DaVita hit by ransomware attack, says patient care continues

 DaVita said on Monday it was hit by a ransomware attack that encrypted certain elements of its network, and some of its operations remained disrupted despite interim measures.

While the dialysis service provider continued to provide patient care as it took measures to restore certain functions, it could not "estimate the duration or extent of the disruption at this time", DaVita said in a regulatory filing.

The measures included separating some impacted systems from its network.

DaVita discovered the cyberattack on Saturday and is now assessing the incident with third-party cybersecurity professionals. It has also notified law enforcement about the attack, the company said.

The dialysis firm did not immediately respond to a Reuters' request for details about its containment measures and the extent of the cyberattack.

DaVita provides dialysis - a treatment which mechanically cleans the blood when the kidneys are not functioning properly - through its network of nearly 3,000 outpatient clinics and at-home services.

Last year, DaVita served around 200,000 patients in the U.S., besides providing services through about 760 hospitals, according to the company's annual report.

The incident marks yet another cyberattack in the U.S. healthcare sector. A U.S. unit of DaVita's rival Fresenius Medical Care was hit by a hack in 2023, in which data including medical records on 500,000 patients and former patients were stolen.

Last year, UnitedHealth Group's tech unit was hit by a ransomware attack that affected the personal information of 100 million people and caused widespread disruptions in processing health insurance claims, including with DaVita.

https://www.aol.com/news/dialysis-firm-davita-hit-ransomware-113342518.html

Verve positive clinical trial results

 Shares of Verve Therapeutics (NASDAQ: VERV) surged 45% following the announcement of encouraging initial data from its Heart-2 Phase 1b clinical trial of VERVE-102, a gene-editing therapy aimed at reducing LDL cholesterol levels. The trial’s positive outcomes have heightened investor optimism, as the company revealed substantial LDL-C reductions and a favorable safety profile for the treatment.

Verve Therapeutics, based in Boston, reported on Monday that the Heart-2 trial, which involves patients with familial hypercholesterolemia or premature coronary artery disease, showed no serious adverse events related to the treatment. The most notable results were observed in the highest dose cohort, where a single infusion of VERVE-102 at 0.6 mg/kg led to an average LDL-C reduction of 53%, with a peak reduction of 69%.

The company’s proprietary GalNAc-LNP delivery technology has been highlighted as potentially best-in-class for safety. These findings are significant as they suggest that a single dose of VERVE-102 could provide a long-term solution for managing LDL-C levels, a key factor in the prevention of atherosclerotic cardiovascular disease, the leading cause of death globally.

Eugene Braunwald, M.D. from Harvard Medical School, noted the potential of VERVE-102 to transform cardiovascular disease treatment, moving away from daily medications to a possible single-dose approach for sustained LDL-C lowering.

Verve Therapeutics also outlined its future plans, which include finalizing the Heart-2 dose escalation data and commencing a Phase 2 clinical trial in the second half of 2025. The company expects a decision from Eli Lilly and Company (NYSE:LLY) regarding the PCSK9 opt-in during the same period.

https://www.investing.com/news/stock-market-news/verve-therapeutics-stock-soars-on-positive-clinical-trial-results-93CH-3983394

Palantir stock rises on NATO AI system acquisition

 Palantir Technologies Inc . (NYSE:NASDAQ:PLTR) shares climbed 5.3% following the announcement that NATO has acquired the company’s AI-powered military system. The acquisition by the NATO Communications and Information Agency (NCIA) represents a significant step in bolstering the Alliance’s warfighting capabilities with advanced technology.

The system, known as the Palantir Maven Smart System NATO (MSS NATO), will be employed within NATO’s Allied Command Operations (ACO) to enhance various aspects of military operations. According to NCIA General Manager, Mr. Ludwig Decamps, the deployment of MSS NATO will provide "customized state-of-the-art AI capabilities to the Alliance," ensuring that forces are equipped with the necessary tools for effective and decisive action on the modern battlefield.

The integration of MSS NATO into NATO’s operations is expected to improve intelligence fusion and targeting, increase battlespace awareness and planning, and expedite decision-making processes through the use of AI applications, including large language models and machine learning. Shon Manasco, Senior Counselor at Palantir Technologies, emphasized the company’s pride in supporting NATO’s technological advancements and the Alliance’s commitment to leading in innovation.

General Markus Laubenthal, SHAPE Chief of Staff, highlighted the operational value of the Maven Smart System NATO, stating that it enables the Alliance to leverage complex data and accelerate decision-making, which is essential to their warfighting ability. The procurement process for MSS NATO was notably swift, taking only six months from the initial requirement definition to the acquisition of the system.

