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Wednesday, September 18, 2024

Analysts say Mossad likely hid explosives in pagers before they reached Hezbollah

 Israel has scored a major intelligence success by apparently infiltrating a supply chain to cause the simultaneous explosion of hundreds of Hezbollah pagers in a blow for the Lebanese terror group and its Iranian backers, analysts say.

At least nine people were killed and some 2,750 wounded, including the Iranian ambassador to Lebanon, when the pagers exploded in Hezbollah strongholds across the country in an unprecedented simultaneous attack.

With Hezbollah appearing to prefer the use of pagers for internal communications over smartphones for security reasons, analysts said it appeared Israel had corrupted the devices before delivery, allowing them to explode at a specific time.

A source close to Hezbollah, asking not to be identified, told AFP that “the pagers that exploded concern a shipment recently imported by Hezbollah of 1,000 devices,” which appear to have been “sabotaged at [the] source.”

Sky News Arabia quoted sources saying that the Mossad spy agency got hold of Hezbollah’s communication devices before they were handed over to the terror group.

The Israeli spy agency placed a quantity of PETN, a highly explosive material, on the batteries of the devices, and detonated them by raising the temperature of the batteries from afar, the source said.

A Lebanese security source quoted by Al Jazeera said an explosive weighing less than 20 grams had been placed in each pager.

The pagers that exploded had been newly acquired by Hezbollah after the group’s leader ordered members to stop using cellphones, warning they could be tracked by Israeli intelligence. A Hezbollah official told The Associated Press the pagers were a new brand the group had not used before.

“Mossad infiltrated the supply chain,” said Charles Lister of the Middle East Institute, referring to Israel’s intelligence agency.

“A small plastic explosive was almost certainly concealed alongside the battery, for remote detonation via a call or page,” he said.

Officials with the group initially suspected overheated lithium-ion batteries may have caused the pagers to explode, but images of the destroyed devices seen Tuesday showed signs of detonation, said Alex Plitsas, a weapons expert at the Atlantic Council.

“A lithium-ion battery fire is one thing, but I’ve never seen one explode like that. It looks like a small explosive charge,” Plitsas said.

Paul Christensen, an expert in lithium-ion battery safety at Newcastle University said the level of damage caused by the pager explosions seemed inconsistent with known cases of such batteries failing in the past.

“What we’re talking about is a relatively small battery bursting into flames. We’re not talking of a fatal explosion here. I’d need to know more about the energy density of the batteries, but my intuition is telling me that it’s highly unlikely,” he said.

Police officers inspect a car inside of which a hand-held pager exploded, Beirut, Lebanon, September 17, 2024. (AP Photo/Hussein Malla)

SMEX, a Lebanese digital rights organization, told Reuters that Israel could have exploited a weakness in the device to cause it to explode. It said the pagers could also have been intercepted before reaching Hezbollah and either tampered with electronically or implanted with an explosive device.

Yehoshua Kalisky, a scientist and senior researcher at the Institute for National Security Studies, a Tel Aviv think tank, noted the possibility of an electronic pulse “that was sent from afar and burnt the devices and caused their explosion.”

“It is not some random action; it was deliberate and known,” he said.

‘Their big comeback’

Hezbollah has blamed Israel for the explosions. Israel, which traditionally does not comment on security operations outside the country, has yet to confirm or deny its involvement.

It remains unclear whether the action could tip the region into a regional war between Israel and Hezbollah that the West has been battling to avoid ever since Hamas’s October 7 massacre on Israel sparked the war in Gaza.

But the images captured on camera of pagers exploding are a major security blow for Hezbollah and an illustration of Israel’s reach even into the terror group’s members’ pockets.

The action comes after senior Hezbollah commander Fuad Shukr was killed in a targeted Israeli airstrike on July 30 that indicated Israel had precise information about his whereabouts.

Just a day later, the political leader of Hamas, Ismael Haniyeh, was killed in a residence in Tehran, reportedly using an explosive device that had been placed by Israeli operatives weeks before. Israel has not confirmed or denied its involvement in the assassination.

French defense expert Pierre Servent said the latest action against Hezbollah would help Israeli intelligence services restore their reputation, which was badly dented by the October 7 massacre when Hamas-led terrorists rampaged across southern communities on October 7, murdering some 1,200 people and taking 251 hostages to Gaza.

