Windy, dry conditions raising fire risks in Hawaii

 Forecasters are warning windy and dry conditions could increase the risk of fires spreading in the leeward portions of each Hawaii island, just three weeks after a deadly wildfire ripped through Maui. 

The National Weather Service (NWS) of Honolulu on Wednesday issued a Red Flag Warning through Thursday afternoon for gusty winds and low humidity. Forecasters noted the wind gusts will not be as strong as Aug, 8, when the wildfires broke out on Maui and burned through thousands of acres of land, especially in the historic town of Lahaina. 

The Aug. 8 event marked the deadliest U.S. wildfire in more than a century, leaving at least 115 people dead and destroying thousands of structures.

On Thursday, winds are expected to be 15 to 30 mph with gusts of 40 to 50 mph while humidity levels are predicted to be 35 to 45 percent, forecasters said. During the Maui wildfires, parts of Hawaii saw wind gusts of more than 80 mph, the weather service noted.

“There is a magnitude difference between the wind speeds in this event versus August 8th,” Maureen Ballard, a meteorologist at the agency’s Honolulu office, told The Associated Press.

“A combination of strong winds, low relative humidity and dry fuels can contribute to extreme fire behavior. Any fires that develop will likely spread rapidly,” the NWS wrote in an advisory, noting a Red Flag warning does not forecast new fires starting.

Forecasters warned against outdoor burning and advised residents to park cars in areas that are paved or where vegetation is trimmed or cleared to avoid heat from vehicle exhaust systems. 

Lahaina’s fire earlier this month was driven by winds from both Hurricane Dora and a very high-pressure system to the north of the islands. Investigators have not determined an exact cause, though Hawaii’s electric utility acknowledged downed power lines may have started the first wildfire on Maui. 

https://thehill.com/policy/energy-environment/4180635-windy-dry-conditions-raising-fire-risks-in-hawaii/

Biden administration announces $450M in funding to beat overdose epidemic

 The Biden administration announced more than $450 million in new funding to combat the overdose epidemic with the goal to reduce deaths, support recovery efforts and invest in information campaigns that target young people.

“We know the overdose epidemic is a national crisis, far too many families have lost loved ones, their children, their siblings, and their partners,” second gentleman Doug Emhoff told reporters Thursday. “Substance abuse disorders impact families across all of our nation, in cities and rural areas, in red states and blue states. In short, this impacts everyone.”

Emhoff and Rahul Gupta, director of the White House Office of National Drug Control Policy (ONDCP), will meet later Thursday with parents who have lost loved ones to drug overdose to mark International Overdose Awareness Day. This is the second year they are hosting this community of parents.

Within that $450 million, ONDCP will invest more than $20.5 million in 164 new Drug-Free Communities Support Programs, which support evidence-based prevention efforts locally; $1 million will go to a campaign to reach young people about Fentanyl awareness; and more than $18.9 million will go to disrupt illicit drug trafficking operations.

Gupta said the Biden administration is focused on “going after” the traffickers “who are responsible for killing Americans” by bringing drugs into the U.S.  

Senior administration officials argued that President Biden “has been tougher in China in terms of making sure that the illicit actors … that are shipping these chemicals — we’re going after.” Officials noted that sanctions have been placed against Chinese chemical companies, Chinese individuals and Mexican cartels.

The investment on Thursday also includes the Substance Abuse and Mental Health Services Administration awarding more than $57.6 million to connect Americans to substance use treatment and recovery support services. The Centers for Disease Control and Prevention will award $279 million in Overdose Data to Action grants to states and localities to expand harm reduction strategies. 

Additionally, the Health Resources and Services Administration will award more than $80 million to rural communities to support strategies to respond to the overdose risk from illicit fentanyl and other opioids.

Neera Tanden, White House domestic policy adviser, told reporters the White House is focused on disrupting the flow of illicit fentanyl into the U.S. and noted the Biden administration has already taken action, pointing to the Food and Drug Administration approval of two naloxone products. The first of the opioid reversal medication, Tanden said, could be available at retail pharmacies as early as next week.

