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Friday, January 10, 2025

FAA: Firefighting aircraft damaged by drone over Palisades Fire

 The Federal Aviation Administration (FAA) reported an aircraft was damaged by a drone Thursday while fighting the deadly Palisades fire in Los Angeles.

“Fire officials informed the FAA that a firefighting aircraft struck a drone while it was operating over the Palisades Fire in Los Angeles on Thursday, Jan. 9,” the agency said in a statement.

“The aircraft landed safely. The FAA will investigate,” it added.

Officials have implemented several Temporary Flight Restrictions (TFRs) in the area and have warned citizens of the danger aircraft can pose while circulating wildfires.

The FAA said unauthorized air activity during the wildfire emergency will warrant criminal charges that can result in up to 12 months in prison for interfering with firefighting efforts on public lands. 

The agency can also impose a civil penalty of up to $75,000 against any drone pilot who interferes with wildfire suppression, law enforcement or emergency response operations when TFRs are in place.

At least 10 people have been killed and more than 10,000 homes and other structures burned to the ground as a result of two of the largest wildfires. Officials are urging more people to heed evacuation orders. More than 180,000 people have been alerted.

Damage from the blazes could amount to between $52 billion and $57 billion, according to a recent analysis from AccuWeather’s Global Weather Center. The number includes direct and indirect impacts from the fires, as well as both insured and uninsured losses.

https://thehill.com/homenews/state-watch/5078761-faa-firefighting-aircraft-damaged-drone-palisades-fire/

'2 spy agencies float possible foreign weapon behind ‘Havana syndrome,’ most find no links'

A report from the intelligence community released Friday maintains its conclusion that a foreign adversary is not behind the mysterious ailments plaguing government workers, but it opened the door to the possibility overseas actors have developed the capability to do so.

Out of seven total agencies tasked with reviewing the source behind anomalous health incidents (AHIs) first reported in Cuba — which have come to be known as “Havana syndrome” — five stood behind a 2023 assessment that found it unlikely a foreign nation was behind the attacks.

But two shifted their stance, with one determining there was essentially a 50-50 chance a foreign adversary had crafted — but not deployed — a weapon capable of such an attack while the other gave similar odds that such a weapon may have already been used.

“One judges there’s roughly even chance a foreign actor has used a novel weapon or prototype device to harm a small undetermined subset of the U.S. government personnel or dependents who reported medical symptoms or sensory phenomena,” an official with the Office of the Director of National Intelligence (ODNI) said on a call with reporters.

“That language is very precise, because none of those components can pinpoint or identify specific events, whether [in] Havana or anywhere else, because … they agree there’s no intelligence linking any foreign actor to a specific event.”

The report does not identify which agencies were behind which conclusions, but it notes that the agencies who floated the possibility of foreign involvement did so with low confidence.

While the bulk of the report stands behind a 2023 ODNI assessment finding no evidence a foreign adversary was behind the attack, the update comes on the heels of a GOP report from a House Intelligence subcommittee concluding it was likely a foreign power was behind the attacks.

However Democrats on the panel swiftly called into question the rigor of that report, saying Republicans failed to uncover any new evidence.

Friday’s ODNI report is the latest to weigh a series of unexplained ailments experienced by those working in the intelligence community, State Department, and elsewhere, complaining of symptoms ranging from headaches to nausea to vertigo and trouble focusing.

“One component assessed it is likely a foreign actor has a [radio frequency] anti personnel capability, and that this capability can cause biological effects consistent with some of the symptoms reported as possible AHI,” the ODNI official said.

The other five agencies, however, still believe it is unlikely that a foreign adversary has a weapon capable of causing the symptoms experienced by AHI reporters. Rather than a lack of evidence a foreign power is behind the attack, they concluded “intelligence reporting points away from key US adversaries being involved.” 

The official said that included reporting indicating credible foreign adversaries and knowledgeable organizations “either expressing surprise or denying their involvement privately.”

ODNI stressed that the report was not meant to cast doubt on the very real symptoms experienced by reporters, a group that now includes about 300 people.

“The incredible analysts working this topic are human. Those reporting AHIs are our colleagues and friends. The goal of our analysis is to find out what happened to them, not to question whether they had medical symptoms. As I said, we follow the facts wherever they lead, and many of us were surprised by the results,” they said.

That rankled those who have reported AHIs, who have both felt sidelined by the agency and believe they were targeted in an attack.

“The evidence has only moved closer to the Intelligence Community acknowledging the involvement of a foreign adversary, not away,” said Mark Zaid, an attorney who represents more than two dozen AHI victims.

“More recently, senior [National Security Council] officials recently shared information with victims, including some of my clients, that they described as having ‘vindicated’ their views. The only view that could apply to is that a foreign adversary was responsible for at least some AHIs,” he added.

