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Saturday, July 11, 2026

'US, Lebanon said to talk framework deal implementation'

 The delegations from the armed forces of the United States and Lebanon met to discuss the implementation of the first "pilot zone" in southern Lebanon as part of the framework agreement reached between Israel and Lebanon, Al-Jazeera reported on Saturday, citing Lebanese sources.

Under the deal, the Israeli forces are set to gradually withdraw from two so-called pilot zones and allow the Lebanese army to deploy its forces there.

https://breakingthenews.net/Article/US-Lebanon-said-to-talk-framework-deal-implementation/66678666

Foreign drugmaker caught faking doctors’ petition to evade China’s price cut scheme

 Amid an ongoing expansion of China’s volume-based procurement (VBP) scheme to lower drug costs, the Chinese government has singled out a fraud case involving a foreign originator drug in a warning to the industry.

In an attempt to influence whether a drug gets selected for price bidding, a foreign drug innovator faked doctors’ signatures in a petition, China’s National Healthcare Security Administration (NHSA) said in a post (Chinese) on Tuesday.

Among the 78 signatures from 31 hospitals, over 80% were found to be doctored. Some signatures were forged by sales representatives, some used misappropriated images from other sources, and some pointed to individuals that do not exist, according to the agency.

As for the few signatures that the experts themselves indeed wrote, the doctors were mostly tricked into signing the document under the guise of survey questionnaires or post-sales follow-up, the agency said.

The drug has since been included in the latest VBP batch of 65 drug varieties, which together represent a total market value of nearly 60 billion Chinese yuan ($8.8 billion), according to the NHSA. 

The VBP, now in its 12th round, is a government-led drug-buying program targeting off-patent medicines. Under the program, generics and the originators offer price cuts to secure procurement contracts with hospitals. The government unveiled the latest list on June 23 and is now in the bidding process. 

In a statement to local news outlet The Paper, Novartis confirmed it was not the unnamed drugmaker flagged in the NHSA alert. The Swiss pharma’s blockbuster heart failure treatment Entresto (sacubitril/valsartan) is one of the biggest products in this VBP round. According to local reports, Entresto and its generics generated more than 6 billion yuan of end-market sales ($880 million) at public hospitals in China last year, with the Novartis originator accounting for more than 90%. 

The VBP program now threatens to split up that huge market by rewarding significant shares to companies that offer lower prices. In what’s slated to be an über-competitive bidding process, more than 30 Entresto generics competitors are vying for a place under VBP, according to local drug intelligence database DXY Insight.

As part of the largest patent expiry in Novartis’ history, Entresto lost its U.S. market exclusivity last year and has seen major sales declines since.

Some uncertainties remain for VBP’s potential impact on Entresto. The Novartis drug is among eight products that carry an asterisk, which indicates ongoing patent disputes. 

A few days before the revelation of the latest VBP list last month, China’s National Intellectual Property Administration doled out a five-year patent-term extension to Entresto to make up for time lost during its drug regulatory review process, effectively pushing back the expiration of its core patent to November 2031. 

In a new rule introduced into VBP this time, generic rivals to those asterisked drugs must submit a declaration of non-infringement or be removed from procurement platforms.

Takeda’s angiotensin II receptor blocker Edarbi (azilsartan medoxomil) and acid blocker Takecab (vonoprazan fumarate), Eli Lilly’s JAK inhibitor Olumiant, Daiichi Sankyo’s factor Xa inhibitor edoxaban and AstraZeneca’s Xigduo XR (dapagliflozin and metformin extended release) are also included in VBP despite ongoing patent disagreements.  

Takeda, Bayer and Eisai have also denied they were the company in the NHSA’s announcement, according to The Paper. Bayer’s drospirenone/ethinyl estradiol oral contraceptive, known commercially as Yaz or Yasmin, and its imaging contrast agent Ultravist (iopromide) are included for VBP bidding against generics. Eisai has anti-vertigo medication Merislon (betahistine) and anti-seizure med Fycompa (perampanel) on the list. 

