Artificial Intelligence
Progenics Pharmaceuticals Announces Phase 3 CONDOR Trial of PyL™ in Prostate Cancer Achieved Primary Endpoint
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– Met Primary Endpoint With a Correct Localization Rate of 84.8–87.0%, Highlighting Strong Diagnostic Performance NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) — Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, today announced positive top line results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL™ (18F-DCFPyL) in men with biochemical recurrence of prostate cancer. PyL is the Company’s PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.
“There is a need for improved diagnostics for prostate cancer to replace conventional imaging tests that have limited performance characteristics, especially in men with biochemical recurrence of their disease,” said Barry Siegel, MD, Professor of Radiology at Washington University School of Medicine in St. Louis. “The high positive predictive value demonstrated in this study reflects the clinical utility of PSMA-targeted PET imaging agents providing actionable information to physicians to guide treatment plans and improve disease management of one of the most prevalent cancers in the U.S.”
The Phase 3 CONDOR trial is a prospective, multi-center, open label pivotal trial in which 208 patients with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities (i.e. Axumin, Choline PET, CT/MR and/or bone scan) were dosed and imaged with PyL at 14 sites in the United States and Canada. The CONDOR trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy.
Safety results showed PyL was well tolerated, consistent with the Phase 2 OSPREY trial results. There was one serious adverse event of hypersensitivity reported in one patient as related to the study drug. The most frequent adverse event reported was headache, which was reported in four patients (1.9% of the trial population). “The positive results of our Phase 3 CONDOR trial reinforce our belief in the potential of PyL to enable better physician treatment decisions and, ultimately, improve patient outcomes. The rapid trial enrollment and physician support further underscore the excitement and positive reception of PyL as a new addition in the fight against prostate cancer and, together with the commercial performance of diagnostic agents in use today, reinforce our belief in the significant market opportunity for PyL,” said David Mims, Interim CEO. “Based on these positive results, we plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL in the second half of 2020.”
Additional results from the CONDOR trial are expected to be presented at an upcoming medical meeting.
Investor Conference Call About PyL™ for PET Imaging of Prostate Cancer About Prostate Cancer About PROGENICS
Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (PyL™ and 1404); and imaging analysis technology (aBSI and PSMA AI). Progenics has three commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy; and oral and subcutaneous formulations of RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which are partnered with Bausch Health Companies Inc.
Forward Looking Statements Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this press release. For more information, please visit www.progenics.com. Information on or accessed through our website or social media sites is not included in the company’s SEC filings. Contact
– Company Expects to Submit an NDA to the FDA in the Second Half of 2020
– Conference Call at 8:00 AM Eastern Time
Progenics will host a conference call today at 8:00 AM Eastern Time to discuss the results. The live and replayed webcast of the call will be available through the Company’s website at www.progenics.com. To participate in the live call by phone, dial (877) 250-8889 (USA) or (720) 545-0001 (international) and enter the passcode 9165086. The replay of the call will be available for 90 days.
PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted positron emission tomography (“PET”) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.
This press release contains projections and other “forward-looking statements” regarding future events. Statements contained in this communication that refer to Progenics’ estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics’ current perspective of existing trends and information as of the date of this communication and include statements regarding Progenics’ strategic and operational plans and delivering value for shareholders. Forward looking statements generally will be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “should,” “estimate,” “expect,” “forecast,” “outlook,” “guidance,” “intend,” “may,” “might,” “will,” “possible,” “potential,” “predict,” “project,” or other similar words, phrases or expressions. Such statements are predictions only and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others: risks associated with the proposed merger transaction with Lantheus Holdings, Inc.; market acceptance for approved products; the risk that the commercial launch of AZEDRA may not meet revenue and income expectations; the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations; the unpredictability of the duration and results of regulatory review of New Drug Applications (NDA) and Investigational NDAs; the inherent uncertainty of outcomes in the intellectual property disputes such as the dispute with the University of Heidelberg regarding PSMA-617; our ability to successfully develop and commercialize products that incorporate licensed intellectual property; the effectiveness of the efforts of our partners to market and sell products on which we collaborate and the royalty revenue generated thereby; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; possible product safety or efficacy concerns, general business, financial, regulatory and accounting matters, litigation and other risks; and risks related to changes in the composition of our Board of Directors following the delivery of shareholder consents in response to the recent consent solicitation conducted by one of our shareholders. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the Securities and Exchange Commission (the “SEC”), including those risk factors included in its Annual Report on Form 10-K for the year ended December 31, 2018, as updated in its subsequent Quarterly Reports on Form 10-Q. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
(PGNX-F)
Melissa Downs
Investor Relations
(646) 975-2533
[email protected]
Artificial Intelligence
Complyport’s new AI tool – ViCA.Chat – set to revolutionise compliance support services
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LONDON, June 14, 2024 /PRNewswire/ — ViCA.Chat, the Virtual Compliance Assistant powered by AI technology, is set to transform regulatory compliance consulting. Developed by ComplyMAP Group’s AI engineers and Complyport’s compliance consulting teams, ViCA redefines compliance support services and propels governance, risk and compliance consulting into a new era of innovation.
