Category: 3. Business

  • Evaluating the Quality of Patient Handoff Communication in the Department of Medicine at Dongola Specialized Hospital

    Evaluating the Quality of Patient Handoff Communication in the Department of Medicine at Dongola Specialized Hospital


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  • US probes near miss between Southwest Airlines jet and helicopter

    US probes near miss between Southwest Airlines jet and helicopter

    • Incident occurred on October 29 near Cleveland airport
    • The aircraft came within a half mile (0.9 km) in the air
    WASHINGTON, Nov 2 (Reuters) – The U.S. National Transportation Safety Board said on Sunday it is sending a team to investigate an October 29 close call between a Southwest Airlines (LUV.N), opens new tab jet and a medical helicopter near Cleveland International Airport in Ohio.

    The NTSB said the two aircraft experienced a loss of separation – meaning they came closer to each other than the required minimum safe distance – when Southwest Flight 1333 was making its final approach on a flight from Baltimore-Washington International Thurgood Marshall Airport (BWI).

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    This prompted the Southwest pilot to abort the landing. Southwest said the Boeing 737 (BA.N), opens new tab landed safely a short time later.

    The NTSB and Southwest did not disclose the number of passengers and crew aboard the airliner. The helicopter appears to have been transporting a patient at the time of the incident, based on how it was identifying itself at the time.

    Southwest said in a statement on Sunday it “appreciates the professionalism of our crew in responding to the situation. We are engaged with the National Transportation Safety Board and will support the investigation.”

    A representative for the medical transport company did not immediately respond to a request for comment.

    A mid-air collision between an American Airlines (AAL.O), opens new tab regional jet and a U.S. Army helicopter on January 29 killed 67 people near Ronald Reagan Washington National Airport outside the U.S. capital and caused alarm about close calls between commercial airplanes and helicopters.

    Aviation tracking website Flightradar24 said air traffic control audio and flight tracking showed that the Southwest plane was forced to deviate from its course to avoid the Eurocopter helicopter that was passing in front of it in the Cleveland incident. Both aircraft were at 2,075 feet (632 meters) altitude at one point and were as close as 0.56 miles (0.9 km) of separation, the site said.

    An air traffic controller asked the medical helicopter to go behind the other flight traffic in the vicinity of the airport but the helicopter pilot responded that it “would be better if we could go above it and in front of it if we can,” and the controller agreed, according to audio posted by Flightradar24.

    The Southwest captain said in a report to the Federal Aviation Administration that it was an “extremely close” incident and required immediate action to avoid a collision, according to two people briefed on the matter.

    The FAA last month said it was modifying helicopter routes in the vicinity of BWI and Washington Dulles International Airport to add buffer zones after the January crash as well as at Reagan.

    The FAA has faced criticism from U.S. lawmakers and NTSB investigators for failing to act on reports of near-miss incidents before the January 29 collision. The Army Black Hawk helicopter was above the maximum permitted altitude at the time of the crash. Both the helicopter and airliner crashed into the Potomac River.

    In May, the FAA barred the Army from flying helicopters near the Pentagon after a May 1 close call that forced two civilian planes to abort landings.

    The NTSB disclosed in March that since 2021 there had been 15,200 loss of air separation incidents near Reagan between commercial airplanes and helicopters, including 85 close-call events.

    Reporting by David Shepardson; Editing by Will Dunham

    Our Standards: The Thomson Reuters Trust Principles., opens new tab

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  • Diogo Alpuim Costa: 21-Gene Recurrence Score on Treatment Decisions in Early HR+/HER2- Breast Cancer

    Diogo Alpuim Costa: 21-Gene Recurrence Score on Treatment Decisions in Early HR+/HER2- Breast Cancer

    Diogo Alpuim Costa/oxyclinic.pt

    Diogo Alpuim Costa, Head of the Oncology Department and Medical Day Hospital at Cascais Hospital, Dr. José de Almeida, and Clinical Director at Cascais Hyperbaric Center, shared a post on LinkedIn about a paper he co-authored with colleagues published in Clinical Breast Cancer:

    “Honoured to be part of this fantastic Portuguese group led by Dr. Teresa Padrão and Prof. José Luis Passos Coelho, which allowed us to assess the Portuguese landscape using a 21-Gene Recurrence Score Assay to guide adjuvant treatment decisions in over 1000 patients with hormone receptor–positive (HR+), HER2- Early Breast Cancer.

