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Saturday, December 6, 2025

BioNTech, OncoC4 Overall Survival Benefit in Squamous Non-Small Cell Lung Cancer



BioNTech (Nasdaq: BNTX) and OncoC4 reported that selective Treg modulator gotistobart (BNT316/ONC-392) showed a clinically meaningful overall survival benefit versus docetaxel in the non-pivotal stage of the global Phase 3 PRESERVE-003 trial in previously treated metastatic squamous NSCLC.

At a 14.5-month median follow-up, median OS with gotistobart was not reached versus 10 months with docetaxel; 12-month OS was 63.1% vs 30.3%. Hazard ratio for death was 0.46 (95% CI 0.25–0.84) with nominal p=0.0102. Safety remained manageable; grade ≥3 TRAEs were 42.2% vs 48.8%.

Legend new Carvykti® data in multiple myeloma, 1st-in-human results in CAR-T in non-Hodgkin

 

  • Triple-class exposed patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median PFS of 50.4 months after a single infusion of CARVYKTI®

  • Translational analyses show stronger immune fitness and a more immunocompetent TME when CARVYKTI® is used earlier in the treatment journey

  • Eighty percent of as-treated patients in CARTITUDE-4 with standard-risk cytogenetics remained progression-free and off treatment at 30 months after a single infusion of CARVYKTI®

  • Promising first-in-human results from allogeneic CAR-T candidate LUCAR-G39D demonstrate encouraging safety and efficacy in B-cell non-Hodgkin lymphoma

Musk denies $800 billion SpaceX valuation reports

 Elon Musk ​on Saturday ‌dismissed media reports that ‌SpaceX is raising funds at an $800 ⁠billion valuation, ‌calling them inaccurate.

"SpaceX has ‍been cash flow positive for many ​years and ‌does periodic stock buybacks twice a year to provide ⁠liquidity for ​employees and ​investors," Musk said in a ‍post ⁠on X.

https://finance.yahoo.com/news/musk-denies-800-billion-spacex-204500593.html

'Data centers rapidly transforming small-town America'

 It’s a digital gold rush as data-center development sweeps through small-town America.

As demand for artificial intelligence, cloud computing and digital storage surges, developers are racing to secure land, power and water.

That growth is becoming increasingly concentrated: nearly 1% of U.S. counties, roughly 33, now account for 72% of all data-center activity as of July 2025, according to a recent Goldman Sachs analysis. But the map is changing almost daily.

One Georgia community is experiencing that shift in real time.

Newton County, about an hour east of Atlanta, is one of four counties that host Meta’s Stanton Springs campus.

FOX Business was granted an exclusive look inside the facility, which opened in 2018 and has continued to expand, with a second campus now under construction. The 1,000-acre site houses eight massive buildings, each roughly the length of four football fields, packed with rows of high-speed servers humming 24/7. The cable network is long enough to reach the moon and back. And it’s where data for Facebook, Instagram, WhatsApp and Meta’s other platforms is processed and pushed at record speeds.

Inside look at Meta's Stanton Springs Data Center.

Technology inside Meta's Stanton Springs Data Center in Social Circle, Georgia. (FOX Business Network)

It’s just one of 26 data centers currently under construction or already in production in the U.S., with even more growth on the horizon.

"I’ve been in the industry for over 20 years, and I've never seen this level of focus on data centers," KC Timmons, director of SiteOps Global Operations at Meta, told FOX Business. "It's innovative. There's so much good that we can do."

Meta’s arrival was largely welcomed, and its investment has become a major economic anchor for the region, creating hundreds of jobs, supporting local contractors and generating long-term tax revenue for schools and public services. The company now employs roughly 400 people in HVAC, electrical, operations and technical roles, most of them hired from the surrounding community.

TickerSecurityLastChangeChange %
METAMETA PLATFORMS INC.673.42+11.89+1.80%

But Meta’s presence now sits alongside the explosive growth the county has experienced just this year. And not everyone is thrilled about it.

"It’s all pie in the sky," Newton County Commissioner LeAnne Long told FOX Business. "It’s not what they say it is. These big developers come in with lucrative promises like zoning, water, electricity. It is the biggest smoke-and-mirror thing you’ve ever seen."

Long, who is also a real estate broker in the region, questions what happens years from now if the industry’s footprint shifts and the massive buildings are no longer needed.

"What happens to the communities that we’ve lost?" Long asked.

