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Tuesday, January 3, 2023

Bills’ Damar Hamlin in critical condition after collapsing on field, receiving CPR

 Bills safety Damar Hamlin collapsed on the field, was administered CPR by medical professionals and put into an ambulance and rushed to an area hospital in one of the scariest on-field scenes in NFL history during a “Monday Night Football” game in Cincinnati. 

Hamlin, 24, suffered cardiac arrest and is in critical condition, according to a statement from the Bills late Monday night. 

“His vitals are back to normal and they have put him to sleep to put a breathing tube down his throat,” Jordon Rooney, Hamlin’s marketing representative at Jaster Athletes, wrote on Twitter in an update about an hour after the league’s statement. “They are currently running tests. We will provide updates as we have them.” 

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Damar Hamlin falls to the ground after attempting a tackle.
Damar Hamlin falls to the ground after attempting a tackle.
Damar Hamlin is treated on the field.
Damar Hamlin is treated on the field.
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Bills players reacts as Damar Hamlin is taken off the field in an ambulance.
Bills players reacts as Damar Hamlin is taken off the field in an ambulance.
Damar Hamlin
Damar Hamlin left the stadium in critical condition.
Bills players Tre'Davious White #27 and Mitch Morse #60 reacts on the field.
Bills players Tre’Davious White #27 and Mitch Morse #60 reacts on the field.
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Damar Hamlin
Damar Hamlin
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A hospital spokesperson canceled a news conference, originally scheduled for around 11 p.m. Monday, according to multiple reports. Hamlin’s agent, Ira Turner of Agency 1 Sports, released a statement asking to “please continue to pray for Damar and his family.” 

Hamlin and his mother, who was watching from the stands, were taken two miles away to the University of Cincinnati Level I trauma center in what was treated as a life-or-death emergency. The ambulance left Paycor Stadium about 30 minutes after the emergency began when Hamlin made a first-quarter tackle on Bengals receiver Tee Higgins but appeared to take the brunt of the hit. 

Hamlin hopped to his feet and adjusted his facemask but almost immediately fell onto his back. 

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Buffalo Bills players huddle and pray after teammate Damar Hamlin collapsed on the field.
Buffalo Bills players huddle and pray after teammate Damar Hamlin collapsed on the field.
The game was suspended for the night and will resume at another date.
The game was suspended for the night and will resume at another date.
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The situation quickly became dire as an ambulance rushed on the field.
Buffalo Bills players after Damar Hamlin was taken away in an ambulance.
Buffalo Bills players after Damar Hamlin was taken away in an ambulance.
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“Something we haven’t seen in our time,” NFL executive vice president Troy Vincent, a former 15-year player, said in a midnight conference call. He said many on site were “traumatized.” 

The crowd and the television audience held its collective breath waiting for the universal sign to exhale — a thumbs-up from an NFL player loaded onto a stretcher, even used in cases of paralysis to show that the player can communicate. It never happened. 

The game was suspended with the Bengals leading, 7-3, after a temporary delay of more than an hour. The ESPN broadcast relayed to viewers that players initially were given a five-minute warm-up period before resuming play, but Vincent, who was in contact with “devastated” commissioner Roger Goodell, denied that such a scenario was ever discussed. 

“Never crossed my mind to talk about warming up to resume play,” Vincent said. “That’s ridiculous, insensitive and not a place we should ever be in.” 

Vincent said that the Bills planned to fly home Tuesday morning but some players were staying behind to be near Hamlin. 

“The thoughts and prayers of all of Bills Mafia are supporting you, Damar,” the Bills wrote on their official Twitter account. 

Hundreds of NFL players, including former teammates of Hamlin’s in Buffalo and at the University of Pittsburgh, took to social media to share prayers. 

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The game was temporary suspended.
The game was temporarily suspended.
Buffalo Bills players after Damar Hamlin was taken away in an ambulance.
Buffalo Bills players after Damar Hamlin was taken away in an ambulance.
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The ambulance leaves the field with Damar Hamlin
The ambulance leaves the field with Damar Hamlin
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“Damar Hamlin is the best of us,” Pitt football tweeted. “We love you, 3. Praying for you.”

