleep—of three minutes. On doses of 4 mg, 6 mg and 8 mg of the drug, patients’ MSL went to 24 minutes, 26 minutes and 28 minutes, respectively. Patients on placebo saw no improvement. Patients also reported that cognitive impairment issues fell away completely, with patients on all doses and at all time points reporting “none or minimal” impairment.

Analysts at Stifel viewed the data with cautious optimism. While they didn’t see the improvements in MSL as “the end all be all” of efficacy for the condition, they added that it did best Takeda’s reported Phase III data for TAK-861 by five minutes, or 25%, the analysts wrote in a note to investors Monday morning.

“The cognition data are especially interesting where at baseline, most patients are reporting mild-to-moderate cognitive impairment that ends up being largely resolved,” the analysts added.

Alkermes also beat Takeda in terms of tolerability. Patients “vote with their feet,” as Stifel analysts put it, with only one patient discontinuation in the Vibrance-1 trial. Alixorexton’s side effects, most notably rates of insomnia at 33% for the high doses and 32% for the mid-dose, were lower than in TAK-861, which had a 57% insomnia rate.

Seven of 24 high-dose patients experienced blurred vision as well, though noting the single discontinuation the Stifel analysts said that adverse effect “seems generally benign.”

Takeda did not share data on improvements in cognition or on discontinuation rates, stating that the company would share more data in oral and poster presentations as the World Sleep Congress progressed.

Alkermes’ stock is down about 8.75% in Monday morning trading.

According to Alkermes’ announcement, the company plans to move the drug into Phase III trials by the first quarter 2026. Alkermes is also currently enrolling patients for two Phase II trials, called Vibrance-2 and Vibrance-3, to test alixorexton in narcolepsy type 2 and idiopathic hypersomnia, respectively.

Both alixorexton and TAK-861 are selective orexin 2 receptor agonists, which modulate receptors of orexin, a neuropeptide that directly controls wakefulness in the body through activation of multiple neurological pathways.

https://www.biospace.com/drug-development/alkermes-one-ups-takeda-in-narcolepsy-clearing-cognitive-impairments-in-mid-stage-trial

Merck, Daiichi Sankyo Stage Lung Cancer Rally With ‘Strong’ Pivotal Data for I-Dxd

 

According to analysts, the new data could present a path to accelerated approval for ifinatamab deruxtecan, a product of Merck and Daiichi Sankyo’s troubled ADC partnership.

Nearly half of patients dosed with Merck and Daiichi Sankyo’s ifinatamab deruxtecan responded to the treatment, helping the partners mount a comeback for their antibody-drug conjugate alliance.

Results from the Phase II IDeate-Lung01 study, presented Sunday at the 2025 World Conference on Lung Cancer, showed that the drug, also known as I-DXd, resulted in a 48.2% confirmed objective response rate (ORR) in patients with extensive-stage small cell lung cancer. These data include three complete responses and 63 partial responses; 54 of the treated patients achieved stable disease.

Writing to investors on Sunday evening, Jefferies analysts called I-DXd’s performance “strong,” noting, however, that these latest data are “lower” than what Merck and Daiichi Sankyo had toplined at last year’s WCLC. At the time, the partners announced a 54.8% ORR.

According to Jeffries, the difference in the two figures came from Sunday’s data, including patients receiving I-DXd in a third-line setting, which could potentially have “diluted” the therapy’s efficacy figures. Focusing on a subset of participants who received I-DXd in the second-line setting, ORR was 56.3%, which Jefferies said was “impressive.”

Given these findings, as well as the breakthrough therapy designation the drug received from the FDA last month, Jefferies believes that an accelerated approval for I-DXd in this indication could be a “distinct possibility.” The FDA has previously demonstrated regulatory flexibility for small-cell lung cancer, with accelerated approvals for Jazz Pharmaceuticals’ Zepzelca and Amgen’s Imdelltra, both drugs working their way through the accelerated pathway, based on pivotal Phase II data.

Sunday’s pivotal readout represents a much-needed win for Merck and Daiichi Sankyo’s antibody-drug conjugate (ADC) collaboration. The companies linked up in October 2023, when Merck paid $4 billion upfront for access to three investigational therapies for solid tumors. All told, Merck could be on the hook for $22 billion.

In June 2024, however, one of the assets under this partnership, patritumab deruxtecan, failed to win the FDA’s approval for locally advanced or metastatic non-small cell lung cancer. Manufacturing problems stymied the application, the companies announced at the time, insisting that there had been no problems with the molecule’s safety or efficacy.

Then, in May this year, Merck and Daiichi Sankyo decided to pull that application completely, noting that the ADC did not show significant overall survival improvements in a Phase III study. It is unclear if they plan to resubmit an approval application for this asset.

https://www.biospace.com/drug-development/merck-daiichi-sankyo-stage-lung-cancer-rally-with-strong-pivotal-data-for-i-dxd

'FDA Demurs on GLP-1 Compounding Fight, Debuts Consumer ‘Green List’ Instead'

 

While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.

The FDA on Friday revealed a “green list” import alert for GLP-1 ingredients in an effort to slow the use of illegal active pharmaceutical ingredients in compounded versions of the weight loss drugs. While the move was a win for consumers, the action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly.

BMO Capital Markets analysts predicted that the move would pressure both companies’ shares. Novo was down about 1.5% Monday morning to $54, while Lilly dropped about a quarter of a percent to $726.

The green list, issued by the Center for Drug Evaluation and Research (CDER), provides a collection of compounders that have acceptable standards and use APIs from FDA-inspected facilities.

“By strengthening oversight of imported APIs and cracking down on illegal drugs entering the U.S., we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs,” FDA Commissioner Marty Makary said in a statement.

But the FDA did not take a stance against compounders, instead acknowledging the public’s use of these unapproved pharmacy-created medicines. Compounders on the list will get a boost from the listing, while those not listed will be subject to detention without examination.

“While this should stop importation of dangerous product, it shows FDA is not more aggressive in stopping production/sales of counterfeit product,” BMO wrote.

This is great news for consumers, who will have an added bit of certainty that the compounded products they use are safe, BMO added. However, the agency seems to be signaling that “some level of compounded product is acceptable as long as it meets quality standards.”

“It is clear that Novo and Lilly will continue to need to rely on litigation to stop production of compounded product,” BMO wrote.

Novo lowered guidance during its second quarter earnings report in August, partly blaming compounded versions of semaglutide, the key ingredient in its GLP-1 blockbusters, in the U.S. market for the reduction. The Danish pharma has filed 140 lawsuits and issued 1,000 cease and desist letters against GLP-1 compounders, BMO noted.

Novo has not yet taken any legal action against Hims & Hers, its one-time partner in selling branded versions of semaglutide, which is marketed as Wegovy for weight loss. The two companies came together in April to sell Wegovy at a reduced price, only to split months later when Novo accused the telehealth provider of continuing to sell compounded versions.

Should this dispute make it to court, BMO said it could be a “game changer” in the fight against compounders.

Lilly has been less impacted by compounders, although the company has filed lawsuits against medical spas and others involved in compounding.

“Bottomline, the compounded GLP1 saga continues and is unlikely to end anytime soon,” BMO concluded.

The FDA removed Lilly’s tirzepatide from the drug shortage list in December 2024 and Novo’s semaglutide in February this year. Compounders were supposed to cease manufacturing their versions in the months after, but many have continued, buoyed by the consumer-driven market and the vast network of options that essentially have the agency playing whack-a-mole.

https://www.biospace.com/policy/fda-demurs-on-glp-1-compounding-fight-debuts-consumer-green-list-instead