In addition to the companies above, the 65-item roster includes brand-name products from almost all major pharmas, including Astellas, Fresenius Kabi, GSK, Johnson & Johnson, Pfizer, Merck & Co., Merck KGaA, Otsuka, Sanofi and Servier. Among the smaller firms involved are Cheplapharm, Dr. Falk Pharma and Grünenthal from Germany; Japan’s Maruishi Pharmaceutical, Sumitomo Pharma, LTL Pharma and Minophagen Pharmaceutical; as well as the Wellcome Foundation and Tillotts Pharma in Switzerland.

https://www.fiercepharma.com/pharma/foreign-drugmaker-caught-faking-doctors-petition-evade-chinas-price-cut-scheme

Ipsen’s Botox rival Dysport charts new horizons with dual phase 3 wins in migraine

 In a first for the neurotoxin market, Ipsen announced Thursday that its Dysport has hit the goals in two phase 3 trials for the prevention of both episodic and chronic migraines.

While AbbVie’s market-leading Botox has been approved by the FDA to prevent headaches in patients with chronic migraine since 2010, Dysport is now the first botulinum toxin to also report positive phase 3 results in episodic migraine, according to Ipsen.

The readouts come from studies in Ipsen’s Beond program, comprising 1,510 patients, split between C-Beond (chronic) and E-Beond (episodic). Both trials have met their primary endpoints, showing a statistically significant reduction in monthly migraine days versus placebo.

“Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population,” Ipsen’s global head of R&D, Christelle Huguet, Ph.D., said in a July 9 statement.

Ipsen will review the full data and prepare for regulatory filings, including with the FDA, a company spokesperson told Fierce Pharma. 

Episodic migraine represents a “substantially larger patient population” than chronic patients, Ipsen pointed out. The E-Beond trial defines episodic migraine as patients experiencing no more than 14 headache days per month, including at least six migraine days. Specific definitions of episodic versus chronic migraine may vary, but the 14-headache-day per-month cutoff is a widely accepted standard. 

The clinical victory gives Ipsen another venue to chip away at Botox’s dominance. The AbbVie blockbuster pulled in nearly $6.4 billion in sales last year across therapeutic and cosmetic indications. By comparison, Ipsen recorded 298 million euros ($341 million) and 436 million euros (about $500 million) in Dysport’s 2025 revenues between the two fields, respectively. 

First approved by the FDA in 2009 for cervical dystonia and glabellar lines, Dysport is also indicated for certain patients with spasticity.

Migraine, including both episodic and chronic forms, affects around 14% to 15% of the global population. Coming at both forms of the disease from another angle, Ipsen is advancing a recombinant neurotoxin called corabotase (IPN10200) in phase 2, while having already moved the asset into phase 3 in aesthetics. 

In the phase 2 Lantic study in aesthetics, corabotase offered a significantly longer duration of effect versus Dysport in terms of achieving a score of “none” or “mild” line severity at week 24, Ipsen reported in September 2025.

The newer molecule was also embroiled in a dispute between Ipsen and its long-time commercialization partner Galderma. The two companies had previously clashed over the control of next-generation neuromodulator projects, as Ipsen moved to terminate their R&D partnership signed in 2014. 

In a final decision issued in January 2026, the arbitral tribunal of the International Chamber of Commerce sided with Ipsen, allowing the French pharma to terminate the R&D agreement and take full control of its clinical-stage toxin programs in the aesthetic field. The R&D legal brouhaha didn’t affect the two companies’ commercialization collaboration around Dysport.

https://www.fiercepharma.com/pharma/ipsen-botox-rival-dysport-charts-new-territory-dual-phase-3-wins-migraine

FDA rejects Hengrui, Elevar’s PD-1 liver cancer combo for a 3rd time

 The third time is not the charm for Hengrui Pharma and Elevar Therapeutics’ star-crossed combination of camrelizumab and rivoceranib at the FDA.

U.S. regulators have declined to approve the anti-PD-1/VEGFR combo for a third time as a first-line treatment for liver cancer, Hengrui and Elevar’s parent company, HLB Group, said in separate announcements Friday.

The problem, again, is manufacturing. Only this time, the complete response letter (CRL) stemmed from deficiencies the FDA had identified in April at the plant producing rivoceranib, also known as apatinib, unlike the previous two rejections, which centered on Hengrui’s camrelizumab facility, according to the Chinese pharma. The rivoceranib manufacturer had passed an inspection by EU authorities in 2025, it noted.

Still, three CRLs do not necessarily mean three strikes and you're out for Hengrui and Elevar.

“The company has thoroughly evaluated the regulator’s feedback and is taking steps to implement appropriate corrective measures,” Hengrui said in a securities filing (Chinese, PDF) in Shanghai. “The company will actively communicate with the FDA and our partner, Elevar Therapeutics, to establish the next resubmission plan.”