Some players surrounded Hamlin as medical professionals assisted with his breathing. Others turned away from the chilling scene and sobbed openly or into towels. The Bills gathered on one knee to say a prayer around McDermott as the ambulance pulled away from midfield. 

Bills quarterback Josh Allen cupped his hands over his mouth in a prayer gesture and later hugged his counterpart Joe Burrow in what was an example of the united front. Players from both teams built a human wall as if to protect Hamlin’s privacy in his most dire moment. 

Vincent credited the leadership with emotions running high of Bengals coach Zac Taylor and Bills coach Sean McDermott, who clearly did not want their teams to resume play. The crowd broke the silence to applaud the visiting Bills in a show of emotional support as teams headed back to their respective locker rooms. 

NFL executives declined comment out of respect to Hamlin’s condition when asked for a plan on when the game between two teams battling for the No. 1 seed in the AFC will be resumed. 

https://nypost.com/2023/01/02/bills-damar-hamlin-collapses-on-field-receives-cpr-after-making-tackle-in-chilling-scene/

Monday, January 2, 2023

Congress Should Investigate 'Gain-Of-Function' Research

 by Bill King via RealClear Wire,

I fear that the investigations Republicans have promised in the House next year will be little more than another round of toxic partisan gamesmanship. But there is one investigation Congress should undertake, and that is into so-called “gain-of-function” research.

Before the pandemic, I suspect that most of you, like me, had never heard of gain-of-function research. What we learned during the pandemic is that scientists around the world routinely tinker with the genome of viruses to see how the induced changes will affect replication of the virus (contagiousness) and the effects it has on its host (lethality). Such research has apparently been going on for decades and is routinely funded by governments, including ours.

Within weeks of the COVID-19 virus emerging in China near the Wuhan Institute of Virology (WIV), many began to question whether the virus had been created by gain-of-function research and somehow escaped from WIV’s labs. Recently analyzed Chinese documents from early in the pandemic seem to suggest the virus might have come from WIV. To many, the proposition that the novel coronavirus just happened to naturally occur a few hundred yards from the WIV facility seemed too much of a coincidence.

But in February 2020, barely three months after the virus’s genome had been sequenced, 27 scientists signed a statement in the medical journal The Lancet, unequivocally declaring that the virus had occurred naturally and that any suggestion to the contrary was quackery and a conspiracy theory. Their statement quickly became the accepted orthodoxy for much of the world’s scientific community and virtually all the mainstream media.

However, as time wore on, circumstances regarding the origin of that statement came under scrutiny. In a 2021 Vanity Fair article, investigative journalist Katherine Eban revealed that the statement was organized by a scientist named Peter Daszak. That statement concluded with a declaration from the scientists who signed it that “we have no competing interests.” However, Eban reported in a follow-up article that Daszak was the director of EcoHealth Alliance, which in 2014 had received a $3.7 million grant from the NIH for gain-of-function research and made a sub-grant for $600,000 – to the WIV.

I wrote to the email address reserved for the statement in the Lancet post, posing a number of questions about the circumstances around the creation of the letter and the “competing interests” statement. I also reached out to two of the scientists who signed the letter asking for an interview regarding the statement. I received no responses.

Questions about gain-of-function research predate COVID. In fact, there has been a robust debate over the potential risks and benefits that dates to, at least, 2011. In 2014, a group of 300 prominent scientists, led by Harvard’s highly regarded epidemiologist Marc Lipsitch, signed a statement raising alarms about risks associated with gain-of-function research.

The academic controversy caused the Obama administration to issue a moratorium on gain-of-function research, but it included a general exception for studies “urgently necessary to protect the public health or national security.” According to Eban’s reporting, the exception quickly became a glaring loophole that essentially rendered the rule useless: the controversial research mostly continued unabated.

The Trump administration scrapped the moratorium in favor of a complex review process. But that process was mostly conducted outside of the public’s view or even significant peer review, leaving many of the critics, including Lipsitch, still wary.

The debate over the origins of COVID still rages today and unfortunately has become politicized, with Democrats and Republicans generally lining up behind the natural and lab-leak theories, respectively. In August 2021, the National Intelligence Council issued an unclassified report in response to an order from President Biden to review the origin of the virus. The report stated that the intelligence community had not been able to reach a conclusion and that the origin would likely never be known without more cooperation from the Chinese government. Of course, the more time that passes the less likely it is that the mystery will ever be solved.

