Category: 3. Business

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This week in oncology has been marked by significant regulatory advancements, the emergence of promising novel agents, and a continued focus on refining treatment strategies to enhance patient outcomes. From FDA approvals streamlining access to critical therapies to new breakthroughs in challenging malignancies, the field of cancer care continues to demonstrate remarkable progress.

FDA Approves Updated Labels on CAR T-Cell Therapies, Eliminating REMS

A pivotal development this week saw the FDA approve updated labels for chimeric antigen receptor (CAR) T-cell therapies, notably eliminating the Risk Evaluation and Mitigation Strategy (REMS) program requirements. This significant regulatory change aims to ease monitoring requirements and expand access for eligible patients, streamlining the delivery of these transformative therapies in oncology. The decision reflects a growing confidence in the safety profile of CAR T-cell therapies as real-world data accumulates, ultimately benefiting patients by reducing logistical burdens and potentially speeding up treatment initiation. Read more about this crucial update here.

Daraxonrasib Earns FDA Breakthrough Status in Pancreatic Cancer

In a promising stride against one of the most challenging cancers, daraxonrasib earned FDA breakthrough therapy designation for the treatment of metastatic pancreatic cancer with KRAS G12X mutations. This designation, granted to therapies that show substantial improvement over available options, highlights daraxonrasib’s potential to significantly impact survival rates in this specific patient population. The focus on KRAS mutations underscores the increasing success of precision oncology in targeting specific genetic drivers of cancer, offering renewed hope for patients battling this aggressive disease. Further details on this exciting breakthrough can be found here.

Oncologists’ Guide to the FDA Approval of Tafasitamab for Relapsed Follicular Lymphoma

Another key regulatory update this week was the FDA approval of tafasitamab (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for relapsed follicular lymphoma. This groundbreaking, chemotherapy-free treatment option represents a significant advancement for patients who have experienced relapse, offering a novel approach with potentially reduced toxicity. The approval of such combinations emphasizes the ongoing efforts to develop highly effective, yet less burdensome, regimens in hematologic malignancies, improving both efficacy and quality of life for patients. Dive deeper into this important approval for oncologists here.

Bladder-Sparing Approaches Gaining Ground in NMIBC

Beyond new drug approvals, this week also highlighted an evolving paradigm in bladder cancer management. This article explored innovative treatments for non–muscle-invasive bladder cancer (NMIBC) that prioritize bladder preservation. These emerging strategies, including novel therapies and refined active surveillance protocols, aim to improve outcomes while minimizing the need for radical surgical interventions. This shift reflects a patient-centric approach, focusing on maintaining organ function and quality of life whenever possible, without compromising oncologic efficacy. Read more about these strategies here.

TROP-2 Inhibitors Are Explored in Breast Cancer

Finally, the cutting edge of breast cancer research was a focal point, as our coverage detailed the exploration of TROP-2 inhibitors in breast cancer. This article, drawing insights from the 24th Annual International Congress on the Future of Breast Cancer® East, highlighted expert perspectives and groundbreaking research in this promising class of agents. TROP-2 inhibitors represent a significant area of investigation, showing potential to expand therapeutic options for various breast cancer subtypes. The continuous research and development in this space underscore the dynamic efforts to identify new targets and deliver more effective treatments for patients with breast cancer. Learn more here.

This past week has vividly illustrated the relentless pace of innovation in oncology. From accelerating access to established therapies to ushering in new breakthroughs for challenging diseases and refining treatment approaches, the commitment to improving patient lives remains at the forefront of cancer care.

Headquartered in Dubai, United Arab Emirates, DP World is one of the world’s largest container terminal operators, with 108,100 employees in 74 countries on six continents. The company also provides logistics solutions, maritime services and free trade zones.

DP World currently has a workforce of nearly 800 logistics and freight forwarding professionals in Mexico.

Donohoe said they are seeing demand for logistics services for both northbound and southbound freight between Mexico and the U.S. 

