Odds ratio

Veru Announces Late-Breaker Oral Presentation of Sabizabulin Treatment for Hospitalized Adults with COVID-19 on Supplemental Oxygen at Infectious Disease Week 2022

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Lunedì, Ottobre 24, 2022
Efficiency, The New England Journal of Medicine, NASDAQ, Acute respiratory distress syndrome, Medicine, Mortality, Zuclomifene, TGA, U.S. Securities and Exchange Commission, Tadalafil, Telehealth, Comorbidity, Infection, AR, Eli Lilly and Company, Private Securities Litigation Reform Act, WHO, Company, GLOBE, Odds ratio, FDA, Government, Hospital, MHRA, Review, Lilly, Vaccine, Security (finance), Collection, Trial of the century, Prostate cancer, Death, Flash, Form 10-Q, CDK, Insurance, Medicines and Healthcare products Regulatory Agency, Disease, Patient, Man, European Medicines Agency, Finasteride, Safety, Fast Track, Gonadotropin-releasing hormone, Forward-looking statement, Pregnancy, COVID-19, Capsule, Pharmaceutical industry, Birth control, Medical imaging, D.C, ICU, Verus Pharmaceuticals

Utilizing sabizabulin in WHO Class 4 patients may help prevent progression of disease, filling a gap in care in our hospitalized patients, said Paula Skarda, M.D.

Key Points: 
  • Utilizing sabizabulin in WHO Class 4 patients may help prevent progression of disease, filling a gap in care in our hospitalized patients, said Paula Skarda, M.D.
  • Internal Medicine/Pediatrics Regions Hospital, St. Paul, Minnesota, a lead investigator in Verus Phase 2 and Phase 3 clinical trials of sabizabulin.
  • Patients were randomized (2:1) to sabizabulin 9 mg or placebo oral daily dose (up to 21 days or discharge from hospital).
  • Randomization was stratified by oxygen requirement at baseline (WHO 4 = supplemental oxygen, WHO 5 = NIV/forced oxygen, WHO 6 = mechanical ventilation).

Yale University Study Demonstrates Significant Survival Benefit in High-Risk PCI with Impella Support

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Giovedì, Ottobre 13, 2022
Medical Devices, Surgery, Hospitals, FDA, Clinical Trials, Health Technology, Cardiology, Biotechnology, General Health, Health, Medicine, Myocardial infarction, Hemodynamics, Patient, Yale New Haven Hospital, IABP, Multimedia, The American Journal of Cardiology, Yale school, Cardiogenic shock, MD, American Journal, Yale School of Medicine, Survival, PCI, Odds ratio, Medical device, Bookkeeping, Impella, Cardiology

Dr. Lansky is also the director of the Yale Heart and Vascular Clinical Research Program and the Yale Cardiovascular Research Center, which specializes in the evaluation of interventional devices.

Key Points: 
  • Dr. Lansky is also the director of the Yale Heart and Vascular Clinical Research Program and the Yale Cardiovascular Research Center, which specializes in the evaluation of interventional devices.
  • The study examined patients in the Premier Healthcare Database treated between 2016 and 2019 with Impella or IABP for non-emergent high-risk PCI.
  • The study found:
    In-hospital survival was significantly higher with Impella compared to IABP (unadjusted 95.3% vs. 91.0%, p=0.0002; adjusted odds ratio (OR) 1.55, 95% confidence interval (CI) 1.02, 2.36, p=0.042).
  • further validate and extend the results of other studies of Impella in high-risk PCI, including the PROTECT II randomized controlled trial (RCT) , the PROTECT III study and the RESTORE EF study .

EQS-News: Atriva Therapeutics announces Topline Results from the Proof of Concept (POC) / Phase 2a RESPIRE study (zapnometinib) in patients hospitalized with COVID-19

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Martedì, Settembre 20, 2022
Adult, Safety, World, POC, Global, Respiratory Medicine, Tablet, Trial of the century, Incidence, Projection, COVID-19, Odds ratio, ODD, Panther, FDA, Prevalence, Orthornavirae, Food, Severe acute respiratory syndrome coronavirus 2, CSS, Respiratory syncytial virus, Therapy, Patient, Program, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RSV, Viral load, MEK, Standard of care, Orthohantavirus, Cell, Pulmonology, Omicron, Data, Degenerative disease, WHO, RNA, Patent, Death, Hepatotoxicity, Medical imaging, Pharmaceutical industry, Vaccine, Delta

Patients enrolled in RESPIRE were well balanced between groups, with 40% of patients requiring supplemental oxygen in the zapnometinib arm and 41% requiring supplemental oxygen in the placebo arm.

