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BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically
Planning Phase 2 human proof-of-concept study to evaluate BXCL501 as a potential adjunctive treatment in MDD
Data further supportive of ongoing clinical programs evaluating BXCL501 for potential at-home use for agitation associated with schizophrenia or bipolar disorders (SERENITY III) and agitation associated with Alzheimer’s disease (TRANQUILITY II and III)
NEW HAVEN, Conn., May 16, 2023 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced positive top-line data from its Phase 1b multiple ascending dose (MAD) trial of BXCL501 (dexmedetomidine) sublingual film. BXCL501 is the Company’s proprietary, orally dissolving film under investigation for the treatment of agitation associated with neuropsychiatric disorders and as a potential adjunctive treatment in Major Depressive Disorder (MDD).
The trial was designed to evaluate the safety and tolerability of repeat dosing of BXCL501 in healthy volunteers as a single agent and in combination with antidepressant duloxetine. These results support dose selection for a Phase 2 proof-of-concept (POC) trial to evaluate BXCL501 in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs) to potentially accelerate antidepressant activity in patients with MDD.
“This positive outcome supports the potential market expansion opportunity for our lead asset, BXCL501, into chronic neuropsychiatric disorders,” said Vimal Mehta, CEO of BioXcel Therapeutics. “Our focus has been on developing innovative treatments for the millions of patients who are impacted by agitation episodes, including Alzheimer’s disease. Our first drug, IGALMI™, is approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. We believe these new data present a transformative opportunity beyond acute treatment for the BXCL501 program, including treatment for MDD. This drug candidate has a pipeline-within-a-product potential across a broad range of neuropsychiatric conditions.”
The study was a double-blind, placebo-controlled evaluation of BXCL501 for once- and twice-daily administration over seven days in ascending dose groups. The study’s primary objectives were to assess the safety, tolerability, and pharmacokinetics of BXCL501 in healthy volunteers in multiple ascending doses. The trial successfully met the primary endpoints.
BXCL501 is designed to activate human presynaptic alpha-2 adrenergic receptors, mediating the ‘fight-or-flight’ reflex that underlies the generation of anxiety and agitation. The Company believes this mechanism has the potential to treat depression where a patient’s insomnia, agitation and anxiety symptoms, core items in the Hamilton Depression Rating Scale (HAM-D), are slow to respond or worsen with current first-line SSRI/SNRI treatments.
“We are pleased with the safety and tolerability results observed across a broad range of BXCL501 in our first-ever chronic dosing trial in healthy volunteers and are encouraged that a maximum tolerated dose (MTD) was not attained,” said Robert Risinger, M.D., Chief Medical Officer, Neuroscience, of BioXcel Therapeutics. “We believe the results support further evaluation of this novel mechanism in combination with first-line standard of care SSRIs and SNRIs to potentially accelerate antidepressant effects, particularly in response to symptoms inadequately addressed by current agents. The data also support the ongoing pivotal SERENITY III and TRANQUILITY II and III trials in agitation.”
Summary of Top-line BXCL501 Phase 1 Study Results
- Multiple Ascending Dose (MAD) Study: 125 healthy adult volunteers were enrolled across seven different cohorts in a 2:1 randomization to BXCL501 or placebo film dosed for seven days. Four distinct cohorts received 30mcg, 60mcg, 80mcg, or 120mcg doses of BXCL501 or placebo once daily. Two additional dosing cohorts received twice-daily (BID) BXCL501 at either 30mcg in the morning and 60mcg in the evening, or 40mcg in the morning and 80mcg in the evening. The final escalation cohort evaluated BXCL501 at 60mcg in the morning and 80mcg in the evening in combination with 30mg of duloxetine BID.
- Safety and Tolerability Results: BXCL501 was well tolerated across all dosing cohorts. MTD was not reached, based on pre-specified stopping criteria. All adverse events were reported as mild or moderate. The most common adverse events reported were orthostatic hypotension, somnolence, headache, dizziness, and hypotension. The highest dose tested was acceptably tolerated in combination with duloxetine. No serious adverse events were reported and there were no adverse event-related dropouts in any cohort. Twice-daily dosing improved daytime tolerability versus comparable once-daily dosing in the morning.