    Published in Clinical Breast Cancer.

    The key messages of the paper ‘The Use and Impact on Treatment Decision of the 21-Gene Recurrence Score Assay for Patients With HR/HER2– Early Breast Cancer in Portugal: A Nationwide Retrospective Cohort Study’ are:

    • The 21-gene Recurrence Score Assay (Oncotype DX) was widely adopted in Portugal and had a substantial impact on adjuvant chemotherapy decisions in hormone receptor-positive, HER2-negative early breast cancer patients, aligning treatment practice with international pivotal trials.
    • After the publication of the TAILORx trial, adjuvant chemotherapy use decreased in patients with Recurrence Score (RS) ≤16 and increased in those with RS ≥25, especially among younger patients.
    • Progesterone receptor (PR) and Ki-67 were independent predictors of high recurrence scores (RS ≥25), supporting the use of these markers to more selectively apply the 21-gene assay in resource-limited clinical settings.
    • The Johns Hopkins Recurrence Score Estimator (JHRE) showed moderate accuracy (53.6%) and low specificity (47.7%) in predicting high-risk scores, suggesting its limited utility for individual decision-making in clinical practice.
    • Chemotherapy was appropriately avoided in low-risk groups and escalated in high-risk groups following the influence of real-world pivotal trial results, confirming the clinical value of the assay for individualized patient care in Portugal.
    • Recurrence rates were low (2.3% median follow-up 29 months), reflecting careful patient selection for chemotherapy de-escalation using the assay.
    • Real-world national data, such as this study, are essential for guiding clinical decision-making, health policy, and the cost-effective use of genomic tests in routine oncology practice.”

    Title: The Use and Impact on Treatment Decision of the 21-Gene Recurrence Score Assay for Patients With HR+/HER2− Early Breast Cancer in Portugal: A Nationwide Retrospective Cohort Study

    Authors: Teresa Gantes Padrão, Diana Pessoa, Joana Alves Luís, Diogo Alpuim Costa, Mário Fontes e Sousa, Ídilia Pina, Susana Palma de Sousa, Débora Cardoso, Sandra Bento, Joana Simões, Ana Ferreira, Renato Cunha, Diogo Martins-Branco, Tiago Dias Domingues, and José Luís Passos-Coelho

    You can read the Full Article in Clinical Breast Cancer.

    Diogo Alpuim Costa: 21-Gene Recurrence Score on Treatment Decisions in Early HR+/HER2- Breast Cancer

    More posts featuring Diogo Alpuim Costa.

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  • Analyst Says Broadcom (AVGO) Among the Best AI Semiconductor Stocks to Benefit from Bull Run Until 2030

    Analyst Says Broadcom (AVGO) Among the Best AI Semiconductor Stocks to Benefit from Bull Run Until 2030

    We recently published Top 9 AI and Non-Tech Stocks to Watch Amid Latest Earnings Season. Broadcom Inc (NASDAQ:AVGO) is one of the top AI and non-tech stocks.

    Vivek Arya, semiconductor analyst at Bank of America, said in a recent interview with CNBC that the current bull market for AI semiconductor companies could go for a couple of more years or “perhaps even” until 2030.

    “The reason is that most infrastructure cycles tend to last for a decade or more. We have seen this with 3G and 4G, and we have the 5G cycle that started. So these cycles can last for a decade or more. And if you look at when ChatGPT started, that was in late 22, so we are just basically in the first three years of what could be a decade-long cycle. Now it’s important to understand why this is happening, and I think why this is happening is that there is this virtuous kind of flywheel that we have where there’s infrastructure spending that is leading to the creation of intelligence, which is being monetized, which is then being fed right back into the deployment of more infrastructure, and I think semiconductors are absolutely in the middle of a lot of those very important building blocks.”

