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Sunday, December 10, 2023

‘Groundbreaking’ anti-aging drug for dogs moves closer to gaining FDA approval

 A drug that could potentially extend the life of large-breed dogs is closer to being approved by the U.S. Food and Drug Administration (FDA).

That’s according to an announcement last week by the San Francisco biotech company Loyal, the company behind the drug. 

Currently, there are no FDA-approved or conditionally approved animal drugs for this purpose.

“There are 25 million large-breed dogs in the U.S. alone — that’s 25 million dogs we can help live longer, and with better quality of life,” Celine Halioua, CEO and founder of Loyal, said in a statement sent to Fox News Digital.

The company claims the drug LOY-001 may help slow down age-related processes for dogs that are 40 pounds or more. 

The medication works by interacting with a hormone called IGF-1 that accelerates the aging process. It is designed to prevent age-related canine diseases — rather than waiting until symptoms appear, according to a spokesperson for Loyal. 

“Loyal’s approach represents a different paradigm, using our understanding of the underlying mechanisms of aging to reduce the risk of these diseases in the first place,” the company stated in a release sent to Fox News Digital.

Last week, the drugmaker announced that LOY-001 has cleared early hurdles with the FDA, which signaled that the data so far shows the drug’s potential effectiveness. 

A drug that possibly may extend the life of large-breed dogs is closer to FDA approval, according to an announcement by the biotech company behind it.X/Celine Halioua

More milestones must be met before the drug is fully approved and can hit the market, however. 

Those include the completion of a large clinical trial and a review of safety and manufacturing data. 

Thus far, the four-year process has included interventional studies of LOY-001 in an FDA-accepted model of canine aging and an observational (no-drug) study of 451 dogs, according to Loyal’s website.

“Today’s milestone is a crucial part of Loyal’s application for conditional approval,” the company said in the news release. 

The drugmaker claims that LOY-001 may help slow down age-related processes for dogs that are 40 pounds or more.X/Celine Halioua

“It means the FDA agrees LOY-001 has a reasonable expectation of effectiveness,” the statement continued. “Once the FDA approves Loyal’s manufacturing and safety data packages, Loyal can market the drug for lifespan extension in the target canine population.”

“Conditional approval lasts for up to five years, during which time Loyal will collect the remaining effectiveness data and apply for full approval.”

The average dog’s lifespan is about 10 to 13 years, with larger breeds aging faster and having an even shorter life expectancy, according to veterinarians who spoke with Fox News Digital.

Larger dog breeds tend to age faster than smaller ones.X/@loyalfordogs

Some believe that is due to selective breeding, which can enhance a dog’s size and development.

Dr. Ivana Crnec, a veterinarian with the Texas-based foundation Veterinarians.org, told Fox News Digital that body size and growth rate are key factors affecting a dog’s longevity.

The growth-promoting hormone IGF-1 — believed to play a role in accelerating aging and reducing lifespan — has been found at much higher levels in large dogs compared to small-breed dogs.

The average dog’s lifespan is about 10 to 13 years, with larger breeds aging faster and having an even shorter life expectancy.X/@loyalfordogs

The new experimental drug targets this growth-promoting hormone to reduce its levels.

“In my professional opinion, the drug is groundbreaking,” said Crnec.

“We still need to wait and see its results and potential side effects, but so far, LOY-001 is definitely promising,” she continued. “The fact that the FDA described the drug as having ‘reasonable expectations of effectiveness’ says a lot about its potential.” (She was not involved in the research.)

The drug is administered by an injection by a veterinarian every three to six months — but the company is working on a daily pill.X/Celine Halioua

By slowing down aging’s effect on vital functions, the drug will “indirectly have a positive impact on the life quality of large and giant dog breeds,” Crnec told Fox News Digital.

Other veterinarians said they were cautiously optimistic.

