JAMA

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

Retrieved on: 
Friday, May 26, 2023
Disease, CRC, Progression-free survival, TAK, New Drug Application, JAMA, NDA, American Medical Association, VEGF, Journal, Patient, PDUFA, BSC, Phase, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCM, Food, Pharmaceutical industry, Takeda

OSAKA, Japan and CAMBRIDGE, Mass. and HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted priority review of the New Drug Application (“NDA”) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC.1,2 The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is November 30, 2023.

Key Points: 
  • — Prescription Drug User Fee Act (PDUFA) Target Action Date set for November 30, 2023 —
    OSAKA, Japan and CAMBRIDGE, Mass.
  • “We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda.
  • “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China.
  • “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients.

Genelux Corporation Announces Publication of Positive Topline Data from Phase 2 VIRO-15 Trial Evaluating Olvimulogene Nanivacirepvec (Olvi-Vec) in Platinum-Resistant or Refractory Ovarian Cancer in the Journal of the American Medical Association (JAMA) On

Retrieved on: 
Thursday, May 25, 2023
Genelux Corporation, Bevacizumab, Duration, Response, Progression-free survival, JAMA, CI, NA, Article, Trae Elston, Woman, Gynecologic Oncology (journal), Oncology, Spotify, Abdominal pain, Associate, JAMA Oncology, PFS, Death, ITunes, City, Medical director, MD, Patient, Neoplasm, Ovarian cancer, ORR, Safety, Disease, Pharmaceutical industry, Medical device, Platinum, Fever

“We are incredibly pleased to have the Phase 2 trial data featured as an Original Investigation in such a prominent peer-reviewed journal.

Key Points: 
  • “We are incredibly pleased to have the Phase 2 trial data featured as an Original Investigation in such a prominent peer-reviewed journal.
  • ORR by RECIST1.1 was 54% (95% CI, 33%-74%), with Duration of Response of 7.6 months (95% CI, 3.7-9.6 months).
  • Median PFS by RECIST1.1 was 11.0 months (95% CI, 6.7-13.0 months), and 6-month PFS rate was 77% in all patients.
  • We believe the currently enrolling Phase 3 OnPrime/GOG-3076 clinical trial will hopefully provide more evidence that we can produce a life changing therapy."

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

Retrieved on: 
Thursday, May 25, 2023
Research, FDA, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Disease, CRC, Progression-free survival, TAK, New Drug Application, JAMA, NDA, PFS, American Medical Association, VEGF, Journal, Patient, VEGFR, PDUFA, BSC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCM, Food, Pharmaceutical industry, Takeda

Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).
  • “We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda.
  • “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China.
  • “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients.

Strivr Advances Content Services with Generative AI, Expands VR Content Library with Mental Health & Well-Being Experiences

Retrieved on: 
Monday, May 22, 2023
Software, Professional Services, Training, Mental Health, Technology, Artificial Intelligence, Health Technology, Education, Data Analytics, Human Resources, Wearables, Mobile Technology, Health, Workforce, Virtual reality, JAMA, Partnership, Depression, Anxiety, Synthetic media, Cognitive science, VR, American Medical Association, Journal, Animation, L&D, SDK, Generative, HR, Artificial intelligence, Meditation, Mental health, Library, Conference, Data science, Video game

With nearly 60,000 hours of content creation experience, Strivr has driven measurable impact for its enterprise customers through a best-in-class content library in the areas of cost savings, increased sales, and faster onboarding.

Key Points: 
  • With nearly 60,000 hours of content creation experience, Strivr has driven measurable impact for its enterprise customers through a best-in-class content library in the areas of cost savings, increased sales, and faster onboarding.
  • “The demand for high-quality, scalable VR experiences that deliver meaningful and impactful results is at an all-time high,” said Derek Belch, founder and CEO at Strivr.
  • Building on this newly expanded offering, Strivr also offers customers choice when it comes to sourcing content to build out their VR libraries.
  • To experience Strivr Home and new content offerings, please visit Strivr at the ATD23 Conference in San Diego, May 21-23 (Booth #1945), or visit www.strivr.com .

