AstraZeneca, Daiichi Sankyo's Enhertu rings up success in another breast cancer trial

 Less than three weeks after AstraZeneca and Daiichi Sankyo reported positive results for oncology powerhouse Enhertu in a first-line breast cancer trial, the companies have scored again in another phase 3 breast cancer study.

The Destiny-Breast11 trial has shown that Enhertu followed by the chemotherapy pacliotaxel, and targeted cancer drugs Herceptin and Perjeta (THP) provides a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) versus standard of care (SOC) when used before surgery in patients with high-risk, locally advanced HER2-positive early-stage breast cancer.

SOC in this indication includes chemotherapies doxorubicin and cyclophosphamide, followed by the THP regimen.

The companies explained that pCR is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment. This is the first phase 3 trial of Enhertu to show its benefit in early breast cancer.

“Enhertu is already an important treatment option in the metastatic setting and these data have the potential to allow this medicine to move into early stages of disease where cure is possible,” Susan Galbraith, who heads up oncology hematology R&D for AZ, said.

The companies said they will share the data with regulatory authorities and present them at a future medical conference.

While data for the secondary endpoint of event-free survival (EFS) was not mature, it did show an early trend favoring the Enhertu arm. Investigators will continue to follow EFS in the study, the companies said. 

Roughly one in three patients with early-stage breast cancer are considered high risk, as they are more likely to experience disease recurrence and have a poor prognosis, the companies said. Achieving pCR in early-stage HER2-positive breast cancer is associated with improved long-term outcomes.

“There are still many patients with early-stage breast cancer who do not achieve a pathologic complete response with treatment in the neoadjuvant setting, increasing the risk of disease recurrence,” Ken Takeshita, Daiichi’s R&D chief, said in a release, adding that the results “could offer patients with HER2-positive breast cancer a promising new treatment approach prior to surgery.”

In the trial, the Enhertu group showed an improved safety profile versus SOC. The safety data remained consistent with previous profile data for Enhertu and the THP treatments.

The announcement comes after the companies reported successful results from the Destiny-Breast09 trial in which Enhertu and Roche’s Perjeta topped THP in delaying tumor progression or death in patients with newly diagnosed HER2-positive metastatic breast cancer. Backed by the data, AZ and Daiichi are preparing submissions for Enhertu as a first-line treatment in the indication.

Enhertu also is under investigation in several other ongoing breast cancer trials, including the Destiny-Breast05, which is evaluating the treatment in the high-risk adjuvant early HER2-positive setting.

The antibody drug conjugate (ADC) was first approved in 2019 for third-line use in patients with HER2-positive unresectable or metastatic breast cancer. The companies have tacked on six FDA label expansions since, including a January endorsement for patients with HER2-low or HER2-ultralow metastatic breast cancer.

Enhertu logged sales of $3.75 billion in Daiichi’s 2024 fiscal year, which concluded at the end of March. The company is projecting sales of the treatment to reach 662 billion Japanese yen in this fiscal year ($4.6 billion).

https://www.fiercepharma.com/pharma/astrazeneca-daiichi-sankyos-enhertu-rings-success-another-breast-cancer-trial

Gilead Sciences (GILD) U.S. Investment to Create $43B in Value to U.S. Economy

 Gilead Sciences is committed to advancing world-class science and driving innovation — with the United States at the heart of our operations. Today, our U.S. R&D and manufacturing footprint is our largest globally. Our U.S. R&D and manufacturing investments in the U.S. will create $43 billion in value to the U.S. economy over the next five years through direct capital investment and job creation. This comprehensive investment further bolsters Gilead’s domestic research, development, and manufacturing capabilities while advancing the company’s mission to discover and develop life-changing medicines.

Details of the overall investment include a newly announced $11 billion in capital and operational investments in the U.S. to supplement an already planned spend of $21 billion in U.S. manufacturing and R&D through 2030. Together, this is estimated to generate an additional $11 billion in U.S. economic impact.

This next phase of investment will support the building three new, state-of-the-art facilities, upgrading three existing sites to expand U.S. manufacturing and R&D capabilities, and investing in new technology and advanced engineering initiatives. Moreover, the additional $11 billion will cover:

$4 billion allocated to capital projects, including labs and equipment.
$5 billion dedicated to technology, operations, and R&D site activities.
$2 billion invested in digital and advanced engineering initiatives
Creation of approximately 800 new direct jobs and support more than 2,200 indirect jobs by 2028.