While we would all like to know how the pandemic started, the mere fact that it might have originated from gain-of-function research gone awry makes it imperative to conduct a detailed investigation of the risks and potential benefits of this kind of research. Of all the things we regulate, surely tinkering with viruses to make them more contagious and more lethal should be right at the top of the list. Congress needs to pass laws closely regulating what Rutgers professor Richard Ebright described to Katherine Eban as “looking for a gas leak with a lighted match” and not leave this up to executive orders.

Congress should also investigate what appears to have been a coordinated attempt to squelch any inquiry into the legitimate questions over COVID’s origins in the early days of the pandemic. For example, the signers of the Lancet statement should be subpoenaed and questioned about what was almost certainly a false certification of “no competing interests” by at least one of the signers. (The criticism regarding potential conflicts of interest is not just coming from the right: The uber-progressive Columbia professor Jeffrey Sachs disbanded a group he had established to study the origins of COVID, citing conflicts of interest. Interestingly, Daszak was part of the group Sachs disbanded.)

I don’t know whether House Republicans can conduct such hearings without turning them into a carnival sideshow. But hopefully they will rise above partisan instincts and deliver much-needed answers for the American people.

Bill King is a businessman and lawyer, and is a former opinion columnist and editorial board member at the Houston Chronicle. He has served in a number of appointed and elected positions, including mayor of his hometown. He writes on a wide range of public policy and political issues. Bill is the author of “Unapologetically Moderate” and currently serves as the co-chair of the Forward Party of Texas.

https://www.zerohedge.com/covid-19/congress-should-investigate-gain-function-research

North Korea's Kim sacks No. 2 military official

 North Korea has sacked Pak Jong Chon, the second most powerful military official after leader Kim Jong Un, state media reported.

Pak, vice chairman of the Central Military Commission of the ruling Workers' Party and a secretary of the party's Central Committee, was replaced by Ri Yong Gil at the committee's annual meeting last week, the official KCNA news agency said on Sunday.

No reason for the change was given. Pyongyang regularly revamps its leadership and the year-end party gathering has often been used to announce personnel reshuffles and major policy decisions.

State television showed Pak sitting in the front row of the podium with his head down during the meeting while other members raised their hands to vote on personnel issues. His seat was later shown unoccupied.

He was also absent in photos released on Monday by the official KCNA news agency of Kim's New Year's Day visit to the Kumsusan Palace of the Sun which houses the bodies of his grandfather and father, unlike in October when Pak accompanied Kim on a trip to the palace to mark a party anniversary.

The party's Central Military Commission, which is headed by Kim, is considered the country' most powerful military decision-making body, above the defence ministry.

Pak's replacement came as Kim called for developing new intercontinental ballistic missiles and a larger nuclear arsenal to counter the United States and South Korea as key to the isolated country's 2023 defence strategy.

Pak had rapidly moved up the military ladder from a one-star artillery commander in 2015 to a four-star general in 2020, taking credit for contributing to progress in the country's short-range missile technology.

In late 2020, Pak was promoted to the politburo and earned the title of marshal, the highest military rank under Kim, and became a leading voice last November against joint South Korea-U.S. military exercises.

Like most other top military aides who went through ups and downs repeatedly under Kim, Pak was briefly demoted in mid-2021 after Kim chided some officials for their handling of North Korea's anti-coronavirus policy, before being promoted again months later.

Pak's dismissal comes despite Kim mostly lauding the military's advances in weapons development during the meeting, unlike other areas where he pointed out some faults and called for improvement.

Oh Gyeong-sup, a fellow at the Korea Institute for National Unification in Seoul, said a recent flare-up in inter-Korea tension over North Korean drones' intrusion into the South could have played a role.

Officials in Seoul said South Korea sent three drones across the border in response to the intrusion, but there was no response from the North, which Oh said could mean that it failed to detect the aircraft.

"Pak might have taken responsibility for the failure of security operations," Oh said.