“We’re seeing strong and sustained demand from shippers for logistics services between Mexico and the U.S. — in both directions,” Donohoe said. “Cross-border freight volumes hit record highs in early 2025, with Mexico exports to the U.S. fueling a significant portion of that growth.”

Donohoe said manufacturers in Mexico across sectors such as automotive, electronics, and industrial goods have been ramping up exports to the U.S. in recent months

“This has led to a surge in need for cross-border freight forwarding, customs brokerage, and multimodal transport solutions,” Donohoe said. “This corridor … is experiencing long-term, structural growth as companies reconfigure supply chains around resilience, regionalization, and speed to market.”

As of Thursday, the SONAR Inbound Ocean TEUs Volume Index shows that import container bookings from China to Mexico (IOTI.CHNMEX) are up 26% since May 12, but down 16% compared to the same period in 2024.

SONAR’s Inbound Ocean TEUs Indices (IOTI) measure bookings of twenty-foot equivalent units on a 14-day rolling average based on departure date from the port of lading. They are representative of maritime shipping container demand and a leading indicator of surface transportation demand.

While it is nearly impossible to say definitively what is driving the container growth from China to Mexico, nearshoring trends can be seen across the Americas, Donohoe said.

“The Americas is one of our fastest-growing and high-priority regions,” Donohoe said.

In September, The Wall Street Journal reported that DP World was in talks with the Mexican government about establishing a large industrial complex in the country, including combining a port and industrial park to streamline cargo bound for the U.S.

While DP World does not operate any U.S. ports currently, the company has been investing in Canadian terminals and U.S. inland logistics businesses. 

Donohoe declined to specifically address whether DP World plans to invest in or operate a port in Mexico.

“Right now, we are very focused on strengthening our inland logistics capabilities in Mexico,” Donohoe said. “Our priorities include freight forwarding, contract logistics, warehousing, and multimodal transport solutions that serve the vital Mexico-U.S. trade corridor.”

In addition to opening a freight hub in Mexico City, DP World has been expanding its presence across Latin America and the Caribbean, particularly in the freight forwarding sector. 

Over the past two years, DP World has opened more than 35 freight forwarding offices across the Americas, with recent additions in Curitiba, Brazil, as well as Toronto.

In May, DP World announced plans for $760 million expansion of the Dominican Republic’s Port of Caucedo and its free trade zone.

“We recently signed a multi-million-dollar MOU with the Dominican Republic to expand cargo capacity and manufacturing operations at the Port of Caucedo and its adjacent special economic zone,” Donohoe said. “This investment will fill a critical demand from global businesses for alternative trade and manufacturing hubs to serve their major American markets.”

Aerospace manufacturer plans $120M expansion in Texas

Germany-based MTU Maintenance plans to invest $120 million to upgrade its 462,847-square-feet facility at Perot Field Fort Worth Alliance Airport in Fort Worth, Texas.

The expansion will create 1,200 direct jobs to the region and up to 2,000 indirect jobs in services, logistics and infrastructure, according to a news release.

MTU will be adding engine maintenance, repair and overhaul services for its clients CFM International and GE Aerospace at the facility. 

“These agreements will see MTU’s site in Fort Worth develop from an on-site service center to full disassembly, assembly and test facility,” the company stated. 

The facility will be renamed MTU Maintenance Fort Worth. Officials did not provide a timeline for the facility’s expansion.

MTU Maintenance operates a global network of service centers, including locations in Germany, Canada, Serbia, China, Brazil, Australia and the U.S. The company is a subsidiary of Munich-based MTU Aero Engines AG.

Third-party logistics provider plans warehouse near Houston

Houston-based Texas Logistic and Fulfillment Services LLC said it is taking over a former Amazon logistics warehouse in Sugar Land, Texas.

The 300,000-square-foot facility is being converted into one of the largest HVAC-enabled third-party logistics hubs in the Houston area, according to a news release.

