US FDA

Jubilant Therapeutics Inc. announces US FDA clearance of IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor, for treatment of solid tumors with brain metastases and primary brain tumors

Retrieved on: 
Wednesday, August 3, 2022
SAM, Algorithm, US FDA, Phase, Brain, Investigational New Drug, PRMT5, Jubilant, Degenerative disease, Food, Patient, Company, CNS, Disease, Cancer, JBI, Pharmacokinetics, Metastasis, Therapy, Incidence, Food and Drug Administration, US, Medical imaging, Pharmaceutical industry, IND

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement,"JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802.

Key Points: 
  • Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement,"JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802.
  • These two programs, along with several others partnered or in preclinical development, highlight Jubilant Therapeutics' proven discovery engine and structure-based drug discovery expertise."
  • Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said,"JBI-778was engineered by our drug discovery team to be a PRMT5 substrate-competitive and brain penetrant drug candidate to address primary brain tumors and brain metastases which currently have limited treatment options.
  • JBI-778 is a potent and selective brain penetrant inhibitor of protein arginine methyl transferase 5 (PRMT5), which is overexpressed in many cancers.

LG Chem Enters Final Stage of Clinical Development for New Gout Drug

Retrieved on: 
Wednesday, August 3, 2022
Science, Other Science, Research, Pharmaceutical, General Health, Health, FDA, Clinical Trials, LG Chem, Inborn errors of metabolism, US FDA, LG, Comparison, Month, Gout, Xanthine, Patient, Company, Lists of diseases, Diabetes, Safety, Ageing, Hyperuricemia, IND, Adult, Uric acid, Population, Pharmaceutical industry

LG Chem recently announced that the Company has submitted an IND application to the US FDA for its first independent global Phase 3 clinical trial of its new gout drug Tigulixostat (clinical program name: EURELIA_1 Study).

Key Points: 
  • LG Chem recently announced that the Company has submitted an IND application to the US FDA for its first independent global Phase 3 clinical trial of its new gout drug Tigulixostat (clinical program name: EURELIA_1 Study).
  • Additionally, LG Chem will be submitting an application to the US FDA for a comparative study with Allopurinol, a first line treatment of gout.
  • LG Chem aims to enter the global gout market in 2028 after obtaining US FDA approval for Tigulixostat as a first line treatment.
  • LG Chem Life Sciences is a business division within LG Chem, engaged in development, manufacturing and global commercialization of pharmaceutical products.

ImmunAbs Inc. Announces US FDA Approval for a Phase 1 Clinical Trial

Retrieved on: 
Wednesday, August 3, 2022
FDA, Diabetes, Health, Pharmaceutical, Clinical Trials, Human, PNH, USD, US FDA, Paroxysmal nocturnal hemoglobinuria, Standard of care, Fatigue, Metabolic syndrome, Degenerative disease, Patient, Paroxysmal attack, Time-invariant system, Seasonal adjustment, US, Anemia, Membrane protein, KRW, Therapy, Diabetic retinopathy, Immune system, Dream, Clinical trial, Growth, Pharmaceutical industry, Vaccine

ImmunAbs Inc. ( www.immunabs.com ) announced that it has received US FDA approval for a Phase 1 clinical trial and that it is now ready to initiate a phase 1 clinical trial in the United States.

Key Points: 
  • ImmunAbs Inc. ( www.immunabs.com ) announced that it has received US FDA approval for a Phase 1 clinical trial and that it is now ready to initiate a phase 1 clinical trial in the United States.
  • ImmunAbs new complement therapeutic IM-101 targets the safest and most potent component of the complement system, complement C5.
  • ImmunAbs will initiate a phase 2a clinical trial in the United States in 2024.
  • Currently, ImmunAbs has several antibody therapeutics in global standard development for autoimmune diseases, diabetic retinopathy, and metabolic syndrome.

ProfoundBio Receives FDA "Study May Proceed" Letter for PRO1184, a Folate Receptor Alpha-Directed ADC with a Topoisomerase 1 Inhibitor Payload, and Welcomes Naomi Hunder, M.D., as Chief Medical Officer

Retrieved on: 
Wednesday, August 3, 2022
Thomas Jefferson University, Chief executive officer, US FDA, VP, Genetics, Medical Affairs Bureau, CDX, Food, Patient, Therapeutic index, Safety, FDA, Fred Hutchinson Cancer Research Center, Internal medicine, IND, AACR, Seagen, Conjugation, Carleton College, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, Cancer, Research, Therapy, FRA, Doctor of Philosophy, Control, University, Mesothelioma, US, Breast, Pharmaceutical industry, Biology

PRO1184 is an antibody-drug conjugate comprising a folate receptor alpha (FRa) directed antibody conjugated to an exatecan payload with a novel, proprietary hydrophilic linker.