Ri, Pak's successor, is also a senior military commander who held key positions including chief of the army's general staff and defence minister.

https://news.yahoo.com/north-koreas-kim-sacks-no-061011838.html

Virgin Islands AG Fired Three Days After Suing JPMorgan Over Jeffrey Epstein

 As we noted last week, US Virgin Islands Attorney General Denise George filed a lawsuit against JPMorgan for allegedly reaping financial benefits from Jeffrey Epstein's sex-trafficking operation - less than a month after George secured a $105 million settlement with Epstein's estate, which agreed to liquidate Epstein's islands and cease all business operations in the region.

Three days later, George is now unemployed, after Governor Albert A. Bryan Jr. fired her for allegedly filing the suit against JPMorgan without his permission.

According to the complaint, for "Over more than a decade, JPMorgan clearly knew it was not complying with federal regulations in regard to Epstein-related accounts as evidenced by its too-little too-late efforts after Epstein was arrested on federal sex trafficking charges and shortly after his death, when JPMorgan belatedly complied with federal law."

It goes much deeper than just the JPMorgan lawsuit...

The suit against JPMorgan Chase was not the whole scope of George’s pursuit of the remnants of Epstein’s network of conspirators. Although Little St. James ("Pedo Island") and its adjacent island owned by the Epstein estate went up for sale in March 2022, action taken by George kept the premise of any sale from going through. Acting in her former capacity as US Virgin Island Attorney General, she placed criminal activity liens on the islands from a civil racketeering lawsuit. That lawsuit was filed in 2020 following Epstein’s “death” in August of 2019. The suit alleged that Little St. James Island was used as part of a network of shell companies that Epstein manipulated to conceal the activities of his human trafficking network.



However, that suit was settled between the Epstein estate and George’s office in early December 2022. Under the agreement, Epstein’s estate would pay over $105 million to the Government of the US Virgin Islands as restitution. In addition to that sum, the liens preventing the sale of Epstein’s islands become removed under the condition that half of the proceeds from the sale will also be given to the US Virgin Islands through a trust it has opened to allocate the money to fund government programs to fight sexual abuse on the archipelago. “This settlement restores the faith of the People of the Virgin Islands that its laws will be enforced, without fear or favor, against those who break them. We are sending a clear message that the Virgin Islands will not serve as a haven for human trafficking,” Attorney General George stated upon the announcement of the settlement in one of her last acts before being fired.

Despite the resolution of the US Virgin Islands' direct case against the assets held by the Epstein estate, questions still linger about its operations in George’s jurisdiction. One of the most mysterious and perhaps most vital to examine of those shell companies, Southern Country International, was the first internationally operating bank to be opened in the US Virgin Islands by Epstein in 2014. The bank opened when John Percy de Jongh Jr. served as the governor of the territory. During his term, de Jongh appointed present-governor Albert A. Bryan Jr. into his administration as Commissioner of the US Virgin Islands Department of Labor. Despite not having much activity on its books, Southern Country International would renew its license with the US Virgin Islands five times before Epstein’s purported demise.

By the time Epstein died, his Virgin Islands based bank had less than $700,000 in assets. However, in December of 2019, months after his purported suicide, Epstein’s estate transferred a whopping $15.5 million into Southern Country International. In under a month, the bank’s assets diminished to less than $500,000. Mark Epstein, Jeffrey's brother and executor of his estate, stated that the bank was used to pay existing debts of the assets he had control over. Though the bank was not explicitly referenced in the press release on the December settlement, that announcement does detail the Virgin Islands action against Southern Trust Company, a holding company which points to a larger scale of Epstein owned enterprises connected to Southern Country International. It is unclear how the allegations made in George's lawsuit against JPMorgan Chase connect to the posthumous activity conducted by Epstein's Virgin Islands banking operation.

Following her dismissal, Assistant Attorney General Carol Thomas-Jacobs has been named to an interim position to fill George’s vacated seat. She will inherit the office as it joins an on-going list of plaintiffs who have taken action against large scale banks relating to their accounts with Epstein. Just over a month before George's filing, multiple class action suits were filed against JPMorgan Chase and Deutsche Bank alleging each institution knowingly profited from Epstein’s criminal activity. Those suits coincided with another filed against Epstein associate Leon Black, the billionaire who previously served as CEO of Apollo Global Management before his relationship with the pedophile thrust him into the spotlight.