Newton County has become one of the most aggressive data center build-out zones in Georgia. Since January alone, local officials say 11 additional data centers are in various stages of planning or construction. Amazon has already begun building on a $25 million acreage purchase – about $50,000 per acre – powered by Georgia Power. And in nearby Social Circle, where Meta is located and which spans both Newton and Walton counties, officials have zoned seven more data-center projects with no long-term land-use plan in place.

Staff inside Meta's Stanton Springs Data Center.

Staff inside Meta's Stanton Springs Data Center in Social Circle, Georgia. (FOX Business Network)

"Some would say we’re building the plane while flying it," Serra Hall, executive director of the Newton County Industrial Development Authority, told FOX Business.

Serra said Meta’s success has drawn a wave of new interest to the region, making strategy and coordination more important than ever. Since the beginning of the year, she says her phone has been ringing off the hook with inquiries from companies looking to build nearby.

Part of the reason the growth is accelerating so rapidly is the county’s access to power, proximity to I-20 and the extensive fiber infrastructure established by Meta. Through the Open Compute Project that Meta co-founded, the initiative to create open-source hardware for scalable and efficient data centers has helped drive down costs. The OCP initiative actively encourages and facilitates more companies to build and adopt high-efficiency data center infrastructure.

"We’re trying to bring everyone to the table and slow things down," Hall said. "It’s about working on the path together. It takes good planning."

Inside Meta's Stanton Springs Data Center.

Meta's Stanton Springs Data Center in Social Circle, Georgia. (FOX Business Network)

The influx of data centers brings benefits beyond jobs. Since 2022, when Meta’s first taxable buildings came online, the company has contributed $12 million in cumulative tax revenue – a number expected to rise as construction continues. Before Meta arrived, the same land had been off the tax digest for nearly two decades under government ownership.

Meta has also launched initiatives to support small businesses, such as workshops teaching local owners how to grow through Instagram Reels. Amazon, meanwhile, has partnered with Newton County Schools and Goodr to open a no-cost grocery store providing students with fresh produce and shelf-stable food.

TickerSecurityLastChangeChange %
AMZNAMAZON.COM INC.229.53+0.42+0.18%

Still, residents say the promises don’t always match their lived experience. Several major manufacturers – including Meta, Rivian and Takeda – have partnered to recycle water back into the community, but concerns persist as the development footprint grows.

"This all has just become so popular since Jan. 1," Long said. "I didn’t even know what a data center was a year and a half ago. We’ve just been bombarded."

Long stressed that Meta itself isn’t the issue – its campus sits in a designated business zone and hasn’t disrupted residential life. Her concern is the wave of newcomers, the risk of future vacant megastructures, and the effect speculative development could have on home values.

For longtime residents, the pace of construction is becoming harder to ignore.

Lisa Miller, 64, lives near land that once held a lumber mill and is now Amazon’s active construction site.

Amazon data center construction site.

An Amazon data center construction site in Oxford, Georgia. (FOX Business Network)

"We’re not a big place," Miller told FOX Business. "People out here are into cattle, horses." The area has shifted among rural, suburban and industrial uses for decades, but never at this speed.

Blasting and heavy construction have also raised safety concerns. Miller described one neighbor’s experience: "She heard the blast – and then her whole living room ceiling fell in."

Amazon told FOX Business its $11 billion investment will enable AI innovation and create thousands of jobs, from network engineers to construction workers, and also give back to the community.

"As we build these facilities over the next several years, we remain committed to being good neighbors," a spokesperson said.

Energy demand is another growing concern. Data centers will use roughly 8% of all U.S. power by 2030, and U.S. utilities will need to invest around $50 billion in new generation capacity to support the facilities, according to Goldman Sachs.

Technology at Meta's Stanton Springs Data Center.

Inside Meta's Stanton Springs Data Center in Social Circle, Georgia. (FOX Business Network)

Despite the anxieties, local leaders and residents agree that the solution isn’t to reject the industry – it’s to slow the pace, coordinate and plan for long-term consequences.

Meta, as the region’s earliest anchor, has committed to supplying more renewable energy than it consumes and becoming water-positive by 2030, aiming to model responsible development.

"If I could say something to the whole nation, it would be: think it through," Miller said. "Plan it. Don’t just stick ’em in every cow pasture that goes up for sale."

https://www.foxbusiness.com/technology/data-centers-rapidly-transforming-small-town-america

The GRANITE Act: How Congress Can Strike Back Against Foreign Censors

 by Preston Byrne,

Please find below the draft text of the GRANITE Act, a bill I have offered to New Hampshire legislators for consideration for enactment in that state. It could serve as a template for a U.S. fightback against global censorship, if adapted for federal use.