“It sounds too good to be true,” Dr. Jeffrey Krasnoff, a veterinarian at Brookville Animal Hospital on Long Island, commented to Fox News Digital about the experimental drug.

“I would love to see the research. It would be awesome if it truly made a difference in the longevity of our large canine friends.”

The drug is administered by an injection by a veterinarian every three to six months, but the company is working on a daily pill, according to Loyal’s website. 

LOY-001 is expected to be available in 2026, subject to FDA approval of Loyal’s manufacturing and safety data.

https://nypost.com/2023/12/10/lifestyle/groundbreaking-anti-aging-drug-for-dogs-moves-closer-to-gaining-fda-approval/

Crazy Chipotle sentencing shows Democrats think there’s no difference between jail and work

 An obscure municipal judge in Ohio made national headlines last week in sentencing an offender to work at a fast-food joint in lieu of prison.

This type of clueless, out-of-touch “enlightenment” points up why Democrats are struggling to maintain any shred of their working-glass voting base against Donald J. Trump. 

The judge’s ruling stemmed from a September misdemeanor assault in a Cleveland suburb: 39-year-old Rosemary Hayne, displeased with her Chipotle order’s quality, flung a bowl of hot food at the counter worker.

She pleaded guilty and faced a 180-day jail sentence, with half suspended — a reasonable penalty.  

But the judge, Democrat Tim Gilligan, wanted to show how creative he is in teaching “a sense of empathy.”  

So he told Hayne she could serve 60 days of her sentence not in jail but in a fast-food restaurant, working 20 hours a week.

This “sentence” sends a message to the 4.7 million Americans who work in fast food: Your job is no better than being in jail.  

People don’t work in fast food to learn how not to throw bowls of food at other people; they work in fast food to earn a living, whether as an end in itself or to save money for trade school or college.

Many work their way up within their companies. 

What makes Gilligan think fast-food employees want to work with someone who can’t control her temper?

Companies should give applicants with criminal histories a chance, if they demonstrate that they’ve learned from their mistakes.

People recently released from jail or prison need jobs.  

But even at her sentencing, Hayne was still lamenting the quality of her Chipotle food, calling it “disgusting.”

Nobody wants to work with someone who could turn violent — including toward the customers! — at the slightest provocation.  

Gilligan seems to have no clue that even entry-level employers have some rationality in their hiring processes: They don’t have to take all comers.

Most employers aren’t even going to hire someone who intends to work only for two months. 

He likely wouldn’t sentence a bank robber to work at a bank or a patient who attacked a doctor to start performing surgeries.

Why does he think the fast-food industry is naturally part of the criminal-justice system? 

Gilligan claims his innovative sentencing technique will “deter others from this type of behavior.” 

Why would it? Is the assaultive portion of the American population suddenly going to be petrified that they’ll have to work at Chipotle? 

What does deter people from committing assault — at least if they’re not severely mentally ill — is knowing they’ll face predictable, consistent punishment.  

Since American cities began pulling back from enforcing laws against small crimes in the wake of the #BlackLivesMatter movement that began in the mid-2010s, workers who interact with the public, in fast-food outlets and retail stores, have become terrified. 

Rosemary Hayne
Hayne pleaded guilty and faced a 180-day jail sentence, with half suspended — a reasonable penalty.  Emily Russell / Facebook

As Bloomberg reports, retail employees are quitting at record levels, in large part because public-facing workers fear for their safety.

Just last week, a shoplifter fatally stabbed a Macy’s security guard in Philadelphia.  

The last thing fast-food and retail workers need is enlightened judges who think the cure for the public disorder that spills over into restaurant and retail space is for these restaurants and stores to become pro-bono halfway houses for the people committing the disorder.  

Fast-food restaurants and stores need the government to protect them and their workers from crime; Gilligan is saying we’ll put the burden right back on you. 

Gilligan’s sentencing came the same week yet another poll, this one from The Wall Street Journal, shows Trump beating President Biden in the polls in 11 months.