“This expansion will unlock major service bottlenecks and support the fast-growing demand for climate-controlled logistics — especially for electronics and temperature-sensitive goods arriving through Port Houston. It also enables us to handle the increasing volume of lithium battery containers flowing into Texas,” Omri Shafran, CEO of Texas Logistic and Fulfillment, said in a statement.

Texas Logistic and Fulfillment Services provides warehousing, logistics and fulfillment services to customers such as Best Buy, CVS, Academy and Costco.

The Butterfly Prostatic Retraction device is currently under investigation in a prospective pivotal trial (NCT05341661) in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH).¹

In a recent interview with Urology Times®, Bilal I. Chughtai, MD, walked through the design and potential implications of the trial for clinical practice. Chughtai is the chief of urology at Plainview Hospital at Northwell Health in Syosset, New York.

The study has completed enrollment at 245 patients. To be eligible for enrollment, patients needed to be aged 50 years or older and have a prostate length between 25 mm to 45 mm, a prostate volume between 30 to 90 mL, and symptomatic BPH.

Those included in the study were randomly assigned 2:1 to receive the Butterfly device or a sham comparator. Patients in the sham arm are able to crossover to the treatment arm at 3 months.

The primary end points for the study include change in International Prostate Symptom Score at 3 months and 12 months. Primary completion of the trial is expected in December 2025.

During the discussion, Chughtai also touched on the potential impact of this device if approved, saying, “Once we have a device like this, I think we’re going to see a paradigm-shift. I think there’s going to be shift away from medications, which have been shown to have additional effects…These meds aren’t as safe as we thought.”

He added, “I think this is going to fill a niche where patients can get an option that is local, reversible, and get decent relief.”

REFERENCE

1. Butterfly pivotal study. ClinicalTrials.gov. Last updated January 15, 2025. Accessed July 6, 2025. https://clinicaltrials.gov/study/NCT05341661

After a new focused update was issued by the American Academy of Dermatology (AAD), adding to the guidelines for topical and systemic atopic dermatitis treatments in adults, Robert Sidbury, MD, MPH, spoke with HCPLive about the update and its relevance to clinicians and patients.^1,2

Sidbury is known for his role as a professor in the Department of Pediatrics at the University of Washington School of Medicine and as chief of the Division of Dermatology at Seattle Children’s Hospital. Sidbury’s multidisciplinary workgroup recently conducted a systematic review that resulted in this update by the AAD, with the investigators having implemented the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing evidence on recently approved drugs.²

“It had a lot to do with just how far down the road the studies [we evaluated] were,” Sidbury explained. “If you look at the National Eczema Association website, it is just a wonderful resource. It’s a patient advocacy group, but it is also a fabulous resource for providers, for journalists, for anyone interested in this space…You can go to a tab on their ‘Research’ page, which lists all of the clinical trials and their various stages of development, phase 1, phase 2, phase 3, and beyond. If you’re in phase 3 development, you’ve passed some significant hurdles, and though it does not mean you’ll be granted FDA approval, it is a significant distance down the road to having a drug you can prescribe.”

The decision to include this update, specifically regarding 4 newly US Food and Drug Administration (FDA)-approved treatments for atopic dermatitis, was the result of the level of research supporting each of their uses. The therapies were roflumilast cream 0.15%, tapinarof cream 1%, lebrikizumab, and nemolizumab (with topical therapy), with each being recommended by the AAD for physicians to integrate into clinical practice.

Sidbury noted that this update allows clinicians to have more options for patients who are prone to various side effects. Sidbury used the examples of dupilumab and Janus-Kinase (JAK) inhibitors to describe scenarios in which clinicians may be able to make informed decisions with more alternatives.