    The analyst believes Broadcom Inc (NASDAQ:AVGO) is one of the top AI semiconductor companies positioned well to benefit from this bull cycle.

    Analyst Says Broadcom (AVGO) Among the Best AI Semiconductor Stocks to Benefit from Bull Run Until 2030

    Polen Focus Growth Strategy stated the following regarding Broadcom Inc. (NASDAQ:AVGO) in its third quarter 2025 investor letter:

    “In early August we initiated positions in both NVIDIA and Broadcom Inc. (NASDAQ:AVGO), after having not owned either company over the past 2½ years following the initial wave of enthusiasm around Gen AI. While we have long admired both companies, their highly cyclical business models have made it extremely difficult to forecast future earnings growth with any degree of conviction. Given our approach of seeking durable and persistent earnings growth that compounds over long holding periods, our concern in holding either was that we would be forced to endure a punishing downcycle within our typical holding period – there is very little room that in a concentrated portfolio of 20-30 companies. In fact, pre ChatGPT, NVIDIA had two punishing down cycles over the preceding five years.

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  • 25% of Warren Buffett’s $315 Billion Portfolio Is Invested in 2 Artificial Intelligence (AI) Stocks

    25% of Warren Buffett’s $315 Billion Portfolio Is Invested in 2 Artificial Intelligence (AI) Stocks

    Legendary investor Warren Buffett took the helm of the holding company Berkshire Hathaway in 1965, and he has led it to fantastic, market-crushing gains. Through the end of 2024, just a year shy of his retirement, Berkshire Hathaway had gained 5,502,284% in per-share market value versus a 39,054% gain for the S&P 500.

    Investors looking to emulate his fantastic success are best off following his advice, or you can easily buy shares of Berkshire Hathaway stock. If you look through the company’s equity portfolio, which is public, you might be surprised to see a few tech stocks.

    Buffett is a fan of value stocks and dividend stocks, and he loves consumer goods. In fact, the two artificial intelligence (AI) stocks he does own — Apple (NASDAQ: AAPL) and Amazon (NASDAQ: AMZN) — are both consumer goods giants, and AI can drive further growth for both of them.

    Image source: Getty Images.

    Apple is one of a trio of stocks that Buffett said he would never sell. While many people would label it a tech company, Buffett loves the consumer goods aspect of its business. It sells lots of devices to lots of people, and the interconnected system creates an Apple community with loyal users and customers who typically buy all-Apple products — iPhones, laptops, and the like.

    The iPhone is its premier product, accounting for about half of total revenue. Users love its design, quality, features, and more. Once converted, they typically don’t look back.

    Although fans are known to upgrade to new models, it often takes a few years. Recently, there have been higher sales from customers who upgraded when digital became more important during the pandemic.

    Increasing iPhone sales have greater implications than simply adding to the top line. Investors and analysts have been worried about the trajectory of Apple Intelligence, which seems to be behind other AI programs.

    But increasing iPhone sales are a clear indication that customers are happy with their devices, that the level of AI is working for them, and that there are other features that may be more important. This is Apple’s edge, and it’s why Buffett loves it.

    Amazon truck.
    Image source: Amazon.

    Amazon is only a small fraction of Buffett’s portfolio, but it packs a mean punch. It’s one of the most important AI companies in the world, and combined with its consumer focus, Amazon still has incredible long-term opportunities.

    The AI business runs on Amazon Web Services (AWS), the cloud services segment. The company has developed a large platform offering all kinds of services, including the tools for developers to build their own large language models (LLMs), as well as to engage with an assortment of LLMs through its Bedrock program.