Key Points: 
  • PRO1184 is an antibody-drug conjugate comprising a folate receptor alpha (FRa) directed antibody conjugated to an exatecan payload with a novel, proprietary hydrophilic linker.
  • Additionally, ProfoundBio announced the appointment of Naomi Hunder, M.D., as Chief Medical Officer.
  • "I am thrilled to welcome Dr. Hunder to the ProfoundBio leadership team, especially during this pivotal transition into a clinical-stage oncology company.
  • Dr. Hunder most recently served as Chief Medical Officer of Silverback Therapeutics, a company focused on the advancement of novel immunotherapies.

ViiV Healthcare and the Medicines Patent Pool Sign New Voluntary Licensing Agreement to Expand Access to Innovative Long-Acting HIV Prevention Medicine

Retrieved on: 
Thursday, July 28, 2022
Biotechnology, Infectious Diseases, AIDS, Health, Pharmaceutical, Infection, HIV-positive people, Diagnosis, Sale, Acquisition, Rash, LA, Sustainable Development Goals, Fever, Food, Use, ViiV Healthcare, Woman, CEO, HIV-1, STI, Medicines Patent Pool, Partnership, Fatigue, Risk, Shionogi, Partner (business rank), MPP, US, Myalgia, Pre-exposure prophylaxis, US FDA, News, Pfizer, GSK, US Foods, FDA, Adolescence, Sustainable Development Goal 3, Central Public Security Comprehensive Management Commission, Subtypes of HIV, HIV, Unitaid, Fortis Healthcare, Non-governmental organization, Condom, Medicine, Pharmaceutical industry, Birth control, Vaccine

Access to an effective long-acting HIV prevention option could significantly contribute towards the goal of ending the epidemic.

Key Points: 
  • Access to an effective long-acting HIV prevention option could significantly contribute towards the goal of ending the epidemic.
  • In particular, voluntary licensing has enabled access to generic products containing another of ViiV Healthcares innovative medicines, dolutegravir, for at least 20 million people living with HIV in low- and middle-income countries, as of December 20214.
  • Deborah Waterhouse, CEO at ViiV Healthcare said, Todays announcement represents a potentially game-changing moment in HIV prevention.
  • Charles Gore, MPP Executive Director said, We are delighted to sign this voluntary licence with ViiV for cabotegravir LA for PrEP.

BioGX Launches CE-IVD Marked Multi-gene COVID-19 Point-of-Care Test at AACC

Retrieved on: 
Wednesday, July 27, 2022
Medical Devices, Health, Infectious Diseases, Genetics, COVID-19, Biotechnology, ISO, RNA polymerase II, Severe acute respiratory syndrome coronavirus 2, View, Environment, CGMP, CEO, Temperature, POC, US, COVID-19, US FDA, Water, XFree86, Technology, Food safety, PCR, Water quality, Vaccine

The test utilizes BioGXs highly successful Xfree direct sample testing chemistry that is included in its US FDA emergency use authorized Xfree COVID-19 Direct RT-PCR test.

Key Points: 
  • The test utilizes BioGXs highly successful Xfree direct sample testing chemistry that is included in its US FDA emergency use authorized Xfree COVID-19 Direct RT-PCR test.
  • This new multi-gene COVID-19 test targets the N1, RdRp and M gene regions for greater redundancy in detecting SARS-CoV-2 emerging variants.
  • This innovative POC test is simple to use and only requires the addition of one drop of sample added directly to the freeze-dried Xfree chemistry.
  • Sample-Ready, Just Add Water and Xfree are trademarks of BioGX, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220727006080/en/

Viz.ai Partners with Hyperfine to Enable New MR Imaging and Workflow Paradigm

Retrieved on: 
Tuesday, July 26, 2022
Health, Medical Devices, Technology, Health Technology, Software, Radiology, Artificial Intelligence, MRI, Algorithm, Diagnosis, Time, Mortality, Neuroimaging, Physician, U.S. Securities and Exchange Commission, Decision-making, Doctor of Philosophy, Health, Hospital, Partnership, Associate, Private Securities Litigation Reform Act, Marketing, University Medical Center, Deep learning, Income, US, Disease, COVID-19, US FDA, EMEA, Multimedia, Neuro, Machine learning, Mission statement, Magnetic resonance imaging, Technology, Â, FDA, Ohio State University Wexner Medical Center, Patient, Transport, ER, Nasdaq, Security (finance), Stroke, Humanitarian use licenses, Forbes, Growth, Swoop, AI, ICU, Surgery, Medical imaging, MD, Hyperfine structure

Together, they will bring MRI to the patients bedside and deliver valuable insights to the clinicians fingertips for timely decision making.

