Firefly Neuroscience acquires Evoke

 Firefly Neuroscience, Inc. (NASDAQ: AIFF), a $38 million market cap company known for its Artificial Intelligence (AI) solutions in brain health, has acquired Evoke Neuroscience, Inc., a medical device company focused on technologies for brain health assessment. The acquisition, announced today, is a strategic move for Firefly to advance its proprietary Brain Network Analytics (BNA™) technology and expand its database and patent portfolio. The company’s stock has shown significant volatility, trading at $3.27, down over 60% from its 52-week high.

The transaction includes a $6 million purchase price, half in cash and half in Firefly common stock, priced at $3.50 per share. Additionally, Evoke investors may receive a $500,000 earn-out if the acquired business achieves $3 million in annualized revenues within three years.

https://in.investing.com/news/company-news/firefly-neuroscience-acquires-evoke-for-brain-health-tech-93CH-4808089

FDA Action Alert: GSK, Sanofi, Merck and More

 

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.

Amid the growing macro-level headwinds in the vaccine space, the FDA this month is expected to decide on Moderna’s mRNA COVID-19 shot, alongside a handful of other big verdicts.

Read below for more.

GSK Asks FDA to Approve Asthma Injection Nucala for COPD

GSK is proposing its subcutaneous biologic Nucala to treat adult patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The FDA’s decision is due on May 7.

A pulmonary disease, COPD is characterized by inflammation in the lungs, manifesting as breathlessness, coughs and airflow obstruction. According to GSK, some 40% of patients suffer from disease exacerbations caused by type 2 inflammation, which in turn is linked to high eosinophil counts in the blood. Nucala, a monoclonal antibody, targets and blocks the IL-5 cytokine, which is crucial to maintain the activity of eosinophils.

GSK is supporting Nucala’s COPD application with data from the Phase III MATINEE trial. The pharma released a topline readout from the study in September 2024, noting that Nucala elicited a “statistically significant and clinically meaningful reduction” in yearly rates of moderate or severe disease exacerbations as opposed to placebo.

Nucala is currently approved for eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome, and as an add-on maintenance treatment for asthma and chronic rhinosinusitis with nasal polyps.

Arcutis Seeks Zoryve Expansion into Body and Scalp Psoriasis

By May 22, the FDA will release its verdict on Arcutis Biotherapeutics’ proposed expansion for Zoryve into body and scalp psoriasis.

Arcutis is backing its expansion bid with data from the Phase III ARRECTOR trial, which found that 66.4% of Zoryve-treated patients achieved clear or almost-clear skin, as opposed to 27.8% in placebo patients. Results also showed that 65.3% of patients in the Zoryve arm saw significant improvements in itch, versus 30.3% in the placebo group.

Arcutis also filed findings from a Phase IIb study as well as long-term efficacy and safety data for Zoryve in plaque psoriasis.

Zoryve is a topical phosphodiesterase 4 inhibitor that works by helping to suppress inflammation in the skin. The drug won FDA approval in 2011 for the treatment of plaque psoriasis in patients aged 12 years and up. If approved for body and scalp psoriasis, Zoryve would be a “truly meaningful innovation” for patients who suffer from inadequately controlled symptoms, Arcutis CEO Frank Watanabe said in a September 2024 release.

Sanofi Eyes Extension of Meningococcal Disease Shot to Infants, Toddlers

Sanofi’s meningococcal disease vaccine MenQuadfi is currently approved for the primary immunization of children aged two years and up. As a booster, it can be used in those 13 years and older who continue to be at risk of meningococcal disease.

Sanofi is seeking to expand MenQuadfi’s label to also include infants and toddlers from six weeks to 23 months of age. The FDA is currently reviewing this proposal and is due to release its decision on May 23. If approved, MenQuadfi could protect this younger population from the A, C, W and Y serogroups of Neisseria meningitidis.

In an April presentation before the CDC’s Advisory Committee for Immunization Practices, Sanofi presented data from several trials, including the Phase III MET42 study. Results showed that MenQuadfi was safe to use in infants and toddlers, with most side effects being mild or moderate in severity. Efficacy-wise, MenQuadfi was able to match a commercially approved vaccine in immune response and seroprotection.

Liquidia Awaits Final Yutrepia Approval in Interstitial Lung Disease

On May 23, Liquidia is expecting to win final approval of its inhalation powder Yutrepia for the treatment of patients with pulmonary arterial hypertension associated with interstitial lung disease (PH-ILD).

The FDA gave the drug tentative approval in August 2024, indicating that it had cleared all efficacy and safety hurdles and satisfied regulatory standards of product quality. However, Liquidia still needed to wait out regulatory exclusivity for a competing product.