    Amazon is investing hundreds of millions of dollars in its AI business, and it’s already paying off: It has a run rate of more than $100 billion, and management thinks it’s just getting started. “Every single area that I can think of in the way we work is likely going to be impacted in some meaningful way by AI,” CEO Andy Jassy has said.

    And it’s still in its early stages. The company is developing its own chips and hardware to offer budget options and compete on price, and it has a long-term vision as it sets up its AI business. That means investing in powerful data centers that can support AI capabilities for its AWS clients.

    It’s important to note that, as with Apple, Buffett didn’t buy Amazon stock for exposure to AI; he’s not a big fan of the technology. The two investments stand out for many reasons, and one of them is that they offer so much more besides the AI opportunity.

    Before you buy stock in Apple, consider this:

    The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Apple wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.

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    Jennifer Saibil has positions in Apple. The Motley Fool has positions in and recommends Amazon, Apple, and Berkshire Hathaway. The Motley Fool has a disclosure policy.

    25% of Warren Buffett’s $315 Billion Portfolio Is Invested in 2 Artificial Intelligence (AI) Stocks was originally published by The Motley Fool

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  • Chinese Report Neutral-Atom Quantum Computer Enters Commercial Use

    Chinese Report Neutral-Atom Quantum Computer Enters Commercial Use

    Insider Brief

    • China’s first atomic quantum computer, “Hanyuan No. 1,” has entered commercial use with more than 40 million yuan in orders, including sales to a China Mobile subsidiary and Pakistan, according to Hubei Daily.
    • The system, developed by the Chinese Academy of Sciences’ Innovation Academy for Precision Measurement Science and Technology with support from Hubei’s “Pioneer” program, uses cold atoms as qubits and operates at room temperature to reduce energy and maintenance costs.
    • Hubei Daily reported that the project built a full domestic supply chain through the province’s Optics Valley cluster and is developing a national quantum computing center to expand industrial applications in finance, logistics, and materials research.
    • Photo by geralt on Pixabay

    China’s first atomic quantum computer has entered commercial use, signaling a milestone in the country’s effort to achieve technological self-reliance in quantum information science. The system, called “Hanyuan No. 1,” has received more than 40 million yuan in orders, including delivery to a subsidiary of China Mobile and an international sale to Pakistan, according to an article on Hubei Daily, computer translated into English.

    Chinese media describe Hanyuan No. 1 as an atomic quantum computer — a Chinese term that likely refers to quantum computers built on the manipulation of individual neutral or “cold” atoms trapped and controlled by lasers. Internationally, this technology is known as neutral-atom quantum computing, an approach that offers advantages in scalability and stability without the need for the ultra-low temperatures required by superconducting quantum systems.

    Developed by the Innovation Academy for Precision Measurement Science and Technology under the Chinese Academy of Sciences, the project received funding from the Hubei Provincial Department of Science and Technology through a “Pioneer” program that targets key emerging technologies, according to the newspaper, which serves as the official newspaper of the Hubei Provincial Party Committee and covers the region’s science and economic developments.

    Teams from Wuhan University, Zhongke Kuyuan Technology, the Optics Valley Information Optoelectronics Innovation Center, the Wuhan Institute of Quantum Technology, and Huazhong University of Science and Technology also contributed.

    The launch marks China’s first complete quantum system using cold atoms as qubits.

    According to Hubei Daily, the Hanyuan No. 1 contains 100 qubits, the basic computational units of a quantum computer, and reaches a reliability level comparable to international standards. Its entire system reportedly fits within three standard equipment racks and operates at room temperature, dramatically reducing energy use and maintenance requirements compared with superconducting machines. The paper indicated that the system can already handle complex applications in areas such as financial modeling and logistics optimization, which are two fields with use cases that could benefit from quantum computing.

    Local Industry, Global Competition

    The Hubei Daily specifically mentions that the Hanyuan project leveraged Hubei’s strong optoelectronics manufacturing base — known nationally as Optics Valley — to build a domestic supply chain for these components. The team established a full R&D pipeline, from chip growth and packaging to system testing. Engineers succeeded in producing high-performance lasers that meet the precision control requirements for atomic qubits while consuming only one-tenth the energy of comparable foreign systems.