Key Points: 
  • Together, they will bring MRI to the patients bedside and deliver valuable insights to the clinicians fingertips for timely decision making.
  • Swoop, the worlds first MR imaging system capable of providing neuroimaging at the point of care, expands patient access to MRI by bringing imaging to the bedside.
  • With this partnership, we will be able to combine Vizs intelligent care coordination platform and leading image viewer with the Hyperfine Swoop Portable MR Imaging System.
  • Hyperfine, Inc. is the groundbreaking medical device company that created Swoop, the worlds first US FDA-cleared portable MRI system.

Global Drug Taste Masking and Taste Assessment Services and Technologies Market Report 2022-2035 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 26, 2022
Health, Pharmaceutical, Tongue, Capsule, Population, Type, Industry, Food, EMA, Partnership, Compliance, US, USD, International Flavors & Fragrances, US FDA, Operation, Taste, US Foods, Patient, Polydactyly, IFF, European Medicines Agency, Growth, School of Business, Technology, Marketing and Finance, API, OSD, Marketing, Generic drug, Medicinal plants, Risk management

The "Taste Masking and Taste Assessment Services and Technologies Market, Distribution by Type of Formulation, Type of Techniques, Scale of Operation and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Taste Masking and Taste Assessment Services and Technologies Market, Distribution by Type of Formulation, Type of Techniques, Scale of Operation and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.
  • 'Taste Masking and Taste Assessment Services and Technologies Market, 2022-2035 report features an extensive study of the current market landscape, offering an informed opinion on the taste masking and taste assessment services and technologies.
  • One of the key objectives of the report was to estimate the existing market size and future growth potential of the taste masking and taste assessment services and technologies market.
  • How is the current and future opportunity, related to taste masking and taste assessment likely to be distributed across key market segments?

ReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise™ System for the Treatment of Hypertension

Retrieved on: 
Tuesday, July 26, 2022
Medical Devices, Health, Radiology, Clinical Trials, Cardiology, CA, Physician, CEO, Columbia University Vagelos College of Physicians and Surgeons, Ōtsuka, US, COVID-19, ReCore, US FDA, PMA, Hospital, Principal investigator, Clinical trial, CE, FDA, TRIO, SOLO, Tokyo Stock Exchange, Patient, Hypertension, Surgeon, Columbia University, Pharmaceutical industry, EU, Medicine

The RADIANCE II US FDA IDE pivotal trial is a randomized, sham-controlled clinical trial of the ReCor Paradise uRDN System for the treatment of patients with uncontrolled hypertension.

Key Points: 
  • The RADIANCE II US FDA IDE pivotal trial is a randomized, sham-controlled clinical trial of the ReCor Paradise uRDN System for the treatment of patients with uncontrolled hypertension.
  • We at Otsuka are very pleased with the positive outcome of the RADIANCE II study, said Kazumichi Kobayashi, Executive Deputy President of Otsuka Medical Devices.
  • With RADIANCE II, ReCor now has a third positive trial, with more than 500 patients randomized in the RADIANCE Global Program.
  • ReCor has also begun the Global Paradise System (GPS) Registrya real-world study of up to 3,000 patients with uncontrolled hypertension.

Global Cancer Vaccine Market & Clinical Trials Outlook 2028: HPV Vaccine Sales Fueling Growth With Other Investigational Vaccines in Late Stage Development - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 21, 2022
Pharmaceutical, Health, Oncology, Algorithm, Awareness, Cervical cancer, BLA, Human papillomavirus infection, Gardasil, Large-cell lung carcinoma, HPV, Cancer, Pancreatic cancer, BCG, Sipuleucel-T, Prostate cancer, Artificial intelligence, US, US FDA, RNA transfection, Machine learning, Company, Patient, Vaccination, Bacillus, Growth, B cell, Vaccine, Pharmaceutical industry

The "Global Cancer Vaccine Market & Clinical Trials Outlook 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Cancer Vaccine Market & Clinical Trials Outlook 2028" report has been added to ResearchAndMarkets.com's offering.
  • The significant increase in the growth of the market is mainly attributed to encouraging sales of HPV cancer vaccines and rising awareness among individuals regarding the benefits of HPV vaccination.
  • Apart from this, several investigational cancer vaccines have progressed towards late-stage clinical trials and are expected to gain market authorization, which will also have a positive impact on the growth of market.
  • Cancer Vaccines Trials Insight By Company, Country, and Indication
    To date, both therapeutic, as well as preventive cancer vaccines, have gained entry into the global market.