Offering real-time assistance across a vast array of UK and EU regulatory frameworks, ViCA delivers unparalleled efficiency, detail and precision in disentangling and dealing with complicated regulatory frameworks.
The key differentiator of ViCA is its specialised and purposely constructed unique databases that leverage Complyport’s 22 years of regulatory expertise, combined with tailored AI training tools, enabling ViCA to operate as an experienced compliance consultant. A dedicated human support team continuously improves and updates ViCA’s knowledge and responses through a feedback loop process and quality assurance sessions. This powerful symbiosis of AI and human expertise sets ViCA apart and ensures businesses have the latest regulatory information instantaneously and seamlessly.
As a result, ViCA’s specialised regulatory database goes beyond readily available online resources which feature into traditional AI tools. ViCA offers exclusive insights, proprietary regulatory interpretations, historical data, bespoke and purposely structured compliance documentation and templates. With advanced scraping capabilities, ViCA also extracts relevant data from selected websites and publicly available information, ensuring an up-to-date and comprehensive understanding of compliance requirements across industries.
From agile fintech startups to established law firms, financial institutions, regulatory bodies, insurance providers, as well as compliance consultants, ViCA seamlessly adapts to unique compliance needs. Its user-friendly interface ensures navigating and analysing regulatory data is swift and intuitive, streamlining the compliance workflow.
“ViCA is a game-changer in how regulatory compliance advice will be provided in the future”, commented Luis Parra, Managing Director of ViCA. “With ViCA, compliance insights become available to all. No longer are regulated firms and responsible people overly dependent on advisors and compliance consultants. Through ViCA, the financial system will not only meet but exceed regulatory standards. Moreover, the level of information made available to the public will benefit society as a whole, in its interactions with the financial services sector.”
Among ViCA’s revolutionary features is its cost-effective model, allowing businesses to significantly reduce reliance on traditional spending with external consultants and advisors.
Visit ViCA.Chat to experience the future of compliance support.
Contact:
Name: Luis ParraTitle: Managing DirectorCompany: Vica.ChatTelephone: +44 20 7399 4980 Email: [email protected]
About ViCA.Chat:
ViCA.Chat is a revolutionary Virtual Compliance Assistant powered by cutting-edge AI technology, designed to demystify the complexities of regulatory compliance. Utilising Complyport’s 22 years of regulatory expertise, ViCA offers real-time assistance and guidance across a wide range of regulatory frameworks, setting a new standard for efficiency and precision in compliance support. From fintech start-ups to established law firms, financial services institutions, regulators, regulatory firms, compliance consultants and insurance firms, ViCA caters to the diverse needs of professionals across all levels in the broader UK financial services sector.
Visit ViCA.Chat to learn more.
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Artificial Intelligence
LoRa and LoRaWAN IoT Market worth $32.7 billion by 2029- Exclusive Report by MarketsandMarkets™
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CHICAGO, June 14, 2024 /PRNewswire/ — The LoRa and LoRaWAN IoT Market is expected to reach USD 32.7 billion by 2029 from USD 8.0 billion in 2024, at a Compound Annual Growth Rate (CAGR) of 32.4 % during 2024–2029, according to a new report by MarketsandMarkets™.