“This will make a huge difference in driving down the numbers of people who have died from fentanyl-related overdoses,” she added.

Biden said on Thursday that he is grieving with families that have lost loved ones to overdoses on Overdose Awareness Day.

“Let’s find hope in the 20 million brave Americans recovering from substance use disorder who show us what’s possible when people receive the care and support they need,” he said on X, formerly known as Twitter. “My Administration will continue to ensure that our nation has the resources we need to address the overdose epidemic.”

Emhoff told reporters that the overall goal of the new funding is to eliminate the stigma of overdoses, invest in behavioral health resources and make sure communities have the tools needed to fight addiction.

He also noted overdoses flattened in 2022 after sharp increases in 2019 and 2021.

When questioned on the data, senior administration officials added that overdose deaths related to other substances are down or flattening, but Fentanyl overdose deaths are increasing because the supply is more lethal.

https://thehill.com/homenews/administration/4180715-biden-administration-announces-450m-in-funding-to-beat-overdose-epidemic/

X, formerly known as Twitter, will collect user biometric data, job and education history

 X, the platform formerly known as Twitter, will begin collecting biometric data and information on users’ employment and education history starting next month, according to the site’s updated privacy policy.

“Based on your consent, we may collect and use your biometric information for safety, security, and identification purposes,” X said in the new privacy policy, set to go into effect on Sept. 29.

The social media platform told Bloomberg Law that the biometric data collection is for X Premium users, or those who pay for the platform’s subscription service, to allow for an additional layer of verification.

X did not specify what biometric data it plans to collect. However, such data can include facial images, fingerprints and iris patterns. 

The new addition to X’s privacy policy comes as the company faces a proposed class action lawsuit in Illinois over allegations that it collected biometric information on users without providing advance notice or obtaining their consent.

X also noted in its updated privacy policy that it may collect information about users’ employment and education history in order to “recommend potential jobs for you, to share with potential employers when you apply for a job, to enable employers to find potential candidates, and to show you more relevant advertising.”

The platform began rolling out its new recruitment tool X Hiring last week, offering verified organizations early access to the beta version of the new feature.

X has undergone significant changes since it was first bought by billionaire Elon Musk last fall. Beyond the rebrand to X, Musk has also made several controversial modifications to the platform, including walking back its content moderation policies and reinstating previously banned accounts.

https://thehill.com/policy/technology/4181120-x-formerly-known-as-twitter-will-collect-user-biometric-data-job-and-education-history/

North Korea says it simulated nuclear attack on South, rehearsed occupation

 North Korea said it simulated a “scorched earth” nuclear attack on South Korea on Thursday and an ensuing land occupation.

The country launched two ballistic missiles from the capital Wednesday night as part of the tests, apparently meant to target command centers, key airfields and other military targets in the case of another Korean military conflict.

The missile tests were standard procedure, but the reveal of extensive occupation war plans shows increased aggression as the country protests joint U.S.-South Korea military drills.

The U.S. flew a group of B-1B bombers near the border Wednesday as part of joint training exercises.

“[The aerial drill] is a serious threat to [North Korea] as it was just pursuant to the scenario for a preemptive nuclear strike at” the country, the North Korean People’s Army (KPA) general staff said. “The KPA will never overlook the rash acts of the U.S. forces and the [South Korean] military gangsters.”

The missiles traveled about 250 miles east into the Sea of Japan, according to South Korean and Japanese assessments. The South Korean Joint Chiefs of Staff called the missiles a “a grave provocation.”

The tests are a continuation of escalated tensions between the U.S. and North Korea. North Korean leader Kim Jong Un ordered factories to “drastically boost” production of ballistic missiles earlier this month.

North Korean state media reported that Kim visited military command posts Tuesday which were drilling occupation plans. The plans are meant to prepare for “occupying the whole territory of the southern half” in the event of war.