- Pharmacokinetics: The profile of BXCL501 exhibited consistency between doses evaluated, proportional increases with dose, and no accumulation with once- or twice-daily dosing, consistent with the half-life of BXCL501. The pharmacokinetics of BXCL501 were similar with or without duloxetine coadministration.
BioXcel Therapeutics plans to present results from the Phase 1b MAD study at an upcoming medical conference.
The Company is developing a Phase 2 human POC trial design to investigate BXCL501 as an adjunctive treatment and its potential accelerant effect in combination with first-line SSRIs and SNRIs.
BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics believes that BXCL501 potentially targets an important mediator of agitation, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 is under investigation for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting, for the acute treatment of Alzheimer’s-related agitation, and as an adjunctive treatment for Major Depressive Disorder. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.
About IGALMI™ (dexmedetomidine) sublingual film
IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
- Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
- Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
- Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.
The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.
Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or [email protected].
About Major Depressive Disorder (MDD)
Major depression is the most common mental disorder in the U.S.1 and is the strongest risk factor for suicide behavior.2−4 From 2015 to 2019, there were widespread increases in depression without commensurate increases in treatment, and in 2020, past 12-month depression was prevalent among nearly 1 in 10 Americans.5 Over 300 million antidepressant prescriptions are filled annually in the U.S.,6 and current treatments are limited by slow onset of action and incomplete responses.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. The Company’s commercial product, IGALMI™ (developed as BXCL501), is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose. For more information, please visit igalmi.com and also see the IGALMI full Prescribing Information. BXCL501 is under evaluation for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for acute treatment of agitation associated with probable Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The safety and efficacy of BXCL501 for these uses have not been established. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia. Under its subsidiary, OnkosXcel Therapeutics, the Company is developing BXCL701, an investigational, oral systemic innate immune activator for the treatment of aggressive forms of prostate cancer and other solid and liquid tumors. The safety and efficacy of BXCL502 and BXCL701 have not been established. For more information, please visit bioxceltherapeutics.com.
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, the Company’s expected timing of, trial design and data results from, future clinical trials of BXCL501, potential safety and tolerability features of BXCL501, the potential benefits from treatment with BXCL501, other indications of potential use of BXCL501 and the Company’s plans to present results from the Phase 1b MAD study at an upcoming medical conference. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited experience in drug discovery and drug development; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502 and BXCL701 and other product candidates; its limited experience in marketing and selling drug products; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Source: BioXcel Therapeutics, Inc.
IGALMI™ is a trademark of BioXcel Therapeutics, Inc.
BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel Therapeutics, Inc.
All other trademarks are the properties of their respective owners.
Copyright © 2023, BioXcel Therapeutics, Inc. All rights reserved.
1. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–1858.
2. Chang SS, Stuckler D, Yip P, Gunnell D. Impact of 2008 global economic crisis on suicide: time trend study in 54 countries. BMJ. 2013;347:f5239.
3. Hasin DS, Goodwin RD, Stinson FS, Grant BF. Epidemiology of major depressive disorder: results from the National Epidemiologic Survey on Alcoholism and Related Conditions. Arch Gen Psychiatry. 2005;62(10):1097–1106.
4. World Health Organization. Depression. Geneva, Switzerland: World Health Organization. http://www.who.int/mediacentre/factsheets/fs369/en/. Published 2016. Accessed June 1, 2021.
5. Goodwin RD, Dierker L, Galea S, et al. Trends in U.S. Depression Prevalence From 2015 to 2020: The Widening Treatment Gap. Am J Prev Med. 2022; 63(5): 726-733.