    The domestically produced components helped the team avoid foreign supply chain dependencies and lower costs, reinforcing China’s drive toward technological self-sufficiency in advanced computing, the newspaper reported.

    Beyond the hardware, the project also aims to build a full commercial ecosystem around the technology. Researchers from Wuhan University and the Wuhan Institute of Quantum Technology developed a cloud-based computing platform that allows users to design and test quantum algorithms without specialized physics knowledge.

    The system integrates visual programming tools, hardware optimization and large-scale simulation capabilities.

    Quantum Computing Ecosystem

    According to Hubei Daily, more than 50 universities and companies have joined the project to begin exploring quantum applications. The project team is also constructing China’s first neutral-atom quantum computing power center, designed to host clusters of machines that will provide continuous 24-hour computing services. Once operational, the facility will focus on computationally demanding problems such as financial risk analysis and the modeling of industrial systems. The center is expected to serve more than a thousand enterprise clients annually.

    The Hubei Daily article suggested that the province’s deep integration of research institutions, manufacturing partners and universities was critical to achieving the project’s goals. The Optics Valley industrial zone provided access to specialized fabrication and testing capabilities, while provincial officials coordinated resources for system integration and commercial deployment. The combination created what officials described as a complete industrial chain, from laboratory research to production and delivery.

    Provincial leaders said the achievement is evidence of Hubei’s emerging role as a national center for advanced computing technologies and its growing importance in China’s broader strategy for scientific and industrial modernization.

    Chinese researchers view the device as an early step toward scalable quantum computing that can support real-world problem solving.

    While the system operates on a smaller scale than machines being developed by global competitors, its stability, room-temperature operation and local component production make it an important proof of concept for China’s neutral-atom approach. The project’s leaders have said future plans include improving system performance and expanding computing clusters to support high-end applications such as materials design and pharmaceutical discovery.

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  • Opec+ to pause oil output rises next year after warnings of glut

    Opec+ to pause oil output rises next year after warnings of glut

    Unlock the Editor’s Digest for free

    Opec+ has responded to fears of an oil glut by pausing its plans to increase production next year.

    Eight members of the oil producers’ group said they would add another 137,000 barrels a day of crude in December, but then halt any further rises in January, February and March.

    The group said the pause was due to “seasonality”. Oil demand in the first quarter is generally weaker after the end of the holiday season when oil refineries often go into maintenance.

    The eight Opec+ countries, led by Saudi Arabia and Russia, have steadily increased their production quotas this year, by 2.91mn b/d including next month’s rise, equivalent to about 2.7 per cent of global oil demand. But they have slowed the pace in recent months. 

    December’s planned increase follows a small rise in October and November as producers respond to forecasts of an oil glut next year.

    Last week, Wael Sawan, Shell’s chief executive, became the latest industry boss to cite the risk, saying “there is a credible scenario of oversupply in the market next year”.

    The small increase in December also suggests Opec+ is not anticipating that large volumes of Russian oil will be removed from the market in the near term by the latest round of US sanctions.

    At the end of October, the US imposed sanctions on Russia’s two largest oil companies, Rosneft and Lukoil, and secondary sanctions on any financial institutions that do business with them. 

    Oil prices, which had fallen to a five-month low of around $60 a barrel ahead of the sanctions, rose to $65 in response.

    Energy Aspects, a research company, estimated that between 1.4mn and 2.6mn b/d of Russian crude could be affected by the sanctions, with India’s imports being the worst hit. 

    But the market remains sceptical that the sanctions will seriously impede the flow of Russian oil, given the extensive structures that Moscow has built since 2022 to work around attempts to control its exports. 

    Jorge León, head of geopolitical analysis at Rystad Energy, a research company, said it remained too early to tell how serious the effect of the sanctions would be.