Elevar “intends to promptly address the aforementioned deficiencies and resubmit the application for FDA approval,” HLB said in its own securities filing to the Korea Exchange.

As Elevar noted, a re-inspection by the FDA may be required to determine that the facility meets CGMP compliance requirements. 

More than two years have passed since the FDA first snubbed the camrelizumab-rivoceranib regimen in May 2024. The second CRL arrived in March 2025. And Elevar refiled the newest application on Jan. 23, 2026.

The latest CRL does not raise any issues with clinical data, Hengrui said. For this application, the two companies provided updated final analysis from the phase 3 Cares-310 trial, which showed a 36% death risk reduction for camrelizumab and rivoceranib versus Bayer’s Nexavar in first-line unresectable hepatocellular carcinoma.   

Chinese companies have long viewed follow-on PD-1 inhibitors as a viable entry point into the highly lucrative U.S. innovative drug market. However, these candidates have faced a string of regulatory and operational setbacks along the way.

n a high-profile decision that triggered ripple effects across the industry, the FDA in 2022 refused to approve Innovent Biologics’ then Eli Lilly-partnered Tyvyt, citing predominantly China-only data as a problem. Thanks to that policy, Novartis abandoned its U.S. submission plan in first-line non-small cell lung cancer for Tevimbra before returning the asset to BeOne Medicines, then known as BeiGene. The same fate met CStone Pharmaceuticals’ PD-L1 inhibitor sugemalimab and its partnership with EQRx, which was absorbed into Revolution Medicines in 2023. 

Besides Hengrui, Fosun Pharma is also angling its China-approved PD-1 inhibitor, serplulimab, for an initial FDA approval in extensive-stage small cell lung cancer. Despite the positive phase 3 Astrum-005 trial, which showed the drug beat placebo, both added to chemotherapy, Fosun had to conduct a U.S. bridging study that compared serplulimab to Roche’s Tecentriq. With that study recently complete, Fosun is in discussions with the FDA about a potential filing this year. 

https://www.fiercepharma.com/pharma/fda-rejects-hengrui-elevar-pd-1-liver-cancer-combo-3rd-time

An American mullah calls for Jihad

 Supreme Court Justice Antonin Scalia thought Justice Robert Jackson (1941-1954) “the greatest legal stylist of the 20th Century.”

It was Jackson who said the Constitution cannot be read to be a suicide pact. Considering how many federal judges, and arguably the current Supreme Court in the birthright citizenship case, are contributing to national suicide, it’s worthwhile to understand the context of Jackson’s wisdom:

Jackson coined the line in a 1949 dissent in Terminiello v. Chicago, a case about the limits of free speech. He was not arguing that constitutional rights should give way whenever they become inconvenient, nor was he defending expansive government authority. His concern was methodological. Jackson criticized the majority for relying “on a conception of freedom of speech so rigid as to tolerate no concession to society’s need for public order.” There was danger, Jackson warned, that “if the Court does not temper its doctrinaire logic with a little practical wisdom, it will convert the constitutional Bill of Rights into a suicide pact.”

How many illegal aliens are living among us while advocating for the destruction of America? How many Americans, including members of Congress, are doing the same? And how many of those illegals calling for the destruction of America are serious about it, not just spouting rhetoric?  In other words: Muslims? Robert Spenser provides a partial answer:

Graphic: X Post

Ragab Abdelmoneim is not some wild-eyed fanatic screaming obscenities on a streetcorner. On the contrary, he is a prominent, respected member of the Muslim community in the U.S. today. Alabama’s 1819 News reported recently that he is “now the Imam and ‘Resident Scholar’ at the Islamic Center of Maryland.” An Alabama publication is reporting on him because before he moved to Maryland, he served as an imam at the Islamic Academy in Huntsville, Ala., and was also a “part-time lecturer at the University of Alabama in Huntsville (UAH).”

 

Abdelmoneim’s educational credentials are apparently the Islamist equivalent of graduating from three or four Ivy League schools. He’s well educated and respected, at least by Islamist standards.

 “In a now widely circulated video on social media,” according to 1819 News, “Abdelmoneim called for Muslims to expand Sharia law by any means necessary, including through bloodshed.”

 

Abdelmoneim said: “We need to… have some people to love their religion and to sacrifice for their religion, sacrifice their money and their blood and their wealth for the sake of Allah.”

It’s easy to understand what Abdelmoneim meant when he said that Muslims should be willing to sacrifice their money and wealth for the sake of Allah. Every religion takes up collections, and the Qur’an exhorts Muslims to “spend your wealth for the sake of Allah” (2:195).

