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Friday, February 10, 2023

Bristol-2seventy Partnered Abecma Cuts Risk Of Disease Progression, Death By 51% In Myeloma

 

  • Bristol-Myers Squibb & Co  and 2seventy bio Inc  announced the first publication and presentation of results from the KarMMa-3 Phase 3 study evaluating Abecma (idecabtagene vicleucel) in The New England Journal of Medicine.
  • The study compared Abecma with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy.
  • At a median follow-up of 18.6 months, Abecma demonstrated a clinically meaningful and statistically significant improvement in progression-free survival compared with standard regimens, with a median PFS of 13.3 months vs. 4.4 months, representing a 51% reduction in risk of disease progression or death.
  • The overall response rate also met statistical significance, with 71% treated with Abecma achieving a response and 39% achieving a complete response or stringent complete response. 
  • In comparison, 41% who received standard regimens achieved a response, with 5% experiencing a complete response or stringent complete response. 
  • Responses with Abecma were durable, with a median duration of 14.8 months compared with 9.7 months for standard regimens. 
  • Bristol-Myers Squibb and 2seventy bio intend to include these data in a planned supplemental Biologics License Application submission to the FDA in 2023. 

Ukraine Almost Solely Reliant On Intelligence From US For HIMARS Rocket Strikes

 by Dave DeCamp via AntiWar.com,

The Washington Post reported Thursday that Ukraine is reliant on coordinates provided or confirmed by the US and its allies to launch strikes using the US-provided HIMARS rocket systems, a revelation that demonstrates Washington’s deep involvement in the war.

The HIMARS is a precision-guided artillery system, one that Ukraine has employed quite a bit in its fight against Russia. One example is a January 1 HIMARS strike on a facility housing Russian forces in Donetsk that killed at least 89 Russian soldiers, one of the deadliest Ukrainian attacks of the war.

Citing three unnamed Ukrainian officials and one unnamed US official, the Post reported that Ukraine also relies on the US for targeting coordinates for similar precision weapons, including the M270 Multiple-Launch Rocket System.

One senior Ukrainian official said that Ukrainian forces almost never launch strikes using these weapons without coordinates provided by US military personnel that are located at a military base in a different country in Europe.

Top Biden administration officials have acknowledged publicly that they have been providing Ukraine with intelligence to carry out attacks on Russian forces, but the details of that cooperation were not previously known.

The Post report said that Ukrainian officials identify targets they want to hit and the location, then provide that information to the US military for more accurate coordinates. The US military then usually sends the coordinates, although sometimes they don’t, and the Ukrainian forces don’t fire.

A senior Ukrainian official said that the cooperation shows the US can provide longer-range weapons without having to worry about them being used to hit inside Russian territory. "You’re controlling every shot anyway, so when you say, ‘We’re afraid that you’re going to use it for some other purposes,’ well, we can’t do it even if we want to," the official said.

But a US official disputed the idea that Ukraine was running the targets by the US for approval and said the US only provides coordinates. Back in August, a top Ukrainian intelligence official said that they consult with the US before launching HIMARS strikes and that the US has veto power over the target. Ukraine could have more freedom now to choose its own targets as the Biden administration is less and less concerned about escalating the war.

Russia has made clear it views the US and Ukraine’s cooperation on targeting as an example of Washington’s direct role in the war, and Moscow isn’t alone in its assessment. Back in March 2022, Rep. Adam Smith (D-WA), former chair of the House Armed Services Committee, said the US wasn’t providing "real-time targeting intelligence" because that kind of cooperation "steps over the line to making us participate in the war."

https://www.zerohedge.com/military/ukraine-almost-solely-reliant-intelligence-us-himars-rocket-strikes

Wainwright Reiterates Buy on Nuvectis

 Maintains $21 Price Target

https://www.benzinga.com/news/23/02/30853157/hc-wainwright-co-reiterates-buy-on-nuvectis-pharma-maintains-21-price-target

Incyte's Oral JAK Inhibitor Shows Durable Efficacy, Safety At One Year In Skin Disorder

 

  • Incyte Corporation (NASDAQ: INCY) announced new 52-week results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS).

  • The study previously met its primary endpoint, demonstrating that at Week 16 – patients receiving povorcitinib once daily (QD) had significantly greater decreases from baseline in Abscess and Inflammatory Nodule (AN) count versus placebo.

  • Results at Week 52, which include the 36-week open-label extension period during which all patients received povorcitinib 75 mg QD, show that average efficacy was sustained for all treatment arms following the switch to povorcitinib 75 mg QD.

  • Povorcitinib also demonstrated durable efficacy at Week 52 in high-threshold outcomes, as evidenced by 22-29% of patients achieving HS Clinical Response 100 (HiSCR100).