    “Crude export numbers look steady, but that is because that crude was produced a month ago or so. In reality, exports will start showing some signals in three to four weeks,” he said. “But the Russians are very worried.” 

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  • October 2025: A Look at FDA Oncology Approvals and Designations | Targeted Oncology

    October 2025: A Look at FDA Oncology Approvals and Designations | Targeted Oncology

    October 2025 proved to be a significant month for the oncology landscape, marked by a wave of key regulatory decisions from the US FDA. This period saw important full and accelerated drug approvals across various cancer types, expanding treatment options for patients with both solid tumors and hematologic malignancies.

    From new combination maintenance therapies for extensive-stage small cell lung cancer (ES-SCLC) and an adjuvant treatment for high-risk cutaneous squamous cell carcinoma (CSCC), to a crucial approval in relapsed or refractory acute myeloid leukemia (AML) with a specific mutation, the month delivered on several anticipated action dates.

    Furthermore, the FDA continued to expedite the development of promising agents by granting several breakthrough therapy and fast track designations, signaling a robust pipeline of innovative oncology therapeutics on the horizon. This roundup delves into the most notable FDA news and designations that will shape cancer care moving forward.

    FDA Accepts sBLA for T-DXd Plus THP in HER2+ Breast Cancer

    On October 1, the FDA accepted the supplemental biologics license application (sBLA) for trastuzumab deruxtecan (T-DXd; Enhertu) followed by paclitaxel (Taxol), trastuzumab (Herceptin), and pertuzumab (Perjeta; THP) for the neoadjuvant treatment of adult patients with HER2-positive stage 2 or 3 breast cancer. A Prescription Drug User Fee Act (PDUFA) target action date of May 18, 2026, has been set.

    FDA Fast-Tracks ETX-636 in PIK3CA-Mutant, HR+ Breast Cancer

    Also on October 1, the FDA granted fast track designation to ETX-636, a pan mutant-specific allosteric PIK3CA inhibitor, for the treatment of patients with PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer.

    FDA Approves Lurbinectedin/Atezolizumab for ES-SCLC Maintenance

    On October 2, the FDA approved the combination of lurbinectedin (Zepzelca) and atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybrezas) as a first-line maintenance treatment in patients with ES-SCLC whose disease has not progressed following first-line induction therapy with atezolizumab, carboplatin, and etoposide.

    AMXT 1501 and DFMO Combination Achieve FDA Orphan Drug Designation

    Also on October 2, the FDA granted orphan drug designation to AMXT 1501 in combination with difluoromethylornithine (Iwilfin; DFMO) for the treatment of patients with neuroblastoma.

    Orca-T Earns FDA Priority Review in Heme Malignancies

    On October 6, the FDA accepted for priority review the biologics license application of Orca-T, an investigational allogeneic T-cell immunotherapy, for the treatment of hematologic malignancies including acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. The FDA has set a PDUFA target action date of April 6, 2026.

    FDA Issues CRL to NDA for Dasynoc in CML and ALL

    On October 8, the FDA issued a complete response letter to the new drug application of Daysnoc, a lower-dose, bioequivalent formulation of dasatinib (Sprycel), based on good manufacturing practice issues observed at Xspray’s contract manufacturer.

    FDA Approves Cemiplimab for Adjuvant Cutaneous Squamous Cell Carcinoma

    Also on October 8, the FDA approved cemiplimab (Libtayo) as adjuvant treatment in adults with high-risk CSCC.

    WTX-124 Earns FDA Fast Track for Refractory Melanoma

    The FDA granted fast track designation to the investigational therapeutic agent WTX-124 for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma that has progressed following standard-of-care immunotherapy, also on October 8.

    FDA Fast Tracks ADCE-D01 for Soft Tissue Sarcoma Treatment

    On October 9, the FDA granted fast track designation to the antibody-drug conjugate (ADC) ADCE-D01 for the treatment of soft tissue sarcoma.

