OS

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, FDA, Clinical Trials, General Health, Pharmaceutical, OS, HER2, IHC, HR, Neutropenia, Congress, DXD, AstraZeneca, NSCLC, Progression-free survival, Patient, Stomatitis, Lung, Doctor of Philosophy, MD, Breast cancer, Anemia, PFS, Fatigue, ADC, Food, BLA, Daiichi Sankyo, PDUFA, Pharmaceutical industry

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • “The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable Non-Small Cell Lung Cancer (NSCLC) at High Risk of Recurrence in Adults

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Civil service commission, OS, Lung cancer, Survival, Disease, Risk, Patient, Committee, Neoplasm, EFS, Merck & Co., Cancer, Death, MRK, European Commission, Recurrence, PD-L1, Marketing, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
  • For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen.
  • The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen.
  • KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU.

MaaT Pharma Announces 2023 Annual Results and Provides a Business Overview

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Pharmaceutical, Finance, Oncology, Health, FDA, Professional Services, Clinical Trials, AP-HP, Bone marrow, Survival, Immunotherapy, Patient, Innovation, IND, Ipilimumab, European Medicines Agency, Therapy, Artificial intelligence, Charcot disease, ASH, EMA, Head, MET, Investigational New Drug, Nivolumab, Safety, SITC, Microbiome, Food, ODD, Development, Acceleration, Maat, ARES, Cancer, AACR, DSMB, Haematopoietic system, Annual general meeting, OS, EUR, Physician, CIMON, CGMP, EAP, EBMT, ICI, Society, Randomized controlled trial, Symantec Endpoint Protection, Pharmaceutical industry

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.
  • In December 2023 , the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) Annual Meeting.
  • In April 2023 , data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH meeting, were also presented at the EBMT 2023 conference.
  • During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
    Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.

SillaJen Submits CSR to the US FDA for REN026 Study in Patients with RCC

Retrieved on: 
Wednesday, March 27, 2024
Biotechnology, Manufacturing, FDA, Health, Pharmaceutical, Oncology, Research, Genetics, Engineering, Science, Clinical Trials, OS, Regeneron Pharmaceuticals, KOSDAQ, Patient, Renal cell carcinoma, Trial of the century, ICI, RCC, CSR, Safety, ICIS

SillaJen, Inc. (KOSDAQ: 215600) has submitted CSR to the US FDA on 06 Feb 2024 for REN026, a phase 1b/2a dose escalation and safety/efficacy evaluation study of Pexa-Vec in combination with cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC).

Key Points: 
  • SillaJen, Inc. (KOSDAQ: 215600) has submitted CSR to the US FDA on 06 Feb 2024 for REN026, a phase 1b/2a dose escalation and safety/efficacy evaluation study of Pexa-Vec in combination with cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC).
  • In 2017, SillaJen began a collaboration agreement with Regeneron for the clinical study of Pexa-Vec in combination with cemiplimab in patients with RCC.
  • The study was conducted in four study arms (A to D) to assess the safety and efficacy of the Pexa-Vec in combination with cemiplimab.
  • Given the typically lower response rates in patients with more prior extensive treatments, the results are considered highly encouraging.

Ouster Announces Record Revenue for Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, March 26, 2024
Technology, Audio, Video, Robotics, Automotive Manufacturing, Manufacturing, Automotive, Vehicle Technology, Autonomous Driving, Vehicles, Transport, Sustainability, Software, Hardware, Semiconductor, Satellite, OS, Growth, Webcast, Statistics, Chronos, Investment, Gemini, Safety, GAAP, ID, Motional, Silicon, Video game

Net loss of $39 million, compared to $35 million in the third quarter of 2023.

Key Points: 
  • Net loss of $39 million, compared to $35 million in the third quarter of 2023.
  • Adjusted EBITDA2 loss of $14 million, compared to a loss of $18 million in the third quarter of 2023.
  • "Ouster had a transformative year, reporting record revenue of $83 million and bookings of $142 million in 2023.
  • For the first quarter of 2024, Ouster expects to achieve $25 million to $26 million in revenue.

VulnCheck Adds Common Platform Enumeration (CPE) Data to its NVD++ Service to Improve Vulnerability Prioritization

Retrieved on: 
Monday, March 25, 2024
Technology, Security, Community, OS, National Vulnerability Database, NVD, Research, Software, NIST, CPE, JSON, API, Common Vulnerabilities and Exposures, Common Platform Enumeration, Government, CVE, Risk management

VulnCheck , the exploit intelligence company, today announced it is enhancing its Community Tier service, NVD++ , with Common Platform Enumeration (CPE) data currently missing from the National Institute of Standards and Technology (NIST) National Vulnerability Database (NVD).