Chinese spy balloon revelations raise stakes for US response

 The discovery that a Chinese spy balloon shot down off the U.S. coast had the equipment to collect communications, and not just images, as it traveled across the country last week has upped the stakes around the incident.

U.S. lawmakers are demanding new action from the Biden administration after the Thursday revelations that the balloon possessed antennas to collect communications signals and solar panels to power its sensors. 

Washington was also rattled by news earlier this week that the airship was part of a much larger operation run by the Chinese military to spy on more than 40 countries across five continents. 

The incursion, which until last week was largely unknown to much of the American public, seems to mark a new era of espionage and counter-espionage activities between the U.S. and China, according to John Ciorciari, the director of the Weiser Diplomacy Center at the University of Michigan. 

“This incident makes it likely the U.S. accelerates different kinds of counterintelligence initiatives and expands to areas like, who do we grant visas to? Who is allowed to study at universities?” Ciorciari told The Hill. “An acceleration of those kinds of policies, the Chinese government will probably mirror.”

The U.S. government isn’t wasting time in punching back at the breach. A State Department official on Thursday said the U.S. is exploring options to take action against the Chinese military and entities supporting the balloon spying operation. Washington will also seek to further expose the Chinese global surveillance campaign, the official said.

Congressional lawmakers also denounced Beijing, with the House later in the day unanimously passing a resolution condemning China’s use of the surveillance balloon over the United States, calling it a “brazen violation” of U.S. sovereignty.

The resolution also calls on the Biden administration to keep Congress abreast of any new information gleaned from the incident.

But lawmakers remain unsatisfied by the information to come out of the White House and Pentagon so far, as well as the reasoning for why the U.S. military didn’t move quicker to down the balloon before it drifted slowly across U.S. territory for days before being shot off the coast of South Carolina on Feb. 4.

Tensions were particularly high at a Senate Appropriations subcommittee hearing with defense officials.

Alaskan Sen. Lisa Murkowski (R), whose state’s airspace was the first to be breached by the Chinese balloon on Jan. 28, was visibly angry as she questioned the witnesses.

“As an Alaskan, I am so angry. I want to use other words but I’m not going to,” she said. “The fact of the matter is, Alaska is the first line of defense for America, right? If you’re going to have Russia coming at you, if you’re going to have China coming at you, we know exactly how they come. They come up and they go over Alaska.”

She later added: “Seems to me the clear message to China is ‘we’ve got free range in Alaska, because they’re going to let us cruise over that.’”

Sen. Susan Collins (R-Maine), meanwhile, said “it defies belief that there was not a single opportunity to safely shoot down this spy balloon prior to the coast of South Carolina.”

And the subcommittee chairman, Sen. Jon Tester (D-Mont.), whose state also was in the balloon’s flight path, demanded answers as to how the administration has responded to past instances of Chinese aerial spying, what the balloons were collecting, and if there are any plans to respond if such a thing happens again.

“Do we have a plan for when this happens again and what we’re going to do and when we’re going to do it?” Tester asked the witnesses, which included Assistant Secretary of Defense for Homeland Defense and Hemispheric Affairs Melissa Dalton and Principal Deputy Assistant Secretary of Defense for Indo-Pacific Security Affairs Jedidiah Royal.

“I don’t want a damn balloon going across the United States when we could potentially have taken it down over the Aleutian Islands,” he added. “I got a problem with a Chinese balloon flying over my state, much less the rest of the country.”

Royal assured Tester that the Defense Department has “some very good guesses” about what intel China was attempting to gather with the balloon, promising more details in the classified version of the hearing.

But Tester responded that while U.S. intelligence agencies may “think we know what they were going to collect, we don’t know. That scares the hell out of me.”

Asked repeatedly why the government didn’t immediately shoot down the balloon when it was detected over Alaska, the defense officials repeated past assertions that the debris field caused by such an operation, even in a remote area such as Alaska, was still too much of a risk to citizens on the ground.

Taking down the balloon over Alaska would have also made it significantly more difficult and dangerous to “salvage, understand and exploit the capabilities” of the devices on board given the cold, volatile and deep waters around the state, Dalton said. 

Also concerning for intelligence officials and lawmakers is that four previous spy balloons flew over the U.S. initially undetected, according to the Pentagon — three during the Trump administration and another months ago during the Biden administration.

Tim Heath, a senior International defense researcher with Rand Corporation, said the incident should prompt the U.S. to develop better technology to detect future balloons.

“It’s possible that the U.S. military really didn’t think the Chinese would have the gall to float one right over our own country,” he said. “I can understand why they didn’t detect them in the past.”

Heath said current radar systems focus on missiles and aircraft coming into U.S. airspace.

“In order to detect [balloons] with radar, you need to have some kind of new technology that can pick up very low observable things in the sky like balloons,” Heath continued.