“Dupilumab, for instance, and other IL-13 category blockers, can have conjunctivitis or irritation of the eyes that is non-infectious. It’s an inflammatory conjunctivitis,” Sidbury said. “But if that patient before you, and you’re talking about various options, has a really bad history of conjunctivitis or other ocular disease, not an absolute contraindication to those medications…you’d want to review all of the options with that patient before choosing that one. Similarly, the JAK-inhibitors, another class of medication that is newer, have a boxed warning with various conditions and concerns that may always be important to discuss with patients, but may, given that particular patient’s history and comorbidities, make that class of medications either a good choice or not.”

To find out more about the AAD’s atopic dermatitis guideline changes, view the full interview video posted above.

The quotes in this summary were edited for the purposes of clarity.

Sidbury has reported serving on Pfizer’s advisory board, for which he receives honoraria; acting as an investigator for Brickell Biotech and Galderma USA, with support through grants and research funding; serving as a principal investigator for Regeneron, also receiving grant and research support; and working as a consultant for Galderma Global and Microes, with compensation provided or, in some cases, not received.

References

1. Smith T. 4 New Recommendations for Atopic Dermatitis Management, with Robert Sidbury, MD, MPH. HCPLive. July 3, 2025. Accessed July 7, 2025. https://www.hcplive.com/view/4-new-recommendations-atopic-dermatitis-management-robert-sidbury-md-mph.

2. Davis DMR, Frazer-Green L, Sidbury R, et al. Focused update: Guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. 2025 Jun 17:S0190-9622(25)02125-5. doi: 10.1016/j.jaad.2025.05.1386. Epub ahead of print. PMID: 40531067.

While it seems like the RTO battles have reached a plateau, with companies settling into a hybrid detente, Salmirs says the fight isn’t over; many CEOs are secretly hoping to add on another day to two of in-person work to employee schedules. That’s particularly true now that the labor market has shifted power away from workers, and back into the hands of bosses. 

“This return to office, it’s still happening, absolutely. I think with this economic climate, we’ll really see what companies are thinking,” Salmirs tells Fortune. 

But there are a few key changes that businesses are making to their offices as they try to lure workers back, says Salmirs. Many large companies are cutting headcount and streamline operations; as a result, they’re trading in more outdated buildings for smaller, higher-quality spaces in centralized locations as a way to attract workers. They’re also ditching their open-plan offices and adding more private spaces to make the space “more hospitable,” he says. And of course, bosses are making sure that the pantries are fully stocked with snacks.  

“They’re looking closely at pantries and what they’re serving, including the coffee, the snacks, all that good stuff,” he says. “It really matters to employees.”

Fortune sat down with Salmirs to discuss the future of office space and what workers can expect going forward.

Fortune: What kinds of trends are you seeing when it comes to RTO? 

Salmirs: There’s been this commercial real estate crisis, if you will, about people not coming to work, and what’s going to happen with office buildings. Predominantly Class A buildings have been really resilient. As people are coming back, the benchmark now is a solid three to four days per week. Over the last 18 months, it’s been more and more. 

But the little-known fact about this more difficult time that we’re having right now economically, is that it gives management teams the ability, especially with the hiring market not being great, to ask workers to come back into the office more. Four years ago there was no way that a management team could tell people they’re coming back. they’ll just go get another job. Not so much now.

What does the future of RTO look like? 

I think with this economic climate, we’ll really see what companies are thinking. It’ll be an incremental “one more day.” So if you’re at three, it’s going to be four, if you’re at four it could be five. This will be, in my mind, over the next six to nine months.

We were promised an office apocalypse a few years ago, when people were saying that corporate real estate would be empty. What are you seeing in the market right now?

We classify real estate into three buckets, class A, class B and class C. Class A is the good buildings, the ones with really good amenities, and those are doing great. I mean the leasing rates are off the hook, the occupancy rate is like 95%. It’s the B and C class spaces that are struggling a lot more. 

Say you have 20,000 square feet, and are in a class B building, paying $50 a square foot for rent. Now with not as many people coming in, you can pay $100 a foot for a 10,000 square foot building with top amenities in the best location because they know that if you want to get your people back to the office, you’ve got to give them good space. 

What are you seeing as the top priorities for companies right now when it comes to office space? 