Yutrepia is Liquidia’s inhalable version of treprostinil, a vasodilator that has known activity against pulmonary hypertension. Yutrepia is backed by data from the Phase III INSPIRE study, which found that the drug was both safe and well-tolerated in patients who were naïve to treprostinil or who were switching to Yutrepia from nebulized treprostinil. The INSPIRE trial found that patients treated with Yutrepia saw symptoms stabilize or improve over one year of dosing.

Merck Hopes to Tack Two Rare Cancers Onto Welireg’s Label

Merck is hoping to expand its oral cancer drug Welireg into advanced pheochromocytoma and paraganglioma (PPGL). The FDA’s decision deadline is May 26.

PPGL refers to two types of rare tumors of the adrenal gland. Diagnosed in some 2,000 patients per year, they are typically caused by specific genetic mutations. Symptoms include high blood pressure, palpitations and headaches. According to Merck, up to 25% of PPGL cases are already at the metastatic stage at diagnosis.

Merck is supporting Welireg’s PPGL bid with data from Cohort A1 of the Phase II LITESPARK-015 study. The pharma did not provide specific data in a January news release, revealing only that the application is based on objective response rate and duration of response in PPGL patients after Welireg treatment. The FDA has granted the drug priority review in this indication.

Welireg is an orally available inhibitor of the HIF-2α transcription factor, which is involved in oxygen sensing and in the body’s response to hypoxia. The drug is indicated for patients with renal cell carcinoma (RCC) and those with von Hippel-Lindau disease—a rare genetic disease involving the formation of tumors across various organs—who also require treatment for associated RCC.

If approved, Welireg will become the only drug for advanced PPGL in the U.S., Merck said.

After Delay, Eton Nears Approval for Oral Hydrocortisone

By May 28, the FDA will release its verdict on Eton Pharmaceuticals’ ET-400, an oral formulation of hydrocortisone, for the treatment of adrenal insufficiency in infants.

This new target action date comes after the FDA in February announced that it needed more time to review Eton’s data package for ET-400. Eton submitted supplemental information in December last year, in response to a request from the regulator.

ET-400 is a proprietary oral formulation of hydrocortisone that, according to the biotech, is stable at room temperature. If approved, ET-400 will follow in the footsteps of Eton’s Alkindi Sprinkle, which also has hydrocortisone as an active ingredient, but is formulated as oral granules. Alkindi Sprinkle, approved in 2020, is designed to rapidly deliver glucocorticoids to children with adrenocortical insufficiency.

In a July 2024 announcement, Eton CEO Sean Brynjelsen said that the approval of ET-400 would allow the biotech to “capture a greater percentage of the oral hydrocortisone market” and, alongside Alkindi Sprinkle, would open up a peak opportunity of “more than $50 million annually.”

Moderna Seeks Approval for Next-Generation COVID-19 Shot

The FDA’s last big milestone for the month belongs to Moderna and its investigational next-generation COVID-19 vaccine mRNA-1283. The regulator is expected to release its decision on May 31.

In June 2024, the company released Phase III data for the experimental shot, touting better efficacy than Spikevax, its currently approved COVID-19 vaccine. Moderna did not provide specific data, only claiming that mRNA-1283 elicited a “higher immune response” against SARS-CoV-2 than Spikevax.

Of note, Moderna emphasized at the time that mRNA-1283 could induce robust responses against Omicron and original strains of the virus—a benefit the company claimed was most evident in seniors over 65 years of age.

The CDC’s vaccine advisors were supposed to convene in late February to discuss various vaccines, including mRNA-1283, before the meeting was postponed. The panel finally convened last month.

https://www.biospace.com/fda/fda-action-alert-gsk-sanofi-merck-and-more

'Surge in UK ill-health welfare not due to healthcare delays, study says'

 A surge in claims for sickness and disability benefits in Britain since the COVID-19 pandemic does not appear to be driven by increased delays for hospital treatment or mental health care, a study said on Friday.

While benefit claims and delays in the National Health Service have both risen, the Institute for Fiscal Studies said the apparent relationship between the two broke down when it examined English data on an area-by-area basis.

"The results strongly indicate that deteriorating NHS performance ... is to blame, at most, for a small fraction of the overall increase in receipt of health-related benefits among working-age individuals in recent years," the think tank said.

Britain's government has said improved access to mental health and other medical support is key to reducing soaring welfare costs. Other researchers have suggested that funds could be further targeted in this way in a public spending review next month.

But the IFS said that at most around 7% of the rise in benefit claims related to mental illness or musculo-skeletal problems could be linked to long waiting times for treatment, and there was less impact for other medical conditions.

