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Friday, May 8, 2026

Capricor sues partner Nippon Shinyaku in DMD therapy spat

 Capricor Therapeutics has fallen out with its commercial partner for Duchenne muscular dystrophy (DMD) cell therapy deramiocel, Nippon Shinyaku, and is taking its complaint to the courts.

The San Diego biotech has filed a lawsuit against the Japanese drugmaker and its US subsidiary, NS Pharma, claiming that the terms of their distribution contract for deramiocel are flawed and could hinder DMD patients from getting access to the therapy if it gets approved by the FDA.

According to Capricor, the distribution agreement with NS Pharma contains a "fundamental pricing flaw" that its partner has refused to address, and it has accused the company of failing to "adequately prepare" for the commercial launch.

Deramiocel was turned down by the FDA last year as a treatment for cardiomyopathy associated with DMD, but has since been refiled as a treatment for skeletal and cardiac manifestations of the muscle-wasting disease, and the US regulator is due to deliver a verdict on that second attempt by 22nd August after a priority review.

The lawsuit is seeking to set aside the agreement altogether, arguing that NS Pharma's actions mean that the deramiocel launch will be "delayed and disrupted" due to a previous pricing structure, described as a "mutual mistake," that it claims "renders commercialisation nonviable."

While Capricor has tried to modify the agreement with a new pricing structure, correcting what it describes as a disconnect between the proposed pricing and the Medicare reimbursement framework that would affect both federal and private reimbursement. However, it contends that NS Pharma has refused to cooperate and effectively has tried to "seize control" of the deramiocel.

"I have spent nearly two decades building Capricor with one goal in mind: making deramiocel available to treat these boys," said Dr Linda Marbán, Capricor's chief executive. 

"I know what every additional month of delay costs them, because I know what is happening inside their muscles when they cannot be treated," she added. "There is no version of this case in which I am willing to watch NS Pharma's inaction take that away from them."

The lawsuit is asking for the distribution agreement to be rescinded and an injunction imposed to prevent NS Pharma from "interfering with Capricor's efforts to distribute deramiocel […] in the US."

Deramiocel consists of donor cardiosphere-derived cells (CDCs), given by intravenous infusion once every three months, that are thought to modulate the immune system and regenerate skeletal and cardiac muscle cells.

Capricor entered into the distribution agreement with Nippon Shinyaku and NS Pharma in 2022, receiving an upfront payment of $30 million and the promise of up to $705 million in milestone payments.

Under the terms of the deal, Capricor would sell supplies of the therapy to NS Pharma for distribution and receive a share of product revenue.

https://pharmaphorum.com/news/capricor-sues-partner-nippon-shinyaku-dmd-therapy-spat

US military says it killed 2 in strike on alleged drug-trafficking boat

 The U.S. military’s latest strike on an alleged drug-trafficking boat in the eastern Pacific Ocean killed two men Friday while leaving one survivor.

Video posted on social media by U.S. Southern Command shows a black, boat-shaped image before what appears to be an explosion, followed by a column of fire rising from the ocean.

Southern Command said it “immediately notified the U.S. Coast Guard to activate the Search and Rescue system for the survivor.”

The White House announced Wednesday that President Donald Trump has signed off on a new U.S. counterterrorism strategy that sets eliminating drug cartels in the Western Hemisphere as the administration’s highest priority.

The Trump administration’s campaign of blowing up alleged drug-trafficking vessels in Latin American waters, including the eastern Pacific and the Caribbean Sea, has gone on since early September and killed at least 193 people in total. The military has not provided evidence that any of the vessels were carrying drugs. The strikes have ramped up again in recent weeks.

At the same time, Trump has sought to press regional leaders to work more closely with the U.S. to target cartels and take military action themselves against drug traffickers and transnational gangs that he says pose an “unacceptable threat” to the hemisphere’s national security.

Critics, meanwhile, have questioned the overall legality of the boat strikes.

https://www.nbcnews.com/politics/trump-administration/us-strike-alleged-drug-boat-eastern-pacific-kills-2-leaves-survivor-rcna344320

US concerned by Taiwan defence delay 'concession' to China

 Further delays to Taiwan military spending are a "concession" to China, the U.S. State Department said, as Taipei's defence ministry detailed the impact of projects excluded from a package passed by the opposition-controlled parliament.

