Chinese Communist Officials Call Harvard Their "Party School"

 The Trump Administration's latest effort to reduce foreign influence in US institutions has led to Harvard University, the oldest university in the country.  It's a fair target considering Harvard's enrollment is nearly 30% foreign nationals, many of them from China.  A common criticism of the US is that American schools produce a limited number of graduates in STEM and leadership related fields, inspiring the claim that the US "needs skilled foreign workers" to continue its edge in business and technology. 

This is a fallacy - It's not that the US doesn't have enough students interested in STEM or leadership.  Rather, the problem is that top US universities have been bought and paid for by NGOs and foreign investors; by extension, they allow foreign students to steal spots that should be reserved for American citizens.  

Furthermore, Harvard is widely considered a stepping stone to a successful career in various areas of law and government, but many positions within the school's political enrollment are taken by foreigners (as well a DEI students).

One blaring example of this is the influence of China and the CCP over Harvard, which enrolls around 2300 Chinese scholar per year making up around 20% of the total international student body. 

Harvard receives hundreds of millions of dollars in foreign funding from numerous countries, but China is the most generous source, providing around $70 million per year to the Ivy League college.  

In a recent expose, The Wall Street Journal examined the CCP's extensive presence at Harvard and their view of the university as their "party school".  As the WSJ notes:

"Harvard enjoys a sterling reputation among Chinese officials thanks to its record in training high-flying bureaucrats who went on to take senior government roles and, in some cases, join the party’s elite Politburo. Some observers dubbed Harvard a de facto “party school,” as the party’s own training academies for promising bureaucrats are known. 

“If we were to rank the Chinese Communist Party’s ‘overseas party schools,’ the one deserving top spot has to be Harvard University’s Kennedy School of Government in the U.S.,” said a 2014 commentary published by Shanghai Observer, an online platform run by the city’s main party newspaper."

The problem, however, goes well beyond the issue of foreign nationals taking American seats in American schools.  The CCP is notorious for using US universities as a training ground for CCP spies, not to mention using them as vehicles for the dissemination of communist propaganda.

Stanford recently addressed the threat within their own halls, noting the exposure of a Chinese spy operating under the alias "Charles Chen" who posed as a student and attempted to glean information from other students and possibly recruit them for CCP operations.  These operations extend to Chinese nationals studying abroad, as The Stanford Review states:

"Transnational repression, $64 million in Chinese funding, and allegations of racial profiling have contributed to a pervasive culture of silence at Stanford and beyond. 

It is this pervasive silence that has compelled us to write. After interviewing multiple anonymous Stanford faculty, students, and China experts, we can confirm that the CCP is orchestrating a widespread intelligence-gathering campaign at Stanford. In short, there are Chinese spies at Stanford..."

Chinese communist propaganda operations in colleges started with the proliferation of the "Confucious Institute" in 2004.  The program latched onto dozens of US schools like a parasitic organism, posing as an effort to foster understanding of Chinese culture.  In reality, it was designed to influence US education to favor CCP ideals, recruit American students to CCP causes and keep an eye on the activities of Chinese students abroad. 

Harvard was, of course, one of those schools.  After the exposure of Confucious Institute and its motives, the CCP shifted into different programs with different names but the same overall goals.  As mentioned, the amount of cash flowing from China into these colleges is extensive, which creates incentives for schools like Harvard to keep their eyes down and their mouth shut. 

Donald Trump placing Harvard under a microscope helps to illuminate the wider problem across all of America's top universities.  It's common to point out the influence of NGOs and woke activism in undermining higher education in the US, but what about foreign interests?  This danger is far less understood. 

Trump's freeze on more than $3 billion in research grants and his actions to ban foreign enrollment at Harvard for Chinese communist party members are an opening salvo in a war that is long overdue.  The fact of the matter is, US colleges have not served the American public in a very long time.  Rather, they have served foreign masters and globalist NGOs, indoctrinating America's youth with deconstruction cultism and communist ideology that poisons the academic nest. 

