Katz: Flydubai incident was 'jihadist terror attack attempt'

 Israeli Defense Minister Israel Katz claimed on Wednesday that today's incident aboard a Flydubai plane flying from Dubai to Tel Aviv was a "jihadist terror attack attempt."

"According to the initial information in our possession, the terrorist had one intention: to crash the plane with all its passengers," Katz stated, adding that the attempt was "thwarted only thanks to the bravery of several Israeli passengers who broke into the cockpit, overpowered the terrorist and, with their own hands, restored control of the plane to another flight crew who was present there."

The Flydubai aircraft diverted from its route and landed safely in Saudi Arabia, where the two pilots were taken to hospital after being injured during the flight. Israeli Prime Minister Benjamin Netanyahu insisted that one of the pilots planned to crash the plane, adding that he is now being interrogated by Saudi authorities.

https://breakingthenews.net/Article/Katz:-Flydubai-incident-was-'jihadist-terror-attack-attempt'/67207936

FTC said to open probe into OpenAI, Anthropic

The United States Federal Trade Commission (FTC) has opened an investigation into OpenAI, Anthropic and other leading artificial intelligence companies over potential risks their technology poses to consumers, the New York Post reported on Wednesday, citing administration officials.

"The agency has plans to compel the executives at these firms to testify about their product [and] about the dangers they allege their products may have to consumers, to Americans," a senior FTC official said. The regulator is preparing civil investigative demands (CIDs) seeking testimony and documents as it examines possible unfair or deceptive practices.

The probe follows Tuesday's White House meeting, where executives from OpenAI, Anthropic, Google, xAI, and other major AI companies signed a voluntary AI safety accord with President Donald Trump. "We want to maintain our dominance," the senior FTC official said. "Nothing in our investigation should remotely get in the way of that at all . . . We are in the investigative phase.”

https://breakingthenews.net/Article/US-watchdog-said-to-open-probe-into-OpenAI-Anthropic/67207667

2 charged with infiltrating fake Ozempic into US

 Two Indian nationals are facing charges relating to the sale of counterfeit versions of Novo's diabetes treatment Ozempic to distributors in the US supply chain.

According to the Department of Justice, Swapnadip Roy (33) and Vicky Ramancha (37) obtained falsified versions of Ozempic (semaglutide) from unauthorised sources in China and sold them on to unsuspecting distributors at deeply discounted prices.

Their alleged activities were discovered in 2023 when the FDA seized some of the counterfeits – inveigled into legitimate US sales channels – after a tip-off from Novo. Since the seizure, the regulator has issued multiple warnings about the fakes.

Ramancha is chief executive of pharma and medical equipment trading company RNR Healthcare, while Roy is publicly identified as a Dubai-based businessman and entrepreneur and CEO of the RNR Group, which has close links to RNR Healthcare. Roy has been extradited to the US from Italy, appearing in court this week, while Ramancha remains at large.

Court documents and media reports note that their customers included Assure Global LLC, which ordered around 125,000 doses of the counterfeits, paying a reported $18.8 million.

The counterfeit Ozempic included counterfeit packaging, package inserts, pen labels, and needles that the FDA said were "meant to deceive downstream customers, including pharmacies and patients, into believing they were receiving authentic, manufacturer-authorised Ozempic."

Some of the distributed counterfeits used a real Novo lot number to try to divert suspicion, and were introduced into the US under the guise of parallel imports – original, brand-name medicine purchased legally in one country at a lower price and imported into another where it can be sold at a premium.

Previous cases of Ozempic counterfeiting have identified products with little or no active drug, impure semaglutide, and other unapproved ingredients, potentially life-threatening substitutions with drugs like insulin, as well as non-sterile needles.

Other drugs used for diabetes and weight loss, including Eli Lilly's experimental therapy retatrutide, have also been targeted by criminals seeking to make a fast buck. Last month, Lilly filed lawsuits against several companies it accused of participating in an illegal black market for the drug.

There have been reports that organised crime networks have started manufacturing counterfeit retatrutide products – complete with fake brand names and bespoke packaging – on an internationally industrial scale. The reports say that the products are often imported from China.