Browse in-depth TOC on “LoRa and LoRaWAN IoT Market”
320 – Tables 58 – Figures294 – Pages
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Scope of the Report
Report Metrics
Details
Market size available for years
2018-2029
Base year considered
2023
Forecast period
2024–2029
Forecast units
Value (USD Billion)
Segments Covered
Offering, Network Deployment, Application, End User, and Region
Region covered
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
List of Companies in LoRa and LoRaWAN IoT
The Bosch Group (Germany), Cisco (US), Orange SA (France), Comcast Corporation (US), Semtech (US), NEC Corporation(Japan), Tata Communications (India), AWS (US), Advantech (Taiwan), SK Telecom (South Korea), Murata (Japan), Kerlink (France), Actility (France), Digi International (US), MultiTech (US), Ezurio (US), Sensoterra (Netherlands), Nwave Technologies (US), RAKwireless (China), TheThings.io (Spain), Datacake (Germany), Milesight (China), LORIOT (Switzerland), Exosite (US), Orbiwise (Switzerland), Netmore Group (Sweden), and Radio Bridge Inc (US).
The LoRaWAN ecosystem influences development of tools, software libraries, and cloud-based platforms that streamline the creation, deployment, and management of IoT solutions. Continuously evolving, this ecosystem boasts a burgeoning array of vendors providing LoRa-compliant devices, gateways, and network management solutions. This vibrant competition within the ecosystem propels innovation while driving down costs for end-users. Moreover, the development of interoperable solutions fosters seamless integration and deployment of LoRaWAN networks, simplifying the implementation process for businesses and organizations. As the ecosystem continues to expand and mature, it empowers developers, system integrators, and IoT enthusiasts to unleash their creativity, accelerate time-to-market, and unlock the full potential of LoRaWAN technology in diverse applications and industries.
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Based on network deployment, the public network segment to hold the largest market size during the forecast period.
The robust security features integrated into public LoRaWAN networks play a significant role in driving the growth and adoption of LoRaWAN technology in the market. End-to-end encryption ensures that data transmitted between devices and gateways is protected from unauthorized access or interception, safeguarding sensitive information such as sensor readings, location data, and command messages. Message integrity checks verify the integrity of data packets, detecting any tampering or alteration during transmission and ensuring data authenticity and reliability. Additionally, mutual authentication mechanisms establish trust between devices and gateways, verifying the identity of both parties before allowing communication to occur. These security measures provide organizations and end-users with confidence in the integrity and confidentiality of their data, mitigating concerns related to data privacy, cybersecurity threats, and regulatory compliance. As a result, implementing robust security features in public LoRaWAN networks enhances trust and credibility in the technology, driving increased adoption and market growth as organizations seek reliable and secure connectivity solutions for their IoT deployments.
By offering, the services segment is expected to hold a higher growth rate during the forecast period.
IoT service providers are pivotal in driving adoption by developing vertical-specific solutions finely tuned to the distinct needs of industries like agriculture, healthcare, logistics, and smart cities. In agriculture, for instance, IoT services offer solutions for precision farming, crop monitoring, and livestock management, enabling farmers to optimize irrigation, monitor soil health, and enhance yields. Similarly, IoT services facilitate remote patient monitoring, asset tracking, and inventory management in healthcare, improving patient care, reducing costs, and ensuring compliance with regulatory standards such as HIPAA. In logistics, IoT services provide real-time tracking of shipments, fleet management, and predictive maintenance, enhancing supply chain visibility, efficiency, and reliability. For smart cities, IoT services offer solutions for traffic management, waste management, energy optimization, and public safety, transforming urban infrastructure and enhancing the quality of life for residents. By addressing industry-specific challenges, compliance requirements, and use cases, vertical-specific IoT solutions deliver tangible business value, driving adoption and fueling the growth of the IoT services market across diverse sectors.
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Asia Pacific is expected to hold a higher growth rate during the forecast period.
In the Asia Pacific region, where agriculture serves as a cornerstone of many economies, adopting IoT technologies, particularly LoRa and LoRaWAN, is revolutionizing traditional farming practices. LoRaWAN’s long-range connectivity and low-power consumption make it well-suited for deployment in rural agricultural settings, where access to reliable connectivity may be limited. Through LoRa-based IoT solutions, farmers can implement precision agriculture techniques to address pressing challenges such as water scarcity, soil degradation, and unpredictable weather patterns. LoRa-enabled sensors facilitate real-time monitoring of soil moisture levels, temperature, and humidity, allowing farmers to optimize irrigation schedules and conserve water resources. Remote sensing technologies powered by LoRaWAN enable farmers to gather actionable insights on crop health, pest infestations, and nutrient deficiencies, facilitating timely interventions and improving overall crop management practices. Furthermore, LoRa-based crop analytics platforms provide farmers with data-driven decision support tools, helping them optimize planting strategies, improve yield forecasting, and mitigate the impact of climate change on agricultural productivity. By harnessing the power of LoRa and LoRaWAN IoT solutions, farmers in the Asia Pacific region can increase yields, conserve resources, and enhance resilience to environmental challenges, driving the adoption and growth of the LoRaWAN IoT market in the agricultural sector.