“The series of operations conducted over the past few months marks their big comeback, with a desire for deterrence and a message: ‘We messed up but we’re not dead,'” he told AFP.

A police officer inspects a car in which a hand-held pager exploded, in Beirut, September 17, 2024. (AP Photo/Hussein Malla)

‘Classic sabotage’

Former CIA analyst Mike Dimino of the US-based Defense Priorities think tank said that judging by images of the injuries a “very small explosive” implanted inside the devices was the most likely cause, rather than an overheating battery.

“This was a classic sabotage operation,” he said on X, adding such an operation takes “months if not years” to orchestrate.

Dubai-based analyst Riad Kahwaji said that Israel had taken advantage of Hezbollah’s move away from smartphones to pagers.

Israel intelligence had conducted a “most professional operation,” he said.

“Without a doubt, one of the factories it (Israel) owns manufactured and shipped these explosive devices that exploded today,” he said.

https://www.timesofisrael.com/analysts-say-mossad-likely-hid-explosives-in-pagers-before-they-reached-hezbollah/

Philip Morris divests Vectura at a loss after backlash

 Philip Morris International (PMI) is selling inhaled drug specialist Vectura to Molex Asia Holdings for a fraction of the £1.1 billion ($1.45 billion) it paid for the business three years ago.

The tobacco group – best known for brands like Marlboro cigarettes – has agreed to divest Vectura to the electronics group for £150 million ($198 million) upfront and potential milestones of another £148 million after experiencing "unwarranted opposition" to its ownership of the company. It has previously taken a $680 million accounting charge in connection with the deal.

PMI's takeover of the company was met with consternation by health charities, public health specialists and doctors' organisations – including the European Respiratory Society (ERS), Asthma UK and the British Lung Foundation – which had questioned the ethics of placing a pharma company in the hands of a big tobacco group. One concern was the potential for legitimising tobacco industry participation in health debates.

In a statement on the decision to divest the business, PMI's chief executive Jacek Olczak said that the takeover had played a key role in developing a pipeline of respiratory therapeutics at its Vectura Fertin Pharma subsidiary.

"We remain committed to driving innovation in this space over the long term," he asserted, but acknowledged that the backlash against PMI's ownership of Vectura had compromised the unit's "scientific engagement" and its ability to secure development and manufacturing contracts, a key part of its business.

When the acquisition was first debated, there had been suggestions that Vectura scientists' participation in medical meetings, publishing of research in medical journals, and establishing links with academia could be under threat, due to policies of non-engagement with the tobacco industry.

Molex is the parent of Phillips Medisize, which also operates in the contract development and manufacturing organisation (CDMO) market, specialising in products like autoinjectors, wearable pumps, continuous glucose monitoring systems, and at-home diagnostic tests.

"With its experience in pharmaceutical drug delivery devices and its global manufacturing footprint, Phillips Medisize is best placed to lead Vectura into the future – while releasing it from the unreasonable burden of external constraints and criticism related to our ownership," said Olczak.

Phillips Medisize chairman Paul Chaffin said the takeover of Vectura would give it a broader portfolio of inhaler device technologies and – with its greater reach and scale – bring Vectura's technologies to more patients around the world and "support our mission to help people live healthier, more productive lives."

PMI has long argued that it wants to go "beyond nicotine" and reinvent itself as a company focusing on health and wellness products, with a target of making sales of $1 billion next year from those activities. It should be noted that the Vectura Fertin Pharma website currently only lists nicotine replacement therapy as a programme in its inhaled therapeutics pipeline.

The pharma unit – which will be renamed after the Vectura divestment – is also developing cannabinoid (CBD) products for medical applications.

Molex said the acquisition is expected to close by the end of 2024, subject to regulatory approvals and other customary closing conditions.

https://pharmaphorum.com/news/tobacco-firm-pmi-divests-vectura-loss-after-backlash

Lilly on alert as new Kisqali approval threatens Verzenio

 Novartis' CDK4/6 inhibitor Kisqali has claimed a broad FDA approval in early breast cancer that could give it an edge over class rival Verzenio from Eli Lilly.