It doesn’t really require a ton of explanation.

The gist is simple: the only real defense a foreign censor has from injunctive relief in a U.S. court, as we saw with Ofcom’s recent fine letter to 4chan and the strategy employed by Trump Media and Technology Group’s attorneys in their case against Alexandre de Moraes in the Middle District of Florida, is sovereign immunity.

Foreign countries can bully the shit out of American citizens and companies because they know that U.S. law potentially protects them from consequences for doing so.

We should take that immunity away from them. Such a move would have teeth because these foreign countries’ economies would break down if they didn’t have access to the U.S. banking system. The UK, for example, has £47 billion custodied in North American banks in order to support its currency.

The GRANITE Act makes foreign censorship inbound to the U.S. a very simple cost/benefit exercise for these countries: you can try to censor an American citizen or corporation, but if you do, they can sue you, and you, Mr. Foreign Censor, are not judgment proof because your country needs access to the U.S. financial system to survive.

This also means that trial lawyers will be responsible for protecting Americans’ rights rather than the State Department/the Executive Branch. This will mean that instead of having to deal with nuisance demands from foreign bureaucrats, President Trump can move on to other, more important matters he has proven so very adept at, like bringing the peoples and nations of the world together in peace and harmony, and blame Congress and aggressive American trial lawyers if any foreigner complains about American rules.

I add: the statutory damages are set at a minimum of $10 million because the UK is threatening Americans with fines of $25 million or 10% of global turnover, whichever is greater. That is the scale of the abuse that American citizens currently have to tolerate from these foreign countries.

I have a feeling, if we create consequences for foreign censorship, inbound foreign censorship will stop.

So, I ask Congress: adapt this for federal use. Enact it. If you do this, you will end the foreign censorship problem in a day.

Model Bill – the GRANITE Act

Section 1. Short Title

This Act may be cited as the Guaranteeing Rights Against Novel International Tyranny & Extortion Act (the “GRANITE Act” or the “Act”).

Section 2. Legislative Purpose

The purpose of this Act is to safeguard the constitutional rights of New Hampshire residents against the extraterritorial application of foreign Internet censorship laws that would restrict speech or compel disclosure of information in violation of the Constitution of the United States or the Constitution of the State of New Hampshire.

Section 3. Jurisdiction and Venue

  1. The courts of this state shall have subject-matter jurisdiction over any action brought by a resident or domiciliary of New Hampshire, a New Hampshire corporation, or a person within the State of New Hampshire alleging that a foreign government, or any officer, employee, or instrumentality thereof, has:
    • (a) issued or attempted to enforce any law, judgment, subpoena, or order purporting to regulate speech or conduct protected by the Constitution of the United States or the Constitution of the State of New Hampshire, in each case occurring wholly within the United States; or
    • (b) sought to compel a New Hampshire resident or entity to comply with such foreign law, judgment, subpoena, or order purporting to regulate speech or conduct protected by the Constitution of the United States or the Constitution of the State of New Hampshire.
  2. Personal jurisdiction shall be deemed established whenever the foreign actor directs or transmits any demand, notice, threat, or other communication into the state or to a resident of this state, whether by electronic means or otherwise.

Section 4. Cause of Action and Remedies

  1. Any resident or domiciliary of New Hampshire who has been, or any person who is physically present in New Hampshire at the time they were, or any New Hampshire corporation who has been victimized by, conduct described in Section 3 may bring a civil action in any court of competent jurisdiction against any person or entity responsible for that conduct or any foreign state authorizing that conduct. Such persons or entities responsible for the conduct described in Section 3 shall be jointly and severally liable for that conduct.
  2. Upon proof by a preponderance of the evidence that the foreign government or its instrumentality acted to chill, restrict, or penalize constitutionally protected expression or association, or otherwise infringe on any right guaranteed by the Constitution of the United States or the Constitution of the State of New Hampshire, the plaintiff shall be entitled to:
    • (a) the greater of:
      1. Treble actual damages; or
      2. statutory damages of not less than $10,000,000 (ten million U.S. dollars) or the equivalent dollar amount of the threatened fine on the date on which the fine was threatened, whichever is greater;

(b) Reasonable attorney’s fees and costs; and

(c) Injunctive and declaratory relief as necessary to prevent further violations of the plaintiff’s constitutional rights.