 

OK, this is just another example of protected speech, isn’t it? Joe Methodist down the street might make some intemperate comments from time to time, but he’s not going to kill Mohamed Muslim on the next block. Unfortunately, Mohamed just might kill Joe:

Also, Abdelmoneim most certainly knows that the Qur’an calls upon Muslims to “kill them wherever you find them” (2:191, 4:89, 4:91, cf. 9:5), and makes it clear that Allah favors those who fight unbelievers over those who do not do so: “Those of the believers who sit still, other than those who have an injury, are not equal with those who wage jihad in the way of Allah with their wealth and lives. Allah has conferred on those who wage jihad with their wealth and lives a rank above the sedentary. Allah has promised good to each, but he has bestowed on those who wage jihad a great reward above that of the sedentary, degrees of rank from him, and forgiveness and mercy. Allah is always forgiving, merciful.” (Qur’an 4:95-6)

Islamists do indeed try to subvert societies within and impose Sharia. They think it their religious duty, which also includes raping non-Muslim women and killing other infidels just because. Europe has some substantial experience with Mohamed Muslim.


Abdelmoneim isn’t kidding or throwing loose, figurative rhetoric about. He’s encouraging the violent overthrow of America and bloody Jihad. USC 1451 addresses revocation of naturalization and citizenship, but like many immigration laws, such as the law that prevents the admission of people who can’t provide for themselves, it’s little known and less enforced.

People like Abdelmoneim are arguably who Justice Jackson was talking about. Why do we allow people like him to stay in this country? For that matter, why are all manner of other violent Islamists and American useful idiots still here?

Letting them stay is the kind of suicidal empathy about which Jackson was speaking. Perhaps it’s time more Americans exercised their free speech right to encourage the invocation of USC 1451.

Mike McDaniel is a USAF veteran, classically trained musician, Japanese and European fencer, lifelong athlete, firearm instructor, retired police officer, and high school and college English teacher. He is a published author and blogger. His home blog is Stately McDaniel Manor. 

https://www.americanthinker.com/blog/2026/07/an-american-mullah-calls-for-jihad/

NATO's last stand?

 Critics may be misreading the recent NATO summit.  

It looks to them as if the U.S. is unilaterally siding with Europe against Russia.  

President Trump is smarter: he knows who has the winning hand, and his direct communications with his peers, Xi and Putin, are not always public. 

President Trump's earliest critical instincts toward the EU and NATO still hold. While the U.S. is currently extending them some diplomatic courtesy and limited support, Europe is ultimately surrounded on all sides by powers that make it irrelevant in global influence terms.  Europe has put itself into this predicament, due to its own domestic economic decline from bad policy choices.  It is using war as a way to revive its fortunes.  Its odds are long. 

The EU is surrounded economically by the U.S. to the west; by Russia and China to the east, by a vast Arctic territory to the north that it cannot control, and by India and a rising Middle East power, Israel, to the south. Europe has no strategic maneuvering room. It has limited prospects to reemerge as a serious power, and NATO is long past relevancy, and solvency.  

Since his first term, President Trump has been right about Russia, and NATO.  

Being “right” means understanding Russia’s long-term economic and trade importance, and appreciating its military prowess. Along with China and the U.S., it makes up the superpower triad. Being right also means he understands that the days are numbered for the EU and NATO, and that the world has changed without them.

After the Anchorage meeting with President Trump, President Putin invited his counterpart to Moscow: Trump's guarded reply was a reminder that productive relations may be welcome by both leaders, but each is also operating in and surrounded by a complex defense and foreign affairs tradition that doesn’t trust the other side.  Some have called this the “crucible of belief,” and past experience is hard to overcome. Change will happen slowly. 

Europe is part of that shared Eurasian landmass, and its security, but “Europe” is not a unified, single country.  Even within its own limited Western sphere, it has been a region constantly engaged in rivalry and war.  There was a period after Napoleon — roughly a hundred years — where relative peace was enjoyed.  But the 20th century has been just the opposite: a nearly unbroken chain of war — regional, revolutionary, world, and cold — and now, a new 21st century war is increasingly seen as inevitable.

There are many political, social, and institutional explanations, but economic decline is at the heart of why the EU is determined to provoke Russia (and why it is pleading before the U.S.).

If Germany, France and the U.K. were strongly led, however, with robust domestic industrial growth, controlled borders via immigration, and with less external energy dependence, if not facing domestic energy bankruptcy, such a conflict would not be necessary, or given any serious consideration. 