These current investments further build on Gilead’s strong history of U.S. investment with $15 billion over the last 10 years and reinforces the company’s role as a key contributor to the U.S. biopharmaceutical industry and a vital partner in driving scientific innovation and solutions for our patients.

https://www.streetinsider.com/Corporate+News/Gilead+Sciences+%28GILD%29+U.S.+Investment+to+Create+%2443B+in+Value+to+U.S.+Economy/24756970.html

Rhythm Pharma Outlook, Guidance

 Rhythm Pharmaceuticals is preparing for a Q3 filing for cetmelanotide in acquired hypothalamic obesity (HO), following positive Phase III trial results. The company anticipates non-GAAP operating expenses between $285 million and $315 million. Future guidance projects continued growth, with revenue forecasts reaching $183.41 million for FY2025 and $290.95 million for FY2026.

https://www.investing.com/news/transcripts/earnings-call-transcript-rhythm-pharmaceuticals-misses-q1-2025-eps-estimates-93CH-4028743

Watch Live: Fed Chair Powell Explains Why It's Different Now Vs September

 With no actions taken and no SEP to discuss (although the statement clearly hints at stagflationary uncertainty), all eyes (and ears) are now focused on every word that Powell says for hints about whether prices (inflation) or jobs (growth) are more of a worry (both are lower recently)...

.. and why he cut rates before the election when financial conditions briefly tightened but refuses to do so now...

Oh and if he mentions, 'soft' vs 'hard' data, it seems that weakness in the soft data mattered last September...

So let's see how Powell explains why it's different this time:

• Sept 2024: weak soft data, tight financial conditions, August market crash, cut rates by 50bps

• May 2025: weak soft data, tight financial conditions, April market crash, pause

Oh and don't forget that Beijing just slashed rates and flooded the zone with liquidity...

China's central bank cuts key rates, injects 1 trillion yuan 3 hours after agreeing to trade talks to prop up economy and give communist party ammo for negotiations.

Tomorrow the Fed will do precisely none of that.

— zerohedge (@zerohedge) May 7, 2025

Watch the full press conference here (due to start at 1430ET):

https://www.zerohedge.com/markets/watch-live-fed-chair-powell-explains-why-its-different-now-vs-september

Satellite Images Uncover China's Buildup In Cuba, Triggering U.S. Spy Concerns

 China’s aggressive push into Cuba is sounding alarm bells, with fears of covert surveillance operations targeting the United States, a concerning new report from Center for Strategic and International Studies (CSIS) reveals. 

The worrying findings, drawn from open-source intelligence, expose a suspected circularly disposed antenna array (CDAA) at Cuba’s Bejucal signals intelligence site, just a stone’s throw from Havana, according to Fox News. The antenna could zero in on radio signals from 3,000 to 8,000 miles away—putting U.S. military bases and even Washington, D.C. within range, the news outlet noted.

"The CCP’s poisonous alliance with Cuba has posed significant threats to U.S. national security for decades," House Intellience Committee Chairman Rick Crawford (R-AK) told Fox News. "Their alleged involvement in signals intelligence hubs in Cuba is outward, unconcealed adversarial behavior against the U.S. The CCP’s actions are becoming increasingly more bold and thereby detrimental to Western Hemisphere security."

The report’s findings have sparked so much concern on Capitol Hill that Republicans are seeking a briefing from Homeland Security Secretary Noem.

"The PRC is positioning itself to systematically erode U.S. strategic advantages without ever firing a shot," read a letter written by Homeland Security Chairman Mark Green (R-TN) and a group of other lawmakers to Noem. "The geographic proximity of suspected PRC-linked facilities in Cuba to sensitive U.S. installations, including Naval Station Guantánamo Bay, Kennedy Space Center, Naval Submarine Base Kings Bay, and Cape Canaveral Space Force Station, may enable the PRC to monitor American detection and response capabilities, map electronic profiles of U.S. assets, and prepare the electromagnetic environment for potential future exploitation.”

"If left unchecked, the PRC’s activities in Cuba could establish a forward operating base for electronic warfare, enable intelligence collection, and influence operations that directly undermine U.S. national security interests," the lawmakers added.

In 2023, the Wall Street Journal reported that China and Cuba reached an agreement under which Beijing would pay Cuba several billion dollars to establish an electronic surveillance facility on Cuban territory, aimed at monitoring the United States.

"We are deeply disturbed by reports that Havana and Beijing are working together to target the United States and our people. The United States must respond to China's ongoing and brazen attacks on our nation's security," Sen. Mark Warner (D-VA) and then-Sen. Marco Rubio (R-FL) said in a joint statement at the time. We must be clear that it would be unacceptable for China to establish an intelligence facility within 100 miles of Florida and the United States, in an area also populated with key military installations and extensive maritime traffic."  

https://www.zerohedge.com/geopolitical/satellite-images-uncover-chinas-buildup-cuba-triggering-us-spy-concerns

Migrant gangs are taking advantage of New York’s weak juvenile-justice laws

The pint-sized Diablos of 42nd Street — Tren de Aragua’s JV squad — are Exhibit A in the case against progressive state and city policies that empower juvenile street gangs, and indeed encourage older gangbangers to recruit the kids.

Yes, Biden-era open-borders policies let TdA set up shop here, but New York’s own policies gave us the Dickensian “little devils.”

Migrant thugs aged 12 to 17 brutally attacked two NYPD cops who tried to stop a “wolf-pack-style” mugging in Times Square over the weekend; police have arrested five suspects so far, thanks significantly to the gang database that progressives want to eliminate. 