"Reducing hospital waiting times is a sensible policy objective," IFS economist Max Warner said. "But we shouldn't necessarily expect it to also deliver a significant reduction in health-related benefit claims. That's a separate policy nut to crack."

Between November 2019 and May 2024 the number of working-age adults receiving health-related benefits in England rose by 40% to around 3 million, while the number of people on hospital waiting lists grew by two thirds to 7.6 million.

Annual spending on disability and long-term sickness benefits for working age people across the whole of the United Kingdom is around 41 billion pounds ($55 billion).

The researchers said increased benefit claims might be linked to more general ill health or other healthcare problems such as difficulty accessing family doctors.

A report published in January by a committee in Britain's upper house of parliament said greater disability benefit claims might reflect higher payouts than standard unemployment benefits and inadequate government checks on the ill-health of claimants.

https://www.msn.com/en-gb/health/other/surge-in-uk-ill-health-welfare-not-due-to-healthcare-delays-study-says/ar-AA1E0Qa8

Zelenskiy says ceasefire with Russia could be put in place at any moment

 Ukrainian President Volodymyr Zelenskyy said at a joint news conference with Czech President Petr Pavel that a ceasefire with Moscow would be possible "at any moment."

"We believe that without increased pressure, Russia will not take real practical steps to end the war. Today marks the 54th day that Russia has ignored even the American proposal to completely cease fire," Zelenskyy told reporters.

"We believe that a ceasefire is possible at any moment, even starting today, and should last at least 30 days to give diplomacy a real chance."

Ukraine accepted a 30-day ceasefire proposed by the United States in March, following peace talks between US and Ukrainian officials in Saudi Arabia.

Russia has yet to accept the offer, and the country's leader, Vladimir Putin, declared a three-day ceasefire over May 8-10 to mark the 80th anniversary of the victory of the Soviet Union and its allies over Nazi Germany in World War II.

Zelenskyy rejected the offer, denouncing it as a "theatrical show" since three days offered no time for talks to end the more than three-year-old war that began with Russia invading Ukraine in February 2022.

https://p.dw.com/p/4tuld

Murder, they wrote? Democrats try to incite violence in another 'summer of love'

 

By Eric Utter

Democrats would root for tooth decay over oral hygiene and Snidely Whiplash over Dudley Do-Right.

Something about them is clearly not right.

To wit: California Democrats have yet again blocked efforts to strengthen protections against underage sex trafficking, this time in the form of a bill to make it a felony to purchase 16- or 17-year-olds for sex.

But, hey, who are we to judge if a California Democrat — or someone from a “marginalized” group -- wants to purchase a 16 or 17-year-old for sex?

Meanwhile, Minnesota Democrats killed an amendment to a crime and public safety bill that would have required law enforcement agencies to report illegal aliens to ICE when they are arrested for a violent crime. In doing so, they ignored the desperate and pitiful pleas of a man whose mother was brutally murdered and beheaded by an illegal alien on the streets of a Minneapolis suburb in the middle of the afternoon.

At this point, one is tempted to say, “What the eff? I mean what the effing eff?” But that would be for nought. Democrats gotta Democrat, right? I mean, the party wanted to enslave blacks a couple hundred years ago, and now wants to free violent criminals.

Illinois Gov. J.B. Pritzker recently told a group of Democrat activists and donors in New Hampshire that he wants to see “mass protests” against the Trump administration.

Pritzker stated:

“Never before in my life have I called for mass protests, for mobilization, for disruption. But I am now.”

He added:

“These Republicans cannot know a moment of peace.”

He sounds nice.

Not to be outdone, Rep. Jamie Raskin (D-MD) appeared on MSNBC’s “The Rachel Maddow Show,” where, when asked how people should be reacting to the arrests of rogue judges, he responded by stating:

“The people need to manifest their outrage about these assaults on judicial independence.”

And how should the people manifest it, Rep. Raskin? Judges do not have independence from the law, prudence, sanity, or morality. And unelected district judges are supposed to be controlled by Congress, not have total control of a duly elected president.

Moreover, JoAnna St. Germain, a Waterville Senior High School English teacher, saw her Facebook posts go viral recently after she called on the U.S. Secret Service to "take out" people who support President Donald Trump 's "illegal, immoral, unconstitutional acts.”

She also directly called for the president's death, stating:

"The Secret Service has the perfect opportunity, if they choose to step up and take it.”

In fact, St. Germain noted that the Secret Service has the ability, if not the moral necessity, to take out every single person who supports Trump’s illegal, immoral, unconstitutional acts. Wow! I guess we should take some precautions, folks.