Drastic measures would have to be taken if the damage is ever to be reversed. 

https://www.zerohedge.com/geopolitical/chinese-communist-officials-call-harvard-their-party-school

New FDA Guidelines Raise the Bar on Nitrosamine Testing for Pharma Industry

 

Here’s how companies can ensure they’re in compliance with new requirements that go into effect in August.

Nitrosamine contamination has become one of the most pressing issues facing the pharmaceutical industry today. In the past few years, these potentially cancer-causing substances have grabbed the public’s attention and become a major focus of regulators, prompting the adoption of rigorous new FDA guidelines that will go into effect this summer.

Since 2018, the FDA has issued more than 500 recalls because of unacceptable levels of nitrosamines in active pharmaceutical ingredients (APIs). As executive director of analytical at SK Pharmteco, I work with pharmaceutical clients to provide comprehensive testing services for a broad range of compounds, including impurities such as nitrosamines. Based on what we’re seeing, it’s clear that the spotlight on nitrosamines will only get brighter with manufacturers having to meet new FDA guidelines for these compounds by August.

The new FDA guidelines, issued last year, are both comprehensive and complex. They cover more than 250 nitrosamine compounds and apply to every drug on the market or in development. These guidelines require detecting minute levels—down to the parts per billion—with limits that vary depending on the specific nitrosamine.

The stakes are high for getting it right. Noncompliance triggers an FDA Class II recall, which means drugs have to be immediately pulled from shelves. The FDA will not approve new drugs unless they meet the guidelines. Compliance may necessitate reformulation of products with different excipients and inputs. Additionally, it could require redesigning production processes, as nitrosamines can form through chemical reactions between precursors that are otherwise not hazardous on their own. In light of these stakes, pharma executives must ensure they have a robust testing program in place now and are proactively addressing any issues with noncompliant nitrosamine levels.

A Fast-Developing Issue

Nitrosamines can be found in a wide range of products, from foods and beverages to cosmetics and pharmaceuticals. These compounds are created when amines react with nitrosating agents such as nitrous acid, nitrogen oxides and nitrites.

Nitrosamines were observed by chemists in the late 1800s, but the dangers were not understood at the time. In the 1970s, William Lijinsky, laboratory director at the National Cancer Institute’s Frederick Cancer Research and Development Facility, became a leading voice in raising concerns about their link to cancer. Initial concerns focused on tobacco products and foods, such as processed meats, where smoking or curing can introduce nitrites to trigger the chemical reaction.

In the following decades, concerns grew as more studies indicated a link between different nitrosamines and cancer. Studies also showed that even small amounts of nitrosamines could be dangerous, leading regulators and experts to place greater scrutiny on their presence in products such as pharmaceuticals.

In 2018, the FDA began an investigation into nitrosamine impurities in drugs that led to high-profile recalls for heartburn medicines. In 2020, the FDA issued its first guidance on the compounds, making nitrosamines an issue for the entire pharmaceutical industry for the first time.

The FDA’s actions corresponded with increasing public concern about potential carcinogens in everything from food to toys and even water. While deaths from cancer have declined in the U.S., the number of new cases continues to climb each year, according to the American Cancer Society.

The existence of nitrosamines in prescription drugs is particularly troubling because the medications are intended to treat illnesses, not cause them. They’re also intended to be taken on a regular basis. The FDA’s rapid and comprehensive response to the nitrosamine issue signals that it has taken a place among the agency’s top priorities in protecting the public.

SK Pharmteco has seen pharma’s quick response to this change. Since the FDA first issued guidelines in 2020, our services for nitrosamine testing have grown more than eight-fold, making them one of the top three areas for our analytical business unit.

A Matrix of Compliance

The scope of FDA’s 2020 guidance was limited to six previously observed nitrosamines and nonspecific guidance for other potential nitrosamines. The agency’s guidelines for nitrosamines will take a significant step forward in August, creating an even greater need for robust testing.

The new guidance includes specific assessment for any potential Nitrosamine Drug Substance Impurities (NDRSIs). These substances could be contained in anything in the drug or used in production of the drug—the APIs, intermediates, solvents or inactive ingredients. Even if each of the inputs are clear by themselves, NDRSIs can be created when the inputs are combined, so an assessment is needed for every drug marketed in the U.S.

