Moderna candidate picked for FDA rare disease accelerated program

 Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. mRNA-3705 is an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency.

"We are excited about this opportunity and proud that our investigational mRNA therapeutic for MMA was selected by the U.S. FDA for the START pilot program. This selection highlights the promise of Moderna's innovative mRNA platform beyond vaccines and the potential this novel medicine may have in addressing the serious and unmet medical needs of MMA," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology. "Selection for this program will enable enhanced communication with the U.S. FDA, resulting in acceleration of our development program as we prepare for pivotal study initiation for mRNA-3705 in 2024."

The START pilot program was initiated by the U.S. FDA in September 2023 to accelerate the development of novel treatments addressing unmet medical needs in rare diseases, with an initial selection of up to seven novel treatments, three by the Center for Drug Evaluation and Research (CDER) and four by the Center for Biologics Evaluation and Research (CBER). The milestone-driven initiative is intended to help the progression to pivotal clinical studies or pre-BLA/NDA meeting stages by enhancing communications between manufacturers and the U.S. FDA. Selected manufacturers will benefit from rapid, ad-hoc U.S. FDA interactions to support clinical development, such as study design, patient population, and statistical methods, beyond standard formal meetings. The program is designed to generate high-quality, reliable data to support marketing approvals, ensuring promising treatments advance efficiently through regulatory milestones.

MMA is a rare, life-threatening, inherited metabolic disorder that is most commonly (approximately 60% of cases) caused by a deficiency in the mitochondrial enzyme MUT. This deficiency can lead to metabolic crises due to a toxic buildup of acids in the body, progressing into multi-organ disease. As a result, MMA is associated with significant mortality and morbidity, and there are no approved therapies. Standard of care includes dietary and palliative measures. Currently, liver or combined liver and kidney transplants are the only effective treatments.

https://finance.yahoo.com/news/modernas-investigational-therapeutic-methylmalonic-acidemia-110000019.html

'UnitedHealth ransomware attack prompts call for mandatory cybersecurity practices'

 Senate Finance Committee Chair Ron Wyden is urging the Department of Health and Human Services to mandate cybersecurity measures for health industry.

https://seekingalpha.com/news/4113696-unitedhealth-ransomware-attack-prompts-call-mandatory-cybersecurity-practices

China's Nvidia Loophole: How ByteDance Got the Best AI Chips Despite U.S. Restrictions

 The U.S. government forbids Nvidia from selling some of its most advanced artificial intelligence chips to customers in China. But that doesn't stop Chinese firms from buying or renting Nvidia chips if they're used within the U.S.

https://www.theinformation.com/articles/chinas-nvidia-loophole-how-bytedance-got-the-best-ai-chips-despite-u-s-restrictions

Virax up on bird flu story?

 Virax Biolabs Group Ltd. is a holding company, which engages in the sale, distribution, and marketing of diagnostics test kits and med-tech and personal protective equipment products for the prevention, detection, diagnosis, and risk management of viral diseases with a particular interest in the field of immunology. The company was founded by James Foster and Cameron Shaw in 2013 and is headquartered in London, UK.

https://finviz.com/quote.ashx?t=VRAX&p=d

LivaNova misses primary endpoint in depression trial

 Primary endpoint did not achieve statistical significance in unipolar patient cohort

Statistically significant and clinically meaningful benefits seen in select secondary endpoints; no safety concerns identified

The Company expects to publish the unipolar cohort data, including details on the PE and secondary endpoints, in peer-reviewed journals in the fourth quarter of 2024. Importantly, no safety issues were reported.

“I am encouraged by the clinically meaningful outcomes for the RECOVER unipolar patient population that is markedly treatment resistant,” said Dr. Charles R. Conway, Director of the Washington University in St. Louis Resistant Mood Disorders Center and Principal Investigator for RECOVER. “As we have previously published, the unipolar patients who entered the RECOVER study were of a greater severity than we had anticipated in the study design and have very few treatment options remaining. We now have a large body of data to evaluate, and I look forward to better understanding it in totality.”

The bipolar patient cohort continues for RECOVER and LivaNova will continue its discussions with the U.S. Centers for Medicare and Medicaid Services (CMS) regarding reconsideration of coverage for VNS Therapy for treatment-resistant depression.

https://www.businesswire.com/news/home/20240606200161/en/

Russian Warships Steam For Caribbean As Ukraine Tensions Go Global

 In a show of force perhaps prompted by President Biden's authorization of Ukrainian strikes inside Russia using US weapons, a group of Russian warships is en route to the Caribbean, a senior US official has told McClatchy and the Miami Herald. White House officials alerted members of Congress to the Russian move on Wednesday. 

The deployment signals Russia's capacity to operate globally while still fully engaged its third year of war in Ukraine. “This is about Russia showing they are still capable of some level of naval power projection,” the official said. “We should expect more of this activity going forward.” In March, Ukraine claimed it had either sunk or disabled a full third of Russia's ships in the Black Sea.