St. Germain added that she was "not talking about assassinating a president" because a president is "a person duly elected" while Trump is heading "a fascist dictatorship."

Note to St. Germain: We saw what you were doing. Trump in fact was duly elected, by both the popular and electoral vote, and it is Democrats who are clearly re-enacting fascist tactics and hoping for a fascist dictatorship.

And then there is Canada. Unfortunately. Nell Thomas, a family physician and the Liberal candidate for Haliburton — Kawartha Lakes, has been criticized after some Canadians circulated screenshots of old social media posts in which she clearly seemed to endorse letting the elderly die and preventing women from giving birth, while referencing her views on “climate change.”

In April of 2023, Nell Thomas wrote: “Imagine my thoughts when assessing a pregnant patient. I telepathically advise the fetus to sue the owner of the uterus while exiting it to this world. Of necessity, a mother must be a climate change denier.”

She “telepathically advises the fetus to sue the owner of the uterus?” Nell Thomas might be crazy. “A mother must be a climate change denier?”

Apparently, Nell Thomas is a reality denier.

In another screenshotted post, Nell Thomas stated: “Canada’s solution MUST INCLUDE stop keeping ancients alive so long/reduce expectations of patients to address every tiny complaint, AND INSERT GOVT PAID HUMAN OFFICE SCRIBES INTO FAMILY PRACTICE.” Another post reads, “Nature will ensure we are reduced to 5 billion. Trust nature.” In yet another hysterical post, Thomas avers, “You must understand eliminating meat from diet is well well well (!!!) recognized as essential – and soon nonnegotiable – if any parts of Earth are to remain habitable.”

In still another she opines: “China is ahead of us on this. Chinese will rule. We are silly twits in NAmerica.”

That may well be true, but not in the way she means. So, let the elderly die, get the federal government even more involved in people’s lives, beg women not to have kids, hope that nature kills off 3 billion of us or so, go vegan, and submit to China.

Who needs homicidal maniacs when you have “health care providers” like this?

Democrats and progressives root for the fire as opposed to the fire department. They quite literally support evil over good. If violence in the streets and/or presidential assassinations are what it takes for them to stay in power, they then say, “so be it.”

They are an existential threat to the “democracy” they purport to want to save.

They must be defeated.

https://www.americanthinker.com/blog/2025/05/murder_they_wrote_democrats_try_to_incite_violence_in_another_summer_of_love.html

New York, halt assisted suicide — the ‘death cult’ won’t stop with the terminally ill

New York is poised to join an unholy alliance of US states that let doctors help people kill themselves.

It’s done under the guise of humanitarian empathy, but in practice it merely cheapens and devalues life.

Advocates say that enabling a speedy death is a kindness for those in pain. They claim it’ll only be employed in the most devastating of circumstances, where a terminally ill patient has just a short time to live and wishes to “die with dignity.”

These are the same people who want us to kill our babies if they’re inconvenient and sterilize our children to placate an adult fantasy that they can swap their sex.

That’s not humanitarianism, it’s selfishness. And so is assisted death.

From 1998 to 2020, more than 5,300 Americans died by assisted suicide in Oregon, Washington, DC and Hawaii, three places where it was then legal.

A 2022 study found that 95% of them were white, mostly college-educated. Almost all, 85%, had cancer or a neurological disease and were in hospice or palliative care.

That’s the image the 81 New York Assembly members who voted last week to legalize what they euphemistically call “Medical Aid in Dying” want you to believe.

Yet the experience of Canada paints a far more disturbing picture.

When Canada first legalized assisted death in 2016, it was strictly limited to the terminally ill — but that wasn’t enough for the suicide advocates, who sued to stretch the rules.  

Today, Canadians can request MAiD even when “death is not reasonably foreseeable” — and nearly 50% of those requests come from the poor and the vulnerable.

The totals are startling: 10,000 Canadians died by assisted suicide in 2021 alone — the same year the program was opened to those with incurable, but not terminal illnesses. In 2022 the number rose to more than 13,000.

One of them, a 51-year-old woman called “Sophia” in a 2024 report from the Ontario Coroner’s Office, chose to die because her chemical sensitivities made life in her apartment unbearable.

“The government sees me as expendable trash, a complainer, useless and a pain in the ass,” Sophia said. 

An Ontario psychiatrist offered death to a man diagnosed with inflammatory bowel disease who had a history of mental illness and drug use.

“You should do the right thing and consider MAiD,” a nurse told Heather Hancock of Alberta, who has cerebral palsy. “You’re being selfish. You’re not living, you’re merely existing.”