Taiwan President Lai Ching-te had sought $40 billion in supplementary defence spending to better deter China, which views the democratically governed island as its own territory and has stepped up its military pressure.

But after repeated delays by opposition parties, who hold the majority of seats, parliament on Friday approved only two-thirds of the money requested, all for U.S. weapons rather than including other projects like domestically developed drones and missiles. 

The opposition said that while it supports defence spending, it would not sign "blank cheques", saying the proposals were vague in places and could open the door to corruption.

A State Department spokesperson said the U.S. supports Taiwan's acquisition of critical defence capabilities "commensurate with the threat it faces" and consistent with the ongoing commitment of multiple U.S. administrations.

"While we are encouraged by the passage of this special defence budget after unhelpful stalling, the United States notes that further delays in funding the remaining proposed capabilities are a concession to the Chinese Communist Party," the spokesperson added.

The U.S. is Taiwan's most important international backer and arms supplier, despite the lack of formal diplomatic ties, and has strongly supported increased military spending. Beijing has repeatedly demanded an end to weapons sales.

In a statement late on Friday, Taiwan's defence ministry said the approved spending completely excludes certain commercial purchases, which is highly likely to create "capability gaps".

"Our country faces a severe and continuously escalating threat environment," it said.

One plan not included is the Chiang Kung, or "Strong Bow", anti-ballistic missile which is meant to form the backbone of Taiwan's new "T-Dome" air defence system, the ministry added.

"Following its removal from the special budget, if it cannot be procured in a timely manner, air defence combat effectiveness will be severely impacted," it said.

Lack of approval for drone systems like sea attack drones will significantly delay asymmetric warfare capabilities and affect projected economic growth and employment opportunities for domestic industry, the ministry said.

Lai said that while he appreciated the approved funding, which allows purchases of such items as the Lockheed Martin-made HIMARS multiple-launch rocket system to proceed, this was only the first step.

"Any gap will affect the integrity of the overall defence system. Any delay will increase the shared security risks borne by the people of Taiwan," he posted on Facebook.

https://www.marketscreener.com/news/us-concerned-by-taiwan-defence-delay-concession-to-china-ce7f5bdbd08ff521

Fed's Christopher Waller Advocates for Centralized Support Functions

 Christopher Waller, a Federal Reserve governor, proposed a new model for the Fed's supportive functions, emphasizing the benefits of centralizing areas such as human resources, IT, and risk management. 

Christopher Waller's proposal at a monetary policy conference at Stanford University highlights a significant shift in the operational structure of the Federal Reserve. By advocating for the centralization of support functions, Waller aims to streamline operations and reduce costs across the 12 regional Reserve Banks, which currently operate independently. This change is expected to enhance risk management and operational efficiency, ultimately benefiting taxpayers. The Fed's focus on operational efficiency is particularly relevant as it plans to reduce its workforce by 10% in the coming years.

https://www.gurufocus.com/news/8847187/feds-christopher-waller-advocates-for-centralized-support-functions

Race Is On to Write Guidance to Contain First Ship-borne Hantavirus Outbreak

 As the cruise ship hit by a hantavirus outbreak sails towards Tenerife, World Health Organization officials are racing to draw up step-by-step guidance for what should happen next for the nearly 150 passengers when they ⁠finally reach land on Sunday.

The hantavirus outbreak – which has killed three people among at least eight suspected or confirmed infections - is the first ever recorded on a cruise ship, so some new protocols are needed.

Half a dozen current and former WHO ⁠officials and hantavirus experts said the outbreak could be managed by adapting standard public health steps, like isolating sick passengers or those who may have been in contact with them. None of the passengers ⁠on the ship now have symptoms, the ship's operator has said.

TIPS ‌FROM ARGENTINA

Officials are also seeking tips from Argentina, where a previous outbreak of the Andes virus, the same strain as on the ship, was snuffed out in 2019. 