“If AHIs could be explained away by other factors, then what explains the sudden development by so many AHI victims of traumatic brain injuries? And why is the US government paying victims compensation for work related injuries that seemingly…do not exist?”

House Intelligence Republicans also viewed the report as a victory.

“This new intelligence, I believe, should completely change the assessment of our adversaries’ capabilities and the risks to our personnel,” Chair Mike Turner (R-Ohio) said in a statement.

Rep. Jim Himes (D-Conn.), however, said the report is part of a “frustrating challenge” of “ real and serious effects, some of which we cannot currently explain.”

“The updated Intelligence Community Assessment confirms that despite considerable efforts by the IC, we cannot tie any AHI report to actions by a foreign actor. At the same time, the shift in key judgments by two intelligence agencies serves to reinforce how critical it is that the IC remain focused on collecting and analyzing new intelligence that could answer the outstanding questions about AHIs,” he said.

The intelligence community has come under fire for its handling of AHIs and those who have reported symptoms.

In a Senate Intelligence report last month, the panel found shortcomings in the CIA’s response to “Havana Syndrome,” finding that the CIA’s “evolving organizational position have greatly complicated CIA’s ability to consistently and transparently facilitate medical care, provide compensation and other benefits, and communicate clearly about AHIs to the workforce.”

The National Security Council on Friday said the report “only reinforces why it is vital that the U.S. Government continue critical research, investigate credible incidents, and strengthen efforts to provide timely care and long-term clinical follow-up.”

https://thehill.com/policy/national-security/5079301-havana-syndrome-foreign-power-intel-community/

Accelerate Diagnostics Prelims

 Accelerate Diagnostics, Inc. (Nasdaq: AXDX) (Accelerate), an in vitro diagnostics company dedicated to providing services that improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections, today announced certain preliminary, unaudited results for the quarter and year ended December 31, 2024.

"During the fourth quarter, we continued our momentum across our innovation pipeline with significant progress of the clinical trial for our Accelerate WAVE™ system and the Gram-Negative assay while also further driving progress in our commercial strategy and making additional meaningful reductions in our cash burn," commented Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. "Specifically relating to our ongoing clinical trial, we believe we are close to finalizing enrollment, with very encouraging results to-date, and anticipate FDA submission shortly after enrollment is complete. Throughout the clinical trial, we have been able to demonstrate the distinct features and benefits of the WAVE system compared to emerging rapid antimicrobial susceptibility systems without any loss of performance or features," Mr. Phillips continued.

2024 Fourth Quarter and Full-Year Operational Results

  • Notable highlights of our ongoing WAVE System and Gram-Negative (GN) Positive Blood Culture (PBC) Assay Clinical Trial:
    • Clinical trial performance consistent with previously released pre-clinical data

    • Anticipate largest Gram-Negative bug-drug combination offering for rapid PBC AST

    • Time-to-result remains approximately 4.5 hours, on average

    • Strong instrument, consumable and software reliability across clinical trial sites

    • Continued positive feedback from laboratory technicians on simple pre-analytical workflow and seamless system ease of use

    • Anticipate remaining on-track for FDA submission during the first quarter of 2025 with anticipated commercial launch in late 2025
  • Contracted a large U.S. reference lab for the Accelerate Arc™ system, underscoring the utility of cost-effective, rapid, and automated microbial identification on MALDI directly from positive blood culture samples.

  • In the U.S., we maintained approximately 350 of our existing clinically live Pheno® revenue-generating instruments, consistent with our commercial strategy.

  • Continued to execute contract extensions with strategic customers with greater than 75% of U.S. Pheno customers secured through the anticipated WAVE commercial launch, subject to regulatory approvals.

  • Received 510(k) clearance of the Accelerate Arc system and BC kit, an innovative, automated positive blood culture sample preparation platform.

2024 Fourth Quarter and Full-Year Financial Results

  • Preliminary revenue was approximately $11.7 million for the year, compared to $12.1 million in the prior year. While year-over-year revenues for consumable products increased by approximately 3%, overall revenue was down year-over-year due to lower revenues from capital sales of Pheno instruments compared to the prior year.

  • Ended the year with approximately $16.3 million in cash and cash equivalents, compared to $20.9 million at the start of the fourth quarter, a reduction in cash and cash equivalents for the fourth quarter of 2024 of $4.5 million. This reflects our continued reduction in operating cash use over the prior quarters of 2024.