The US regulator has cleared Kisqali (ribociclib) to reduce the risk of recurrence in patients with HR+/HER2- early breast cancer, based on the results of the NATALEE trial. In the study, Kisqali given alongside endocrine therapy as adjuvant therapy for stage 2 or 3 patients reduced their risk of recurrence by 25% compared to those on the endocrine therapy alone after three years.

Verzenio was approved for a similar adjuvant indication last year, having been used for a couple of years only in patients who tested positive for a specific biomarker. However, its label only covers the use of the drug in patients whose cancer has spread to the lymph nodes, while Kisqali can be used in both node-positive and node-negative cases.

Novartis' drug is the first direct rival to Verzenio in this setting, as Pfizer's CDK4/6 inhibitor blockbuster Ibrance (palbociclib) failed to show efficacy as adjuvant treatment for early breast cancer in the PALLAS and PENELOPE trials. That lack of competition has spurred Verzenio to sales of $3.86 billion in 2023, a 56% rise on the prior year, and it is now Lilly's third biggest seller.

At the just-concluded ESMO congress, Novartis presented new data from NATALEE showing that the risk of recurrence continued to fall after four years of patient follow-up, with a 28.5% difference between Kisqali and placebo in invasive disease-free survival (iDFS) and a trend towards improved overall survival (OS).

Kisqali has been approved by the FDA since 2017 as a treatment for metastatic HR+/HER2- metastatic breast cancer, and after a somewhat slow start has been gathering sales momentum, growing by 75% to just under $2.1 billion last year. Novartis has previously said the early breast cancer approval could help drive peak sales to $7 billion.

On the company's second-quarter results call, Novartis' chief executive Vas Narasimhan said that the drug was growing on the back of "an outstanding data profile in the metastatic breast cancer setting" and looks on track to become "the preferred medicine for patients with early breast cancer."

People with stage 2 or 3 HR+/HER2- early breast cancer face a significant risk of recurrence – often as incurable metastatic disease – despite adjuvant endocrine therapy. That applies to those with node-negative disease as well, as around 10% of this group will have a recurrence within three years of diagnosis.

"With this approval, we are redefining treatment options for a broader population of people impacted by breast cancer and facing the persistent risk of recurrence," said Victor Bultó, president of Novartis' US operations.

https://pharmaphorum.com/news/lilly-alert-new-kisqali-approval-threatens-verzenio

Despite Win Over Keytruda, Summit’s NSCLC Bispecific Still Has Something to Prove

 

Summit Therapeutics’ ivonescimab has the potential to challenge Merck’s blockbuster checkpoint inhibitor in non-small cell lung cancer, but experts stress the need for diverse and overall survival data.

Summit Therapeutics wowed attendees at the World Conference on Lung Cancer with late-stage data for its in-licensed bispecific ivonescimab, declaring victory over Merck’s blockbuster Keytruda, which has historically led the non-small cell lung cancer treatment space. Since Summit’s Sept. 9 presentation, eager investors have sent Summit’s stock skyrocketing as much as 140%.

Still, some analysts urged caution, as the data was from a trial run only in China.

“Results may or may not be generalizable beyond the China-focused patient population initially assessed,” BMO Capital Markets analyst Evan Seigerman wrote in a note to investors, adding that FDA consideration will likely require U.S. data. Summit has already announced it will take its bispecific into a multi-regional study of non-small cell lung cancer (NSCLC) in early 2025. And at the 2024 European Society for Medical Oncology (ESMO) annual meeting this week, Summit reported that ivonescimab also showed promising anti-tumor activity in small trials for colorectal cancer, triple negative breast cancer and head and neck squamous cell carcinoma—all indications where Keytruda is also approved.

Ryan Schoenfeld, CEO of The Mark Foundation for Cancer Research, said it’s not too early to get excited about the NSCLC data. Despite checkpoint inhibitors shifting the curve for lung cancer patients, there are still patients with a lot of unmet need, so “this is a really big deal,” he told BioSpace. It’s reasonable to think that ivonescimab might be competitive with Keytruda plus chemo, Schoenfeld added, potentially sparing patients from chemotherapy treatments, which come with a host of side effects including fatigue, nausea and low blood cell counts.

John Heymach, head of the Heymach Laboratory at MD Anderson Cancer Center, which specializes in NSCLC research, agreed. “By any measure, the data is impressive,” he told BioSpace.