The new system is expected to be operational within ACO in the next 30 days, marking a quick integration of this advanced capability into NATO’s defense framework.

https://www.investing.com/news/stock-market-news/palantir-stock-rises-on-nato-ai-system-acquisition-3983497

US Strips Benefits From Thousands Of Criminal Aliens, Those On Terror Watchlist

 by Chase Smith via The Epoch Times,

The Trump administration has ended temporary immigration parole and revoked federal benefits for thousands of foreign nationals flagged as national security risks, part of a broader effort to roll back immigration programs implemented under the Biden administration.

According to White House officials, more than 6,300 individuals who were paroled into the United States during or after 2023 were identified as having criminal records or were listed in the FBI’s Terrorist Screening Database. Their parole was terminated starting April 8.

As part of the enforcement action, the Social Security Administration reclassified those individuals’ Social Security numbers into its Ineligible Master File, a restricted database that prevents improper payment of federal benefits. Formerly known as the Death Master File, the system is used to ensure that only lawfully eligible individuals can access programs such as Social Security, Medicaid, and other federally administered aid.

Immigration parole allows certain noncitizens to temporarily enter and remain in the United States, during which they may receive work authorization and Social Security numbers if granted parole for more than one year.

White House assistant press secretary Liz Huston said the action fulfills President Donald Trump’s campaign pledge to enforce immigration laws more strictly.

“President Trump promised mass deportations, and by removing the monetary incentive for illegal aliens to come and stay, we will encourage them to self-deport,” Huston said in an emailed statement to The Epoch Times. “He is delivering on his promise he made to the American people.”

The policy change follows a March 25 notice in the federal register from the Department of Homeland Security (DHS ) formally ending the CHNV parole programs. Those programs, created in 2022 and 2023, allowed approximately half a million citizens of Cuba, Haiti, Nicaragua, and Venezuela, along with their immediate family members, to request authorization to enter the United States and apply for parole under categorical criteria.

“DHS has determined that it is now appropriate and necessary to terminate the CHNV parole programs,” the notice stated. “These programs do not serve a significant public benefit, are not necessary to reduce levels of illegal immigration, did not sufficiently mitigate the domestic effects of illegal immigration, are not serving their intended purposes, and are inconsistent with the administration’s foreign policy goals.”

DHS also noted that the parole period for individuals still present in the United States under CHNV authority will end on April 24, unless the secretary of Homeland Security makes an individual exception. Those without a lawful basis to remain after that date must depart voluntarily or face enforcement.

The changes are being implemented under Executive Order 14165, Securing Our Borders, signed by Trump on Jan. 20. The order directed the department to terminate parole programs deemed inconsistent with the administration’s immigration priorities.

https://www.zerohedge.com/political/us-strips-benefits-thousands-criminal-aliens-those-terror-watchlist

Intel To Sell 51% Of Altera To Silver Lake In $8.75 Billion Deal As Turnaround Accelerates

 Intel has reached a definitive agreement to sell a 51% stake in its programmable chip unit, Altera, to Silver Lake Management for $8.75 billion, marking the latest step in its ongoing turnaround strategy. The transaction aims to reduce Intel's expenses and improve its balance sheet as the struggling chipmaker refocuses on core operations and capital efficiency. The deal also positions Intel to shift more aggressively toward ramping up its foundries in a potential joint venture with Taiwan Semiconductor Manufacturing. 

"The transaction, which values Altera at $8.75 billion, establishes Altera's operational independence and makes it the largest pure-play FPGA (field programmable gate array) semiconductor solutions company," Intel wrote in a press release. 

"Altera offers a proven and highly scalable architecture and tool chain and is focused on driving growth and FPGA innovation to meet the demands and opportunities of an AI-driven market," Intel said, adding, "Intel will own the remaining 49% of the Altera business, enabling it to participate in Altera's future success while focusing on its core business." 

Here's a timeline of headline developments featuring Altera:

Sept. 2024: Worst Finally Over? Intel To Move Forward With Assessing Strategic Transactions This Month

Dec. 2024: Intel Shortlists Suitors For Chip Division Altera Amid Turnaround Efforts

Intel announced that Raghib Hussain, former president of Products and Technologies at Marvell, will succeed Sandra Rivera as CEO of Altera on May 5. 

"Today's announcement reflects our commitment to sharpening our focus, lowering our expense structure and strengthening our balance sheet," Intel CEO Lip-Bu Tan stated, adding, "Altera continues to make progress repositioning its product portfolio to participate in the fastest growing and most profitable segments of the FPGA market." 

Hussain said, "I am excited to lead Altera in its next chapter, and this milestone with Silver Lake furthers Altera's journey to be the world's No. 1 FPGA solutions provider" and "backed by Silver Lake's strong track record and now with clarity of focus as an independent company, Altera is well-positioned to build on its momentum and deliver breakthrough FPGA-based solutions that are shaping the future of compute driven by AI." 