Key Points: 
  • Patients enrolled in RESPIRE were well balanced between groups, with 40% of patients requiring supplemental oxygen in the zapnometinib arm and 41% requiring supplemental oxygen in the placebo arm.
  • Safety data from RESPIRE indicate a favorable profile, with a balanced incidence of treatment-emergent adverse events (TEAEs) between study groups.
  • Dr. Stephan Stenglein, CMO Atriva Therapeutics, adds: We are pleased to see impressive data from our first clinical study (RESPIRE).
  • RESPIRE1 is a randomized, double-blind, placebo-controlled, international, multi-center POC (Proof of Concept) / Phase 2 clinical trial in adult patients with moderate-to-severe COVID-19.

GNT Pharma Provides Update on Two Phase III Studies of Nelonemdaz for Acute Ischemic Stroke Patients Treated with tPA (ENIS-3) or Endovascular Thrombectomy (RODIN)

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Lunedì, Settembre 19, 2022
II, NIHSS, Safety, Human, COVID-19, Cell biology, National Institutes of Health Stroke Scale, National, Ophthalmology, Administration, Stroke, NMDA, IND, Efficacy, MRI, Psychology, Patient, BI, IDMC, CEO, III, Odds ratio, TPA, MRS, SONIC, Neuroprotection, Connective tissue disease, MFDS, Toxicity, Pharmacology, NR2B, Thrombectomy, Reperfusion, Research, Cerebral infarction, GLOBE, Mortality, GNTP, GNT, Rankine scale, Antioxidant, Brain, Pharmaceutical industry, Vaccine, Food, Neurology

Promising efficacy and safety profiles were observed in prior Phase II studies in acute ischemic stroke patients treated with recanalization therapies.

Key Points: 
  • Promising efficacy and safety profiles were observed in prior Phase II studies in acute ischemic stroke patients treated with recanalization therapies.
  • In the prior phase II trial in China (ENIS, 237 patients), administration of nelonemdaz reduced disability primarily in moderate to severe ischemic stroke patients treated with a thrombolytic drug.
  • The ENIS-3 trial was then designed to examine the efficacy and safety of nelonemdaz in 946 patients with moderate to severe acute ischemic stroke treated with tPA within 8 hours of stroke onset.
  • In China, a phase II study of nelonemdaz (ENIS trial) has been completed in acute ischemic stroke patients receiving a thrombolytic drug within 8 hours of stroke onset (n=237).

Coherus to Launch CIMERLI™ (ranibizumab-eqrn) in the United States on October 3, 2022

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Lunedì, Settembre 19, 2022
Retinal, ATE, Safety, Diabetic retinopathy, Â, Infection, Patient, Endophthalmitis, Thrombosis, D-2, Ateş, Myocardial infarction, Death, Adoption, Food, Macular edema, Neovascularization, VEGF, DR, Excipient, Central retinal vein occlusion, Venous thrombosis, FACS, Fatal, Risk, FDA, Protein, Degenerative disease, CEO, Odds ratio, GLOBE, Intraocular pressure, RVO, Fatality, Vance DeGeneres, Clinical research, IOP, Hypersensitivity, Intravitreal injection, DME, Stroke, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AMD, BLA, Generic drug, Pharmaceutical industry, Vaccine, Ranibizumab

REDWOOD CITY, Calif., Sept. 19, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) today announced the commercial availability, beginning October 3, 2022, of CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all approved indications. CIMERLI is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision. CIMERLI was approved by the U.S. Food and Drug Administration (FDA) in August 2022, having met FDA’s standards of biosimilarity and interchangeability to the reference product, including safety, efficacy and quality.1

Key Points: 
  • CIMERLI is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.
  • As a company, we embrace high performance in everything we do, while valuing our patient-centric approach to our mission.
  • CIMERLI is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in Lucentis and CIMERLI.
  • Coherus licensed CIMERLI from Bioeq AG, a joint venture between Polpharma Biologics Group B.V. and Formycon AG.