“If we follow public health measures and the lessons we learned from Argentina ... we can break this chain of transmission. This doesn't need to be a large epidemic,” Abdi Rahman Mahamud, director of the WHO's alert and response coordination department, said.

He said the focus was on isolation for sick people, and monitoring and quarantining for other passengers, subject to national government decisions. 

The WHO may also ‌recommend that some people with links to the outbreak take their temperature daily for at least 42 days as the Andes strain has a ​long incubation period, ‌Anais Legand, WHO technical officer for viral threats, said at an online briefing on ‌Friday.

National authorities may also be asked to set up regular contact with those people, and give them a phone number to call if they feel at all unwell, she added. 

Passengers are being split into high-risk and ⁠low-risk contacts based on their interactions with sick travellers, the WHO said. Contact-tracing is also key for ‌any who have left the ship already.  

The Andes hantavirus ⁠is known to spread through close and prolonged contact, and chiefly ​when a patient is already symptomatic. That information is based largely on the ‌one outbreak where the Andes virus spread between people in Argentina in 2018-19, in which 34 people were infected and 11 died. 

“We essentially learned that once you implement basic measures of social distancing, that are essentially very simple – stay home when you are not feeling well – that diminished the circulation and the outbreak burned out,” said Gustavo Palacios, ​a professor at Icahn School of Medicine at Mount Sinai, in the United States, who is originally from Argentina and a ‌co-author ‌of a key paper on that outbreak.

He and others have been advising WHO on the outbreak since May 2, he said, adding he hoped more attention would now be paid ‌to the risks of hantaviruses, which can have ​fatality rates of up to 50%.  

SOME PLANS IN PLACE

Some governments are already making plans: the UK government said on Friday morning it would repatriate its citizens on a flight under strict infection-control measures, and then passengers would be asked to isolate for 45 days, with testing as required. 

Krutika Kuppalli, associate professor of medicine ⁠at the University of Texas Southwestern Medical Center in the U.S., who formerly worked on mpox protocols at the WHO, said measures ‌could be taken from previous outbreaks.

“It’s the same principle as for measles, or Ebola. Contact tracing doesn’t change,” she said.

The WHO said late on Thursday it was still finalizing ​guidelines.

https://www.medscape.com/s/viewarticle/experts-race-write-guidance-contain-first-ship-borne-2026a1000exo

'Does Vaping Cause Cancer?'

 A scientific review has raised fresh concerns about the long-term cancer risks of vaping, concluding that e-cigarettes are probably carcinogenic, while also acknowledging significant gaps in the evidence.

The analysis of reviews and single studies published since 2017 concluded that nicotine vaping “likely” contributes to oral and lung cancers. But the actual risks and how they compare with those from smoking are impossible to calculate at this point. 

E-cigarettes are relatively new, having hit the market about 20 years ago. Unlike the case with tobacco use, where decades of epidemiological data firmly establish its cancer risk, long-term population studies of e-cigarette users are lacking.

“Sufficient time to reveal any consequential burden of cancer wholly attributable to vaping has not yet passed,” said Bernard Stewart, PhD, a professor at the University of New South Wales in Sydney, Australia, who led the review.

The upshot, in the words of one researcher, is that society is in the midst of a “natural experiment” to see what the ultimate health risks of vaping are.

The State of the Evidence

When first introduced, e-cigarettes were touted as being a less harmful alternative to traditional smoking and possibly a way to help smokers quit. A recent Cochrane Review concluded that nicotine-based vaping can, in fact, boost quit rates compared with nicotine replacement products.

And on May 5, the FDA announced a first: It authorized the marketing of fruit-flavored vapes, citing a need for an “expanded array of flavored options” for adults who want to give up traditional cigarettes.

At the same time, no e-cigarette product is FDA-approved for smoking cessation, and health authorities have for years raised concerns about vape marketing that targets adolescents, as well as the lack of data on long-term health risks.

Enter the new review, published in Carcinogenesis. Stewart’s team compiled the most up-to-date evidence on the “carcinogenicity” of e-cigarettes, using biomarker studies of people who vape, case reports, animal research, and analyses of e-cigarette aerosols.

