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Category: 3. Business

  • Pakistan Moves Toward Tokenizing $2B in Government Assets With Binance

    Pakistan Moves Toward Tokenizing $2B in Government Assets With Binance

    Binance is set to explore the tokenization of up to $2 billion in bonds, treasury bills and commodity reserves in Pakistan, Reuters reported on Friday.

    The memorandum of understanding (MOU) with the world’s largest crypto exchange by trade volume highlights Pakistan’s push to use blockchain technology to unlock liquidity and attract foreign investment as it explores a formal crypto regulatory framework.

    Pakistan’s Finance Ministry said the initiative could pave the way for tokenizing additional government-owned real-world assets and distributing them on blockchain-based platforms.

    The announcement comes one day after the Chairman of Pakistan’s Virtual Assets Regulatory Authority (VARA), Bilal Bin Saqib, announced in a video interview with CoinDesk his country’s plans to accelerate crypto adoption, leverage Bitcoin mining, and launch a national stablecoin.

    Pakistan’s regulatory moves mirror a broader global trend. The United Arab Emirates, Japan and parts of the European Union are expanding formal licensing rules ‍for crypto exchanges amid broader global regulatory tightening.

    Binance founder Changpeng Zhao said the agreement was “a great signal for the global blockchain industry and for Pakistan”, adding that it marks the start of a move toward full deployment of the tokenization initiative.

    Also today, according to Reuters, the VARA said it issued early approvals to Binance and HTX after reviewing their governance and compliance controls, allowing them to register on the Anti-Money Laundering system, set up local units and prepare full applications.

    Binance did not immediately respond to a CoinDesk request for more information.


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  • FDA Approves Two Oral Therapies to Treat Gonorrhea – fda.gov

    1. FDA Approves Two Oral Therapies to Treat Gonorrhea  fda.gov
    2. Blujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC)  GSK
    3. New gonorrhoea treatment could help beat drug-resistant infections  Euronews.com
    4. Top Infectious Disease News Stories Week of December 6 – December 12  Contagion Live
    5. Oral Nuzolvence Approved for Uncomplicated Gonorrhea  Infectious Disease Special Edition

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  • week of quality 2024 training kit

    week of quality 2024 training kit

    Overview

     

    Ensuring quality of the health product ensures its safety and efficacy. Manufacturers in lowand middle-income countries (LMICs) face challenges to achieve quality in local production,
    such as the lack of an available manufacturing workforce trained in quality and understanding
    regulatory quality standards and difficulties in implementing a quality culture in the
    manufacturing facility.

    The Local Production and Assistance (LPA) Unit in the Innovation and Emerging Technologies
    Department (IET), Access to Medicines and Health Products Division (MHP), WHO, supports
    Member States (MS), particularly LMICs, to strengthen sustainable local production and
    technology transfer to improve timely, equitable access to quality, safe and effective essential
    medical products. The LPA Unit provides assistance and support to MS with an ecosystem wide and holistic approach, such as conducting ecosystem assessments for sustainable,
    quality local production, developing and implementing strategies, roadmaps and tools,
    providing comprehensive capacity building and technical assistance, including for WHO
    Prequalification (PQ)/Emergency Use Listing (EUL), and facilitating technology transfer (TT).

    To support MS to overcome challenges to locally produce quality-assured vaccines and
    biotherapeutics, medicines and in vitro diagnostics (IVDs), the LPA Unit organized a new
    global training event – Week of Quality – to complement the annual Virtual cGMP Training
    Marathons also organized by the LPA Unit. The first Week of Quality was organized from 16 to
    20 June 2023 and focused on establishing quality specifications of vaccines, medicines and
    IVDs based on WHO and other international guidelines, one of the stepping stones to
    achieve quality. The second week of quality took place from 15 April to 13 June 2024 and
    focused on exploring key aspect of regulatory compliance for Medicines, IVDs and Vaccines
    and biotherapeutics. More than 1700 vaccine and biopharmaceutical manufacturers and
    regulators attended the sessions on key aspects of vaccine and biotherapeutic
    regulatory compliance. More than 1400 pharmaceutical manufacturers and
    regulators strengthened their knowledge on quality requirements for pharmaceutical
    product development.

