The 510(k) Clearance from the United States Food and Drug Administration (FDA) allows for the U.S. commercialization of FemaSeed®, an intratubal artificial insemination option designed to augment the natural fertilization process -
- FemaSeed® is an innovative infertility treatment designed to deliver sperm directly to where conception occurs in a woman’s fallopian tube -
https://finance.yahoo.com/news/femasys-inc-receives-u-fda-212500126.html
A newly aired "60 Minutes" segment entitled The unexpected way American tax dollars are being used in Ukraine has uncovered that the US government is paying the salaries of some 57,000 Ukrainian civic services personnel.
The report details the various ways non-military aid is being spent at a moment GOP Congressional leaders are intensely debating whether to move forward with a proposed defense budget that includes Biden's push for $24 billion more in military assistance for Kiev. Watch:
Costco Wholesale is partnering with a startup on a move that will make various medical care available to the retailer’s members.
Sesame, the company that Costco is teaming with, unveiled the partnership on Monday. Under it, the startup will provide "special discount pricing" for services listed on its online health care marketplace, according to the press release.
In late May, Costco said its total number of cardholders stood at roughly 124.7 million.
A Costco store is seen in Monterey Park, California, on Sept. 23, 2022. (Eric Thayer/Getty Images / Getty Images)
Sesame’s marketplace has "primary care doctors and nurse practitioners, more than 40 health specialties, labs and imaging centers, and is inclusive of both virtual and in-person care," the company said.
The deal for Costco members is available across the country, according to Sesame.
Virtual primary care, health check-ups and virtual mental health therapy are among the services that Costco members can find on the platform, with the company pegging their respective prices at $29, $72 and $79. The health check-up includes a "standard lab panel, plus a virtual follow-up consultation with a provider," according to Sesame.
A man receives an injection in his doctor's office. (iStock)
The company, which does not take insurance, will also knock 10% off all the other medical care offered through its platform, Sesame said.
With its marketplace, Sesame said it aims to replace "historically inefficient, expensive healthcare with a direct connection … between patients and physicians." That, according to the company, makes it possible to have significantly lower prices on health care services for its users.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| COST | COSTCO WHOLESALE CORP. | 558.62 | +0.03 | +0.01% |
Powered By | ||||
Groups such as GV, billionaire Richard Branson’s Virgin Group and General Catalyst have put money in Sesame, the startup has previously said. GV stands for Google Ventures.
The announcement of the Sesame partnership comes ahead of Costco on Tuesday putting out its financial results for its fourth quarter.
In late May, Costco said its total number of cardholders stood at roughly 124.7 million. (iStock / iStock)
In the third quarter, the company reported generating nearly $53.65 billion in revenue, including $1.04 billion from membership fees and $52.6 billion from net sales. That marked a year-over-year increase of 2%.
Its quarterly net income, meanwhile, came in at $1.3 billion.
I am pleased to report a global backlash against woke madness, climate change silliness, and immigration polices is underway in the US, Europe, and Australia.
The New Moral Order Is Crumbling
Globalism, climate-change alarmism, and cultural self-annihilation have all come under serious challenge. It’s a welcome start to a Well-Deserved Thrashing of the New World Order.
In Lampedusa, the Italian island midway between Europe and Africa, and at Eagle Pass, Texas, and elsewhere along the visible and increasingly invisible frontiers that separate the global North from the South, the idea of permissive migration in an economically unequal world is being tested to destruction. Lampedusa was inundated last week with another surge of migrants from Africa, larger than the population of the island itself. In Texas, the influx across the border with Mexico became a torrent.
The demographic tsunami from the global South as the North’s population shrinks is in its early stages, and most people can see clearly what happens when leaders insist on a moral code that suggests our obligations to indigent foreigners are as great as those to our own citizens. It won’t survive the political backlash now under way in both Europe and America, as even U.S. Democrats and Brussels Eurocrats are slowly starting to grasp.
The second pillar, the moral imperative of self-abasing action to combat climate change, is falling too—most interestingly again in Europe and the U.K., where it has long been the official religion of the secularist priesthood.
There is an air of surrealism around the climate-change debate in Britain and in much of Europe. The U.K. has dramatically reduced carbon emissions over the past 30 years, thanks in significant part to technological innovation. Its emissions per capita are now down to where they were in the mid-19th century. The British government could mandate tomorrow the elimination of all carbon emissions and a return to agrarian subsistence, and, given the massive and rapidly rising levels of emissions from China, India and elsewhere, it wouldn’t make the slightest difference to the climate.