6. IQVIA, 2021.
Cisco Doubles Down on Network Assurance with AWS
Cisco delivers seamless integration between ThousandEyes and Amazon CloudWatch Internet Monitor.ThousandEyes’ unmatched cloud and Internet visibility combined with AWS’s Internet health and performance insights will allow a complete view of an application’s entire service delivery path, across private environments, the public Internet and into AWS’s network.Customers benefit from new operational insights and recommendations enabling them to optimize deployments and assure exceptional digital experiences for any AWS-hosted application.LAS VEGAS, Nov. 28, 2023 /PRNewswire/ — AWS re:Invent — Today at AWS re:Invent 2023, Cisco (NASDAQ: CSCO) announced new integrations between Cisco ThousandEyes and Amazon CloudWatch Internet Monitor (CWIM), a new Internet monitoring service from Amazon Web Services (AWS). The first-of-its-kind integration empowers customers with unparalleled visibility into their cloud deployments, enabling them to deliver unmatched optimized digital experiences.
With this new integration, customers can leverage operational insights to ensure optimal placement of AWS instances and monitoring coverage based on user traffic profiles. This integration comes on the heels of ThousandEyes announcing AWS Network Path Enrichment, giving customers deeper visibility into AWS by enriching ThousandEyes Path Visualization with data from AWS data sources—helping customers work more collaboratively with providers to resolve issues that are impacting application performance.
Building upon the existing relationship between AWS and Cisco, the new integration demonstrates Cisco’s deep commitment to its end-to-end network assurance vision. Cisco securely and sustainably connects everyone to everything and assures the digital experience of every one of those connections. By working with AWS, Cisco is delivering on its promise to provide visibility into every domain that impacts digital experience—whether user, enterprise, Internet, or cloud—so it can ultimately provide artificial intelligence (AI)-driven insights, recommendations, and remediations to support the digital transformation of every customer, wherever they are on their journey.
“Since launching one year ago, Amazon CloudWatch Internet Monitor has delivered real-time insights into the traffic and performance of our customers’ AWS VPCs, CloudFront distributions, and Workspaces towards Internet destinations. In-depth Internet visibility is critical to our customers, so we’re excited to combine forces with ThousandEyes to provide a comprehensive view of Internet health.” — Robert Kennedy, VP of AWS Border Network Engineering, AWS
“Connectivity is key to Sutherland’s business model and to our customer interactions. Cloud visibility is a big part of that and with ThousandEyes’ end-to-end visibility all the way from our employees’ home environments to AWS, we’re able to quickly catch and resolve issues which allows us to deliver consistent high-quality application experiences to both our employees and customers.”—Ted Sanfilippo, VP Infrastructure, Head of Global Network Services and GTOC, Sutherland
“Customers today need to assure digital experiences over any network—the ones they own and the ones they don’t. As the leader in Internet visibility, Cisco is on a mission to deliver unmatched, end-to-end network assurance. Today’s integration with AWS demonstrates our shared commitment to empower our customers to more effectively monitor and manage their cloud environments.”— Mohit Lad, Senior Vice President and General Manager, Network Assurance, Cisco, and Co-Founder, ThousandEyes
For more information and live demos visit ThousandEyes at AWS re:Invent at booth #1621. Join our Lightning Talk on the exhibit floor: NET102-S, “Extending ThousandEyes visibility to the AWS network,” November 28 at 3:30 PM – 3:50 PM (PDT)
The Amazon CloudWatch Internet Monitor integration will be available in Cisco ThousandEyes in spring 2024. The ThousandEyes platform is available for purchase today in AWS Marketplace.Additional Resources
ThousandEyes Announcement BlogAWS Marketplace: CiscoCisco at AWS re:Invent 2023Additional Cisco news at AWS re:InventAbout CiscoCisco (NASDAQ: CSCO) is the worldwide technology leader that securely connects everything to make anything possible. Our purpose is to power an inclusive future for all by helping our customers reimagine their applications, power hybrid work, secure their enterprise, transform their infrastructure, and meet their sustainability goals. Discover more on The Newsroom and follow us on X at @Cisco. Cisco and the Cisco logo are trademarks or registered trademarks of Cisco and/or its affiliates in the U.S. and other countries. A listing of Cisco’s trademarks can be found at www.cisco.com/go/trademarks. Third-party trademarks mentioned are the property of their respective owners. The use of the word partner does not imply a partnership relationship between Cisco and any other company.
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Artificial Neural Network Market to Reach $1.4 Billion by 2032 at 19.9% CAGR: Allied Market Research
The growing demand for AI-based solutions and the rising need for intelligent business processes are expected to drive the global artificial neural network market growth.