The preliminary financial results set forth above are unaudited, are based on management's initial review of Accelerate's results as of and for the year ended December 31, 2024, and are subject to revisions based upon Accelerate's year-end closing procedures and the completion of the external audit of Accelerate's year-end financial statements. Actual results may differ materially from these preliminary unaudited results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that Accelerate's financial results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of Accelerate's financial results for the year ended December 31, 2024, should not be viewed as a substitute for full, audited financial statements, prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company's results for any future period. Accordingly, investors are cautioned not to place undue reliance on these preliminary unaudited results.

Accelerate expects to announce full-year 2024 financial results in advance of its earnings conference call in March 2025. 

https://www.prnewswire.com/news-releases/accelerate-diagnostics-announces-certain-preliminary-fourth-quarter-and-full-year-2024-results-302348340.html

Biden and Zelenskiy discuss US support for Ukraine, sanctions, air defenses

 U.S. President Joe Biden and Ukrainian President Volodymyr Zelenskiy discussed on Friday Washington's support for Ukraine, new U.S. sanctions against Russia and boosting Ukrainian air defenses, Zelenskiy said.

Zelenskiy, in a social media post, thanked Biden for Washington's support in Ukraine's nearly three-year war with Russia and for "the vital role the United States has played in uniting the international community".

Zelenskiy said the presidents also discussed new U.S. sanctions against Russia's energy sector, "which helps (Russian President Vladimir) Putin bankroll the war".

"He must feel the cost of his war by seeing it directly impact his own pockets," he wrote.

Zelenskiy said he and Biden discussed the need to keep building up Ukraine's air defenses "to protect lives in Ukrainian cities and villages from Russian terror - daily missile and drone attacks".

U.S.-supplied Patriot missiles, he said, "have proven their effectiveness, and we must continue to enhance this capacity".

https://www.marketscreener.com/news/latest/Biden-and-Zelenskiy-discuss-US-support-for-Ukraine-sanctions-air-defenses-48732187/

As China hacking threat builds, Biden to order tougher cybersecurity standards

 President Joe Biden is calling for tighter cybersecurity standards for federal agencies and contractors in a new executive order due to be published in the coming days, pushing reforms designed to address repeated Chinese-linked cyber operations and cybercriminal operations, according to a draft of the order seen by Reuters.

The order is set to land in the waning days of Biden's presidency, during which several high-profile, Chinese-linked hacks occurred, according to the U.S. government and cybersecurity research groups. The alleged activity targeted critical infrastructure, government emails, major telecom firms and, most recently, the U.S. Treasury Department. Beijing has rejected the allegations.

Biden's proposal calls for tougher standards for secure software development, the ability to verify that those standards have been met, and a process for the Cybersecurity and Infrastructure Security Agency (CISA) to evaluate the process, according to the draft.

Vendors will have to provide secure software development documentation to be evaluated and validated by CISA through the agency's software attestation program. Attestations that "fail validation" could be referred to the attorney general for "action as appropriate," according to the draft.

Tom Kellermann, senior vice president of cyber strategy at cybersecurity company Contrast Security, said the attestation provisions do not go far enough but that he "applauds" the efforts to push more secure software development. The timelines for implementation laid out by the order seem "arbitrary," he said, given the immediacy of the threats from China, Russia and powerful cybercriminal syndicates.

"They're already here," Kellermann said. "We are dealing with literally an insurgency across critical infrastructure and U.S. government agencies that has been stoked by the Russians and Chinese."

The order also mandates the development of guidelines to securely manage access tokens and cryptographic keys used by cloud providers. Chinese-linked hackers abused this method to access email accounts used by top U.S. government officials in May of 2023, Microsoft said at the time.

Brandon Wales, vice president of cybersecurity strategy at cybersecurity company SentinelOne and formerly a top CISA official, told Reuters the order builds on ongoing work over the last five years to develop capabilities, get the right authorities, and funding. While the threat from China looms large - a "pacing threat" that is "driving the urgency and focus across the government" - the U.S. government and the private sector face a plethora of threats that need to be addressed.

"It makes sense to continue to look for ways to get the most value out of capabilities that have been built over the past two administrations," Wales said. 

The White House declined to comment and CISA did not respond to a request for comment.

https://www.marketscreener.com/news/latest/As-China-hacking-threat-builds-Biden-to-order-tougher-cybersecurity-standards-48732415/

'Part D Drugs Almost Doubled in Cost Since Launch, Underscoring Importance of IRA: AARP'

 

Concurrently, a preprint from the industry-backed Vital Transformation found a 50% drop in company investments into small-molecule drug development.

The 25 branded drugs with the highest 2022 Medicare Part D spending have become nearly twice as expensive since they entered the market, pointing to the value of pricing-control policies such as the Inflation Reduction Act, according to a report published Thursday by the AARP. But a recent study by an industry group suggests the IRA also has downsides for small molecule development.