    And for the first time, over 1000 IVD manufacturers and
    regulators, built capacity in principles of design, quality and compliance for optimizing IVD
    product development.
    Questions raised by manufacturers and regulators in the second Week of Quality have been
    assembled in this training material with questions-and-answers (Q&A) with answers prepared
    and peer-reviewed by experts with long and rich experience in the vaccine, medicine or IVD
    industry, national regulatory authority (NRA), and other organizations. This document has
    been developed to provide manufacturers and other relevant stakeholders with a continuous
    learning resource and reference document to acquire new and fortify existing, knowledge
    and capacities to strengthen the local production of quality vaccines, medicines and IVDs.

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  • Airline Service Quality Performance Data – September 2025

    Airline Service Quality Performance Data – September 2025

    BTS 82-25

    The U.S. Department of Transportation (DOT) today released its Airline Service Quality Performance data compiled for the month of September 2025 for on-time performance, mishandled baggage, mishandled wheelchairs, and scooters. 
     

    For additional information and interactive charts on transportation’s role in aviation, please visit BTS’ Aviation Facts and Figures. BTS regularly updates TranStats, with both Marketing Carrier On-Time Performance (Beginning January 2018) and the Reporting Carrier On-Time Performance (1987-present).

    To receive updates from BTS directly to your email, please consider subscribing to our GovDelivery service.

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  • Dentons advises Mitsui on the sale of its interest in Oman's Blocks 3 and 4 and 9 – Dentons

    1. Dentons advises Mitsui on the sale of its interest in Oman’s Blocks 3 and 4 and 9  Dentons
    2. Kistos to Acquire Minority Stakes in Omani Producing Blocks  Rigzone
    3. Exploration-production – Kistos Energy acquires Blocks onshore Oman  Oil Review Middle East
    4. UK firm acquires stakes in key Oman upstream block  ZAWYA
    5. Kistos Expands into MENA with Strategic Acquisition in Oman  TipRanks

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  • Gedatolisib Plus Fulvestrant ± Palbociclib Is a Potential New SOC in HR+ PIK3CA Wild-Type Advanced Breast Cancer

    Gedatolisib Plus Fulvestrant ± Palbociclib Is a Potential New SOC in HR+ PIK3CA Wild-Type Advanced Breast Cancer

    Gedatolisib plus fulvestrant (Faslodex) with or without palbociclib (Ibrance) continued to showcase significant efficacy vs fulvestrant alone when used as second-line treatment in patients with hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer, irrespective of duration of prior treatment, according to updated data from the phase 3 VIKTORIA-1 trial (NCT05501886).1

    Findings from additional analyses, which were shared during the 2025 San Antonio Breast Cancer Symposium, looked at progression-free survival (PFS) by time to progression (TTP) on immediate prior therapy. Those with a TTP longer than 6 months who received the gedatolisib triplet experienced a median PFS of 9.9 months (95% CI, 7.2-19.2) vs just 1.9 months (95% CI, 1.8-2.3) with fulvestrant monotherapy (HR, 0.20; 95% CI, 0.13-0.30; P < .0001); those given the gedatolisib doublet experienced a median PFS of 7.6 months (95% CI, 5.5-10.0; HR, 0.25; 95% CI, 0.17-0.37; P < .0001). Those with a TTP longer than 12 months who received the triplet had a median PFS of 10.7 months (95% CI, 7.2-19.2) vs 1.9 months (95% CI, 1.8-3.5) with the monotherapy (HR, 0.21; 95% CI, 0.15-0.31; P < .0001); treatment with the doublet led to a median PFS of 9.1 months (95% CI, 5.5-13.6; HR, 0.26; 95% CI, 0.18-0.37; P < .0001).