I think it’s how they organize the space, because now that more people are coming back, there’s usually a shortage of private spaces. People used to want this big open plan where everyone was sitting at long desks. To get people back, companies are realizing that they have to give people some more privacy. So we’re seeing them convert open space into conference rooms, or areas with more secluded space.

Also, they’re looking closely at pantries and what they’re serving, including the coffee, the snacks, all that good stuff. It really matters to employees.

Since COVID, companies are also prioritizing clean spaces. We’re seeing a lot of [companies] making sure that they could say to employees that their workspace is healthy and clean. Some clients are moving some of our cleaning people on to the day staff, so they’re more visible, so people can see them cleaning and walking around the office.  

The most important thing is to really pay attention to people’s work habits. Are they working in groups collaboratively? Is it solo work? Are they on the phone a lot? Are they on video a lot? What we always say to our clients is that you really have to start with understanding the culture of the organization and the different use cases.

Less than a year after the spectacular cyber-triggered shutdown of Sea-Tac Airport, the FBI has issued an urgent and chilling new warning. On June 27, 2025, the agency declared that America’s airlines are under attack. Not from hijackers with boxcutters, but from cybercriminals with keyboards. And the timing is no coincidence. With global tensions escalating, the possibility of a devastating cyber event in aviation is no longer a remote risk. It is a real threat that must now be part of our national security calculus.

As former White House cyber advisor Tom Kellermann warned, “The cyber 9/11 is coming.”

Meet “Scattered Spider”

This warning was not buried in bureaucratic language or a quiet bulletin. It was issued plainly, publicly and with urgency. The FBI confirmed that Scattered Spider, one of the most dangerous and sophisticated cybercrime gangs operating today, is now targeting the airline industry. This group, already infamous for crippling MGM Resorts and Caesars Entertainment, has pivoted its tactics toward aviation.

Their strategy is simple and sinister. By impersonating airline employees or IT contractors, they trick help desks into bypassing multi-factor authentication. Once inside, they exfiltrate data and deploy ransomware across critical systems. According to Google’s Mandiant division, Scattered Spider excels at persistence, lateral movement and rapid escalation. “They can detonate ransomware within hours of breach,” said Mandiant CTO Charles Carmakal.

The Stakes Could Not Be Higher

This is not a drill. Over the past 60 days, a disturbing pattern has emerged:

• WestJet in Canada confirmed a cyberattack that disrupted internal systems and its mobile app
• Hawaiian Airlines reported a breach affecting non-critical IT operations
• Qantas disclosed that the personal data of over six million passengers was accessed in a call center platform breach

All of this comes on the heels of the August 2024 ransomware attack on Sea-Tac Airport, which forced port officials to disconnect critical systems, stranding nearly 1,400 passengers.

Let’s be clear. This is not about delayed boarding passes or missing loyalty points. Today’s air travel depends on deeply interconnected digital systems. Reservation systems, crew scheduling, maintenance tracking, flight planning and air traffic communication are all vulnerable. A breach in any one of them can ripple outward and cause catastrophic disruption.

What the FBI is signaling is a shift from isolated data theft to coordinated campaigns targeting aviation infrastructure. And Scattered Spider may just be the beginning. Experts warn that nation-state actors like China, Iran, Russia and North Korea are observing, learning and potentially preparing to strike. More importantly, non-state actors affiliated with Al Qaeda and ISIS, the same groups responsible for the 9/11 attacks, are undoubtedly watching as well. They have long viewed aviation as both a symbolic and strategic target and the rise of digital vulnerabilities gives them new avenues to exploit.

Could Terrorists Hijack A Plane Through Code

That is the question no one wants to ask aloud. While no attack to date has compromised flight-critical avionics, security researchers have demonstrated that aircraft systems could be targeted through satellite links, Wi-Fi networks, or compromised ground systems.