Because each nitrosamine has a different potential effect, the FDA uses a potency categorization system depending on the particular impurity and the dose for the drug. The result is a complex matrix for testing to ensure compliance across hundreds of potentially cancer-causing substances with countless pathways to creating those substances.

Technical Challenges in Testing

This matrix has raised the bar on testing and compliance for the pharma industry. For other impurities, testing is usually focused on a smaller set of substances and concentrations in the parts per million. Under the new FDA guidelines, the acceptable limits for certain nitrosamines in some drugs could be as low as one part per billion.

Detecting a substance at these minute levels requires the most advanced liquid, gas and high-resolution mass spectrometers. It also requires experts in testing to read the results and develop testing platforms. To detect all possible forms of nitrosamines, lab professionals often have to create tailored testing platforms that can detect multiple impurities, each with its own acceptable level. In working with clients, SK Pharmteco has created more than 100 different platforms for testing.

Robust testing can be complex and time-consuming, but the payoff is worth it. Aside from avoiding the consequences associated with noncompliance, companies can benefit from positive aspects of thorough testing. I.e., companies can typically justify skipping lot testing by reaching 30% of acceptable limits and typically justify no routine testing by reaching 10% of acceptable limits.

A Looming Deadline

If they haven’t already, pharma companies should take action now to implement a robust testing program. Testing typically takes six weeks from developing and validating the appropriate testing platform to providing results. With the August deadline approaching, many labs already have testing backlogs.

Pharma executives should also be developing a long-term strategy for nitrosamine testing and compliance. The FDA’s list of regulated nitrosamines will continue to grow, and the public’s concern over this issue is likely to continue to increase as well. The American Cancer Society estimated the U.S. had a record 2 million new cases of cancer last year.

Every drug company operating in the U.S. will need to create a flexible, robust and sophisticated plan that can continue to evolve. Compliance with the new guidelines in August should be viewed as a starting point for addressing the ongoing challenge of nitrosamine contamination.

https://www.biospace.com/fda/opinion-new-fda-guidelines-raise-the-bar-on-nitrosamine-testing-for-pharma-industry

FDA Action Alert: Merck, Moderna, Gilead, Regeneron/Sanofi and More

 

Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir.

Despite some high-profile recent delays, work continues for the FDA, which is due in the next two weeks to release important decisions on a handful of drug applications, including one for a rare genetic disease and two for RSV immunization.

Read below for more.

Merck Steps Up to RSV Starting Line With Clesrovimab

Merck is proposing its long-acting antibody clesrovimab to induce immunity against respiratory syncytial virus (RSV) infection in infants. The FDA is reviewing Merck’s application and is expected to release its decision by June 10.

Clesrovimab is backed by data from the Phase IIb/III CLEVER study, a pivotal, double-blind and placebo-controlled study that enrolled more than 3,600 infants up to 1 year of age who were entering their first RSV season. Results published in October 2024 showed that a single dose of clesrovimab could cut RSV-associated medically attended lower respiratory infection by 60.4% at 150 days versus placebo.

At this same time point, clesrovimab lowered RSV-associated hospitalizations by 84.2% and hospitalizations linked to lower respiratory infections in RSV by 90.9%.

If approved, clesrovimab will go toe-to-toe with Sanofi and AstraZeneca’s Beyfortus, likewise a monoclonal antibody that can prevent RSV infection in infants up to 24 months of age. Beyfortus has a nearly 2-year head-start—it won the FDA’s approval in July 2023—and a wealth of evidence that Merck will need to surmount. In March 2024, for instance, data from the U.S. Centers for Disease Control and Prevention showed that Beyfortus was 90% effective against RSV hospitalizations.

Moderna Seeks Broader Adult Label for RSV Vaccine

Also awaiting an RSV verdict is Moderna, which is trying to expand its RSV vaccine mRESVIA into high-risk adults aged 18 to 59 years. As per the company’s fourth-quarter and full-year 2024 business report, the FDA’s target decision date is June 12.