    In those who had a TTP of longer than 18 months, the median PFS with the gedatolisib triplet was 12.4 months (95% CI, 7.0-19.3) compared with 1.9 months (95% CI, 1.8-3.5) with fulvestrant alone (HR, 0.17; 95% CI, 0.11-0.28; P < .0001); the median PFS with the gedatolisib doublet was 10.0 months (95% CI, 5.6-not evaluable [NE]; HR, 0.19; 95% CI, 0.12-0.31; P < .0001). Lastly, in those with a TTP of longer than 24 months who received the combination vs the monotherapy, the median PFS was 12.4 months (95% CI, 7.4-NE) vs 2.0 months (95% CI, 1.8-3.7), respectively (HR, 0.26; 95% CI, 0.26-0.28; P < .0001); with the gedatolisib doublet, the median PFS was 13.6 months (95% CI, 7.6-NE; HR, 0.14; 95% CI, 0.08-0.27; P < .0001).

    “VIKTORIA-1 is the first study to demonstrate a statistically significant and clinically meaningful improvement in PFS with PAM inhibition in patients with PIK3CA wild-type disease, all of whom received prior CDK4/6 inhibition,” Barbara Pistilli, MD, the head of the Breast Cancer Unit at Gustave Roussy, in Villejuif, France, said in a rapid fire presentation of the data. “These additional analyses confirm the efficacy of gedatolisib irrespective of the duration of prior treatment.”

    What was the design of the VIKTORIA-1 trial evaluating gedatolisib in this breast cancer population?

    Gedatolisib at a Glance: What Updated VIKTORIA-1 Data Reveals

    • Gedatolisib plus fulvestrant, with or without palbociclib, consistently improved PFS vs fulvestrant alone, regardless of prior treatment duration in patients with hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer.
    • Benefit was observed in both bone-only and non–bone only metastases, with the strongest gains seen in non–bone only disease.
    • Stomatitis was the most common toxicity reported on the trial but was mostly low grade and manageable.
    • The median time to definitive deterioration was meaningfully delayed with gedatolisib regimens vs fulvestrant monotherapy.

    The study enrolled premenopausal and postmenopausal patients with hormone receptor–positive, HER2-negative, advanced breast cancer who progressed on or following CDK4/6 inhibition and a nonsteroidal aromatase inhibitor.2 Patients received no more than 2 prior lines of endocrine therapy for advanced disease, were tested for PIK3CA status, and did not have prior exposure to an mTOR inhibitor, a PI3K inhibitor, an AKT inhibitor, or chemotherapy for advanced disease.

    Those with PIK3CA wild-type disease were randomly assigned 1:1:1 (n = 392) to 1 of 3 treatment arms: gedatolisib plus palbociclib and fulvestrant (arm A), gedatolisib plus fulvestrant (arm B), and fulvestrant alone (arm C). Gedatolisib was administered at a once weekly dose of 180 mg as part of a 3-weeks-on/3-weeks-off schedule; palbociclib was given at a daily dose of 125 mg for 21 days on and 7 days off; and fulvestrant was administered at 500 mg on days 1 and 15 and then every 4 weeks. Those in arm C were able cross over to arms A or B when they experienced disease progression.

    Stratification factors included presence of lung or liver metastases (yes vs no), TTP on immediate prior therapy (≤6 vs >6 months), and region (US/Canada vs rest of the world).

    The primary end points of the study were PFS by blinded independent central review for arm A vs arm C and for arm B vs arm C. Key secondary end points comprised overall survival (OS), objective response rate (ORR), safety, and quality of life (QOL).

    What data have previously been reported from VIKTORIA-1 with the gedatolisib combinations?

    Data from the primary analysis of VIKTORIA-1 presented during the 2025 ESMO Congress indicated that the gedatolisib triplet (n = 131) led to a median PFS of 9.3 months (95% CI, 7.2-16.6) vs 2.0 months (95% CI, 1.8-2.3) with fulvestrant monotherapy (n = 131), translating to a 76% reduction in the risk of disease progression or death (HR, 0.24; 95% CI, 0.17-0.35; P < .0001). The gedatolisib doublet (n = 130) led to a median PFS of 7.4 months (95% CI, 5.5-9.9), which translated to a 67% reduction in the risk of disease progression or death vs single-agent fulvestrant (HR, 0.33; 95% CI, 0.24-0.48; P < .0001).