The civil suit against Black alleges that the disgraced financier raped the plaintiff in 2002 at a mansion owned by Epstein. A spokesman for Black told Forbes that the claims made against their client were “categorically” false. Their response to Forbes follows one of a similar like from Deutsche Bank who told the publication that the suit filed against them “lacks merit.” Despite the magnitude of these lawsuits, the gravity of George’s suit against JPMorgan Chase surely made the biggest splash in the once-stagnant waters of the cesspool of the Epstein debacle. However, the firing leaves little hope that the waves caused by her last act as Attorney General will wash any truth to shore.

https://www.zerohedge.com/political/us-virgin-islands-fires-district-attorney-following-suit-against-jpmorgan-regarding

Duping antibodies with decoy may prevent rejection of transplanted cells

 Researchers at UCSF have developed a novel, potentially life-saving approach that may prevent antibodies from triggering immune rejection of engineered therapeutic and transplant cells.

Rejection mediated by —as opposed to the chemical assault initiated by —has proven particularly tricky to resolve, a factor holding held back the development of some of these treatments.

The new strategy, described in the Monday, Jan. 2, 2023 issue of Nature Biotechnology, involved using a "decoy" receptor to capture the antibodies and take them out of circulation before they could kill the therapeutic , that they treat as invading foreigners. The tactic may also be useful for .

"This antibody-mediated rejection is really hard to overcome," said Tobias Deuse, MD, the Julien I.E. Hoffman, M.D. Chair in Cardiac Surgery and senior author on the study. "So, rather than trying to suppress the patient's , we looked for ways we can alter the cells that the patient will receive and better enable them to survive."

Protecting friendly-but-foreign cells

The most celebrated cellular therapies in the U.S. are  (CAR) T-cell therapies. These CAR-T therapies are often used to successfully treat specific forms of lymphomas, a type of often-deadly cancer. But deploying them against solid tumors has proved much more difficult.

Until recently, most CAR-T therapies have been made using the patient's own cells, but the long-term commercial viability of cellular therapies of all types will rely on "allogeneic" cells—mass-produced therapeutic cells grown from a source outside the patient.

As with transplanted organs, the recipient's immune system is likely to treat any outsider cells, or tissues developed from them, as foreign and to reject them, according to Deuse. "We have been through this with , so we know what's coming for cellular transplantation," said Deuse, a cardiac transplant surgeon who is no stranger to the troubles caused by . "This issue is likely to be a severe obstacle in any type of allogeneic cell transplantation."

Clinical trials of allogeneic CAR-T therapies have had worse outcomes than treatments derived from the patients' cells, Deuse noted, adding that immunotherapy entails the added challenge of these free-floating cells being more exposed to immune attack than those in a transplanted organ.

"We have to find better ways to protect these cells," he said.

Duping antibodies with a decoy

Normally when an antibody binds to a cell, it acts as a sort of tag, calling out for an immune cell to bind to the antibody and set off an efficient process of destroying the tagged cell. To stop this , Deuse and his team devised a method to catch the antibodies before they bind to cells, preventing activation of the immune response.

The researchers genetically engineered three types of cells—insulin-producing pancreatic islet cells, thyroid cells, and CAR-T cells—so that each type made and displayed large numbers of a protein called CD64 on their surfaces.

On these engineered cells, CD64, which tightly binds the antibodies responsible for this type of immune rejection, acted as a kind of decoy, capturing the antibodies and binding them to the engineered cell, so they wouldn't activate immune cells.

"We saw that we can snatch up high levels of these antibodies, which resulted in very robust protection for the ," said Deuse. "This is clear proof-of-concept for this approach."

There's more work to do before the approach can be tested on cells that are designed to be therapeutics or transplanted cells, he said. While such cells are biologically sophisticated, they are also expensive and hard to manufacture.

"My hope is that our concept can help bring about the development of universally usable allogeneic cells." said Deuse. "That would make treatment with cellular therapies cheaper and more accessible, putting them within reach for many more patients."