The third pillar—cultural self-annihilation—is also wobbling.
The most interesting evidence of this is an electoral debate under way in Australia. The left-wing government there, eager to impress the world with its moral bona fides, has called for a reform to the constitution designed to redress the grievances of the Aboriginal population. Called the Voice to Parliament, the measures would create a constitutional body that Parliament would be required to consult on all legislative and other matters relating to indigenous peoples.
The referendum that was expected to approve this change takes place next month, but the campaign has run into fierce opposition. The most recent polls suggest Australians will reject the move by a large majority. It seems they—like many of us in the rest of the West—have had enough of leaders’ insistence on dividing us by race and other attributes rather than uniting us around our common national identity.
New York Mayor Eric Adams Says Migrant Crisis “Will Destroy New York City”
Adams wants Biden to do something. That something is the same as always. NYC wants a bailout of policies it put in place.
The City has a right-to-shelter mandate, which requires the city to provide a bed to anyone who asks for one.
Adams now says the city will ask judge to suspend right-to-shelter rules for migrants. There either is a right or there isn’t. Since the city was stupid enough to agree to the right, I suggest the city end that right instead of asking a judge for temporary help and Biden for more money.
The Gothamist notes “More than 110,000 migrants have come to the city over the last year, and around 60,000 are currently living in the city’s shelter system at a cost of billions of dollars annually, according to city officials.”
Check out this Irony
Adams has demanded more help from the state and federal governments, and has especially pressured the White House to expedite work permits for migrants so that they may eventually be able to leave the shelter system.
On Wednesday night, the Biden administration announced the U.S. would extend temporary protected status to some Venezuelans, allowing them to remain in the country legally and apply for work permits.
Adams thanked the president for his actions, which he estimated would help roughly 9,500 adult migrants who are currently in the city’s care.
Adams praises the president for “temporary” protected status to Venezuelans that will protect 9,500 in NYC while asking a judge to suspend rights to shelter.
Adams has lost his marbles.
Suing. Heckling. Cursing. N.Y.C. Protests Against Migrants Escalate
The New York Times reports Suing. Heckling. Cursing. N.Y.C. Protests Against Migrants Escalate
In August, after weeks of protests over the school being used as a shelter, Staten Island officials went to court to block the city’s plans, and secured a brief victory when a judge issued a temporary restraining order that prevented city officials from placing migrants at the St. John Villa Academy shelter, as reported by the Staten Island Advance.
But the city won its emergency appeal and the judge’s ruling was overturned. So residents turned to other measures — heckling migrants who came looking for shelter and protesting loudly.
Then the speaker appeared. Blasting a rotation of messages in five different languages,
The Children Win In North Carolina
I am pleased to report that The Children Win In North Carolina
North Carolina on Friday became the tenth state to approve universal school choice. Democratic Gov. Roy Cooper says he won’t veto the bill passed by the Legislature, no doubt because Republicans have enough votes to override.
The fight illustrated both the importance of Republican unity and the vulnerabilities of Democrats who take orders from the teachers union and ignore parents. In May, when legislators signaled their intentions, Gov. Cooper released a video declaring a “state of emergency.” “It’s clear,” he said, “that the Republican legislature is aiming to choke the life out of public education.”
The emergency stunt did nothing but make the Governor look weak. It also highlighted his double standard. Mr. Cooper was happy to choose private school for one of his daughters. But when the legislators were ready to give North Carolinians the same choice, suddenly it was an attack on public schools.
Backlash in Chicago
In Chicago, the president of the Chicago Teachers Union (CTU) is facing backlash for choosing to send her child to a private school despite previously opposing school choice efforts.
A Step in the Right Direction: UK Prime Minister Trashes Climate Change Goals
On September 21, I cheered a A Step in the Right Direction: UK Prime Minister Trashes Climate Change Goals
Prime Minister Rishi Sunak announced he will push back a ban on selling new petrol and diesel cars from 2030 to 2035, slow down plans to phase out gas boilers, and reject calls to regulate efficiency for homeowners.
Perhaps this is an election ploy. Regardless, it’s the right move. If the whole world switched to EVs it would not make a damn bit of difference for the climate in the long term.
In the short term, it’s inflationary madness because neither the infrastructure or supply chains are in place for a radical push.