Top Key Companies in LoRa and LoRaWAN IoT Market:
The major vendors covered in the LoRa and LoRaWAN IoT Market are The Bosch Group (Germany), Cisco (US), Orange SA (France), Comcast Corporation (US), Semtech (US), NEC Corporation(Japan), Tata Communications (India), AWS (US), Advantech (Taiwan), SK Telecom (South Korea), Murata (Japan), Kerlink (France), Actility (France), Digi International (US), MultiTech (US), Ezurio (US), Sensoterra (Netherlands), Nwave Technologies (US), RAKwireless (China), TheThings.io (Spain), Datacake (Germany), Milesight (China), LORIOT (Switzerland), Exosite (US), Orbiwise (Switzerland), Netmore Group (Sweden), and Radio Bridge Inc (US). These players have adopted various growth strategies, such as partnerships, agreements and collaborations, new product launches, enhancements, and acquisitions to expand their footprint in the LoRa and LoRaWAN IoT Market.
Browse Adjacent Markets: Digitalization and Internet of Things (IoT) Market Research Reports & Consulting
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Artificial Intelligence
Scoring a Seat at UEFA EURO 2024™ with Top-Performing AI-Powered TOSHIBA TV Lineup
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HONG KONG, June 14, 2024 /PRNewswire/ — Football fans are in for a treat as they gear up for UEFA EURO 2024™ with Toshiba TV’s top-performing Gaming TV Z670. As the OFFICIAL TV OF UEFA EURO 2024™, Toshiba TVs present immersive viewing of the football game by their AI-powered TV lineup. To celebrate the brilliant moments it can bring, Toshiba TV are gifting USD100 Amazon Gift Card via their social platform! By simply like, follow and comment on @ToshibaTVGlobal, fans can boost their chances of scoring this prize.
Optimized Visuals Tailored for Football Dynamics
The Toshiba REGZA Engine ZRi in Z670 transports football fans into the heart of the action. With the AI Football Mode, they’ll be able to see fast-moving objects crystal clear and football field actions much enriched. To see their favourite player score that winning goal, the AI Picture Optimizer automatically adjusts visual contrast and precision adapted to the game. From vivid green fields and vibrant player kits, every play comes to life with AI 4K Upscaling and Quantum Dot Color, transforming lower-resolution broadcasts into near-4K quality and unleashing lifelike visual color.
Powerful Audio Effects for a Live Stadium Experience
The Toshiba TV Z670’s powerful audio system makes viewers feel like they’re right in the game. With the REGZA Bass Woofer Pro, Tru Bass Booster, and Dolby Atmos, they’ll experience heart-thumping 3D surround sound that captures the live stadium atmosphere. Whether it’s the roar of the crowd or the intensity of each play, the rich audio brings the excitement of each game right into their room.
Bringing Everyone Together for UEFA EURO 2024™
Available in sizes ranging from 55″ to 85″, Z670 is equipped with a Wide Viewing Angle and Anti-reflection features that ensures a clear picture from all viewing positions with the non-glare panel. Gather everyone for “Brilliant Every Moment” in UEFA EURO 2024™ with Toshiba TV!
Please find the high-resolution TVC here: Link
About Toshiba TV:
With 70+ years of history in TV production, Toshiba TV is known for its exquisite craftsmanship, innovative ideas and groundbreaking inventions. By prioritizing superior image quality and auditory experiences, Toshiba TV sets new standards in entertainment. Toshiba TV stems from the excellence quest of customers, providing the world with responsible products to make the world a better place. Emphasizing attention to product details and technological advancement, Toshiba TV integrates aesthetically pleasing design, quality assurance, and brand reputation to underscore its commitment to authenticity in the actual world and a sincere dedication to its consumers, showcasing Toshiba TV’s long-standing design philosophy and continuous pursuit of product quality.
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