The FDA first cleared mRESVIA in May 2024, allowing its use in older adults aged 60 and up. By then, however, Moderna’s vaccine already had two powerhouse competitors in GSK’s Arexvy and Pfizer’s Abrysvo, both of which were given regulatory clearance in mid-2023—nearly a year ahead of mRESVIA—in the same target population. The head start has given both vaccines enough time to expand beyond seniors: Pfizer pushed Abrysvo into adults 18 through 59 years in October 2024, while GSK secured approval for at-risk people aged 50 through 59 in June of last year.

Just weeks after Arexvy’s expanded approval by the FDA, however, the CDC dealt the RSV space a blow, narrowing its vaccination guidelines to cover only seniors aged 75 and up, and those 60 through 74 years who are at risk of contracting severe disease.

Data backing mRESVIA’s expansion, presented during Moderna’s R&D day in September 2024, showed that the vaccine was safe and well-tolerated in this at-risk younger population and could match its immunogenicity profile in its currently approved population.

UroGen’s Bladder Cancer Drug Nears Decision Date After Losing AdComm Vote

By June 13, the FDA is expected to release its verdict on UroGen’s investigational cancer drug UGN-102, which the biotech is proposing for the treatment of low-grade, intermediate-risk non–muscle invasive bladder cancer.

UroGen is backing its approval bid with data from the Phase III ENVISION trial, a readout from which in December 2024 demonstrated “promising” long-term outcomes, according to the biotech. At three months, 76.9% of patients achieved a complete response. Duration of response at 12 months was 82.3% among complete responders.

Despite this encouraging profile, the FDA’s Oncologic Drugs Advisory Committee last month voted against recommending the approval of UGN-102. According to reporting from OncLive at the time, the panel was narrowly divided, with the vote ultimately coming in at 5–4 against UroGen. Among the issues cited by the outside experts were the lack of a completely randomized trial and the short follow-up.

KalVista Oral Angioedema Drug Awaits FDA Response

Massachusetts biotech KalVista is developing its oral plasma kallikrein inhibitor sebetralstat for the on-demand treatment of hereditary angioedema (HAE) in patients aged 12 and up. The FDA is currently reviewing the drug application and is set to release a decision on June 17.

Afflicting one in every 50,000 people, HAE is a rare genetic disorder characterized by frequent, painful and often debilitating tissue swelling across the body, which can become life-threatening in certain cases. The disease is caused by a deficiency or dysfunction in the C1 esterase inhibitor protein, which normally helps keep the kallikrein-kinin pathway in check. The kallikrein-kinin system, in turn, helps maintain healthy blood pressure, renal function and immunity.

Sebetralstat works by inhibiting kallikrein, assuming the role of the deficient C1 esterase inhibitor. KalVista is backing sebetralstat’s FDA bid with data from the Phase III KONFIDENT trial, which showed that both 300-mg and 600-mg doses of the drug achieved symptom relief significantly faster than placebo. Sebetralstat was also safe and well-tolerated, with an adverse event profile similar to that of placebo.

If approved, sebetralstat will become the first oral and on-demand HAE drug to lower the incidence of attacks in adult and pediatric patients 12 and above, according to a September 2024 release from KalVista.

Gilead Prepares for Twice-Yearly PrEP Approval

Arguably the most highly anticipated regulatory action on this list is the FDA’s decision for Gilead’s twice-yearly lenacapavir injection for pre-exposure prophylaxis (PrEP) for HIV. The FDA is scheduled to release its decision on June 19.

Anticipating an approval, Gilead has been preparing to launch the product, engaging in what Chief Commercial Officer Johanna Mercier called “market development initiatives” on an investor call in April. “We are absolutely ready for the launch,” she said, noting that partly because of Gilead’s efforts, the U.S. PrEP market has grown 16% year-on-year.

Writing to investors on Feb. 12, Jefferies analysts noted that the HIV community appeared to be “educated” and prepared for lenacapavir, with some observers “already seeing increases in HIV doc appointments scheduling” ahead of approval.