Still to Prove: Overall Survival

Heymach noted that Summit’s HARMONi-2 trial is one of the few instances of a candidate successfully taking on Keytruda head-to-head in a population where the latter is approved. He said that he and other investigators had previously believed Summit to be overly optimistic in in how it powered its HARMONi-2 trial, but that the latest results have largely put those concerns to bed.

The trial was run by Summit’s development partner Akeso and pitted ivonescimab, a bispecific antibody combining the powers of anti-PD-1 and anti-VEGF, against Keytruda, itself an anti-PD-1 checkpoint inhibitor, as a first-line treatment for patients withadvanced NSCLC. Median progression free survival after nine months of follow-up was 11.14 months in the treatment arm vs. 5.82 months in the Keytruda group. Summit’s bispecific cut the risk of disease progression or death by nearly 50% compared to Keytruda.

HARMONi-2 included a variety of patient subgroups, including high and low PD-L1, and squamous and non-squamous cancer. Ivonescimab was effective across all groups, with no obvious outlier driving results, Heymach said.

An earlier study echoed this efficacy in a different setting of NSCLC patients with EGFR mutations on platinum chemotherapy. HARMONi-A compared patients receiving chemo alone to patients on chemo plus ivonescimab, with the latter showing significantly improved progression-free survival (PFS). Heymach noted that this is a subgroup in which Keytruda had been tested and did not show benefit.

“That’s two consecutive, randomized Phase III [trials] where [ivonescimab] overperformed compared to expectations,” he told BioSpace.

After a string of attempted checkpoint combo attempts were “horribly unsuccessful,” Christiana Bardon, co-managing partner at MPM BioImpact, said, “this is really the first data of something that’s worked beyond that first crop. And it’s pretty shocking that it works.”

While Bardon called Summit’s data “definitive,” she said they are lacking the holy grail of trial results—overall survival (OS). Summit stated in its press release that OS data was not yet mature and would be evaluated in the future.

Heymach said that although improvements to PFS have sometimes not translated into OS improvement, given the magnitude of PFS benefit, it would be surprising if it was not reflected in this outcome measure.

Summit will also likely need to demonstrate an improvement on the therapeutic index, which could be achieved from combining an anti-VEGF with an anti-PD-1 as separate agents for treatment, Schoenfeld said. According to Summit, ivonescimab does more than just combine two treatments into one. The bispecific antibody has a unique cooperative binding that results in a higher affinity in the presence of both PD-1 and VEGF.

Diverse Data Needed

With the current results coming from China-only trials, all three experts who spoke with BioSpace agree that the FDA will need to see more data from a diverse population in order to consider approval. The use of China-only data can be skewed by factors such as variation in genetics, less patient follow up and cultural differences in reporting side effects.

Bardon emphasized that safety/side effects in particular could be a concern for the FDA when reviewing China-only data. For example, in HARMONI-2, there were very few grade 3 adverse events. “[Adverse events] are probably underestimated compared to what we would see in a Western-based population,” Bardon said.

If the data indeed hold up in a broader population, Summit could tap into a portion of Keytruda’s $25 billion in overall annual sales. While Akeso has already garnered approval for ivonescimab in China where it holds the rights, Summit’s license extends to the U.S., Canada, Europe, Japan, Central, South America and a handful of other markets.

Of course, Summit is not the only bispecific developer to announce impressive results of late. On Saturday, BioNTech reported at ESMO 2024 that its own bispecific targeting both PD-L1 and VEGF-A, BNT327, elicited a 57.8% confirmed objective response in a Phase II trial of 64 Chinese patients with EGFR-mutant NSCLC, according to Endpoints News. Meanwhile, Instil Bio, and its China-based partner ImmuneOnco Biopharmaceuticals, are gearing up to begin a Phase II trial of their own bispecific antibody SYN-2510/IMM2510 in NSCLC and triple-negative breast cancer.

“This [bispecific] therapeutic modality has definitely arrived,” Schoenfeld said.

https://www.biospace.com/drug-development/despite-win-over-keytruda-summits-nsclc-bispecific-still-has-something-to-prove

'Ex-WSJ Journo Uncovers Hub Of An Alleged Migrant Trafficking Network In Springfield, OH'

 Wall Street Journal reporter Asra Nomani has published a shocking report that could soon change the national discussion from Haitians and other migrants eating cats or dogs in Springfield, Ohio, to one that is more sinister: The hub of a complex "hidden human trafficking network" in the tiny rust belt town. 