Other UCSF authors are Alessia Gravina, Grigol Tediashvili, and Sonja Schrepfer of the Transplant and Stem Cell Immunobiology (TSI)-Lab, Raja Rajalingam of the Immunogenetics and Transplantation Laboratory, Zoe Quandt of the Division of Diabetes, Endocrinology and Metabolism. Chad Deisenroth of the U.S. Environmental Protection Agency, Center for Computational Toxicology & Exposure is also an author.

More information: Tobias Deuse, Protection of cell therapeutics from antibody-mediated killing by CD64 overexpression, Nature Biotechnology (2023). DOI: 10.1038/s41587-022-01540-7www.nature.com/articles/s41587-022-01540-7
https://medicalxpress.com/news/2023-01-duping-antibodies-decoy-aim-transplanted.html

Biden rejects South Korea nuclear exercises suggestion with firm ‘no’

 President Biden smacked down South Korean President Yoon Suk-yeol’s proposal for joint nuclear exercises Monday, telling reporters he’s not discussing the idea.

Hours earlier, a South Korean newspaper quoted Yoon as saying that joint military exercises involving nuclear weapons are under consideration and that US officials are “quite positive” about the idea.

A reporter asked Biden about the report on the White House lawn as he returned to Washington from a donor’s beach home in St. Croix, USVI.

“President Biden, are you discussing joint nuclear exercises with South Korea right now?” the journalist asked.

“No,” Biden replied, shooting the questioner a disbelieving look.

It’s unclear if the 80-year-old president was unaware of any talks among his subordinates. The White House did not immediately offer additional comment.

The Chosun Ilbo newspaper ran an interview with Yoon on Monday describing the idea for joint nuclear exercises to deter nuclear-armed North Korean tyrant Kim Jong Un.

“The nuclear weapons belong to the United States, but planning, information sharing, exercises and training should be jointly conducted by South Korea and the United States,” Yoon said.

President Biden denied a report that he is discussing a joint nuclear exercise with South Korean President Yoon Suk-yeol.
President Biden denied a report that he is discussing a joint nuclear exercise with South Korean President Yoon Suk-yeol.
AP Photo/Patrick Semansky
Yoon told a South Korean newspaper that US officials were “quite positive” about the idea of a joint exercise.
Yoon told a South Korean newspaper that US officials were “quite positive” about the idea of a joint exercise.
YONHAP/POOL/EPA-EFE/Shutterstock

It’s not the first time Yoon, who took office in May, has had an embarrassing interaction with his American counterpart.

In September, the South Korean president, 62, said into a hot mic at a United Nations event in New York City that it would be “humiliating” for Biden if Congress rejected his $6 billion pledge to global health projects.

According to a translation published by the Washington Post, Yoon said to his aides, “It would be so humiliating for Biden if these idiots don’t pass it in Congress.”

Yoon said the "planning, information sharing, exercises and training" should be jointly conducted between the United States and South Korea in order to deter North Korea.
Yoon said the “planning, information sharing, exercises and training” should be jointly conducted between the United States and South Korea in order to deter North Korea.
South Korean Defense Ministry via AP

A different translation, by the South China Morning Post, had Yoon saying, “How could Biden not lose damn face if these f–kers do not pass it in Congress?”

Kim said Sunday that his new year resolution is an “exponential” increase in North Korea’s nuclear weapon arsenal, which has grown to as many as a few dozen bombs since 2006.

The portly 38-year-old dictator reportedly has been ignoring US outreach since Biden took office after meeting three times with former President Donald Trump.

https://nypost.com/2023/01/02/joe-biden-rejects-south-korea-nuclear-exercises-plan-with-no/

Legend Bio: Application for Ciltacabtagene Autoleucel (Cilta-Cel) Accepted in China

 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).

This submission is based on data from the confirmatory Phase 2 clinical study CARTIFAN-1 (NCT03758417) conducted in China, which evaluated the efficacy and safety of cilta-cel in adult patients with relapsed or refractory multiple myeloma who have received 3 or more prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug.

https://www.biospace.com/article/releases/legend-biotech-announces-acceptance-of-its-new-drug-application-for-ciltacabtagene-autoleucel-cilta-cel-in-china/