In recent history, one only has to review Angela Merkel’s disastrous “green energy” policy, deindustrialization, open borders, and the idling of German nuclear power, as a strong explanation.  She fell completely for naive progressive ideology which asserts that oil no longer matters.  

But for President Trump, the U.S. was going down the same path.

France and the U.K. are just as bad in their string of weak leaders, uncontrolled borders, domestic violence from cultures foreign to their own, and deindustrialization and outsourcing. It is little wonder that Europe’s “leaders” are now economically trapped, and are turning to war as a desperate form of economic recovery.

NATO’s putative head, Mark Rutte, was recently in the White House, pitching for war and U.S. financial backing, with slides and charts that looked more like a failed business recovery plan.  The old saying “be careful what you ask for” may be relevant, as NATO is functioning as a proxy for Western Europe, and looking to the U.S. as its pre-bankruptcy sponsor.  President Trump has seen this before.

There are obviously many other interests and players driving this strategy, but German-French-British decline may be the largest factor. Scandinavia is somewhat immune, especially Norway with its natural resources and capital, but it is susceptible to European political and policy contamination. 

Economic historian Walt Rostow, a White House national security advisor to U.S. presidents Eisenhower, Kennedy and Johnson, provided a powerful economic model that goes a long way to partly explain why Eurasia, and Europe, have always been unstable and in conflict.  His “The Stages of Economic Growth: A Non-Communist Manifesto,” maps how countries grow in relative stages of maturity.

But it also predicts how countries will turn to war when those stages are challenged, interrupted, or allowed through poor leadership, or state interference, to stagnate or backslide. Europe has slid backwards from an advanced industrial and colonial power, to an effective open border welfare state, led by a weak political class with no plans, ideas, commitment, or national loyalties.

Russia’s Kremlin has recently announced that its Special Military Operation in Ukraine has been converted to formal war.  While predicting its development is problematic, Russia's power advantage is so overwhelming that NATO can only been seen as engaging in effective suicide.  Given Europe’s cultural tendency to existentialist gloom, perhaps it is understandable.

When war finally stops, as it must, it usually results in new borders, relationships, alliances, and deals being formed.  NATO and Europe seem to be counting on the chaos of war as a path out of their own weakness.

The U.S. may lend some technical military support to them as a simple matter of arms sales, but this may be their own self-inflicted, poisoned chalice. 

And in the end, the U.S., Russia, and China will simply resume their global dominance and power alliance. The EU will likely collapse or shrink; NATO will finally be decommissioned, and the old Atlantic Alliance will bypass Europe and align economically with Eurasia’s east and south — because that is where the power is.  

That is what the stages of growth predict.

The EU is also going to be further eclipsed commercially and militarily and by a rising Israel-dominated Middle East, because they know what they want, they have a plan, and they know how to fight.  European bureaucrats like Rutte, Macron, Merz, and von der Leyen do not, and face an interesting fate when they finally realize that this battle is likely their last political stand.

The citizens of Europe may be relieved. 

Matthew G. Andersson is a former aerospace CEO and law and policy author.  He has worked in Russia and Europe on commercial joint ventures and regulatory policy, and has testified before the US Senate. He is a graduate of the University of Chicago and University of Texas at Austin where he worked with economist and White House national security advisor W.W. Rostow at the LBJ School of Public Affairs.

https://www.americanthinker.com/blog/2026/07/nato-s-last-stand/

Obstructive Sleep Apnea pharma Apnimed files for a $100 million IPO

 Apnimed, a late-stage pharma developing oral therapies for sleep-related breathing diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Apnimed's sole clinical candidate, AD109 (Oxnimbi), is a fixed-dose, anti-apneic neuromuscular modulator that combines a novel anti-muscarinic and a selective norepinephrine reuptake inhibitor for the treatment of obstructive sleep apnea. It is designed to improve upper airway muscle activity and prevent airway collapse during sleep. Oxnimbi was most recently studied in 1,300 patients across multiple Phase 3 trials, and the company has since submitted an NDA in April 2026.

The Cambridge, MA-based company was founded in 2017 and booked $120 million in revenue for the 12 months ended March 31, 2026. It plans to list on the Nasdaq under the symbol APMD. Apnimed filed confidentially on July 1, 2024. BofA Securities, Evercore ISI, and Cantor Fitzgerald are the joint bookrunners on the deal. No pricing terms were disclosed.