CBS News reports that long-range Russian bombers will rendezvous with the ships for combined naval and air maneuvers. Such exercises are not without precedent: Russia conducted similar combined-arms Caribbean maneuvers in 2019, and had a streak of sending ships into the Western Hemisphere at least annually from 2013 to 2020. Following the summer exercises, Russia is expected to engage in a worldwide naval exercise this fall, sources tell CBS. 

The Pentagon is tracking a "handful" of ships and support craft that are expected to reach Caribbean waters in the upcoming weeks. US analysts speculate that the flotilla will make port calls in both Cuba and Venezuela. Cuba's likely relishes the opportunity to host the Russian warships: Last year's docking of a US nuclear submarine at Guantanamo Bay Naval Base ruffled feathers in Havana, with the Cuban government calling it a "provocative escalation."

  

"Clearly, [the Russians] are unhappy — needless to say — with our support for Ukraine and support for our NATO allies,” the official said. Last week, the Biden administration quietly gave Ukraine the green light to use US weapons to strike targets inside Russia. That marked a major policy reversal, as such strikes had previously been barred as too escalatory. 

Ukraine has apparently wasted little time in exercising its new freedom, as images circulated on social media that appeared to show burning S-300 and S-400 mobile surface-to-air missile systems inside Russian territory:

On Wednesday, Russian President Putin said he was considering some kind of retaliation-in-kind:

If they consider it possible to deliver such weapons to the combat zone to launch strikes on our territory and create problems for us, why don’t we have the right to supply weapons of the same type to some regions of the world where they can be used to launch strikes on sensitive facilities of the countries that do it to Russia?...We will think about it."

Expect America's warmongers to shriek at Russia's upcoming Caribbean exercises -- despite the fact that US military forces routinely buzz by the territorial waters and airspace of Russia, China and many other countries around the world. 

https://www.zerohedge.com/geopolitical/russian-warships-steam-caribbean-ukraine-tensions-go-global

NAACP threatens American Airlines with travel ban after cited body odor when removing 8 Black men from flight

 The NAACP has threatened to reinstate a travel ban on American Airlines after the company removed eight Black men from a flight last month when a white flight attendant complained an unidentified passenger had body odor. 

In 2017, the civil rights organization issued a travel advisory for their airline, warning African American passengers to “exercise caution” after multiple reports of discrimination. At the time, the organization cited four “alarming” incidents that seemed to show Black Americans were subjected to “disrespectful, discriminatory or unsafe conditions” when booking or boarding with the airline. 

American Airlines responded by instituting a diversity, equity and inclusion (DEI) panel, and the NAACP lifted its ban in July 2018. 

But amid growing politicization of DEI programs, American Ariline’s council was disbanded last year.

Now, the NAACP is once again calling on the company to respond to mounting allegations of discrimination.

“Recent discriminatory actions from company employees prove that there is a dire need for continued accountability and resolution to this clear pattern,” NAACP President and CEO Derrick Johnson said in a statement. 

In 2023, track star Sha’Carri Richardson alleged that a flight attendant “threatened” her and a fan who wanted a picture. That same year, American staff members questioned musician David Ryan Harris at LAX because they suspected he was trafficking children — though the boys were his own sons.

Earlier this year, retired Circuit Judge Pamela Hill-Veal told NPR that as she and her family flew first class on American from Chicago to Phoenix in February, a flight attendant accused her of “slamming” the first class bathroom door and then told her she would have to use the bathroom at the back of the plane for the rest of the flight.

And just last month, three Black men filed a lawsuit against American Airlines, alleging employees forced them and the other Black male passengers to deboard a flight from California to New York. 

According to the suit, the plaintiffs were not immediately given a reason for their removal. Only after demanding an explanation multiple times did a representative finally tell them a white male flight attendant had complained about an unidentified passenger’s body odor. None of the men removed were accused of having an offensive odor, the lawsuit states. 

Video recordings of the incident show several of the men alleging they were being discriminated against. At least one American representative can be heard saying “I agree” in response to the accusations.

“We encourage American Airlines to come revive the advisory panel and reconvene with the NAACP to devise a path forward that ensures equitable experiences for all American Airlines customers,” Johnson said. “Without a swift and decisive response, the NAACP will be forced to reinstate an advisory against the airline.”

A spokesperson for the company told The Hill that American Airlines has “worked with the NAACP to institute education and training programs to address issues of bias on our aircraft and within our hiring practices to eliminate bias and create a workforce and customer experience that represents the customers we serve.”

Counsels for the plaintiffs Susan Huhta, partner at Outten & Golden, and Michael Kirkpatrick, attorney at Public Citizen Litigation Group, said in a statement Wednesday that their three clients are “still waiting or American Airlines to provide them with a reasonable explanation for why they were removed from the airplane and publicly humiliated.”

American Airlines previously told The Hill that the company takes “all claims of discrimination very seriously and want our customers to have a positive experience when they choose to fly with us.” The company added that the matter was being investigated and that “the claims do not reflect our core values or our purpose of caring for people.”

https://thehill.com/homenews/race-politics/4705815-naacp-american-airlines-travel-ban-body-odor-black-passengers/