"The story in this town is not about cats or dogs. It's about mules. It's a twin tragedy of migrant workers from Haiti exploited and locals from Springfield marginalized," Nomani wrote in the Jewish Journal

She said, "Just about every week since 2019, First Diversity Staffing Group Inc. has shuttled vulnerable Haitian migrants in unmarked white Ford and Chevy vans from Florida to Ohio, where they are allegedly exploited for cheap labor by companies like Dole Food Company Inc.," adding, "It is a secretive and sinister operation that has gone unchecked for more than five years." 

What began as my efforts to track down a rumor about animal cruelty has turned into an investigation that reveals a malignant system of labor exploitation involving a local businessman, George Ten, whom Haitians and local residents call "King George," the chief executive at First Diversity Staffing Group Inc., a Springfield company that has been the tip of the spear in the alleged trafficking operation of Haitians to the town.

***

This is a story of unchecked greed and cruelty, committed not by the immigrants, but to the immigrants, with local residents of Springfield also a casualty.

Nomani provided an image of one of those vans owned by staffing companies that shuttles the migrants to factories. 

The ex-WSJ journo said 'George Ten', the alleged mastermind behind this scheme, lives in a mansion in rural Ohio. She continued, "His nickname is "King George" because of his opulent lifestyle of luxury cars, cash handouts, and fast talk. For years, he has operated his reign of alleged exploitation." 

This is stunning, as Nomani noted: 

One Haitian man I interviewed asked to be anonymous for fear of retaliation and recalled how he was picked up by a driver for one of Ten's vans on a street corner near a Winn-Dixie grocery store in Immokalee, Florida. After the long journey to Springfield, he was dropped off at a rundown home on Rice Street, infested with cockroaches. He soon found work through First Diversity at Jefferson Industries Corporation, earning $12.50 an hour; he didn't know how much George skimmed off his wages. The home he lived in had no working heat, and he bought an electric heater to survive the cold Ohio winter, the heater barely heating his room.

What essentially began as an unverified claim by Trump about migrants eating pets has led to the disturbing truth of alleged labor trafficking and modern-day slavery in Springfield. The Haitians, here legally, are being exploited by mega corporations... 

In March, we previewed to readers...

She said her reporting on this would "blow your mind." 

What will also blow your mind is that this alleged labor trafficking network has possibly also surfaced in Charleroi, Pennsylvania

We cited a resident of the town, who spoke on the condition of anonymity for fear of retribution. In a video, the resident revealed the complex network of staffing vans in a town that is 50% Haitian. The vans shuttle migrants back and forth to several food packaging plants.

Here's the full video:

What the Trump team is discovering - the story from Springfield and possibly even Charleroi, is not about cats and dogs. It's about the federal government, and maybe even a shadowy network of NGOs, that dumped the migrants into small towns nationwide. This cheap and exploited labor benefits mega corporations but crushes native blue-collar workers

At the end of the day, this is not 'America First' - terrible foreign policy by the radicals in the far-left Biden-Harris admin has sold out the blue-collar worker. 

https://www.zerohedge.com/political/blow-your-mind-ex-wsj-journo-uncovers-hub-alleged-migrant-trafficking-network-springfield

Democrats block Cruz attempt to pass GOP IVF bill

 Democrats on Tuesday blocked an attempt by Republican Sens. Ted Cruz (Texas) and Katie Britt (Ala.) to pass a GOP in vitro fertilization (IVF) access bill through unanimous consent, repeating a similar showdown that occurred earlier this year.

Cruz sought unanimous consent for the IVF Protection Act, which was blocked by Democrats in June at the same time their own IVF access bill, the Right to IVF Act, was blocked by Republicans.

The senator from Texas blasted the vote on the Democrats’ bill Tuesday as a “show vote” as Republicans blocked it once again. He accused Democrats of using the vote to reap material for campaign commercials and damaging headlines.

Cruz called for attention to how Democrats would act on his and Britt’s IVF legislation.

“If you hear the words ‘I object’ from Senate Democrats, then you will understand the only reason that IVF is not protected with strong, ironclad protection in federal statute is because Senate Democrats cynically object to protecting IVF,” Cruz said.