"Counterfeit prescription drugs – especially common ones – threaten the health and safety of every American who depends on the integrity of our pharmaceutical supply,” said Assistant Attorney General Tysen Duva of the Justice Department’s Criminal Division.

"These defendants allegedly exploited people’s health to pay themselves," he added. "We will keep pursuing anyone who seeks to deceive American consumers with counterfeit drugs."

Roy and Ramancha are charged with one count of conspiracy to commit smuggling and to defraud the US, three counts of smuggling, and two counts of selling counterfeit drugs and holding them for sale. If convicted, they each face a maximum penalty of 71 years in prison.

https://pharmaphorum.com/news/two-men-charged-infiltrating-fake-ozempic-us

Why Grail May Have More Room to Run

 Grail's (NASDAQ: GRAL) stock surged after a Food and Drug Administration (FDA) Advisory Committee voted favorably on the safety, benefit-risk profile, and effectiveness of its multi-cancer early detection test (MCED), Galleri. It marks a remarkable turnaround for the stock after a February crash following the release of top-line results from a landmark Galleri trial that revealed it had missed its primary endpoint. Here's why this recovery could continue.

The investment case for Grail stock

The Galleri test is already in use. It's available on an "out-of-pocket" basis, whereby patients must pay for the test directly. However, sales will really grow when medical insurers start covering it. While FDA approval isn't strictly necessary for insurers to cover it, in practice, it is a prerequisite for widespread coverage. In addition, Grail needs to convince insurers that it's efficacious and cost-effective.

The first aim moved a step closer with the vote from the Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee in favor of Galleri. The vote is likely to lead to pre-market approval for Galleri, which will inevitably prompt insurers to evaluate it. The second needs more discussion.

What insurers need to see

The key decisions that will guide Galleri's adoption are likely to be in insurers' spreadsheets and cost/benefit modeling. Beyond assessing clinical utility and comparing it with existing care, insurers will likely assess the cost-effectiveness of using Galleri. For example, they may compare the cost of the test and the cost of more expensive, refined testing to address false positives from Galleri testing against the benefit of earlier cancer detection from using Galleri.

Detecting cancers earlier is not only good for patients, as it can improve outcomes and help them avoid invasive, painful treatment at a later stage, but it can also save costs, since late-stage cancer treatment can be incredibly expensive.

Grail's data supporting the case for Galleri

To support these decisions, insurers need to see a few things in the trial results, including:

• A reduction in late-stage cancer detection that demonstrates test efficacy.

• A high episode sensitivity rate (percentage of cancers detected among those confirmed within cancer within 12 months) that demonstrates the ability to detect cancers.

• A high positive predictive value, or PPV (percentage of true positives among positive Galleri results), which demonstrates the ability to avoid costly and unnecessary testing of false positives.

Evidence from two large-scale studies (NHS-Galleri in England and a 35,878-enrollment study in the U.S., (PATHFINDER 2) shows that Galleri performs better on the 12 deadly cancers responsible for two-thirds of cancer-related deaths than overall across the more than 50 cancer types it tests for.

Study	Episode Sensitivity (Overall)	Episode Sensitivity (12 Deadly Cancers)	Positive Predictive Value
NHS-Galleri	30.7%	54.7%	52%
Pathfinder 2	39.3%	69.8%	60.3%

Data source: Grail presentations.

While the NHS trial missed its primary endpoint of "statistically significant Stage III-IV reduction," management noted that it "did show reduced Stage IV diagnoses of 12 prespecified aggressive cancers by 22% and 26% in the second and third screening rounds" in the top-line results release.

If insurers are satisfied with the merits of Galleri, particularly its efficacy and benefits for the 12 deadliest cancers, adoption could be widespread, and the recent FDA committee vote is a plus to that end.

https://finance.yahoo.com/markets/stocks/articles/grail-stock-soared-180-6-122000095.html

https://www.iranintl.com/en/202609306034

https://breakingthenews.net/Article/US-personal-spending-up-by-0.9-in-August/67206626

https://breakingthenews.net/Article/US-trade-deficit-up-to-dollar132.6B-in-August/67206634