In a heightened era of U.S.-China tensions, it’s possible that other technologies and Chinese tactics will fall under more scrutiny. 

Areas of concern include social media app TikTok, which is owned by a Chinese company and is already being banned on government devices in Republican-led states, along with Chinese companies buying up land near U.S. military bases and Beijing’s deployment of covert agents at American universities .

Ciorciari, of the University of Michigan, said espionage is common among nations — but the Chinese spy balloon placed the image of such spying “in the minds of average American citizens.”

Because of this, he predicted, there will be “more pressure to limit espionage” by the U.S. government.

“The threat that I see is not so much the intelligence collection capabilities of the balloons,” he said, but “where this set of episodes fit in the broader relationship.”

And there’s still much to learn about the balloon shot down over the weekend. 

The Navy, helped by the Federal Bureau of Investigation, is still attempting to collect balloon debris from the Atlantic Ocean to glean information on the Chinese technology. 

So far, dive teams have only pulled the canopy, some wiring and a small amount of electronics from the water, FBI officials said in a briefing Thursday. The rest is at the “ocean bottom,” including the majority of the balloon’s payload, with recovery efforts expected to take a while due to weather.

https://thehill.com/policy/defense/3852009-chinese-spy-balloon-revelations-raise-stakes-for-us-response/

Norovirus outbreaks are increasing across the US: Which regions have it the worst?

 An uptick in outbreaks of norovirus may be contributing to rising cases across the country — but some regions are feeling it more than others.

Norovirus, sometimes called the “stomach flu,” is generally a seasonal virus that causes acute gastroenteritis, leading to symptoms including diarrhea, vomiting and nausea, according to the Centers for Disease Control and Prevention (CDC). Despite its nickname, this type of “stomach flu” isn’t caused by the influenza virus, but rather “by accidentally getting tiny particles of feces (poop) or vomit from an infected person in your mouth,” the CDC says.

Outbreaks of norovirus generally peak between November and April of any given year, though early reporting from labs across the country shows an earlier uptick when compared to the previous norovirus season.

Between Aug. 1, 2022, and Jan. 8, 2023, there were 225 norovirus outbreaks among the 14 states that participate in the CDC’s NoroSTAT reporting program, a significant increase over the same time period between Aug. and Jan. 2022, when there were only a reported 172 outbreaks.

These findings aren’t entirely unexpected, according to Marisa Lubeck, a health communication specialist with the CDC.

“Prevention measures implemented during the COVID-19 pandemic were likely effective in preventing norovirus outbreaks,” Lubeck explained in an emailed statement. “As pandemic restrictions have relaxed, the number of norovirus outbreaks has returned to levels similar to pre-pandemic years.”

That said, Lubeck confirmed that the current outbreak count is still “within the expected range” for any given norovirus season.

Despite this, some parts of the country have noted especially high positivity rates slightly earlier than in previous years, mirroring an overall national trend. Participating laboratories in the Midwest, for instance, had observed a 19.4% positivity rate among patients who took polymerase chain reaction (PCR) tests as of Feb. 4 — topping the previous year’s high of 16.1%, recorded in April 2, 2022.

The Western region also appears on track to exceed last year’s top positivity rate of 13.49% (observed at the end of April) with recent positivity rates at 13.42%, and likely rising, as of Feb. 4.

Positivity rates in the Northeast and Southern regions have yet to exceed 2022’s peaks, despite being slightly higher than where they were at the same time last year, according to the CDC’s data.

The CDC generally records roughly 2,500 outbreaks of norovirus each year, with around 19 to 21 million thought to be infected annually. Of those, approximately 110,000 will be hospitalized, and around 900 die, on average.

Tips for preventing the spread of norovirus include frequent handwashing (especially after using the bathroom, and before handing food or caring for sick individuals) as well as disinfecting shared surfaces. Sickened individuals can still spread the virus for weeks afterward, even if symptoms subside within days, according to the CDC.

There is no current treatment for norovirus, though experts recommend drinking lots of fluids to prevent dehydration.

https://thehill.com/homenews/nexstar_media_wire/3852822-norovirus-outbreaks-are-increasing-across-the-us-which-regions-have-it-the-worst/

US shoots down another ‘high-altitude object’ over Alaskan airspace

 The U.S. military on Friday took down an object flying over Alaskan airspace days after shooting down a Chinese spy balloon along the South Carolina coast, the White House confirmed.

John Kirby, a national security spokesperson for the White House, said the Defense Department was tracking a “high-altitude object” over Alaska at 40,000 feet that posed “a reasonable threat to the safety of civilian flight.

The object was shot down within the last hour at President Biden’s direction, Kirby said, and landed in U.S. waters.

https://thehill.com/policy/defense/3852988-us-shoots-down-another-high-altitude-object-over-alaskan-airspace/