Modern planes are flying data centers. The same technologies that enable efficiency and automation such as real-time telemetry, remote diagnostics and automated cockpit integrations can also become potential attack surfaces. A hacked flight planning system or corrupted weather feed could ground planes or worse.

As cybersecurity strategist Theresa Payton put it, “The future of warfare will be about disrupting trust and sowing chaos in the systems we rely on every day. Aviation is right at the top of that list.”

Sea-Tac was a wake-up call. But what happens when a coordinated cyberattack strikes multiple major airports or airlines at once? For a chilling preview, watch the dystopian film Leave the World Behind, starring Julia Roberts and produced by former President Barack Obama and former First Lady Michelle Obama. In the story, a wave of cyberattacks collapses infrastructure, sparks global conflict and pushes civilization to the edge. It is fiction, but it is not far-fetched. The breadcrumbs are there and the warnings are real.

History Is Warning Us

This is not the first time the aviation industry has been tested:

• In 2015, hackers grounded 1,400 passengers in Warsaw by crashing LOT Airlines’ flight plan system
• In 2018, British Airways and Cathay Pacific suffered breaches exposing hundreds of thousands of passenger records
• In 2020, EasyJet disclosed that data on nine million customers had been compromised
• In 2024, Sea-Tac’s ransomware event shut down critical airport functions for days

Every one of these incidents revealed cracks in the aviation system. And each time, the industry promised reforms. But promises do not stop payloads. The adversary is better funded, more persistent and more creative than ever.

Six Actions That Must Be Done Now

The time for incremental fixes is over. The aviation industry must act boldly and immediately across six critical areas:

1. Redesign Identity Verification Processes: Most breaches begin with social engineering. Airlines must implement zero-trust architectures, verify identity through multiple independent channels and eliminate single points of failure. Help desks must be trained to recognize manipulation and resist pressure tactics.
2. Secure The Entire Ecosystem: The FBI’s warning was not limited to airlines. Vendors, contractors, call centers and outsourced IT firms are all part of the threat surface. Every third party must be held to the same standard. Require them to meet strict cybersecurity protocols, report breaches promptly and enforce robust multi-factor authentication.
3. Adopt And Enforce CMMC-Level Standards Across The Industry: Aviation is already considered critical infrastructure and must be treated accordingly. The industry should proactively adopt the Cybersecurity Maturity Model Certification framework and require its implementation across all airline systems and supplier networks. The airline industry has long been a global model for standardization, from flight safety to maintenance. This is your digital preflight checklist. Make it mandatory.
4. Segment And Harden Core Infrastructure: Critical flight systems must be isolated from public-facing applications. Outdated or vulnerable platforms should be patched, upgraded or retired. Emergency response plans must be tested and drilled with the same rigor as inflight safety protocols. Assume failure, then build resilience.
5. Report And Share Intelligence In Real Time: Silence helps the enemy. Airlines must embrace a culture of transparency, sharing threat intelligence in real time with FAA, TSA and CISA. The only way to outpace the attackers is through collective defense and constant communication.
6. Fund Cyber Resilience Like Safety: Cybersecurity is not just an IT function. It is national infrastructure defense. Boards, regulators and investors must fund cyber programs with the same urgency as they fund runway repairs or flight safety. Every dollar spent on digital defense is a dollar that protects passengers, preserves trust and prevents the next crisis.

Final Approach

The consequences are no longer theoretical. Without immediate action, we risk:

• Systemwide outages that ground fleets
• Breaches that expose millions of passengers
• An erosion of trust in the safety of air travel
• And in the worst case, a cyber-induced mass casualty event

That last scenario may sound extreme. But there was a time when hijacking four commercial aircraft and flying them into American landmarks was unthinkable too.

We are entering an era where a few lines of malicious code can do what bombs and bullets once did. This is not science fiction. It is the next frontier of terrorism and organized crime. As we remember those lost on 9/11, we must not forget the lesson of that day. Complacency is the co-pilot of catastrophe. The FBI is warning us. Breaches are happening. The time to act is now.