    At the time of the interim analysis, immature OS data showed that the median OS with the triplet was 23.7 months (95% CI, 21.4-NE) vs 18.5 months (95% CI, 15.8-NE) with fulvestrant alone (HR, 0.69; 95% CI, 0.43-1.12; P = .1328); the median OS with the gedatolisib doublet was not reached (NR; 95% CI, NE-NE; HR, 0.74; 95% CI, 0.46-1.19; P = .2122). Additionally, ORRs of the the triplet, doublet, and monotherapy were 31.5%, 28.3%, and 1.0%, respectively; with median duration of response of 17.5 months (95% CI, 8.8-NE), 12.0 months (95% CI, 8.1-NE), and NR (95% CI, NE-NE).

    What additional efficacy data were reported from the analyses shared during SABCS?

    PFS was also examined by bone metastases status.1 Findings indicated that in those with bone-only metastases, the gedatolisib triplet led to a median PFS that was NR (95% CI, 7.0-NE) vs 8.2 months (95% CI, 1.7-NE) with fulvestrant (HR, 0.30; 95% CI, 0.04-2.37; P = .2969); the gedatolisib doublet resulted in a median PFS that was also NR (95% CI, 3.5-NE; HR, 0.41; 95% CI, 0.12-1.54; P = .2098).

    In those with non–bone only metastases, the gedatolisib triplet resulted in a median PFS of 9.3 months (95% CI, 5.7-16.6) vs 1.9 months (95% CI, 1.8-2.0) with fulvestrant (HR, 0.23; 95% CI, 0.16-0.33; P < .0001); the gedatolisib doublet led to a median PFS of 7.3 months (95% CI, 5.5-9.4; HR, 0.32; 95% CI, 0.23-0.45; P < .0001).

    What did additional safety analysis reveal about the gedatolisib regimens?

    “Stomatitis was the most frequent adverse [effect] reported in the VIKTORIA-1 trial, and I want to remind you that the study protocol recommended prophylactic use of a steroid containing mouthwash,” Pistilli noted. “The majority of patients experienced grade 1 stomatitis as the first event.”

    Treatment-related stomatitis was reported in 69.2% of those given the triplet (n = 130) and in 56.9% of those given the doublet (n = 130), and the median time to onset was 7.5 days (range, 1-259) and 4.0 days (range, 1-524), respectively. Of those in the triplet arm, 57 had a grade 1 event, 24 experienced a grade 2 event, and 9 had a grade 3 event; the median time to first onset ranged from 4.0 days (range, 1-20) to 8.0 days (range, 1-259). In the doublet arm, 48 patients experienced a grade 1, 16 had a grade 2 event, and 10 had a grade 3 event with median time to first onset ranging from 3.5 days (range, 2-87) to 4.5 days (range, 1-524).

    “Most stomatitis events occurred within the first 3 weeks of treatment initiation, the majority were grade 1, and very few patients experienced grade 3 stomatitis as this event,” she said.

    In the triplet arm, the median time to improvement from grade 3 to lower was 12.0 days (range, 3-103), from grade 2 to lower was 14.0 days (range, 4-229), and from grade 1 to lower was 27.5 days (range, 1-402). In the doublet arm, the median time to improvement from grade 3, grade 2, or grade 1 to lower was 7.5 days (range, 2-112), 9.0 days (range, 3-41), and 17.5 days (range, 1-317), respectively. “Grade 2/3 [effects] generally improved to a lower grade within 1 to 2 weeks,” Pistilli said.

    She added that median glucose levels were stable. All-grade hyperglycemia occurred in 9.2% of those who received the triplet, 11.5% of those given the doublet, and no patients who received the monotherapy. Change in median HbA1c from baseline to end of therapy in the respective arms was 0.5 (range, –1.6 to –2.9), 0.6 (range, –0.7 to –8.2), and 0.2 (range, –0.6 to 1.3). “Gedatolisib did not produce clinically relevant hyperglycemia and had no dose reductions or withdrawals due to hyperglycemia,” Pistilli said.

    What was learned in terms of PROs?

