Health Sciences Authority

Molecular Targeting Technologies, Inc. and Molecular Theranostics Center of Singapore Receive HSA Approval for Clinical Trial Authorization for EBTATE® in Nasopharyngeal Cancer

Retrieved on: 
Wednesday, August 2, 2023
Research, Clinical Trials, Biotechnology, Radiology, Health, Pharmaceutical, General Health, Science, Oncology, NICS, Nephrotoxicity, Prevalence, GBM, Half-life, National University of Singapore, National university, Glomus tumor, Safety, Hope, CTA, Multimedia, NSCLC, Lung cancer, HTC, Glioblastoma, Death, Carcinoma, Serum albumin, MD, NCIS, Patient, PRRT, Outline of health sciences, Cancer, SSTR2, Neoplasm, NPC, MTCS, Health Sciences Authority, HSA, NUS, Pharmaceutical industry, Medical imaging

Molecular Targeting Technologies, Inc. (MTTI), and its wholly owned subsidiary, Molecular Theranostic Center of Singapore (MTCS), announced the approval of a Clinical Trial Authorization (CTA) application by the Health Sciences Authority (HSA) of Singapore.

Key Points: 
  • Molecular Targeting Technologies, Inc. (MTTI), and its wholly owned subsidiary, Molecular Theranostic Center of Singapore (MTCS), announced the approval of a Clinical Trial Authorization (CTA) application by the Health Sciences Authority (HSA) of Singapore.
  • View the full release here: https://www.businesswire.com/news/home/20230802243597/en/
    Somatostatin receptor 2 (SSTR2) is found in 81% of primary, recurrent, and metastatic NPC patients.
  • A recent three-year clinical trial follow-up* showed EBTATE was effective at controlling tumor and well tolerated without serious adverse events or nephrotoxicity.
  • MTTI’s products include: EBTATE (neuroendocrine tumors (“NET”); Hürthle thyroid cancer (HTC), and nasopharyngeal cancer (NPC); EBRGD for non-small cell lung cancer (NSCLC) and glioblastoma (GBM).

Chinese Patent Granted for A*STAR Spinoff, CytoMed Therapeutics' Licensed Allogeneic CAR-Gamma Delta T Cell Technology

Retrieved on: 
Tuesday, August 1, 2023
GMP, China National Intellectual Property Administration, Patent, Antigen, CNIPA, Partnership, IPSC, NKT, STAR, National University Hospital, Clinical trial, Cell, Immunotherapy, CN, NUH, Agency for Science, Technology and Research, Hematological Cancer Research Investment and Education Act, Biological patents in the United States, Risk, A*STAR, Cytomics, Blood, Agency, Cancer, Same, Outline of health sciences, Health Sciences Authority, T, HSA, NKG2D, Pharmaceutical industry, Vaccine, Science, Research

SINGAPORE, Aug. 1, 2023 /PRNewswire/ -- CytoMed Therapeutics Limited (NASDAQ: GDTC) ("CytoMed" or "Company"), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor-derived cell-based immunotherapies for the treatment of various cancers, announced that the chimeric antigen receptor gamma delta T cell (CAR-γδ T cell) technology, which is exclusively licensed from the Agency for Science, Technology and Research (A*STAR), has been granted a patent by the China National Intellectual Property Administration (CNIPA).

Key Points: 
  • The Company holds an exclusive, worldwide license, for use in immunotherapy, including stem cell therapy, until the expiration of the patent covering technology.
  • CytoMed's CAR-γδ T cell technology has been developed as an investigational cancer therapy to target NKG2D ligands, a type of stress-induced cancer antigens.
  • The Company's other licensed technology from A*STAR is an induced pluripotent stem cell (iPSC)-based technology to derive a novel synthetic γδ NKT cells for the treatment of various types of cancers.
  • A patent for this proprietary technology has already been granted in Japan, and this asset is under preclinical development.