Starting with people: Numerous studies have established that vapers are exposed to known or suspected carcinogens. E-cigarette users have elevated urinary markers of volatile organic compounds, such as acrylamide and acrylonitrile, vs nonusers. They also have higher levels of metals such as lead and cadmium, as well as certain polycyclic aromatic hydrocarbons.

In nearly all of those cases, vapers show far lower exposure than cigarette smokers do. Still, biomarker studies have pointed to potential consequences from e-cigarette chemical exposures, including elevated indicators of DNA damage, oxidative stress, chronic inflammation, and epigenetic changes in tissue samples from vapers compared with controls (typically identified as nonsmokers).

Meanwhile, lab studies of e-cigarette aerosols have turned up all 10 “key characteristics” of carcinogens, including the capacity to alter DNA repair, induce inflammation, and suppress immune system activity. And based on animal research, exposure to those aerosols can cause lung tumors.

The main gap? Data on human cancer are scarce. Stewart and his colleagues cite case reports of oral cancers among people who vaped for over a decade. And together with the other data sources, they consider the evidence strong enough to call e-cigarettes a likely contributor to oral and lung cancer risk.

But to “move beyond isolated case reports,” the researchers say, longitudinal studies linking e-cigarette use to cancer incidence in population-based registries are necessary.

The review was restricted to nicotine-delivering e-cigarettes and did not assess marijuana vaping. There is early research suggesting that cannabis aerosols trigger inflammation, apoptosis, and “cancer pathways” in human bronchial cells, but the evidence base is even more limited than that for e-cigarettes.

Why Certainty Remains Elusive

A chief reason for the uncertainty is the long latency of cancer.

“The evidence from biomarkers is consistent, but the magnitude of the effect long term in human studies will likely take much more time to be known,” Michael Chaiton, PhD, of the Center for Addiction and Mental Health and Ontario Tobacco Research Unit, University of Toronto, Toronto, Canada, told Medscape Medical News

Product variation is another factor. E-cigarettes differ in device design and e-liquid composition, while user behavior varies, too — all of which make it difficult to quantify exposure or compare studies.

It’s also tough to tease out the effects of e-cigarettes, per se, from those of cigarette smoking, because many people are “dual users,” Stewart pointed out. 

Chaiton agreed, noting that this type of research is “inherently tricky.”

“It’s hard to find large groups of people who have never smoked cigarettes but have been frequent vapers for a long time,” he said. “That’s particularly true for older people.” 

Essentially, Chaiton said, “as a society, we are currently running a natural experiment,” where health risks attributable to vaping itself may only become clear in younger cohorts.

The Bottom Line

While many questions remain, it is safe to make certain assumptions based on the existing evidence, according to Chaiton.

“First,” he said, “there are harms associated with vaping exposure compared to non-exposure. Second, harms associated with vaping will be less than harms associated with smoking for most diseases, including cancer. The level of biomarker exposure is good evidence for that.”

However, the relative disease risks — how much worse is vaping than nonuse and how much better is it than smoking nonexposure — remain to be seen, Chaiton said. And those are critical unknowns from a public health standpoint. 

“The challenge,” Chaiton said, “is that from a policy perspective, it does make a difference if vaping is 30% as harmful as smoking, or 5%.”

https://www.medscape.com/viewarticle/does-vaping-cause-cancer-2026a1000euv

US and Korea sign shipbuilding pact

 The United States and South Korea signed a Memorandum of Understanding to expand cooperation in shipbuilding, the US Department of Commerce's International Trade Administration (ITA) announced in a statement.

The agreement establishes the Korea-US Shipbuilding Partnership Initiative, which is said to promote collaboration in "workforce training, industrial modernization and maritime investment," the agency said.

Oversight will be provided by US Secretary of Commerce Howard Lutnick and Republic of Korea Minister of Trade, Industry and Resources Jung-kwan Kim, with a new partnership center expected to open later this year in Washington DC.

https://breakingthenews.net/Article/US-and-Korea-sign-shipbuilding-pact/66257434