    The median time to definitive deterioration in EQ-5D-5L was “meaningfully delayed” with gedatolisib vs fulvestrant,” she added. In the triplet arm the median time to definitive deterioration was 23.7 months (95% CI, 6.8-NE) vs 4.0 months (95% CI, 2.8-8.2) in the monotherapy arm (HR, 0.39; 95% CI, 0.25-0.67; P = .0003); in the doublet arm, the median time to definitive deterioration was NR (95% CI, 7.1-NE; HR, 0.37; 95% CI, 0.24-0.66; P = .0003).

    What is the take-home message of the updated VIKTORIA-1 data?

    “Gedatolisib plus fulvestrant, with or without palbociclib, represents a potential new standard of care for patients with hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor,” Pistilli concluded.

    In November 2025, a new drug application seeking approval of gedatolisib for use in patients with hormone receptor–positive, HER2-negative advanced breast cancer was submitted to the FDA for review.3 The NDA was supported by findings from the PIK3CA wild-type cohort of VIKTORIA-1.

    Disclosures: Pistilli disclosed receipt of consulting fees from Astrazeneca (institutional), Seagen (institutional), Gilead (institutional), Novartis (institutional), Lilly (institutional), MSD (institutional), Pierre Fabre (personal), Daiichi Sankyo (institutional/personal), and Olema (institutional). Research funding (institutional) was provided by AstraZeneca, Daiichi Sankyo, Gilead, Seagen, and MSD. Travel support was provided by AstraZeneca, Gilead, MSD, Daiichi Sankyo, Accord, and Pfizer.

    References

    1. Pistilli B, Layman RM, Curigliano G, et al. Gedatolisib, a multitarget PI3K/AKT/mTOR inhibitor, plus fulvestrant with or without palbociclib for second-line treatment of patients with HR+/HER2-/PIK3CA-WT advanced breast cancer: updated results from the randomized, phase 3 VIKTORIA-1 trial. Presented at: 2025 San Antonio Breast Cancer Symposium; December 9-12, 2025; San Antonio, TX. Abstract R47-04.
    2. Hurvitz SA, Layman RM, Curigliano G, et al. Gedatolisib plus fulvestrant, with and without palbociclib, vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer: first results from VIKTORIA-1. Presented at: 2025 ESMO Annual Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA17.
    3. Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. News release. Celcuity, Inc. November 17, 2025. Accessed December 11, 2025. https://ir.celcuity.com/press-releases/

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  • Consultation: Major Revision to Sustainable Grasslands Methodology  

    Consultation: Major Revision to Sustainable Grasslands Methodology  

    Verra has opened a public consultation on a major revision to VM0032 Methodology for the Adoption of Sustainable Grasslands through Adjustment of Fire and Grazing, v1.0 in the Verified Carbon Standard (VCS) Program. The revised methodology would be published as VM0032 Sustainable Native Grasslands Management through Adjustment of Fire and Grazing, v2.0. The consultation will run from December 11, 2025, through January 23, 2026.

    VM0032 is globally applicable and quantifies the greenhouse gas emission reductions and removals from sustainable practices that sequester carbon in soil and woody biomass and/or avoid emissions from natural fires.

    The proposed revision includes the following:

    • Enhanced grasslands definition
    • Updated applicability conditions and specifications for project boundaries
    • Updated additionality requirements
    • Introduction of a modeled way of setting a baseline
    • Introduction of true-up mechanism for soil organic carbon (SOC) modeling
    • Introduction of control sites for SOC and woody biomass measurements
    • Updates to leakage and uncertainty sections
    • Updates to ensure consistency between VM0032, v2.0 and the proposed major revision to VM0042 for grazing projects implemented on pastures and rangelands, clarifying each methodology’s applicability in terms of agricultural and livestock management, land use, and land cover
    • Introduction of differentiation between emission reductions and carbon dioxide removals

    Verra is seeking general feedback on the proposed revisions, as well as targeted feedback on whether to keep VM0032 as a standalone methodology or integrate it into VM0042.

    Option 1: VM0032 remains active, and Verra would clarify that native grasslands are not eligible under VM0042, v3.0.