Significantly Reduce Manufacturing Cost and Increased Local Production: SCG Cell Therapy Opens State-of-the-art Cell Therapy Manufacturing Facility and R&D Centre in Singapore

Retrieved on: 
Wednesday, July 19, 2023
GMP, White House, Biotechnology, IPSC, Cell therapy, Innovation, Infection, Cell, SCG, Government, Ministry, Agency for Science, Technology and Research, Patient, CGMP, Risk, A*STAR, Agency, Outline of health sciences, Cancer, EDB, Growth, The Singapore Economic Review, R, Health Sciences Authority, Christy, FDA, HSA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ministry of Trade and Industry, Food, Pharmaceutical industry, Fine chemical, State, Science, Research

SCG Cell Therapy celebrates the opening of its new Cell Therapy Manufacturing Facility and R&D Centre, launching a new first-of-its-kind automatic cell therapy manufacturing system in Singapore, pioneering Singapore's Manufacturing 2030 Vision.

Key Points: 
  • SCG Cell Therapy celebrates the opening of its new Cell Therapy Manufacturing Facility and R&D Centre, launching a new first-of-its-kind automatic cell therapy manufacturing system in Singapore, pioneering Singapore's Manufacturing 2030 Vision.
  • Facility will substantially increase local production capacity while significantly reducing the cost of cell therapy.
  • In 2021, SCG collaborated with the Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF) to validate its proprietary closed and automated cell therapy manufacturing system.
  • "Apart from the cGMP facility, SCG Cell Therapy is also opening an R&D centre to facilitate the research of its pipeline of cell therapy product candidates.

A*STAR Spinoff CytoMed Therapeutics Announce a Patent for its Licensed CAR-Gamma Delta T Cell Technology Has Been Granted in the US

Retrieved on: 
Thursday, July 6, 2023
Yee, Patent, Antigen, Cytomics, IPSC, NKT, STAR, National University Hospital, Alberta Enterprise Group, United States patent law, Innovation, Research, Immunotherapy, NUH, Assistant, CAR, Cancer, Hematological Cancer Research Investment and Education Act, Gamma delta T cell, Biological patents in the United States, Patient, Risk, A*STAR, Same, Outline of health sciences, Health Sciences Authority, Therapy, T, HSA, NKG2D, Vaccine

Our CAR-γδ T cell technology has received a US patent as we embark on our first-in-human trial.

Key Points: 
  • Our CAR-γδ T cell technology has received a US patent as we embark on our first-in-human trial.
  • CytoMed holds an exclusive, worldwide license, for use on immunotherapy, including stem cell therapy, until the expiration of the patent covering technology.
  • The Company's other licensed technology from A*STAR is an induced pluripotent stem cell (iPSC)-based technology to derive γδ NKT cells for cancer treatments.
  • A patent for this proprietary technology has already been granted in Japan and this asset is under preclinical development.

CorDx COVID-19 Antigen Test Receives Approval for Use in Singapore

Retrieved on: 
Thursday, March 2, 2023
Health Sciences Authority, Safety, Public, SAN, COVID-19, Outline of health sciences, HSA, Health, Pharmaceutical industry, Vaccine

The test is designed for non-prescription home use and features a 10-minute time to result.

Key Points: 
  • The test is designed for non-prescription home use and features a 10-minute time to result.
  • The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
  • On January 12, 2023, CorDx announced a new Asia-Pacific (APAC) business development center in Singapore, as well as plans for an R&D laboratory there.
  • For more information about the CorDx COVID-19 AG Test or to inquire about wholesale opportunities, visit cordx.com .

Remidio's Revolutionary AI on a smartphone for Referable Diabetic Retinopathy (DR) Receives EU MDR Class II Regulatory Approval

Retrieved on: 
Thursday, February 23, 2023
Diabetes, Moorfields Eye Hospital, Paratriathlon, Smartphone, DR, Research, FDA, Health Sciences Authority, Patient, Instituto de Química Física de los Materiales, Medio Ambiente y Energía, AI, HSA, Sale, Dietary Reference Intake, Professor, Federal Food, Drug, and Cosmetic Act, Deep learning, Outline of health sciences, Physician, Medicine, Medical device

BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR. This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.

Key Points: 
  • BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR.
  • This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.
  • Dr. Divya Rao, Remidio's Medical Director & Head of AI, called the approval a 'key milestone' as the first step towards transforming global DR screening.
  • Remidio's vision to eradicate preventable blindness has led it to publish research on a device-agnostic application for Medios DR AI.