Key Points: 
  • VulnCheck , the exploit intelligence company, today announced it is enhancing its Community Tier service, NVD++ , with Common Platform Enumeration (CPE) data currently missing from the National Institute of Standards and Technology (NIST) National Vulnerability Database (NVD).
  • By enriching NVD++ with CPE data, VulnCheck is helping solve an industry-wide issue, enabling defenders to identify vulnerable assets for newly published Common Vulnerabilities and Exposures (CVEs) in the NVD.
  • CPE data plays a crucial role in vulnerability management by providing a standardized method for identifying and documenting software applications, operating systems, and hardware components.
  • The source data VulnCheck used to produce “known vulnerable configurations” containing CPEs in NVD++ is the same used by NIST.

Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, March 21, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, OS, Pemetrexed, Chemotherapy, NSCLC, Progression-free survival, Patient, Carboplatin, Merck & Co., MRK, PARP, Cisplatin, PFS, Pharmaceutical industry

In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).

Key Points: 
  • In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).
  • The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies.
  • “These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer.
  • We sincerely thank the patients and investigators for their important contributions to this study.”

Stratodesk Partners with Island to Offer Modern, Secure Alternative Workspace

Retrieved on: 
Wednesday, March 20, 2024
Data Management, Security, Technology, Software, Networks, Internet, Hardware, OS, Organization, Data as a service, Software as a service, Environment, Partnership, VDI, Senior, Investment, Ecosystem, BYOD, Online shopping

Stratodesk and Island are offering customers an alternative choice to their traditional physical desktop, VDI or DaaS approach.

Key Points: 
  • Stratodesk and Island are offering customers an alternative choice to their traditional physical desktop, VDI or DaaS approach.
  • Partnering with Island advances this evolution by modernizing the browser, the now de-facto access point for the majority of business-critical applications.
  • Stratodesk NoTouch OS including Island’s certified solution, the Island Enterprise Browser, is available immediately.
  • Customers can get access to the solution by contacting their preferred channel partner or an Island or Stratodesk representative.

DigiLens ARGO™ Now Certified for Use with Leading Mobile Device Management (MDM) Solution Microsoft Intune

Retrieved on: 
Tuesday, March 19, 2024
Technology, Other Technology, Audio, Video, Mobile, Wireless, Software, Wearables, Mobile Technology, Hardware, Diamond, ARGO, Microsoft, OS, Continental AG, Qualcomm Snapdragon, Organization, Augmented reality, Microsoft Intune, XR, AOSP, Universal Display Corporation, MDM, Samsung Electronics, Samsung Electro-Mechanics, GameWeek Magazine, OEM, Mitsubishi Chemical Holdings, API, Niantic, Inc., Multimedia, Android, Human, Video game

DigiLens Inc., a leading nanotechnology innovator in waveguide display technologies and XR smartglasses, announces that its flagship Augmented Reality (AR) device, the DigiLens ARGO™, has been certified for use with Microsoft Intune , a leading cloud-based MDM solution.

Key Points: 
  • DigiLens Inc., a leading nanotechnology innovator in waveguide display technologies and XR smartglasses, announces that its flagship Augmented Reality (AR) device, the DigiLens ARGO™, has been certified for use with Microsoft Intune , a leading cloud-based MDM solution.
  • View the full release here: https://www.businesswire.com/news/home/20240319733368/en/
    DigiOS, ARGO's spatial-based OS, now certified for use with Microsoft Intune.
  • Microsoft Intune (part of Microsoft Endpoint Manager) offers support for AOSP (Android Open Source Program) device management.
  • Intune joins ArborXR as part of DigiLens’ expanding list of MDM solutions that enable enterprise customers to provision, configure, and secure DigiLens devices.

Global and China Automotive AUTOSAR Platform Research Report 2024 Featuring 10 International AUTOSAR Companies and 9 Chinese AUTOSAR Companies - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 19, 2024
Autonomous Driving, Vehicles, General Automotive, Technology, Automotive, Software, Eclipse, Algorithm, Face, University, Vehicle, MCU, EOL, Adapter, Original equipment manufacturer, SOA, Zero-copy, SDV, Dongfeng, CP, ADC, Baidu, Vector, AP, FC, Volkswagen, Attitude, Architecture, FAS, EEA, CES, Engineering, Diagnosis, Release, OS, Attention, 2,5-Dimethoxy-4-isopropylamphetamine, EM, DDS, Chery, Huawei, Ecosystem, Workload

The "Global and China Automotive AUTOSAR Platform Research Report, 2024" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global and China Automotive AUTOSAR Platform Research Report, 2024" report has been added to ResearchAndMarkets.com's offering.
  • AUTOSAR Platform research: the pace of spawning the domestic basic software + full-stack chip solutions quickens.
  • In the Release R23-11, the architecture of AUTOSAR Adaptive Platform (AP) is readjusted, and its functions are reorganized and described.
  • Driven by the boom of intelligent vehicles in China, AUTOSAR catches the increasing attention of the Chinese market, specifically:
    First, AUTOSAR works hard on layout in the Chinese market.