Dupixent® (dupilumab) Late-breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine

Retrieved on: 
Sunday, May 21, 2023
COPD, The New England Journal of Medicine, Depression, Smoking, University, Hospital, Anxiety, ATS, JAMA, Quality of life, Risk, Associate, Cough, NEJM, Sleep, Chronic obstructive pulmonary disease, Periodic breathing, Regeneron Pharmaceuticals, Clinical trial, American Thoracic Society, International Conference on Population and Development, Patient, Health, Death, Conference, News, Disease, Critical Care Medicine (journal), Pharmaceutical industry, Medicine, Dupilumab, Sanofi

TARRYTOWN, N.Y. and PARIS, May 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive Phase 3 results evaluating the investigational use of Dupixent® (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. The Dupixent Phase 3 results were presented in the 2023 American Thoracic Society (ATS) International Conference session “New England Journal of Medicine and JAMA. Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM). These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22.

Key Points: 
  • The Dupixent Phase 3 results were presented in the 2023 American Thoracic Society (ATS) International Conference session “New England Journal of Medicine and JAMA.
  • Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM).
  • These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22.
  • The results presented at ATS and published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints.

Press Release: Dupixent® (dupilumab) late-breaking Phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine

Retrieved on: 
Sunday, May 21, 2023
COPD, The New England Journal of Medicine, Depression, Smoking, University, Hospital, Associate professor, Critical Care Medicine (journal), Anxiety, ATS, JAMA, Quality of life, Risk, Cough, NEJM, Sleep, Chronic obstructive pulmonary disease, Periodic breathing, Clinical trial, American Thoracic Society, International Conference on Population and Development, Patient, Health, Death, Conference, News, Disease, Pharmaceutical industry, Dupilumab, Medicine

Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM).

Key Points: 
  • Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine (NEJM).
  • These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22.
  • The results presented at ATS and published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints.
  • The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

Suzuki, Daihatsu, and Toyota to Unveil Mini-Commercial Van Electric Vehicles

Retrieved on: 
Wednesday, May 17, 2023
BEV, Transport, Bev, Exhibition, Japan Automobile Manufacturers Association, Carbon, CN, JAMA, Automotive industry, Daihatsu, Suzuki

Toyota City, Japan, May 17, 2023 - (JCN Newswire) - Suzuki Motor Corporation (Suzuki), Daihatsu Motor Co., Ltd. (Daihatsu), and Toyota Motor Corporation (Toyota) will unveil prototype mini-commercial van electric vehicles (BEVs) equipped with a jointly developed BEV system.

Key Points: 
  • Toyota City, Japan, May 17, 2023 - (JCN Newswire) - Suzuki Motor Corporation (Suzuki), Daihatsu Motor Co., Ltd. (Daihatsu), and Toyota Motor Corporation (Toyota) will unveil prototype mini-commercial van electric vehicles (BEVs) equipped with a jointly developed BEV system.
  • The exhibition event will be organized by the Japan Automobile Manufacturers Association (JAMA) along with the G7 Hiroshima Summit.
  • Daihatsu will produce the vehicles, and Suzuki, Daihatsu, and Toyota will each release their own version within fiscal 2023.
  • The three companies Suzuki, Daihatsu, and Toyota will continue to promote efforts to achieve CN by providing sustainable means of transportation.