NEW CASTLE, Del., Nov. 28, 2023 /PRNewswire/ — Allied Market Research published a report, titled, “Artificial Neural Network Market by Component (Solution and Service), Deployment Mode (On-premise and Cloud), Enterprise Size (Large Enterprises and Small & Medium-sized Enterprises), and Industry (Healthcare, BFSI, Retail and E-commerce, Manufacturing, Automotive, and Others): Global Opportunity Analysis and Industry Forecast, 2022–2032”. According to the report, the artificial neural network industry generated $227.8 million in 2022 and is anticipated to generate $1.4 billion by 2032, witnessing a CAGR of 19.9% from 2023 to 2032.
Prime determinants of growth
The notable factors positively affecting the artificial neural network market include the growing demand for AI-based solutions and the rising need for intelligent business processes. However, a lack of computational resources and a skilled workforce with expertise in artificial neural network (ANN) can hinder market growth. Furthermore, advancements in big data analytics and the availability of high-performance computing systems offer lucrative market opportunities for the market players.
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Report coverage & details:
Market Size in 2022
Market Size in 2032
No. of Pages in Report
Component, Deployment Mode, Enterprise Size Industry, and Region.
Growing demand for AI-based solutions
The rising need for intelligent business processes
Advancements in big data analytics.
The availability of high-performance computing systems.
A lack of computational resources and a skilled workforce with expertise in artificial neural network (ANN)
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The solution segment to maintain its leadership status throughout the forecast period
Based on component, the solution segment held the highest market share in 2022, accounting for less than two-fifths of the artificial neural network market revenue, and is estimated to maintain its leadership status throughout the forecast period. This is attributed to the growing need for a high level of personalization which is one of the primary reasons enterprises are increasing their investment in the artificial neural network market. However, the services segment is projected to manifest the highest CAGR of 21.8% from 2023 to 2032. The services segment is expected to witness the highest growth, as these services help to reduce the time and costs associated with optimizing systems in the initial phase of deployment.
The on-premise segment to maintain its lead position during the forecast period
Based on deployment mode, the on-premise segment accounted for the largest share in 2022, contributing for more than one-fourth of the artificial neural network market revenue. An increase in the need for secure and reliable data within the organization is fueling the market growth for on-premises-based artificial neural network solutions. However, the cloud segment is expected to portray the largest CAGR of 21.2% from 2023 to 2032 and is projected to maintain its lead position during the forecast period. It provides several advantages such as reducing costs, supporting business, and effectively controlling the business environment in the organization.
The large enterprises segment to maintain its lead position during the forecast period
Based on enterprise size, the large enterprises segment accounted for the largest share in 2022, contributing for more than one-fourth of the artificial neural network market revenue, owing to the growing demand for artificial neural network solutions in large enterprises which is fueling the market growth in these enterprises. However, the small and medium-sized enterprises segment is expected to portray the largest CAGR of 22.2% from 2023 to 2032 and is projected to maintain its lead position during the forecast period. It provides various benefits to the small and medium-sized enterprises organization.
The healthcare segment to maintain its lead position during the forecast period
Based on industry vertical, the healthcare segment accounted for the largest share in 2022, contributing for less than two-fifths of the artificial neural network market revenue, owing to the development of digital technologies in IT sector. However, the manufacturing segment is projected to manifest the highest CAGR of 24.3% from 2023 to 2032. The surge in implementation of automation trends and the increase in utilization of digital technology in this sector are expected to provide lucrative opportunities for the market.
North America region dominated the global artificial neural network market in 2022
Based on region, the North America segment held the highest market share in terms of revenue in 2022, accounting for less than two-fifths of the artificial neural network market revenue. The increase in the usage of artificial neural network solutions in businesses to improve businesses and the customer experience is anticipated to propel the growth of the market in this region. However, the Asia-Pacific segment is projected to manifest the highest CAGR of 21.8% from 2023 to 2032. Countries such as China, India, and South Korea are at the forefront, embracing digital technologies to enhance their effectiveness and competitiveness, which is further expected to contribute to the growth of the market in this region.