Sen. Patty Murray (D-Wash.), a key sponsor of the Democrats’ Right to IVF Act, objected immediately after Cruz spoke.

“I have been perfectly clear about the glaring issue with this Republican bill,” Murray said. “The cold, hard reality is this Republican bill does nothing to meaningfully protect IVF from the biggest threats from lawmakers and anti-abortion extremists all over this country. It would still allow states to regulate IVF out of existence. And this bill is silent on fetal personhood, which is the biggest threat to IVF.”

In a press release shortly after she blocked Cruz and Britt’s bill, Murray similarly criticized it as a “show-bill.”

While both bills had similar aims of ensuring IVF access at the federal level, there were some distinct differences. The GOP bill would bar states from receiving Medicaid funding if they implement a ban on IVF but explicitly does not guarantee a right to IVF services.

https://thehill.com/policy/healthcare/4884839-democrats-block-ted-cruz-gop-ivf-bill/

Travis County sues Ken Paxton over widening Texas crackdown on voter registration

 The fight over voter registration in Texas Democratic-leaning cities is heating up.

In Tuesday, Travis County sued Texas state officials — including right-wing Attorney General Ken Paxton — over his repeated attempts to block the state’s urban counties from registering voters by mail.

“Today, Travis County, once again, fights back,” county attorney Delia Garza told reporters on Tuesday, The Texas Tribune reported. Travis County is home to the state’s capital, Austin.

The countersuit comes in the context of a tightening election — and less than three weeks before the critical Oct. 7 deadline to register Texans to vote.

In the suit, Garza asserts that Paxton and State Secretary of State Jane Nelson are in violation of Title 52 of the Voting Rights Act, which makes it “the duty of the Federal, State, and local governments to promote the exercise of [the] right” to vote.

The Travis countersuit follows three weeks after Paxton sued Travis County itself, alleging that county leadership’s use of a third-party voter registration company violated state law.

The suit comes in the context of legal action in other major Texas cities. Travis County officials filed the suit the day after a state district court judge dismissed Paxton’s suit against Bexar County, about 90 miles to the south of Travis and home of the similarly blue city of San Antonio. 

Paxton sued Bexar earlier this month on similar grounds — legal action that came weeks after agents working for his office searched the homes and offices of local Democratic organizers and of a candidate for a crucial state representative’s seat coveted by the GOP.

It is in Harris County — the state’s most populous and a key Democratic base — that the GOP legal campaign has borne the most fruit. Paxton and Houston-area state Sen. Paul Bettancourt also threatened suits against Harris County, if the county proceeded with its own plan to send out registration forms by mail.

That county was the center of a 2020 legal campaign by Paxton to block vote-by-mail during the height of the COVID-19 pandemic, which he has credited with holding the state for Donald Trump.

Harris County has now run out of time to send out its own registration forms, Houston Public Media reported. 

Texas Democrats in the House of Representatives have called on the Department of Justice to investigate Paxton’s alleged violations of the Civil Rights and Voting Rights Act.

The legal wrangling happens as the intersection of two long-running political fights between the states GOP-dominated leadership and the largely Democratic-controlled metro areas where most of its population actually lives.

Most immediately, Paxton’s suits are part of a broader trajectory of unproven claims, largely based on conspiracy theories but echoed by the national party, that Democrats are trying to steal the election by importing undocumented voters.

“Travis County has blatantly violated Texas law by paying partisan actors to conduct unlawful identification efforts to track down people who are not registered to vote,” Paxton said in a statement on the day he sued the county.

Paxton has made variations of this argument since 2020 — when he unsuccessfully alleged before the Supreme Court that Joe Biden had stolen the election from Donald Trump, earning an attempted censure from the State Bar. 

But Republicans have intensified those claims as the presidential race in Texas has tightened and Senate challenger Rep. Colin Allred (D-Texas) has closed to within the margin of error with incumbent Sen. Ted Cruz (R).

The election fight is however a subset of a broader war within Texas: A decadelong attempt by a dominant but internally-divided GOP to strip authority from the state’s cities over issues from overseeing elections to running public schools to mandating rest breaks for construction workers in the state’s punishing heat.

https://thehill.com/homenews/state-watch/4886164-texas-voter-registration-fight-travis-county/