EVs don’t do a damn thing for the environment. See Biden’s Solar Push Is Destroying the Desert and Releasing Stored Carbon
And to top it off, The National Highway Traffic Safety Administration has concluded Biden’s mileage standards have “Net benefits for passenger cars remain negative across alternatives” vs doing nothing at all.
Those are the right reasons to kill this insane push. And it’s safe to add inflation to the mix, not that additional reasons are needed.
Increasing Backlash Everywhere
There’s increasing backlash everywhere. It out to be a wakeup call for Progressives but I guarantee you they will sleep right through it.
The beneficiary is obvious, Republicans, especially Trump.
Obesity is becoming more common in a growing number of states, according to new data from the US Centers for Disease Control and Prevention.
In 2022, 22 states had at least 35% of adults with obesity, up from 19 states in 2021. Ten years ago, CDC said, no state had an adult obesity prevalence at or above 35%.
The new data show prevalence was highest in Louisiana, Oklahoma and West Virginia, where more than 40% of adults had obesity.
Overall, prevalence was highest in the Midwest and the South, where about 36% of adults had obesity. In the Northeast and West, about 30% of adults had obesity in 2022.
The data is from the Behavioral Risk Factor Surveillance System, a survey conducted by the CDC and state health departments. Adults were considered to have obesity if their body mass index was at least 30, based on self-reported measurements of height and weight.
The new data, published Thursday, found “notable differences” in obesity prevalence by race and ethnicity.
At least 35% of Black adults had obesity in 38 states, and the same was true for American Indian adults in 33 states and Hispanic adults in 32 states. Obesity rates among Asian adults did not exceed 35% in any state, and only 14 states reached that metric for White adults.
Obesity rates were lowest among young adults, with about 1 in 5 people ages 18 to 24 considered to have obesity. Rates were about twice as high among adults 45 to 54, with a prevalence of about 2 in 5, according to the CDC data. Obesity prevalence also decreased as level of education increased.
“Our updated maps send a clear message that additional support for obesity prevention and treatment is an urgent priority. Obesity is a disease caused by many factors, including eating patterns, physical activity levels, sleep routines, genetics, and certain medications. This means that there is no one size fits all approach,” Dr. Karen Hacker, director of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, said in a statement.
“However, we know the key strategies that work include addressing the underlying social determinants of health such as access to healthcare, healthy and affordable food, and safe places for physical activity.”
https://www.cnn.com/2023/09/21/health/obesity-more-common-states-cdc-data/index.html
Liquidia says the Food and Drug Administration agreed to review an amendment to its new drug application for Yutrepia to add the treatment of pulmonary hypertension associated with interstitial lung disease to the label.
The biopharmaceutical company on Monday said the FDA set a prescription drug user fee act goal date of Jan. 24, 2024.
If the amendment gets approved by the FDA, Yutrepia would be indicated for the treatment of both pulmonary hypertension and interstitial lung disease and pulmonary arterial hypertension.
The FDA tentatively approved Yutrepia to treat pulmonary arterial hypertension in November 2021.
Shares of Tango Therapeutics (TNGX 8.04%) were up 16.7% for the week as of Thursday's close, according to data provided by S&P Global Market Intelligence. The clinical-stage biotech company's stock closed at $7.06 last week, then rose as high as $8.53 on Tuesday. The stock is up 13% so far this year.
The CRISPR gene-editing stock kept climbing because the company announced last week that the Food and Drug Administration (FDA) had cleared the company's Investigational New Drug (IND) application for cancer therapy TNG348. The company said it will start a phase 1/2 clinical trial for TNG348 to treat BRCA mutant and other homologous recombination deficient cancers early next year.
The company is beginning to see momentum in terms of its clinical pipeline, with TNG348 the latest therapy to begin early-stage trials. The company also has TNG908 and TNG462 in phase 1/2 trials to treat patients with MTAP-deleted tumors. Tango also has TNG260 in a phase 1/2 trial as a combination therapy with pembrolizumab to treat STK11-mutant cancers.
Like any clinical-stage company, there's plenty of risk to go with the upside for Tango. The company doesn't have any product revenue yet, but as of the second quarter, it said it had $9.6 million in collaboration revenue, up from $5.7 million in the same period last year. It also reported $310.7 million in cash, enough, it said, to fund operations into 2026, and that was before a $80 million private stock sale.
It's worth noting that the company is also seen as a potential buyout candidate, another reason to buy and hold the stock despite its risks.
https://www.fool.com/investing/2023/09/14/why-shares-of-tango-therapeutics-climbed-this-week/