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Recent Product launches in the Artificial Neural Network Market
In April 2023, Google LLC launched a cloud-based automation toolkit for healthcare organizations and previewed Med-PaLM 2, a neural network capable of answering medical exam questions.In August 2021, IBM Corporation unveiled details of the upcoming new IBM Telum Processor designed to bring deep learning inference to enterprise workloads to help address fraud in real-time..Recent Partnerships in the Artificial Neural Network Market
In June 2023, Snowflake partnered with Microsoft to simplify joint customers’ artificial intelligence projects. A core focus of the collaboration is Microsoft’s Azure OpenAI Service. It provides cloud-based versions of OpenAI LP’s machine learning models, including GPT-4.In November 2021, Qualcomm Technologies partnered with Google Cloud, on Neural Architecture Search (NAS), enabling the companies to create and optimize AI models automatically rather than manually.Leading Market Players: –
Amazon Web Services Inc. Google Inc. Hewlett Packard Enterprise Development LP IBM Corporation Intel Corporation Microsoft Corporation NVIDIA Corporation Oracle Corporation Qualcomm Technologies Inc. Salesforce Inc.The report provides a detailed analysis of these key players in the artificial neural network market. These players have adopted different strategies such as new product launches, collaborations, expansion, joint ventures, agreements, and others to increase their market share and maintain dominant shares in different countries. The report is valuable in highlighting business performance, operating segments, product portfolio, and strategic moves of market players to showcase the competitive scenario.
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Allied Market Research (AMR) is a full-service market research and business-consulting wing of Allied Analytics LLP based in Wilmington, Delaware. Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of “Market Research Reports Insights” and “Business Intelligence Solutions.” AMR has a targeted view to provide business insights and consulting to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domain.
We are in professional corporate relations with various companies, and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Allied Market Research CEO Pawan Kumar is instrumental in inspiring and encouraging everyone associated with the company to maintain high quality of data and help clients in every way possible to achieve success. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry.
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New process definition capabilities in PIMS further enhance quality assurance and “right -first-time” initiatives for pharma manufacturers
WOKING, England, Nov. 28, 2023 /PRNewswire/ — IDBS unveils new process definition templates in its latest release, PIMS 5.1. Process definition templates enable pharma manufacturers to template process steps and quality specifications for faster process definition set-up and improved harmonization across the manufacturing teams to further enhance quality assurance (QA) and “right-first-time” initiatives.
Providing contextualized access to aggregated manufacturing data, PIMS offers a single source of data truth for efficient gathering, sharing and analysis of critical manufacturing process and quality data to support continued process verification (CPV), investigations and process optimization.
This release builds on recent PIMS’ process definition enhancements that added process definition versioning and approvals to help alleviate manual standard operating procedure (SOP) requirements and enhance QA for a more robust GxP environment.
PIMS’ customers report that these standardized process definition templates will reduce their manual process definition set-up and enable easy, harmonized site and product comparisons.
“Our customers recognize the value of being able to trace their process data over time, not only for tech transfer but also to help them learn from their historical data and optimize future process development,” says Pietro Forgione, General Manager at IDBS. “Having their critical process data in PIMS already gives them the assurance of data integrity and these new enhancements now make it even easier to complete QA and validation steps and move them closer to ‘right-first-time’ manufacturing.”
To learn more, register for the December 6 webinar here.
IDBS helps BioPharmaceutical organizations accelerate the discovery, development and manufacturing of the next generation of life-changing therapies that advance human health worldwide. From lab through manufacturing, IDBS leverages its 30+ years of experience working with a diverse list of customers – including 18 of the top 20 global BioPharma companies – and deep expertise in scientific informatics and process data management to tackle today’s most complex challenges.
Known for its signature IDBS E-WorkBook product, IDBS has extended solutions across the entire value chain for BioPharma Lifecycle Management (BPLM). Built on analytics-centric and cloud-native technology, IDBS Polar and Skyland PIMS platforms are powered by a digital data backbone to drive faster and smarter decisions in drug development and across the supply chain.
Learn more at idbs.com.
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- New process definition capabilities in PIMS further enhance quality assurance and “right -first-time” initiatives for pharma manufacturers
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