Xevinapant Five-Year Data Show Survival Rate Nearly Doubled in Patients with Unresected LA SCCHN, When Added to Standard of Care

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Mercoledì, Settembre 7, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Tao, Safety, Research, Multiple sclerosis, Sun, Standard of care, Dysphagia, Health, Science, Cisplatin, Lancet, Odds ratio, Radiation, Head and Neck Cancer Alliance, Electronics, Merck, Neutropenia, Risk, Mucositis, Congress, Patient, Merck Millipore, Cancer, Survival, Chemoradiotherapy, IAP, OS, Death, Head, Incidence, Food, Intelligence, CRT, LA, Progression-free survival, Oncology, Gene editing, Recurrence, HR, Teaching hospital, University Hospital (Newark, New Jersey), Speech, Probability, Management, Entrepreneurship, Infertility, X-ray, Sleep, Mortality, Merck Serono, Anemia, Phase, Neck, Veni, vidi, vici, The Lancet, Merck Group, EMD, Apoptosis, Life, Abstract, Pharmaceutical industry, Dietary supplement, Debiopharm

There is a clear need for improved treatment options for patients with unresected locally advanced head and neck cancer.

Key Points: 
  • There is a clear need for improved treatment options for patients with unresected locally advanced head and neck cancer.
  • Median OS was prolonged with xevinapant (median not reached; 95% CI, 40.3 months-not evaluable) versus placebo (36.1 months; 95% CI, 21.8-46.7 months).
  • Treatment with xevinapant nearly doubled OS, with a 53% (95% CI, 37-66%) probability of survival after five years compared with 28% (95% CI, 15-42%) with placebo.
  • Adverse events of grade 3 or higher were reported in 41 (85%) of 48 patients in the xevinapant group and 41 (87%) of 47 patients in the placebo group.

Xevinapant Five-Year Data Show Survival Rate Nearly Doubled in Patients with Unresected LA SCCHN, When Added to Standard of Care

Retrieved on: 
Mercoledì, Settembre 7, 2022
Oncology, Health, Genetics, Clinical Trials, Radiology, Biotechnology, Tao, Safety, Sun, Standard of care, Dysphagia, Health, Science, Cisplatin, Lancet, Odds ratio, Radiation, Head and Neck Cancer Alliance, Electronics, Neutropenia, Risk, Mucositis, Congress, Patient, Merck Millipore, Survival, Chemoradiotherapy, IAP, OS, Death, Head, Incidence, Food, Intelligence, CRT, LA, Progression-free survival, Cancer, Oncology, Gene editing, Recurrence, HR, Teaching hospital, University Hospital (Newark, New Jersey), Speech, Probability, Management, Entrepreneurship, X-ray, Sleep, Mortality, Merck Serono, Anemia, Phase, Neck, Veni, vidi, vici, The Lancet, III, Apoptosis, Abstract, Pharmaceutical industry, Dietary supplement, Merck, Debiopharm

There is a clear need for improved treatment options for patients with unresected locally advanced head and neck cancer.

Key Points: 
  • There is a clear need for improved treatment options for patients with unresected locally advanced head and neck cancer.
  • Median OS was prolonged with xevinapant (median not reached; 95% CI, 40.3 months-not evaluable) versus placebo (36.1 months; 95% CI, 21.8-46.7 months).
  • Treatment with xevinapant nearly doubled OS, with a 53% (95% CI, 37-66%) probability of survival after five years compared with 28% (95% CI, 15-42%) with placebo.
  • Adverse events of grade 3 or higher were reported in 41 (85%) of 48 patients in the xevinapant group and 41 (87%) of 47 patients in the placebo group.