Gilead is backing lenacapavir’s application with data from the Phase III PURPOSE 1 and PURPOSE 2 studies. PURPOSE 1, which focused on cisgender women, demonstrated a 100% efficacy rate for preventing HIV infection. PURPOSE 2, meanwhile, enrolled a more diverse population of cisgender men, transgender men, transgender women and nonbinary individuals who have sex with partners assigned male at birth. Results showed that twice-yearly lenacapavir cut HIV incidence by 96%.

Sanofi, Regeneron Eye Expansion of Dupixent Into Bullous Pemphigoid

Sanofi and Regeneron are looking to add another indication to the label of their blockbuster biologic Dupixent, this time seeking approval in bullous pemphigoid. Their application is currently undergoing regulatory review, with a decision set for June 20.

Pivotal data backing the application showed that five times more patients on Dupixent achieved sustained disease remission versus placebo, being able to taper oral corticosteroids by week 16 and stay off such medication for at least 20 weeks. Dupixent likewise significantly improved disease severity and itch in patients with moderate-to-severe bullous pemphigoid.

If approved, Dupixent will become the first targeted therapy for bullous pemphigoid in the U.S., as per a February news release from Sanofi.

An approval would also continue Dupixent’s regulatory winning streak after the subcutaneous injection in September 2024 won clearance for chronic obstructive pulmonary disease—likewise making it the first biologic for this disease.

https://www.biospace.com/fda/fda-action-alert-merck-moderna-gilead-regeneron-sanofi-and-more

'CrowdStrike and Microsoft Collaborate to Harmonize Cyber Threat Attribution'

 

• CrowdStrike (CRWD, Financial) and Microsoft collaborate to unify adversary attribution in cybersecurity.
• The partnership simplifies threat actor identification across diverse vendor platforms.
• More than 80 adversaries have been deconflicted through this joint effort.

CrowdStrike (CRWD) and Microsoft have announced a significant collaboration aimed at harmonizing the attribution of cyber threat actors across security vendors. This initiative seeks to reduce the confusion caused by divergent naming systems, thereby accelerating threat response and fortifying global cyber defense.

The cybersecurity landscape is characterized by its complexity, amplified by multiple naming conventions for threat actors that provide essential context about potential adversaries. With the development of a shared mapping system likened to a 'Rosetta Stone' for cyber threat intelligence, CrowdStrike and Microsoft aim to streamline the identification of adversaries such as COZY BEAR and Midnight Blizzard, resulting in faster and more coordinated responses.

The collaboration has already seen success, with over 80 adversaries deconflicted, including the confirmation that Microsoft's Volt Typhoon and CrowdStrike's VANGUARD PANDA are both linked to Chinese state-sponsored activities. Moreover, Secret Blizzard and VENOMOUS BEAR have been confirmed as the same Russia-nexus adversary, highlighting the real-world benefits of this partnership.

CrowdStrike's leadership in adversary intelligence, combined with Microsoft's vast data sources on adversary behavior, positions both companies to deliver enhanced clarity, speed, and confidence to global defenders. This initiative invites other partners to join and sustain a shared threat actor mapping resource, epitomizing the collaborative spirit necessary in cybersecurity.

As cyber threats evolve in an increasingly AI-driven era, this partnership underscores the critical need for collective action in security. Microsoft's Corporate Vice President, Vasu Jakkal, emphasizes the importance of this collaboration in achieving actionable threat intelligence, a testament to the idea that "security is a team sport".

https://www.gurufocus.com/news/2902356/crowdstrike-and-microsoft-collaborate-to-harmonize-cyber-threat-attribution-crwd-stock-news

Jazz Ziihera Achieves Over 3 Years Median Overall Survival in Gastroesophageal Cancer

 Phase 2 trial results continue to show clinically meaningful efficacy and durable responses, including 36.5-month median overall survival after four years of follow-up, with a manageable safety profile

Findings presented today at ASCO 2025 and concurrently published in The Lancet Oncology

https://finance.yahoo.com/news/jazz-pharmaceuticals-reports-clinically-meaningful-163500150.html

Amgen's Imdelltra Shows Lower Risk of Death, Other Benefits in Phase 3 Trial

 Amgen said interim results from a Phase 3 trial showed Imdelltra reduced the risk of death and other benefits for patients with small cell lung cancer.