New Data Release Highlights Japanese-Brand Automakers’ Contributions to U.S. Economy, Workforce

Retrieved on: 
Tuesday, May 16, 2023
Vehicle Technology, Performance & Special Interest, EV, Electric Vehicles, Fleet Management, Alternative Vehicles, Fuels, General Automotive, Automotive, Autonomous Driving, Vehicles, Advocacy Group Opinion, Automotive Manufacturing, Other Automotive, Public Policy, Government, Manufacturing, Employment, JAMA, COVID-19, Multimedia, Doctor of Philosophy, Investment, Japan Automobile Manufacturers Association, Growth, Director general, Motorcycle, Car dealership

View the full release here: https://www.businesswire.com/news/home/20230516005207/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230516005207/en/
    The contributions update shows that Japanese-brand automakers have continued to invest in American manufacturing and have cumulatively invested over $60.4 billion since first starting production in 1982.
  • The update also highlights how Japanese-brand automakers directly employ over 107,000 U.S workers and have continued to invest in areas beyond the manufacturing floor.
  • In addition to JAMA's annual contributions data, Dr. Prusa's employment study shows that in 2022, Japanese-brand automobile direct employment supported 499,000 intermediate jobs and 399,000 additional “spin-off” jobs.
  • The study also highlights the $197 billion in employee compensation across Japanese-brand automakers’ manufacturing and supporting operations and new vehicle dealers' employment.

TGH Imaging has Expanded Its Hologic Genius™ 3D Mammography™ Services Across 18 Centers in 4 Counties

Retrieved on: 
Monday, May 15, 2023
The Lancet, Conant, E pluribus unum, Enterprise, Hologic, 3D, Gates Rubber Company v. Bando Chemical Industries, Ltd., et al, Breast cancer, Breast, Radiology, Cancer, CAD, Woman, Tomosynthesis, Macdonald, Synthesis, 2D, Mammography, SM, Patient, Tampa General Hospital, JAMA Oncology, Digital, FDA, SVP, Computer-aided, JAMA, Medical imaging

TAMPA, Fla., May 15, 2023 /PRNewswire/ -- As the need for more advanced technology continues to grow, TGH Imaging is increasing patient access across four counties for breast cancer screening by adding Genius™ 3D Mammography™ exams made by Hologic to 18 locations in Hillsborough, Pasco, Pinellas and Palm Beach counties. Also called tomosynthesis, 3D mammography is a form of mammography that creates a 3D image of the breast that can better detect breast cancer.

Key Points: 
  • Also called tomosynthesis, 3D mammography is a form of mammography that creates a 3D image of the breast that can better detect breast cancer.
  • "3D mammography has become the superior choice in breast imaging," said Dr. JoAnn Gierbolini, a Women's subspecialized radiologist at TGH Imaging and collaborative assistant professor at the USF Morsani College of Medicine.
  • A 3D mammogram can be done in conjunction with a synthesized 2D mammogram and does not require additional exam time or compression.
  • "3D Mammography is the standard of care in breast imaging, and we're thrilled to expand this service further throughout TGH Imaging," says Sherri Lewman, SVP of Enterprise Imaging at Tampa General Hospital.

ECINS Student Mental Health Survey Emphasizes Challenges for Adolescents During Mental Health Awareness Month

Retrieved on: 
Tuesday, May 9, 2023
School, Communication, JAMA, Violence, National Assessment of Educational Progress, Mental Health Awareness Month, CDC, American Medical Association, Student, Journal, Community, Growth, Mental health, Counselor, Nursing, Management, Tutoring, The New York Times

JERSEY CITY, N.J., May 9, 2023 /PRNewswire-PRWeb/ -- ECINS, the global provider of a unique, collaborative, cloud-based case management system for schools, commemorates Mental Health Awareness Month at a critical time for student mental health.

Key Points: 
  • Survey emphasizes the crucial role schools play in addressing students' mental health and the need for innovative, collaborative technology solutions.
  • JERSEY CITY, N.J., May 9, 2023 /PRNewswire-PRWeb/ -- ECINS , the global provider of a unique, collaborative, cloud-based case management system for schools, commemorates Mental Health Awareness Month at a critical time for student mental health.
  • Schools are increasingly on the front lines of this enormous challenge, and ECINS' The State of Student Mental Health Survey highlights these trends.
  • ECINS' survey identified technology as a solution, helping school personnel connect students to resources and support their growth and development.