FDA Approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis® for All Five Indications, with 12 Months of Interchangeability Exclusivity

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Mercoledì, Agosto 3, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Thrombosis, Visual acuity, BLA, DR, Intraocular pressure, Macular edema, Retinal, Safety, News, IOP, VEGF, Death, Knowledge, Infection, Diabetic retinopathy, Retina, Odds ratio, Ateş, Intravitreal injection, Excipient, ATE, GLOBE, Food, CHRS, Central retinal vein occlusion, Endophthalmitis, Biosimilar, Fatality, CEO, RVO, Venous thrombosis, Pharmacy, Severe cognitive impairment, FDA, Myocardial infarction, Hypersensitivity, FCB, DME, Degenerative disease, Commercial, AMD, Risk, Stroke, Fatal, Retinal haemorrhage, D-2, Protein, Pharmaceutical industry, Vaccine, Generic drug, Ranibizumab, Ophthalmology

REDWOOD CITY, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all five indications, meeting the FDA’s rigorous standards to the reference product, including safety, efficacy and quality.1 CIMERLI™ belongs to the anti-VEGF therapy class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.

Key Points: 
  • Coherus is the only company in the $7 billionanti-VEGF ophthalmology market with a demonstrated track record of U.S. commercial biosimilar success.
  • Our upcoming launch of CIMERLI and planned launch next year of our third approved product, our Humira biosimilar, YUSIMRY, will leverage this experience and knowledge.
  • Commercial availability of CIMERLI, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022.
  • An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.

Access to Myriad Genetics’ GeneSight Test Improves Depression Remission Rates In Largest Ever Mental Health PGx Randomized Controlled Trial

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Martedì, Luglio 12, 2022
Precision medicine, Anxiety, MDD, Odds ratio, Health, Practitioner, JAMA, MYGN, Disorder, Genetics, Myriad Genetics, American Medical Association, Prequel, Risk, U.S. Department of Veterans Affairs, Office of Inspector General, Patient, CEO, Journal, Manchester VA Medical Center, Mortality, GLOBE, Major depressive disorder, Depression, Psychotherapy, Lists of diseases, Office of Inspector General, U.S. Department of Health and Human Services, Genetic testing, Johns Hopkins Bayview Medical Center, PHQ-9, Mental health, HIV disease progression rates, ADHD, Randomized controlled trial, Research, Disability, Myriad, Fast Company, SALT, Health care provider, RCT, NASDAQ, Pharmaceutical industry, Medical imaging, Medical device, Veteran

The PRIME Care (Precision Medicine in Mental Health Care) study is the largest pharmacogenomic (PGx) randomized controlled trial (RCT) ever conducted in mental health.

Key Points: 
  • The PRIME Care (Precision Medicine in Mental Health Care) study is the largest pharmacogenomic (PGx) randomized controlled trial (RCT) ever conducted in mental health.
  • The PRIME Care study showed that veterans are more likely to achieve depression remission when GeneSight test results are available to inform medication treatment, said Paul J. Diaz, president and CEO, Myriad Genetics.
  • The study showed a meaningful increase in remission rates for patients whose providers had access to GeneSight test results, said Jay Elliott, vice president, medical affairs of mental health, Myriad Genetics.
  • The GeneSight Psychotropic test from Myriad Genetics is the category-leading pharmacogenomic test for 64 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions.

MyOme Presents New Data at ASCO 2022 on Cross-ancestry Polygenic Risk Score for Breast Cancer

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Mercoledì, Giugno 1, 2022
Woman, American Cancer Society, Death, Association, Clinical Laboratory, Research, Society, Doctor of Philosophy, Breast cancer, CLIA, ASCO, Polygene, Annual general meeting, Multimedia, American Society of Clinical Oncology, PRS, Risk, Odds ratio, Cancer, Medical imaging, MD

MENLO PARK, Calif., June 1, 2022 /PRNewswire/ -- MyOme, a clinical whole genome platform analysis company, today announced new data on a cross ancestry polygenic risk score (caPRS) for breast cancer that will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Using a proprietary informatics approach to PRS that provides benefit across multiple ancestries, MyOme showed a significant association between their caPRS and breast cancer in a study including more than 130,000 women across multiple ancestries

Key Points: 
  • MENLO PARK, Calif., June 1, 2022 /PRNewswire/ -- MyOme , a clinical whole genome platform analysis company, today announced new data on a cross ancestry polygenic risk score (caPRS) for breast cancer that will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • Polygenic risk scores aggregate hundreds or potentially thousands of variants into a single measure of disease risk.
  • PRS has the potential to inform the 90-95% of women without rare breast cancer genetic mutations of their risk for breast cancer," said Akash Kumar, MD, PhD, chief medical officer of MyOme.
  • Breast cancer is the most common cancer among women and a leading cause of cancer mortality.