JAMA

Don Hardison Appointed Chairman of the Board at Geneoscopy

Retrieved on: 
Thursday, November 9, 2023
Biometrics, Biotechnology, Oncology, General Health, Health, Health Technology, Genetics, Other Health, Exact sciences, Food, RNA, Colorectal cancer, JAMA, Acquisition, PMA, Regulation of tobacco by the U.S. Food and Drug Administration, Growth, CRC, Labcorp, Quest Diagnostics, GSK plc, Hologic, Management

Geneoscopy , a life sciences company focused on developing diagnostic tests for gastrointestinal health, has appointed Don Hardison as Chairman of its Board of Directors.

Key Points: 
  • Geneoscopy , a life sciences company focused on developing diagnostic tests for gastrointestinal health, has appointed Don Hardison as Chairman of its Board of Directors.
  • Having previously served as a strategic advisor to Geneoscopy before joining the board in February 2023, Hardison is well-acquainted with the company's vision and strategy.
  • In his expanded role as Chairman of the Board, he will provide insight and guidance as Geneoscopy prepares to commercialize its flagship product – ColoSense™, a noninvasive, stool-based, at-home screening test designed to detect colorectal cancer and advanced adenomas in average-risk individuals.
  • "As an advisor and board member, I have been impressed by what Geneoscopy has accomplished, and I'm honored to assume the role of Chairman of the Board at Geneoscopy during this exciting inflection point for the company," said Hardison.

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Wednesday, November 8, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Survival, VEGF, TAK, RAS, PDUFA, Food, Colorectal Cancer Alliance, MAA, Priority, JAMA, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Priority review, PMDA, Colorectal cancer, CRC, EMA, FACP, Cancer, Metastasis, Patient, Diagnosis, Vanderbilt University Medical Center, Pharmaceutical industry, Takeda, EU, Lancet

"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.

Key Points: 
  • "There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.
  • “For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • “Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized.

Otsuka Medical Devices and Recor Medical Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023
Medical Devices, FDA, Health, Clinical Trials, General Health, Cardiology, JAMA, ReCore, Food, Physician, Blood pressure, American Medical Association, News, Medical device, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal, Hypertension, Overactive bladder, RDN, Patient, Pharmaceutical industry

Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) and Recor Medical, Inc. (“Recor”, subsidiary of Otsuka Medical Devices) announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) and Recor Medical, Inc. (“Recor”, subsidiary of Otsuka Medical Devices) announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.
  • It is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.
  • The Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023
Biotechnology, FDA, Medical Devices, Health, Cardiology, JAMA, ReCore, Harvard Medical School, Food, American Medical Association, Blood pressure, Physician, Mortality, MD, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal, Hypertension, Division, Overactive bladder, Diabetes, RDN, Patient, Associate, Pharmaceutical industry, Endocrinology, Medicine, Brigham

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.
  • The Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves.
  • The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023
JAMA, FDA, Harvard Medical School, Brigham and Women's Hospital, Food, American Medical Association, Blood pressure, Physician, Mortality, MD, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal, Hypertension, Division, Treatments for overactive bladder, Diabetes, RDN, Patient, Hospital, Associate, Pharmaceutical industry, ReCore, Endocrinology, Medicine

PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Approval of the Paradise™ Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the U.S.
    PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient's blood pressure.
  • The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
  • Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023
JAMA, FDA, Harvard Medical School, Brigham and Women's Hospital, Food, American Medical Association, Blood pressure, Physician, Mortality, MD, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal, Hypertension, Division, Treatments for overactive bladder, Diabetes, RDN, Patient, Hospital, Associate, Pharmaceutical industry, ReCore, Endocrinology, Medicine

PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Approval of the Paradise™ Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the U.S.
    PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient's blood pressure.
  • The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
  • Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009.