Remidio's Revolutionary AI on a smartphone for Referable Diabetic Retinopathy (DR) Receives EU MDR Class II Regulatory Approval

Retrieved on: 
Thursday, February 23, 2023
Diabetes, Moorfields Eye Hospital, Paratriathlon, Smartphone, DR, Research, FDA, Health Sciences Authority, Patient, Instituto de Química Física de los Materiales, Medio Ambiente y Energía, AI, HSA, Sale, Dietary Reference Intake, Professor, Federal Food, Drug, and Cosmetic Act, Deep learning, Outline of health sciences, Physician, Medicine, Medical device

BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR. This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.

Key Points: 
  • BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR.
  • This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.
  • Dr. Divya Rao, Remidio's Medical Director & Head of AI, called the approval a 'key milestone' as the first step towards transforming global DR screening.
  • Remidio's vision to eradicate preventable blindness has led it to publish research on a device-agnostic application for Medios DR AI.

InnoCare Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Mantle Cell Lymphoma in Singapore

Retrieved on: 
Tuesday, November 22, 2022
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, FDA, NMPA, Outline of health sciences, Breakthrough therapy, HKEX, Neuromyelitis optica spectrum disorder, Knowledge, MCD, National Medical Products Administration, ITP, Health Sciences Authority, Cancer, SSE, Mantle cell lymphoma, NDA, CLL, Lymphoma, DLBCL, Safety, Degenerative disease, HSA, SLL, Food and Drug Administration, B-cell lymphoma, Disclosure, NMOSD, NHL, SLE, BTK, MCL, NRDL, Food, Multiple sclerosis, New Drug Application, Patient, Incidence, Fine chemical, Pharmaceutical industry

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, Orelabrutinibs NDA approval in Singapore marks the commercialization of InnoCare go international.

Key Points: 
  • Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, Orelabrutinibs NDA approval in Singapore marks the commercialization of InnoCare go international.
  • As a highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy and safety in the treatment of R/R MCL.
  • The approval in Singapore will offer a new option to the local MCL patients with the innovative therapy.
  • Mantle cell lymphoma (MCL) is a unique subtype of B-cell non-Hodgkin's lymphoma (NHL), which is invasive and incurable, with increasing incidence rate year by year1.

A Pain Relief Option That Is Only Possible When East Meets West

Retrieved on: 
Monday, November 21, 2022
Spouse, Health Sciences Authority, Health, Pain, Drug development, Nonsteroidal anti-inflammatory drug, Inflammation, PPT, Pharmaceutical industry, Frankincense

FORT LAUDERDALE, Fla., Nov. 21, 2022 /PRNewswire/ -- The health and wellness industry is currently suffering from an excess of pain relief options. From dangerously strong NSAIDs to highly skeptical homeopathic dilutions, consumers face an endless selection of products to choose from. Typically, they are left to choose something that lines up with their personal lifestyles and then accept that it comes with shortcomings and an inability to comprehensively address their pain.

Key Points: 
  • FORT LAUDERDALE, Fla., Nov. 21, 2022 /PRNewswire/ -- The health and wellness industry is currently suffering from an excess of pain relief options.
  • From dangerously strong NSAIDs to highly skeptical homeopathic dilutions, consumers face an endless selection of products to choose from.
  • This oversaturation of the pain relief market is largely fueled by the extreme diversity between different medicinal viewpoints.
  • Proflexa is already a solution that stands on its own as a unique, effective, and revolutionary way to relieve pain.

Cue Health to Announce Third Quarter 2022 Financial Results

Retrieved on: 
Wednesday, October 26, 2022
General Health, Health Technology, Health, Union, Health Sciences Authority, Telephone, Hand, Interim order, Central Drugs Standard Control Organisation, Nasdaq, PSAR, Cue, Health Canada, Health, CE, FDA, COVID-19

Cue Health Inc. (Cue) (Nasdaq: HLTH), a healthcare technology company, announced today that it will release its third quarter 2022 financial results on Wednesday, November 9, 2022.

Key Points: 
  • Cue Health Inc. (Cue) (Nasdaq: HLTH), a healthcare technology company, announced today that it will release its third quarter 2022 financial results on Wednesday, November 9, 2022.
  • In conjunction with the release, Cue will host a conference call and webcast that day at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss its financial results and recent highlights.
  • Cue Health (Nasdaq: HLTH) is a healthcare technology company that makes it easier for individuals to access health information and places diagnostic information at the center of care.
  • Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, regulatory approval from India's Central Drugs Standard Control Organization, and PSAR authorization from Singapore's Health Sciences Authority.