The South Korean Unification Ministry condemned the military planning and said it’s the first time the country has acknowledged occupation drills since Kim came to power in 2011.

https://thehill.com/policy/international/4180611-north-korea-says-it-simulated-nuclear-attack/

ICE sends deportation flight to Haiti after warning US citizens to evacuate

 The Biden administration is conducting a deportation flight to Haiti on Thursday, a day after the State Department called on all U.S. citizens to leave the country immediately due to security concerns.

The scheduled deportation flight, the second to Haiti this month, left Alexandria, La., shortly before 8 a.m. EDT and is scheduled to land in Port-au-Prince shortly after 11 a.m.

“Those two cannot happen at the same time. You cannot be evacuating people and deporting people at the same time. That is beyond inhumane. It is definitely a violation against human rights,” said Guerline Jozef, executive director of the Haitian Bridge Alliance.

According to unconfirmed reports Wednesday, the flight was scheduled to depart with more than 60 Haitians on board.

Immigration and Customs Enforcement (ICE) did not immediately return a request for comment.

Earlier in August, ICE commissioned about 850 flights to move immigration detainees within the United States, a 50 percent increase from the month before, as well as approximately 150 removal flights, up 51 percent from July.

ICE air operations are at a 44-month high, and the 150 removal flights this month are the most since September of 2021, when the Biden administration operated 193 such flights, including many to Haiti.

ICE has also increased the visibility of those flights, touting its efforts to repatriate foreign nationals: On Wednesday, it offered media footage of three separate deportation flights to Ecuador.

Though advocates have been sharply critical of the Biden administration’s policy of parading deportee “perp walks,” ICE has continued to distribute the footage.

And human rights advocates are baffled over many elements of the administration’s policies toward Haiti, from its support for the current regime to continued deportations to a country in chaos.

“What’s unconscionable is that the U.S. is propping up the illegitimate and abhorred regime which is responsible for the hellish conditions Haitians endure every day,” said Steven Forester, immigration policy coordinator at the Institute for Justice and Democracy in Haiti.

Jozef said the administration’s record on Haiti has some bright spots, with policy wins such as the expansion of Temporary Protected Status (TPS) for Haitians.

“We fought really hard to get TPS, we say thank you for that; really hard for the humanitarian parole, thank you for that. We worked really hard for them to push on family reunification. Not only do we support, we work with them, and we say thank you for that and we continue to do so,” said Jozef.

“However, when what they are doing is wrong, we have to hold them accountable.”

On July 27, the State Department issued a “do not travel” notice for Haiti; ICE did not conduct removal flights to the country that month.

Over that month, conditions there continued to deteriorate with the kidnapping of a U.S. national and her daughter, and an announcement that a U.N.-brokered, Kenya-led peacekeeping force, supported by the United States, would be deployed to Haiti. 

On Aug. 2, ICE repatriated 55 people to Haiti.

On Wednesday, the State Department escalated its warning on conditions in Haiti, calling on all U.S. nationals to leave the country “as soon as possible via commercial or private transport,” just hours before Thursday’s removal flight.

“Our ask is for the United States to turn that plane around,” said Jozef.

“The United States must not deplane people, deported people. They need to turn that thing around.”

https://thehill.com/latino/4180930-ice-sends-deportation-flight-to-haiti-after-warning-us-citizens-to-evacuate/

Sage Cuts Staff by 40% After FDA’s MDD Rejection

 Sage Therapeutics on Thursday announced a strategic review and reorganization plan to support its long-term business growth and the launch of its postpartum depression drug Zurzuvae (zuranolone).

As part of the realignment, Sage will let go of approximately 40% of its workforce, which the company says will “right-size the organization” and help it achieve sustained growth. The layoffs are also meant to provide Sage with more resources for commercial hires that will support the launch of Zurzuvae. The company expects to launch the postpartum depression (PPD) drug later this year.