Allegedly led by a 12-year-old mastermind, the Little Devils robbery crew has more than 34 known members with over 240 arrests among them, per police.

By law, these tween and teen terrors must have their crimes adjudicated in Family Court, where judges are reluctant to remand even the worst offenders to juvenile detention. 

That near-immunity encourages adult gangbangers to do heavy underage recruiting, yet another perverse result of “reforms” like the Raise the Age law.

But the powers that be don’t want to hear it: Last year, Democrats ousted “progressive” Albany DA David Soares for blaming soaring youth gun violence on the state’s bungled criminal-justice reforms.

New Yorkers can at least hope to see career-criminal Tren gang-groomers deported, but “asylum seekers” are only part of the problem.

Teens and even tweens caught with loaded weapons, in violent attacks or in repeated crimes shouldn’t go to Family Court for little more than lectures; police and prosecutors must be able to treat them as the menaces they’ve become.

In a press conference Tuesday, Mayor Eric Adams pointedly asked city and state lawmakers, “Whose side are you on?”

Good question.

But will any of the candidates in the city’s Democratic mayoral primary stand with the mayor in demanding the Legislature stop siding with the criminal class?

https://nypost.com/2025/05/06/opinion/migrant-gangs-are-taking-advantage-of-new-yorks-weak-juvenile-justice-laws/

Washington Should Take Efficiency Seriously

 As someone who has represented the United States abroad, first as ambassador to Hungary and later as U.S. chief of protocol, I’ve seen how American leadership is measured not just by strength or ideals, but by functionality. Our allies watch how we govern ourselves. And too often, what they’ve seen in recent decades is an increasingly bloated federal government, mired in duplication, inefficiency, and bureaucratic inertia.

That’s why the work of the Department of Government Efficiency, or DOGE, deserves serious consideration. Led by Elon Musk, DOGE has taken on a task that most administrations have promised but failed to achieve: modernizing how our federal government operates. It has consolidated overlapping offices, canceled wasteful contracts, sold underutilized properties, and implemented data-driven reforms, all aimed at reducing cost, improving performance, and saving taxpayer money. 

Since it began in January, DOGE has either cut or reduced grants, leases, and contracts in over 176 departments or agencies. On its website the department reports saving $160 billion. For comparison, that’s more than the entire annual budget of the Department of Transportation. Even according to independent data and analysis, DOGE efforts have already generated billions in savings. This is not a theoretical exercise in reform. It is tangible, measurable, and aligned with what the American people have repeatedly said they want: a government that delivers more by doing less.

Polling backs this up. A February Harvard CAPS/Harris poll found that 72% of Americans support the existence of an agency focused solely on eliminating waste and inefficiency in government. A clear majority (60%) said they believe DOGE is helping to rein in unnecessary federal spending. That’s not a left-wing or right-wing perspective; that’s a mainstream one.

DOGE’s creation may have sparked controversy, particularly among those uncomfortable with Musk’s unconventional approach and public persona. But we shouldn’t allow style to eclipse substance. If government is functioning more effectively and at a lower cost to taxpayers, then we must look seriously at how those outcomes are being achieved, and what lessons can be responsibly applied more broadly.

Having served in federal roles that demand strict compliance with law, protocol, and tradition, I know firsthand that reform must operate within the boundaries of our values. Rule of law and adherence to institutional norms are non-negotiable. Yet so, too, is the need for honest appraisal: Much of our federal bureaucracy has become outdated, sprawling, and resistant to change. Streamlining is not an assault on government. It is, in fact, an affirmation of it – an attempt to make public institutions worthy of public trust.

Of course, DOGE’s approach is not without flaws. Musk himself has candidly admitted as much. Critics have questioned whether all reported savings are fully verified, and transparency around decision-making needs improvement. Oversight is not only appropriate – it’s essential. But the existence of imperfections should not be a pretext for dismissing a bold, productive effort to modernize government. We cannot let perfect be the enemy of progress.

It’s a time-honored tradition in Washington for good ideas to wither under partisan suspicion. But government reform should not be the property of any one party. For decades, both Republicans and Democrats have campaigned on promises to cut waste, modernize services, and rein in unnecessary spending. 

DOGE is doing what many in both parties have failed to do: take those promises seriously.

The real question is not whether DOGE is controversial – it is. The real question is whether it is effective. So far, the evidence suggests that it is. The challenge ahead is to preserve that momentum, institutionalize the best of what DOGE is doing, fix mistakes, and ensure it is guided by transparency, accountability, and legal rigor.

This moment presents a rare opportunity: the chance to reshape how government operates in a way that is more responsive to the people it serves. Instead of vilifying reformers, we should come together around a shared goal that transcends politics: building a government that works.

If DOGE continues to help us get there, it deserves not derision, but support.

Nancy Brinker served as U.S. ambassador to Hungary and as chief of protocol during the George W. Bush administration. She is the founder of the Susan G. Komen Race for the Cure and the Promise Fund.

https://www.realclearpolitics.com/articles/2025/05/07/washington_should_take_efficiency_seriously_152754.html