    Ficerafusp Alfa Earns FDA Breakthrough Therapy Designation for HPV-Negative R/M HNSCC

    On October 13, the FDA granted breakthrough therapy designation to the bifunctional antibody ficerafusp alfa (BCA101) in combination with pembrolizumab (Keytruda) for the first-line treatment of HPV-negative, recurrent or metastatic head and neck squamous cell carcinoma.

    FDA Breakthrough Designation Signals New Therapeutic Avenue in R/R MCL

    On October 14, the FDA granted breakthrough therapy designation to the investigational BCL-2 inhibitor sonrotoclax (BGB-11417) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following therapy with a BTK inhibitor and an anti-CD20 agent.

    FDA Grants Fast Track to NG-350A for pMMR Rectal Cancer

    Also on October 14, NG-350A, an intravenously delivered oncolytic immunotherapy, was granted fast track designation by the FDA for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer.

    FDA Grants Orphan Drug Status for MNV-201 in Low-Risk MDS

    On October 15, the FDA granted orphan drug designation to the investigational mitochondrial cell therapy MNV-201 for the treatment of myelodysplastic syndrome.

    Immunotherapy EO2463 Receives FDA Fast Track for Follicular Lymphoma

    On October 16, the FDA granted fast track designation to the novel immunotherapy EO2463 for the treatment of follicular lymphoma, backed by positive interim data from the ongoing phase 2 SIDNEY trial (NCT04669171).

    FDA Accepts NDA for New Nilotinib Formulation in Chronic Myeloid Leukemia

    On October 21, the FDA accepted the new drug application for XS003, a formulation referencing the TKI nilotinib (Tasigna), for treatment of chronic myeloid leukemia. A PDUFA target action date has been set for June 18, 2026.

    FDA Prioritizes sBLA Review for Enfortumab Vedotin/Pembro in MIBC

    Also on October 21, the FDA granted priority review to the sBLA of enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab, radical cystectomy, and standard pelvic lymph node dissection as perioperative treatment for patients with muscle-invasive bladder cancer who are ineligible for or decline cisplatin-containing chemotherapy.

    FDA Grants Fast Track Status to MT-125 in Glioblastoma

    On October 22, the FDA gave fast track designation to MT-125, a first-in-class dual small-molecule inhibitor, for the treatment of glioblastoma.

    Novel ADC Pamlectabart Tismanitin Earns FDA Fast Track for Myeloma Treatment

    On October 23, the FDA granted fast track designation to the novel amanitin-based ADC pamlectabart tismanitin (HDP-101) for treatment of patients with relapsed or refractory multiple myeloma.

    FDA Approves Revumenib in Mutant NPM1 AML

    On October 24, the FDA approved the application for revumenib (Revuforj) in the treatment of relapsed or refractory NPM1-mutant AML, supported by positive data from the phase 2 portion of the AUGMENT-101 trial (NCT04065399).

    FDA Grants Breakthrough Therapy Status to Zenocutuzumab for Patients with NRG1 Fusion

    Also on October 24, the FDA granted breakthrough therapy designation to zenocutuzumab (Bizengri) for the treatment of patients with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion. This designation was supported by results from the ongoing phase 2 eNRGy trial (NCT02912949).

    FDA Fast Tracks Anti-HER2 Biparatopic ADC for Platinum-Resistant Ovarian Cancer

    On October 27, the FDA granted fast track designation to JSKN003, a biparatopic HER2-targeting ADC, for the treatment of platinum-resistant ovarian cancer, regardless of HER2 expression.

    Daraxonrasib Earns FDA Orphan Drug Designation in Pancreatic Cancer

    Also on October 27, the oral, multiselective inhibitor daraxonrasib (RMC-6236) was awarded orphan drug designation by the FDA for the treatment of pancreatic cancer.

    FDA Awards Orphan Drug Status to ZEN-3694 for NUT Carcinoma

    The FDA granted orphan drug designation to ZEN-3694, a novel oral therapy, for the treatment of NUT carcinoma, also on October 27.