Using 2022 data from the Centers for Medicare and Medicaid Services, the AARP researchers zeroed in on the 25 Part D drugs, which had not yet been selected for price negotiations. The report found that taken together, these medicines were collectively dispensed to more than 7 million beneficiaries—and accounted for almost $50 billion in spending.

Following the prices of these medicines from their respective launches, the researchers found that their list prices have ballooned by 98% on average, with the cost hikes ranging from 0% to 293%. For 20 of the 25 drugs, the lifetime price increases “greatly exceeded” the annual rate of general inflation over the time span that these products have been on the market, according to the report.The lifetime price increases since market launch accounted for more than 40% of the current list prices for these 25 drugs.

“Higher government spending driven by high and growing drug prices will affect all Americans in the form of higher taxes, cuts to public programs, or both,” the report read, adding that the growing expense of the treatments makes them inaccessible to more patients, leading to an overall decline in health outcomes.

“These findings highlight the importance of Inflation Reduction Act provisions that allow the Medicare program to negotiate prescription drug prices and require drug companies to pay penalties when they increase their prices faster than the rate of inflation,” the report states.

While the long-term effect of the IRA drug price negotiation program “remains to be seen,” according to the AARP, “given current prescription drug prices and the magnitude of lifetime price increases seen among many popular brand-name drugs, even a small movement in the right direction will result in a substantial improvement over the status quo.”

Hurting Innovation

In contrast, a study posted on January 7 by the industry-backed analytics firm Vital Transformation highlighted purportedly negative impacts of the IRA on innovation and investment.

The study—which has yet to be peer-reviewed and is currently up on the preprint server medRxiv—focused on biopharma companies below $2 billion in market cap and found that the number of early-stage clinical trials for small-molecule drugs has crashed by 70% since the IRA was passed into law. Investments in the modality, meanwhile, dropped by 50%.

According to the preprint, its results constitute “evidence of a decline in the development of new therapies” for the Medicare-aged population since the passage of the IRA. On the other hand, while its analysis of large-molecule drugs remains “statistically inconclusive,” the Vital Transformation study suggests that “investors perceive large molecules to be of a lower investment risk relative to small molecules after IRA’s passage.”

In an investor note late Thursday, Leering Partners analysts noted that given the results of the preprint, “industry participants need to commit more time and capital to educate industry stakeholders, political officials, and the public about the value of novel therapies.” Still, the analyst firm pointed out that Vital Transformation is an industry-sponsored firm “whose clients include many of the leading biopharmaceutical companies and innovation advocacy organizations.”

https://www.biospace.com/policy/part-d-drugs-almost-doubled-in-cost-since-launch-underscoring-importance-of-ira-aarp

Trump Confirms Meeting Being Set Up With Putin As Kremlin Expresses Readiness

 US President-elect Donald Trump has confirmed that a meeting is being set up between him and Russian President Vladimir Putin, according to Politico on Friday.

While giving no specific timeline details, Trump said of Putin from his Mar-a-Lago resort in Florida, "He wants to meet and we are setting it up."

Via Reuters

The day prior Trump had also said "President Putin wants to meet." The Kremlin has yet to confirm the talks, but has repeatedly said Putin remains open to the possibility.

"He has said that even publicly and we have to get that war over withThat's a bloody mess," Trump had said in the Thursday part of the remarks.

Moscow's newest Friday statement reaffirmed openness to such a meeting, "but that any concrete steps to set up such talks could be made only once Mr. Trump is sworn into office on Jan. 20," The New York Times notes.

"We need a mutual desire and political willingness to engage in a dialogue," Putin spokesman Dmitri Peskov told reporters"We see that Mr. Trump also declares his readiness to solve issues via dialogue. We welcome that."

Peskov added that Russia's understanding is that there is a "mutual readiness for a meeting" but that "it looks like things will start to move after Trump enters the Oval Office."

The Kremlin stopped short of specifying how soon such a meeting might take place or whether a final go-ahead has been given.

This also comes after earlier in the week Trump said he was sympathetic to Moscow's critiques of NATO expansion:

Speaking at a news conference on Tuesday, Mr. Trump said that he was sympathetic with the Russian position that Ukraine should never join NATO, one of the main conditions put forward by the Kremlin to end the war.

Prior reporting on the 'Trump peace plan' suggests that the US side will offer Ukraine a twenty-year waiting period before it can hope to join NATO; however, Moscow has rejected even this possibility as a non-starter.

Without doubt, Moscow sees itself in the driver's seat - even as Ukraine tries to inflict as much damage as possible through drone and missile strikes on Russian territory. Russian forces have made weeks of rapid gains in the Donetsk, including having captured another key industrial town just this past week.

https://www.zerohedge.com/geopolitical/trump-confirms-meeting-being-set-putin-kremlin-expresses-readiness