Biden is losing “groups who would consistently vote Democratic — young voters and Black and Latino voters.”

Might that be because so many young, black and Latino voters work in restaurant and retail jobs and can see for themselves how Democratic policies toward crime and disorder harm them and their colleagues?

Only 30% of potential voters think Biden is the better candidate on crime (compared with 47% for Trump).

Learning that a Democratic judge thinks their workplaces are interchangeable with jails is hardly going to send these voters back to the polls to vote for Biden again next fall. 

Nicole Gelinas is a contributing editor to the Manhattan Institute’s City Journal.

https://nypost.com/2023/12/10/opinion/crazy-chipotle-sentencing-shows-democrats-think-theres-no-difference-between-jail-and-work/

Top ex-Hamas minister blames Gaza ‘madmen’ for war, says Palestinians do not support them

 A former top Hamas official says Gaza “madmen’’ including infamous leader Yahya Sinwar caused the war and that everyday Palestinians do not support them, according to a newly released interrogation video.

Yousef al-Mansi, an ex-communications minister for the Palestinian terror organization, surrendered to Israel — and proceeded to slam Sinwar as the boss of a group of crazies who threw the Jewish state and Gaza into horrific conflict again by orchestrating the Oct. 7 terrorist attack that killed more than 1,200 people, the Times of Israel reported.

“A madman threw a big stone,” al-Mansi said, summing it up for Israel’s Shin Bet interrogators in a video published Sunday.

“This is a group of madmen that Sinwar leads. They destroyed the Gaza Strip. Set it back 200 years,” he said.

Al-Mansi described Sinwar as a man who suffers “delusions of grandeur” and claimed that no civilians in Gaza support Hamas or its leadership after more than two months of war have devastated the Palestinian enclave.

Yousef al-Mansi, a former Hamas communications minister, blamed leader Yahya Sinwar for the Israel-Hamas war.X/@JoeTruzman
Sinwar, who remains in hiding, poses with an armed child in May 2021.NurPhoto via Getty Images

Gaza’s Hamas-tied Health Ministry estimates that more than 17,000 Palestinians have been killed in the war, mostly women and children, with the United Nations and independent research groups estimating that a majority of northern Gaza’s infrastructure has been damaged or destroyed, too.

“People in the Gaza Strip say that Sinwar and his group destroyed us,” al-Mansi said. “I have not seen anyone in the Gaza Strip who supports Sinwar, nobody likes Sinwar. There are people who, day and night, pray that God will free us from him.” 

As with other members of Hamas whose interrogations were filmed and released to the public, al-Mansi added that the group knew the Oct. 7 attack stood against the values of Islam, which forbids the killing of women, children and seniors.

Stay on top of news out of the Israel-Hamas war and the global surge in antisemitism with The Post’s Israel War Update, delivered right to your inbox every Monday, Wednesday and Friday.

Smoke from airstrikes and artillery fire hangs above Khan Younis on Sunday as the war continues to devastate Gaza.REUTERS
Palestinians are forced to free further south as the war grows to consume all of Gaza.AFP via Getty Images

“What they did is unacceptable according to logic, religion or intellect,” al-Mansi said.

The condemnation by the former Hamas official came as Israeli Prime Minister Benjamin Netanyahu touted the latest wave of Hamas surrenders in Gaza, calling on more members of the terror group to give up and no longer fight for Sinwar.

“They are laying down their weapons and turning themselves in to our heroic soldiers,” Netanyahu said of the surrenders in recent days.

“I say to the Hamas terrorists: It’s over. Don’t die for Sinwar. Surrender now,” he added.

Last week, the IDF encircled Sinwar’s home but believe he escaped and is hiding somewhere in Hamas’ underground tunnel system.

https://nypost.com/2023/12/10/news/ex-hamas-minister-blames-gaza-madmen-for-war-says-palestinians-do-not-support-them/