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  • Fountain Pens Are More Popular Than Ever—and Purists Are Fuming

    Fountain Pens Are More Popular Than Ever—and Purists Are Fuming

    Paul Homchick bought his first fountain pen three decades ago. He was working as an engineering consultant and wanted to seem trustworthy as he took notes. 

    Since retiring, the 76-year-old has been more interested in exploring different types of nibs, the metal tip of a fountain pen, than impressing clients. To save money, he decided to give Chinese brands a shot.

    Copyright ©2025 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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  • Another European car company gets knocked out by tariffs

    Another European car company gets knocked out by tariffs

    U.S. tariffs have taken their toll on a myriad of industries as the world continues to navigate the new international trade order instituted under President Donald Trump.

    But this week, German automakers were in the spotlight as some of the world’s best-known Bavarian brands all reported the same thing: profits are falling, and tariffs are to blame.

    The European Union has been able to negotiate its tariff burden down from 25% to 15%, but the 15% number still weighs heavily on automakers’ bottom lines.

    German auto marque Volkswagen said that U.S. tariffs would cost the company up to 5 billion euros this year ($5.8 billion). Through the first three quarters, tariffs have shaved 58% off its year-over-year profit.

    The company is shipping fewer vehicles to the States to avoid tariffs, and U.S. consumers are shying away from foreign brands that are now more expensive. Volkswagen’s sales in North America are down 11% through the first three quarters.

    Volkswagen and other German automakers have had to limit exports to the U.S. amid tense tariff circumstances.picture alliance/Getty Images

    The German auto industry struggles extend well past just Volkswagen.

    On Oct. 29, fellow German auto Mercedes-Benz Group reported a 70% year-over-year decline in EBIT to 750 million euros ($870 million) while overall revenue fell 7% to 32 billion euros ($37.13 billion).

    Related: Luxury automaker takes major hit

    Mercedes says it has been carefully managing its U.S. inventory as its third-quarter net profit fell to 1.19 billion euros, down from 1.72 billion euros a year ago ($1.38 billion from $1.99 billion).

    But it wasn’t all bad news for the luxury automaker on this side of the pond.

    “Despite the noticeable impact of US tariff policy on the US trade balance, after a slight decrease in the first quarter, GDP in the United States grew visibly in the further course of the year,” the company said in its earnings release.

    Overall, the company sold 12% fewer vehicles in the third quarter than it did the previous year.

    The one bright spot was for the company’s “top-end” category, where it reported 10% growth in unit sales.

    Despite the struggles, Mercedes-Benz reiterated its full-year guidance, unlike fellow German automaker Audi, which was forced to lower expectations due to the tariff impact.

    Audi Group said that its financial performance in the quarter “reflects the challenging economic situation” all German automakers are finding themselves in.

    Again, it wasn’t all bad for the company; revenue through the first three quarters rose 4.6% year over year to € 48.4 billion ($56.14 billion), including a 3.2% increase in the third quarter to € 15.81 billion ($18.34 billion).

    Related: Mercedes-Benz develops a unique way to solve a serious issue

    However, the Audi Group, which includes Audi, Bentley, Lamborghini, and Ducati, has lowered its operating margin expectations for the year to between 4% and 6%, down from its previous view of between 5% and 7%. Before the summer, the company had forecast an operating margin between 7% and 9% for the year.

    It left revenue and net cash flow guidance unchanged, at between € 65 billion and € 70 billion and between € 2.5 billion and € 3.5 billion, respectively.

    “We are responding to the challenging overall economic situation and intensified competition with stringent cost control measures and are continuing to work on our financial performance,” said CFO Jürgen Rittersberger.

    Related: Tesla report reveals concerning customer behavior

    This story was originally reported by TheStreet on Nov 2, 2025, where it first appeared in the Automotive section. Add TheStreet as a Preferred Source by clicking here.

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