Section 5. Waiver of Sovereign Immunity

  1. A foreign state, foreign agency, or foreign instrumentality, or any person employed by such foreign state, foreign agency, or foreign instrumentality, that engages in conduct described in Section 3 shall not be immune from the jurisdiction of the courts of this state.
  2. The doctrine of sovereign immunity shall be deemed waived for any act undertaken to enforce or threaten enforcement of a foreign law that is contrary to the public policy or constitutional guarantees of the United States or the State of New Hampshire.

Section 6. Non-Recognition of Foreign Judgments

No court of this state shall recognize, enforce, or give any effect to a foreign judgment, order, or administrative action that infringes rights protected by the United States or New Hampshire Constitutions.

Section 7. Construction

This Act shall be liberally construed to provide maximum protection for New Hampshire residents against the extraterritorial enforcement of foreign censorship laws. Nothing in this Act shall limit any other cause of action or remedy available under federal or state law.

*  *  *

Update 1: Since the initial draft of this blog post, it has been converted into an actual bill and been filed in the State of Wyoming. New Hampshire to follow soon.

Update 2: The United States Under Secretary of State for Public Diplomacy, Sarah Rogers, has told GB News that UK censorship of Americans has crossed a “red line” and that a version of the GRANITE Act, presumably derived from the Wyoming bill, is on the verge of introduction in the U.S. House of Representatives. I can also personally confirm a derivative of the Wyoming GRANITE Act continues to move forward in New Hampshire and filing is expected in weeks. 


Preston Byrne is Head of Legal and Compliance at Arkham and managing partner of Byrne & Storm, P.C. 

For nearly two decades, he has worked at the intersection of international regulation and emerging technologies, as a founder, attorney, think tank fellow, law professor, and executive.

https://www.zerohedge.com/political/granite-act-how-congress-can-strike-back-against-foreign-censors

Texas Law Allowing Ivermectin To Be Sold Over The Counter Goes Into Effect

 by Darlene McCormick Sanchez via The Epoch Times,

A Texas law allowing ivermectin to be sold over the counter went into effect Dec. 4, but rollout appears slow as pharmacies wrestle with how to proceed.

House Bill 25, signed into law by Gov. Greg Abbott in August, allows pharmacies to sell the antiviral drug without a prescription.

Ivermectin gained popularity for off-label use during the COVID-19 pandemic, which influenced support and criticism of the measure. The drug was discovered in the 1970s and developed to treat parasites in humans and animals, and has been studied for its cancer-fighting properties.

Medical freedom advocates supported the bill, but others, such as the Texas Medical Association, worried about health risks to patients.

“Removing clinical involvement is a risk to patient safety,” the group said on its website.

The law indicates a pharmacy may dispense the drug “in accordance with any written standardized procedures or protocols issued by the Texas State Board of Pharmacy, including, if required, providing the person with instructions on the proper use of ivermectin.”

Tyler RX Pharmacy indicated it would eventually dispense ivermectin without a prescription, but said the protocols for doing so haven’t been finalized yet.

“The law states to follow the state Board of Pharmacy guidelines, but there are no guidelines in place yet,” the store’s pharmacist, Katelin Nuon, told The Epoch Times.

At Cody Pharmacy in Sulfur Springs, Texas, the store manager said they didn’t have ivermectin available yet because the law just went into effect, but advised checking back next week.

However, Republican state Sen. Bob Hall, who sponsored a companion bill in the Texas Senate, told The Epoch Times that pharmacies could sell ivermectin even if the pharmacy guidelines were not in place.

“There is nothing in the bill that requires the pharmacy board to do anything,” he said. “We’re checking with the pharmacy board to see if there is something buried in their rules that preempts this changeover.”

The Texas State Board of Pharmacy did not immediately respond to The Epoch Times’ request for comment.

Hall said he has received calls from constituents complaining that their local pharmacies claim they can’t sell ivermectin.

Despite this, Hall believes that independent pharmacies will take the lead in offering the drug to the public. He noted that some outlets have told him they intend to mail it to consumers if needed.

Hall said he has not received information that large retail pharmacies intend to sell the drug over the counter.

Texas is one of five states to legalize the sale of the drug without a prescription. The others are Arkansas, Idaho, Louisiana, and Tennessee.

https://www.zerohedge.com/medical/texas-law-allowing-ivermectin-be-sold-over-counter-goes-effect