Thursday’s strategic reorganization follows the FDA’s bittersweet verdict earlier this month. While the regulator gave Sage’s fast-acting pill the greenlight in PPD, it rejected the drug’s use in patients with major depressive disorder (MDD)—a much larger and more lucrative indication. Despite winning one approval, Sage’s shares tanked nearly 50% in response to the MDD rejection.

In an interview with Reuters earlier this month, Jeffries analyst Mike Yee said that zuranolone had a more than $1 billion sales opportunity in clinical depression “compared with $250 million to $500 million potential for postpartum depression.”

Soon after zuranolone’s rejection in MDD, Sage CEO Barry Greene said in an investor call that the company is looking to extend its cash runway and is “currently evaluating resource allocation, including pipeline prioritization and a workforce reorganization.”

Alongside the layoffs announced Thursday, Sage said it will focus R&D efforts on two mid-stage assets. These include its oral neuroactive steroid SAGE-324, in development for essential tremor, epileptiform disorders and Parkinson’s disease. The company will also continue advancing its oral NMDA modulator SAGE-718, being trialed for Alzheimer’s disease and mild dementia, as well as cognitive dysfunction in Huntington’s disease and Parkinson’s disease.

Meanwhile, Sage will suspend work on “certain earlier-stage programs, with the goal of making evidence-driven investments,” the company said in Thursday’s announcement.

Sage will also adjust its leadership team structure to be more aligned with its pipeline and commercial properties. In line with these changes, CSO Al Robichaud will step down from his post but will stay onboard as a scientific consultant and will remain part of Sage’s Medicinal Chemistry and Pre-Clinical Scientific Advisory Boards. Robichaud has been with the company since its founding in 2011.

Sage CDO Jim Doherty and Senior Vice President of Medical Affairs Mark Pollack will also depart “to pursue new opportunities,” the company announced.

The pipeline and workforce reorganization plan is meant to help Sage strengthen its balance sheet by generating annualized net savings of $240 million. As of June 30, 2023, Sage had approximately $1 billion in cash, cash equivalents and marketable securities, which will help fund the company’s operations into 2026.

https://www.biospace.com/article/sage-cuts-staff-by-40-percent-after-mdd-rejection-by-fda/

Investor Tarsadia urges Cue Health to review options, add new director

 Tarsadia Investments is urging Cue Health to review its strategy, including options for a possible sale, to help reverse its stock plunge of 98% in the last two years, according to a letter seen by Reuters.

The investment firm, which owns just under 5% of the diagnostic company's shares and invests for wealthy families, also wants it to cut costs and add a shareholder director, said the letter, which was sent to the board on Thursday.

Tarsadia wants drastic action after Cue Health's value has been nearly wiped out since it went public in September 2021.

The stock closed at 44 cents on Wednesday, leaving the company with a market value of $67 million. Its stock was priced at $16 a share at its initial public offering and climbed to $20 on the first day of trading.

While Cue Health's COVID tests were in high demand during the pandemic, a rapid decline in testing recently led to a drop in revenue even as operating expenses, including research and development, remained high.

"We are recommending the Board ... conduct a strategic review of management's standalone long-term business plan and the capital required to execute on that plan," Tarsadia wrote in the letter.

A representative for Cue Health did not immediately respond to a request for comment.

To reverse the company's downward spiral, Tarsadia urged it to hire financial advisers, to "realign its unsustainable cost structure" and to add a shareholder to its seven-member board to help evaluate strategic alternatives.

Tarsadia's lawyers are also filing a request to inspect the company's books and records, the letter said.

The investment firm wrote that "Cue's industry-leading technology has the potential to transform how acute and chronic conditions are diagnosed and managed."

But at the moment, Cue Health is in "dire financial straits" and its "trajectory is not sustainable and puts all stockholders at risk," the letter said.

https://finance.yahoo.com/news/investor-tarsadia-urges-cue-health-130000170.html