Intel's turnaround plan also includes a potential joint venture with TSMC to operate the company's chipmaking factories. Under the proposed deal, TSMC would take a 20% stake in the JV and offer manufacturing expertise and personnel training. 

In markets, Intel shares are up 4% in premarket trading. On the year, shares are flat and hovering around the $20 handle - a level that dates back to near GFC lows. 

Will Intel shares fly in Trump's America First era? 

https://www.zerohedge.com/markets/intel-sell-51-altera-silver-lake-875-billion-deal-turnaround-accelerates

FDA Action Alert: Regeneron, Sanofi and Abeona

 

Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.

The FDA has three big decisions slated for the back half of April, two of which are for Regeneron’s blockbuster franchises.

Read below for more.

Regeneron, Sanofi Eye Another Expansion for Dupixent

Following an initial rejection in October 2023, Regeneron and Sanofi are again trying to expand their anti-inflammatory antibody Dupixent into chronic spontaneous urticaria (CSU). The FDA’s decision is due on April 18.

To support their bid for label expansion, the pharma partners submitted data from the Phase III LIBERTY-CUPID clinical program. Data from Study A, released in July 2021, showed that Dupixent could nearly double itch reduction and urticaria activity scores versus antihistamines. Study B, meanwhile, found a numeric improvement in itching and hives versus antihistamines in patients refractory to omalizumab, as per a February 2022 readout, though the study did not reach statistical significance. It was terminated due to futility.

These two studies formed the backbone of Dupixent’s initial failed attempt at an approval for CSU, which the FDA rebuffed due to the lack of efficacy data. In their resubmission, Regeneron and Sanofi filed additional data from a third trial, dubbed Study C, which also showed a nearly 50% drop in itch and urticaria activity.

If approved, Dupixent would be the first targeted option for CSU in a decade, according to a November 2024 news release.

Regeneron Proposes Longer Dosing Interval for Eylea HD

In a bid to maintain the market dominance of its blockbuster biologic Eylea, Regeneron is working to improve the product profile of the high-dose (HD) formulation of the drug. In line with this, the company is proposing a longer dosing duration for Eylea HD, for which the FDA is expected to release its verdict by April 20.

In its presentation at the J.P. Morgan Healthcare Conference in January, Regeneron announced that the FDA was already reviewing its application for 24-week dosing for Eylea HD in wet age-related macular degeneration and diabetic macular edema. The biotech is also building toward an application for prolonged Eylea HD dosing in retinal vein occlusion.

Eylea HD is a longer-acting version of the original drug and, with less frequent injection, it is designed to be more convenient to the patient. In August 2023, data from Regeneron’s Phase III PULSAR trial confirmed that even at dosing intervals at least 12 weeks long, high-dose Eylea did not sacrifice vision gains while also helping patients maintain their treatment schedules.

Despite a differentiated product profile, Eylea HD has had trouble getting off the ground. In the fourth quarter of 2024, the drug brought in $305 million in sales, far below the analyst consensus of $336 million.

Abeona Awaits Approval for Autologous Gene Therapy in Rare Skin Disease

Abeona Therapeutics is developing prademagene zamikeracel, also called pz-cel, for recessive dystrophic epidermolysis bullosa. The FDA is reviewing the biotech’s application and is expected to release its verdict on April 29.

Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genetic disorder characterized by fragile skin that is highly prone to wounds and blisters. The disease is caused by a mutation in the COL7A1 gene, which encodes for a key component of collagen that helps to stabilize and strengthen the skin.

Pz-cel addresses this underlying cause of RDEB by restoring a patient’s ability to produce functional collagen. The therapy is derived from patients’ own skin cells with genetically corrected copies of COL7A1.

In the Phase III VITAL trial, patients treated with pz-cel saw wound healing success greater than 50%. At 6 months, wounds dropped by 81% in the pz-cel arm versus controls. Abeona also filed Phase I/IIa data with up to 8 years of follow-up to support pz-cel’s application.

If approved, pz-cel would be the first autologous, cell-based gene therapy for RDEB, the biotech said in November 2024.

https://www.biospace.com/fda/fda-action-alert-regeneron-sanofi-and-abeona

Holcim Expects Amrize Spinoff in June

 Holcim said it expects its Amrize spinoff to take place in June, having previously targeted the second quarter of 2025.

The Swiss building-materials company on Monday also proposed a dividend-in-kind of one Amrize share for every Holcim share to bring about the spinoff of the North American business.

https://www.morningstar.com/news/dow-jones/20250414421/holcim-expects-amrize-spinoff-in-june