The British Columbia oncologist who diagnosed Allison Ducluzeau’s abdominal cancer in 2023 offered her death — but refused to authorize surgery or chemotherapy through Canada’s single-payer health-care system. She paid for out-of-pocket treatment in the US, and lived.

In Quebec, doctors can issue “advance directives” for dementia patients so they can essentially be euthanized.

Now the Dignity with Dying advocacy group wants Canada’s program extended to terminally ill “mature minors” under age 18.

By 2027, Canada’s mentally ill will become eligible to end their suffering by assisted suicide for that reason alone.

Canada’s government gone so far as to create a coloring book for children to help adults explain that they’re going to kill themselves. 

It’s a death cult, plain and simple.

Assisted suicide is the worst idea since child sacrifice. Sacrifice is exactly what it is. 

We don’t want to comfort our sick or pay for their care. We don’t want to look in their faces and acknowledge what death is. 

We’re so afraid of confronting the end of life that we want to hasten it as it approaches.

Yet the consciousness of death is part of what makes us human. Tending to our dying is an honor — one we were deprived of, and agonized about, during COVID. 

There’s nothing humane about turning our healers into merchants of death, or in giving sick people the idea that killing themselves is their best and noblest option.

New York voters must realize that MAiD for the terminally ill is just where it starts.

Vermont’s law mandated that only state residents could obtain assisted suicide — but in 2023, a Connecticut woman sued and won the right to end her life there. Oregon, too, has abandoned its residency requirement.

Just as Canada started with strict limits, whatever boundaries Albany may erect will surely lapse. 

Each of us gets our short time on Earth with hope for connection to each other, to ourselves, to the universal great beyond in which every culture in some form or another believes.

The truth is, no matter what our challenges, we must face every day we’re given with as much strength, courage, love and kindness as we can muster. 

Life is not optional. It is not for us to determine how long our lives get to be, or how short.

California, Maine, Colorado, Hawaii, Montana, New Jersey, New Mexico, Oregon, Vermont, Washington, DC and Washington state have fallen for legislation that rejoices in a culture of death.

Don’t let New York be next.

Libby Emmons is the editor-in-chief at the Post Millennial.

https://nypost.com/2025/05/04/opinion/halt-assisted-suicide-death-cult-never-stops-expanding-it/

Newark airport air traffic controller offers damning assessment: ‘It is not safe. Don’t fly into Newark’

 Newark Liberty International Airport is “not safe” for travelers, one air traffic controller at the delay-plagued travel hub reportedly warned.

“It is not safe. It is not a safe situation right now for the flying public,” the federal air safety employee reportedly told NBC News correspondent Tom Costello.

“Really an incredible statement, unsolicited. He just said that to me, and separately, ‘Don’t fly into Newark. Avoid Newark at all costs,’” Costello recounted on MSNBC.

The airport, which served 49 million travelers in 2024 and is the second busiest in the New York City area, has been drowning in delays and cancellations for days.

Planes ready for boarding at Newark’s airport.John McAdorey – stock.adobe.com

Federal Aviation Administration has blamed a shortage of air traffic controllers at the airport, along with runway construction.

Newark has lost 20% of its air controllers in recent weeks, according to United Airlines CEO Scott Kirby, who issued a statement Friday claiming they had “walked off the job.”

The situation has grown so dire that United Airlines — which uses the airport as its primary East Coast hub — announced it was cancelling 35 roundtrip flights daily, saying it was necessary “in order to protect our customers.”

“This particular air traffic control facility has been chronically understaffed for years and without these controllers, it‘s now clear — and the FAA tells us — that Newark airport cannot handle the number of planes that are scheduled to operate there in the weeks and months ahead,” Kirby said.

And last week, Transportation Secretary Sean Duffy issued a plea for more air traffic controllers – offering $5,000 bonuses for new hires and warning that the system was beginning to deteriorate.

A view of the series of Newark Liberty International Airport control towers.AP

“You’re starting to see cracks in the system,” Duffy in a press conference Thursday. “It‘s our job to actually see over the horizon what the issues are and fix it before there is an incident that we will seriously regret.”

Aviation safety has been a point of controversy since even before President Trump took office in January. As of September 2023, the FAA was nearly 2,000 air traffic controllers short of its staffing goal, according to the agency. 

Just a month after Trump was sworn in, 400 FAA employees were cut, but Duffy said none were air traffic controllers or safety personnel.

Delays at Newark continued on Sunday, with inbound flights waiting more than two hours before being allowed to land, according to Flight Aware’s Misery Map.

https://nypost.com/2025/05/04/us-news/newark-airport-air-traffic-controller-offers-damning-assessment/