The biotechnology company said the trial showed the risk of death was reduced by 40% and the median overall survival was extended by more than five months, compared with standard-of-care chemotherapy in patients with small cell lung cancer who progressed on or after one line of platinum-based chemotherapy.

At the planned interim analysis, the Phase 3 DeLLphi-304 trial met its primary OS endpoint and key secondary progression-free survival endpoint, Amgen said.

Small cell lung cancer comprises about 15% of the more than 2.4 million patients diagnosed with lung cancer each year, according to Amgen.

https://www.morningstar.com/news/dow-jones/202506024331/amgens-imdelltra-shows-lower-risk-of-death-other-benefits-in-phase-3-trial

Trump administration proposal would lift Biden-era limits on Alaska oil drilling

 The Trump administration is moving to repeal Biden-era curbs blocking oil drilling across most of the mammoth petroleum reserve in Alaska that is home to an estimated 8.7 billion barrels of recoverable oil.

Interior Secretary Doug Burgum announced the planned policy shift late on June 1 at a townhall meeting in Utqiagvik, a village on the Chukchi Sea coast, as he and fellow members of President Donald Trump’s Cabinet visit Alaska to promote energy development in the region.

The measure would open up new opportunities for oil and gas development in the 9.3 million ha National Petroleum Reserve-Alaska (NPR-A), an Indiana-size parcel in the north-west of the state that was set aside as a source of energy for the navy a century ago.

The action responds to a directive that Mr Trump issued after his inauguration in January, when he signed an executive order compelling a host of policy changes meant to expand oil, natural gas and mineral development in Alaska.

The reserve holds an estimated 8.7 billion barrels of recoverable oil, according to a 2017 assessment by the US Geological Survey.

And its production is set to skyrocket, with the development of recent discoveries. Alaska has forecast that crude production from the reserve will climb to 139,600 barrels per day in fiscal year 2033, up from 15,800 barrels per day in fiscal year 2023.

Mr Trump’s measure would repeal a 2024 rule imposed under then President Joe Biden, who designated 5.25 million ha of the reserve as “special areas”, limiting future oil and gas leasing, while maintaining leasing prohibitions on 4.3 million ha of the NPR-A.

The rule has complicated future oil drilling and production in the reserve, where companies including ConocoPhillips, Santos, Repsol and Armstrong Oil & Gas have been active. ConocoPhillips is developing its 600-million-barrel Willow project in the refuge, and is expected to start producing commercial volumes of crude oil there in 2029.

Mr Burgum’s announcement was greeted with applause inside a heritage centre in Utqiagvik, where local residents had gathered to speak with officials from the Trump administration, as well as Senator Dan Sullivan and Alaska Governor Mike Dunleavy, about resource development.

Mr Burgum, who leads the National Energy Dominance Council, was joined by the panel’s vice-chairman, Energy Secretary Chris Wright, and Environmental Protection Agency administrator Lee Zeldin.

Mr Wright said he anticipated increased oil development in Alaska – possibly quadrupling oil output on its prolific North Slope – and decried years of policies he said were “smothering” the region’s potential.

Mr Rex Rock Sr, head of the Arctic Slope Regional Corporation, one of 13 Alaska native regional corporations created under federal law, said that the 2024 rule restricting energy development in the far north did not have the backing of the region.

Environmentalists had argued that Mr Biden’s rule was essential to protect a large stretch of unspoiled land in the Arctic, a vast region of tundra and wetlands that teems with wildlife. And, they insisted, in a warming world, there is insufficient justification for burning the large cache of oil the reserve contains.

The new proposal will give the public 60 days to comment, setting the stage for a potentially rapid reversal and new leasing in the reserve.

Conservationists who cheered the original protections could seek to challenge the pivot in federal court

https://www.straitstimes.com/world/united-states/trump-moves-to-lift-biden-era-curbs-on-arctic-oil-drilling