    Option 2:  VM0032 will be inactivated and VM0042 would be revised to include all grassland system types, i.e., all native grasslands management projects that focus on soil organic carbon stock increases would be required to use VM0042.

    Verra also welcomes more specific feedback on whether projects using VM0026 (any version) or VM0032, v1.0 should be able to transition to VM0032, v2.0.

    Please note that the public consultation on VM0042, v3.0 is expected to start in January 2026.

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  • Press Briefing Transcript: China Article IV Consultation – International Monetary Fund

    1. Press Briefing Transcript: China Article IV Consultation  International Monetary Fund
    2. IMF chief urges China to curb exports, boost consumption  Dawn
    3. Xinhua Headlines: Int’l community expects high for Chinese economy despite global challenges  Xinhua
    4. World Bank raises China’s growth forecasts signaling confidence in economic resilience  China Daily – Global Edition
    5. IMF lifts China’s growth outlook bu…  Mysteel

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  • News | Collins Elbit Vision Systems’ Zero-G Helmet Mounted Display System+ achieves key milestone with U.S. Navy

    News | Collins Elbit Vision Systems’ Zero-G Helmet Mounted Display System+ achieves key milestone with U.S. Navy

    ###

    About Collins Aerospace
    Collins Aerospace, an RTX business, is a leader in integrated and intelligent solutions for the global aerospace and defense industry. Our 80,000 employees are dedicated to delivering future-focused technologies to advance sustainable and connected aviation, passenger safety and comfort, mission success, space exploration, and more.

    About RTX
    RTX is the world’s largest aerospace and defense company. With more than 185,000 global employees, we push the limits of technology and science to redefine how we connect and protect our world. Through industry-leading businesses – Collins Aerospace, Pratt & Whitney, and Raytheon – we are advancing aviation, engineering integrated defense systems for operational success, and developing next-generation technology solutions and manufacturing to help global customers address their most critical challenges. The company, with 2024 sales of more than $80 billion, is headquartered in Arlington, Virginia. For questions or to schedule an interview, please contact [email protected].

    About Elbit Systems of America, LLC 
    Elbit Systems of America, headquartered in Fort Worth, Texas, is a leading provider of high-performance products, system solutions, and support services focusing on the defense, homeland security, law enforcement, commercial aviation, and medical instrumentation markets. With facilities throughout the U.S., Elbit Systems of America is dedicated to supporting those who contribute daily to the safety and security of the United States. Elbit Systems of America, LLC is wholly owned by Elbit Systems Ltd. (NASDAQ: ESLT and TASE: ESLT), a global high technology company engaged in a wide range of programs for innovative defense and commercial applications.  For additional information, visit www.ElbitAmerica.com, or follow us on X, LinkedIn, Facebook, and YouTube.

    About Elbit Systems
    Elbit Systems is a leading global defense technology company, delivering advanced solutions for a secure and safer world. Elbit Systems develops, manufactures, integrates and sustains a range of next-generation solutions across multiple domains. Driven by its agile, collaborative culture, and leveraging Israel’s technology ecosystem, Elbit Systems enables customers to address rapidly evolving battlefield challenges and overcome threats. Elbit Systems employs approximately 20,000 people in dozens of countries across five continents. The Company reported $1.9 billion in revenues for the three months ending March 31, 2025, and an order backlog of $23.1 billion as of such date. For additional information, visit: https://elbitsystems.com/, follow us on Twitter, or visit our official Facebook, YouTube, and LinkedIn channels.


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  • FDA approves BioCryst's oral pellet version of swelling disorder drug for children – Reuters

    1. FDA approves BioCryst’s oral pellet version of swelling disorder drug for children  Reuters
    2. Why Are Retail Traders Going Gaga Over BioCryst Pharma Stock Today?  Stocktwits
    3. BioCryst’s Orladeyo wins expanded FDA approval  The Pharma Letter
    4. FDA approves berotralstat for patients aged 2 to  Contemporary Pediatrics
    5. FDA Gives Green Light to BioCryst’s (BCRX) ORLADEYO for Pediatri  GuruFocus

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