Mineralys Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
JAMA, Nissen, Insurance, BP, Obesity, Biotechnology, American Medical Association, Blood pressure, Treatment, American Heart Association, Uncontrolled, Albuminuria, Conference, Journal, R, Poster, Society, Chronic kidney disease, Cleveland, ASN, Hypertension, Research and development, Medicare Part D, CKD, Safety, AHA, Therapy, Patient, Investment, Cleveland Clinic, Administration, Conference call, Pharmaceutical industry, Cryptocurrency, Part

RADNOR, Pa., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending September 30, 2023, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending September 30, 2023, and provided a corporate update.
  • Research and Development (R&D) expenses were $22.5 million for the quarter ended September 30, 2023, compared to $6.1 million for the quarter ended September 30, 2022.
  • General and Administrative (G&A) expenses were $3.8 million for the quarter ended September 30, 2023, compared to $1.4 million for the quarter ended September 30, 2022.
  • Net loss was $22.8 million for the quarter ended September 30, 2023, compared to $6.7 million for the quarter ended September 30, 2022.

Mineralys Therapeutics Presents New Post-Hoc Analysis from Target-HTN Phase 2 Trial of Lorundrostat in Late-Breaking Poster Session at ASN Kidney Week 2023 Meeting

Retrieved on: 
Thursday, November 2, 2023
JAMA, Mercury (element), BP, BMI, Obesity, Physician, Blood pressure, Target, American Medical Association, Publication, American Heart Association, Journal, Society, American Society of Nephrology, Chronic kidney disease, Hypertension, ASN, Risk, Factorization of polynomials, Body mass index, CKD, AHA, Therapy, Mercury, Pharmaceutical industry

RADNOR, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today presented a new post-hoc analysis from the Target-HTN Phase 2 trial of lorundrostat, a highly selective aldosterone synthase inhibitor, in individuals with uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). The data were presented during the Late-Breaking Posters session at the American Society of Nephrology (ASN) Kidney Week 2023, which is being held in Philadelphia from November 2–5.

Key Points: 
  • The data were presented during the Late-Breaking Posters session at the American Society of Nephrology (ASN) Kidney Week 2023, which is being held in Philadelphia from November 2–5.
  • In this new analysis, investigators identified a population of responders to lorundrostat who experienced a median reduction in systolic blood pressure (BP) of 32 millimeters of mercury (mmHg).
  • “We were able to show in this post-hoc analysis additional evidence corroborating the association between BMI and blood pressure reduction with lorundrostat.
  • Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for uncontrolled and resistant hypertension.

Ambry Genetics Unveils at ASHG New Insights on the Use of Multiomic Testing in 43,000 Patient Study

Retrieved on: 
Saturday, November 4, 2023
Science, Biotechnology, Research, Oncology, General Health, Health, Genetics, Clinical Trials, ASHG, Patient, Cancer, VUS, Genetic testing, Ambiguity, Health equity, RNA, JAMA, Society, Genome, Database, Disease, Classification, American Society of Human Genetics, Medicine, Biology, Human genetics, JAMA Oncology, DNA, Vaccine, Pharmaceutical industry

Key findings from this study indicate that RNA-dependent classifications were instrumental in enhancing the accuracy of genetic testing.

Key Points: 
  • Key findings from this study indicate that RNA-dependent classifications were instrumental in enhancing the accuracy of genetic testing.
  • Reducing Inconclusive Rates: The number of variants of uncertain significance reduced considerably, providing clarity and enhancing the overall reliability of multi-gene panel testing.
  • Patients and the healthcare teams who care for them deserve nothing less,” said CEO of Ambry Genetics, Tom Schoenherr.
  • It is a leader in genetic testing that aims to improve health by understanding the relationship between genetics and disease.

Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India

Retrieved on: 
Friday, October 27, 2023
JAMA, Name, FDA, Trastuzumab, SCLC, Policy, Stomach, Food, European Commission, Cancer, ESCC, Intas Pharmaceuticals, American Medical Association, Independence, Lung cancer, MSI-H, European Medicines Agency, MSI, EC, Regulation of tobacco by the U.S. Food and Drug Administration, Carcinoma, Research, Commonwealth, Journal, Senior, Civil service commission, Growth, Clinical trial, Partnership, EMA, ASEAN, Patient, Nature Medicine, Fosun Pharma, Pharmaceutical industry, Accord

In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.

Key Points: 
  • In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.
  • Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018.
  • Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius.
  • This collaboration will further bolster Intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide.