IRB

Novotech Launches Dedicated Early Phase Unit for Biotechs Leveraging the Australian and New Zealand Clinical Environment

Retrieved on: 
måndag, juni 3, 2024
Drug development, Toxicology, Therapy, DDC, SAN, ANZ, GMP, Clinical trial, CMC, EP, IRB, Bluck, FDA, Contract research organization, Pharmaceutical industry

SAN DIEGO, June 03, 2024 (GLOBE NEWSWIRE) -- Novotech , the global full-service Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, today announced the launch of a dedicated early phase unit focussed on leveraging the unique advantage of Australian and New Zealand (ANZ) for early phase clinical development.

Key Points: 
  • SAN DIEGO, June 03, 2024 (GLOBE NEWSWIRE) -- Novotech , the global full-service Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, today announced the launch of a dedicated early phase unit focussed on leveraging the unique advantage of Australian and New Zealand (ANZ) for early phase clinical development.
  • This Early Phase Strategic Delivery Unit (EP SDU) is the first in a series of new Strategic Delivery Units (SDUs) to be launched by Novotech over the course of 2024, each one being a dedicated delivery unit with specialist teams and tailored processes, for different types of complex clinical trials.
  • Novotech has long been a partner of choice for biotechs wanting to conduct early phase trials in ANZ and benefit from the clinical and scientific excellence, attractive financial rebates, and rapid start-up with streamlined regulatory processes.
  • “The DDC is a full-service global product development and strategic regulatory group that supports sponsors through every phase of clinical development.

Lipella Pharmaceuticals Announces Completion of Site Initiation Visit for Phase 2a Trial of LP-310 in Oral Lichen Planus

Retrieved on: 
fredag, maj 31, 2024
Toxicity, FDA, Male, OLP, Safety, LIPO, Tacrolimus, SIV, Institutional review board, Pain, Lichen planus, IRB, Female, Pharmaceutical industry

PITTSBURGH, May 31, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the successful completion of its first Site Initiation Visit (SIV) for the Phase 2a trial evaluating LP-310 in the treatment of Oral Lichen Planus (OLP). With clearance received from the central Institutional Review Board (IRB), the Phase 2a trial is set to commence with site qualifications completed and patient recruitment underway.

Key Points: 
  • Patient recruitment is underway for Phase 2a multicenter, dose-ranging study
    PITTSBURGH, May 31, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the successful completion of its first Site Initiation Visit (SIV) for the Phase 2a trial evaluating LP-310 in the treatment of Oral Lichen Planus (OLP).
  • With clearance received from the central Institutional Review Board (IRB), the Phase 2a trial is set to commence with site qualifications completed and patient recruitment underway.
  • Lipella’s Phase 2a trial is a multicenter, dose-ranging study involving adult male and female subjects experiencing symptomatic OLP.
  • Dr. Jonathan Kaufman, CEO of Lipella, expressed his enthusiasm, stating, “We are extremely pleased to announce the completion of the Site Initiation Visit for our Phase 2a trial of LP-310.

BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer

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torsdag, maj 30, 2024
CTA, MPH, Patient, Tislelizumab, Investigational New Drug, FDA, IND, BCT, Safety, PD-1, Cancer, Immunotherapy, Institutional review board, TSX, Quality of life, IRB, Pharmaceutical industry

PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab , in advanced metastatic breast cancer.

Key Points: 
  • PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab , in advanced metastatic breast cancer.
  • “Advancing Bria-OTS™ as our second novel immunotherapy candidate into the clinic is a significant milestone for BriaCell.
  • We believe personalization through our Bria-OTS™ immunotherapy platform will produce more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor,” stated Dr. William V. Williams, BriaCell’s President & CEO.
  • Additionally, we expect the preferred safety profile of our personalized immunotherapy, Bria-OTS™, to improve the quality of life and add months and even years to the lives of these heavily pretreated patients, a distinctive combination of benefits in late-stage cancer care.”

Sleep Number Presents Research on Snoring, Apnea, Excessive Daytime Sleepiness and Cardiovascular Health at SLEEP 2024

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torsdag, maj 30, 2024
Home Goods, Retail, Research, Oncology, Software, Online Retail, Hardware, Luxury, Professional Services, Fitness & Nutrition, Consumer Electronics, Science, Technology, General Health, Data Analytics, Health, HVAC, Specialty, Snoring, Sleep, Data collection, University, Obstructive sleep apnea, Risk, Sleep Number, Somnolence, Sleep disorder, HR, Sleep apnea, OSA, Narcolepsy, Mortality, Apnea, American Cancer Society, Bed, Multimedia, IRB, Pharmaceutical industry

Today, Sleep Number Corporation (Nasdaq: SNBR), a sleep wellness technology leader, announced it will present new research at SLEEP 2024 in Houston.

Key Points: 
  • Today, Sleep Number Corporation (Nasdaq: SNBR), a sleep wellness technology leader, announced it will present new research at SLEEP 2024 in Houston.
  • These studies further demonstrate the research capabilities of Sleep Number smart beds to understand the impact of sleep on health and advance sleep science without an in-lab sleep study.
  • (Graphic: Business Wire)
    “Sleep Number is continuously introducing data-driven approaches for improved sleep and health care outcomes,” said Annie Bloomquist, Executive Vice President and Chief Innovation Officer, Sleep Number.
  • "Sleep Number continues to be at the forefront of sleep research, harnessing the power of our wellness technology to uncover new links between sleep and overall health,” said Rajasi Mills, Vice President, SleepIQ Health and Research, Sleep Number.

Stress testing with multiple scenarios: a tale on tails and reverse stress scenarios

Retrieved on: 
tisdag, maj 28, 2024
Entropy, Risk, Principal component analysis, Classification, Research Papers in Economics, Social science, Section 3, STN, XT, Central bank, Y0, XTC, LTN, JEL, Medical classification, GDP, Chapter Eight, Section 5, ESRB, ECB, Probability, Studer, BEAST, Reproduction, Element, FIN, Fed, Thumb, MTC, Pliszka, G28, NPL, Communication, Behavior, ESX, Section 8, RHS, Lens, European Central Bank, Projection, European Systemic Risk Board, Flood, COVID-19, Literature, Row, Public Security Section 9, Prasanta Chandra Mahalanobis, Federal Reserve, Safety, GARCH, GFC, Appendix, Macroprudential regulation, LHS, WC, ROA, Policy, HICP, Central Bank of India, G21, VAR, Section 2, A.5, SSM, IRB, PDF, Cross, Unemployment, Website, A.2, LCR, PCA, Section 4, Coal, Sciences Po, Exercise, Tail, STA, Buffer, Bank, NFC, URX, Eye, SOV, EBA, Knowledge, History, Common equity, Risk management
Key Points: 

    Foundation for Sarcoidosis Research Launches the Coalition for Clinical Trial Equity to Address Barriers Faced by Black Patients

    Retrieved on: 
    torsdag, maj 16, 2024
    Patient, ACTE, Doctor of Philosophy, Organization, American Heart Association, Sarcoidosis, Conditional sentence, Coalition, Yale school, Education, Patient education, Compensation, Clinical trial, Yale School of Medicine, Chan Zuckerberg Initiative, Mallinckrodt, Engagement, Associate, African Americans, Committee, Quality of life, FSR, IRB, Pharmaceutical industry

    This initiative aims to increase representation of Black and African American patients in clinical trials, thereby improving health outcomes for marginalized communities.

    Key Points: 
    • This initiative aims to increase representation of Black and African American patients in clinical trials, thereby improving health outcomes for marginalized communities.
    • Lack of diversity in clinical trials hinders the development of effective treatments that cater to the needs of all populations, especially those most severely impacted.
    • "This coalition will leverage the extensive experience and diverse professional expertise of its leaders to drive forward actionable strategies.
    • By increasing clinical trial participation among Black Americans, we can advance therapies, curtail medical costs, and enhance the quality of life for those affected by chronic illness."

    ZyVersa Therapeutics Reports First Quarter, 2024 Financial Results and Provides Business Update

    Retrieved on: 
    onsdag, maj 15, 2024
    Diabetic nephropathy, Patient, UM, University of Miami, Inflammasome, Investigational New Drug, Clinical trial, University, IND, Therapy, Government, Research, Atherosclerosis, PIPE, GLP, VAR, Toxicology, MJFF, Suggestion, Institutional review board, Protocol, IRB, Pharmaceutical industry

    WESTON, Fla., May 15, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for the quarter ended March 31, 2024 and provides business update.

    Key Points: 
    • Initiation of preclinical study to assess Inflammasome ASC Inhibitor IC 100 for obesity-associated metabolic comorbidities scheduled to begin Q2-2024 with completion expected by year’s end.
    • WESTON, Fla., May 15, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for the quarter ended March 31, 2024 and provides business update.
    • “We are pleased to announce that ZyVersa is on track to achieve key development milestones over the next 3 quarters,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President.
    • ZyVersa will need additional financing to support its continuing operations and to meet its stated milestones.

    Shuttle Pharma Provides First Quarter 2024 Corporate Update

    Retrieved on: 
    tisdag, maj 14, 2024
    Patient, Prognosis, Planet, Survival, Glioblastoma, Food, Letter, HERE, Diagnosis, FDA, Radiation, Indian stock exchange, Prostate cancer, Cancer, Research, HDAC6, Brain, Therapy, Quality of life, RT, IRB, Georgetown University

    GAITHERSBURG, Md., May 14, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the first quarter ended March 31, 2024.

    Key Points: 
    • GAITHERSBURG, Md., May 14, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the first quarter ended March 31, 2024.
    • Finalizing site enrollment with up to six institutions with ‘first patient, first dose’ expected in the second quarter of 2024.
    • Created Shuttle Diagnostics, Inc., a wholly owned subsidiary of Shuttle Pharma, which will focus on developing a diagnostics laboratory to develop its metabolite discovery platform technology and to support multi-institutional clinical trials.
    • Anatoly Dritschilo, M.D., Chief Executive Officer of Shuttle Pharma, participated in a presentation at the Planet MicroCap Showcase: VEGAS 2024 on May 1, 2023.

    Azitra, Inc. Announces Q1 2024 Financial Results and Provides Business Updates

    Retrieved on: 
    torsdag, maj 9, 2024
    Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, FDA, Society, Cancer, Skin, Safety, Research, Joint, Research and development, IRB, Cell, Administration, IND, LEKTI, ASCO, Ichthyosis, Patent, Patient, Gene, Bayer, Prevalence, Rash, Quarter, EGFR, G&A, Netherton syndrome, BTK, Chemotherapy, Pharmaceutical industry

    Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.

    Key Points: 
    • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.
    • Moreover, preclinical evidence suggests that ATR-12 can markedly reduce IL-36g, a pro-inflammatory cytokine implicated in Netherton syndrome, further validating the potential of our approach.
    • Net Loss was $2.9 million for the quarter ended March 31, 2024, compared to $2.5 million for the comparable period in 2023.
    • Cash and cash equivalents: As of March 31, 2024, the Company had cash and cash equivalents of $3.0 million.

    uniQure Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress

    Retrieved on: 
    tisdag, maj 7, 2024
    FDA, Phase, Safety, Food, Fabry disease, Research, Immunosuppression, Male, Hand, IRB, Conference, Information technology, RBC Capital Markets, Patient, ALS, Acquisition, CSL, POC, Clinical trial, Temporal lobe epilepsy, SOD1, Pharmaceutical industry

    LEXINGTON, Mass. and AMSTERDAM, May 07, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the first quarter of 2024 and highlighted recent progress across its business.

    Key Points: 
    • ~ Clinical trial initiation for Fabry disease on track to begin in second quarter of 2024, followed by refractory mesial temporal lobe epilepsy and SOD1-ALS in third quarter of 2024 ~
      LEXINGTON, Mass.
    • and AMSTERDAM, May 07, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the first quarter of 2024 and highlighted recent progress across its business.
    • We have obtained IRB approvals for initial sites, which are poised for imminent activation, and have also identified prospective patients.
    • The Company expects cash, cash equivalents and investment securities will fund operations into the second quarter of 2027.