Mitt

First Real-World Outcomes Data and New Analyses of Data for REBYOTA® (fecal microbiota, live – jslm) Presented at DDW 2024

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星期一, 五月 20, 2024
Biotechnology, General Health, Pharmaceutical, Health, OLS, DDW, Patient, Phase 3, PPI, Ferring Pharmaceuticals, Risk, Food, AGAF, Clostridioides difficile infection, Recurrence, FDA, PUNCH, CDI, FACG, Clostridioides difficile, Mitt, Safety, Enzyme inhibitor, Bacteria, Dysbiosis, MD, Yale School of Medicine, Poster, Gastrointestinal disease, Multimedia, Roger Hawkins (drummer), Infection, Pharmaceutical industry

Those with 8-week follow-up were further evaluated and the efficacy of REBYOTA was assessed as the absence of recurrence at 8 weeks after administration.

Key Points: 
  • Those with 8-week follow-up were further evaluated and the efficacy of REBYOTA was assessed as the absence of recurrence at 8 weeks after administration.
  • Nearly 74% of these patients (25/34) maintained the effectiveness of REBYOTA at eight weeks, despite having a higher risk of further recurrence.
  • In the analysis, most TEAEs were mild or moderate gastrointestinal disorders and related to preexisting conditions or C. diff infection.
  • For at least six months, the number of REBYOTA responders with engraftment continued to rise and persist.

Cerus Corporation Announces Positive Topline Results for the Phase 3 Clinical Trial of the INTERCEPT Blood System for Red Blood Cells in Cardiovascular Surgery Patients

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星期二, 三月 19, 2024
Medical Supplies, Biotechnology, Practice Management, Other Health, Health, General Health, Health Technology, Medical Devices, Hospitals, Surgery, Clinical Trials, Red blood cell, STARS, Platelet, SPARC, Incidence, AKI, Patient, Corporation, Mitt, News, CERS, RBC, Acute kidney injury, Clinical trial, Antibody, Transfusion medicine, PMA, Safety, DSMB, Data, Food, FDA, Physician, Cerus Corporation, Pharmaceutical industry

Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.

Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.
  • There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs.
  • This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs.
  • “We are extremely pleased by the positive topline results of the ReCePI clinical trial,” stated Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer and principal investigator for the ReCePI clinical trial.

Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis

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星期四, 三月 28, 2024
OHE, Week, Cirrhosis, Patient, Mitt, NDA, MOA, File, Stage 2, SMI, Recurrence, FDA

SALT LAKE CITY, March 28, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148.

Key Points: 
  • SALT LAKE CITY, March 28, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148.
  • LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action (MOA).
  • This Phase 2 proof of concept study was a randomized placebo-controlled study in sarcopenic male patients with cirrhosis on the liver transplant waitlist.
  • During Stage 2, 8 participants who were on placebo in Stage 1 converted to LPCN 1148, and 11 participants who started the study on LPCN 1148 continued treatment with LPCN 1148.

DuPont Announces 2023 North America Protection Innovation Award Winners

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星期二, 二月 27, 2024
NFPA, EV, Research, Personal protective equipment, Construction, SWAT, Finger, ASTM, PPE, Mechanix Wear, ANSI, Level 4, Needlestick injury, Mitt, Hand, Wound, Explosive

WILMINGTON, Del., Feb. 27, 2024 /PRNewswire/ -- DuPont Personal Protection today announced the winners of the 10th annual Protection Innovation Award recognizing the use of Kevlar® and/or Nomex® materials in gloves or sleeves. The award highlights the design innovation, driven by DuPont Brand Licensees who are utilizing proprietary fiber solutions, in personal protective equipment (PPE) offering industry leading comfort and performance.

Key Points: 
  • WILMINGTON, Del., Feb. 27, 2024 /PRNewswire/ -- DuPont Personal Protection today announced the winners of the 10th annual Protection Innovation Award recognizing the use of Kevlar® and/or Nomex® materials in gloves or sleeves.
  • DuPont Brand Licensees are investing in expanded research to find innovative new materials that offer cut, heat, flame and electrical arc protection.
  • They can count on their status as a licensee, and our support as an innovation leader, to help them address changing regulatory standards and unmet worker protection needs," said Christine Christmas, Global Market Leader, DuPont Personal Protection.
  • For more details on DuPont collaboration with our brand licensees, connect with DuPont Personal Protection on LinkedIn for the latest updates.

Ultragenyx Announces Data Demonstrating Treatment with UX111 Results in Significant Reduction in Heparan Sulfate Exposure in Cerebrospinal Fluid Correlated with Improved Long-term Cognitive Function in Patients with Sanfilippo Syndrome Type A (MPS IIIA)

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星期二, 二月 6, 2024
Sanfilippo, Family, Cognitive development, Research, Patient, Cerebrospinal fluid, HS, AAV, CSF, MPS, Mitt, Pharmaceutical industry

These data are from the modified intention to treat group (mITT) in the pivotal Transpher A study (N=17).

Key Points: 
  • These data are from the modified intention to treat group (mITT) in the pivotal Transpher A study (N=17).
  • 8 of 17 patients in the mITT group who reached 24 months post-treatment achieved an overall mean percent reduction from baseline of 51% (p
  • Specifically, 15 of 17 patients had both a reduction in toxic CSF HS exposure and an improvement in cognitive function.
  • Both trials are ongoing, and patients will continue to be followed for a minimum of 5 years following treatment with UX111.

Napp announces authorisation of REZZAYO® (rezafungin) in Great Britain by the UK Medicines and Healthcare Products Regulatory Agency for the treatment of invasive candidiasis in adults1

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星期五, 二月 2, 2024
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Multimedia, Hypokalemia, Tremor, Mortality, Mycology, Immunodeficiency, Hospice and palliative medicine, Nausea, MHRA, Immune system, UV, Candidiasis, Anemia, Caspofungin, Disease, Wheeze, Patient, Safety, DRC, Abdominal pain, Flushing, Diagnosis, Erythema, Hyponatremia, Rash, Sensation, Royal College of Pathologists, Radiation, Hypotension, Constipation, Risk, Vomiting, Restore, Medication, Phototoxicity, Infection, Medicine, Common, ODD, Diarrhea, Mitt, Pharmaceutical industry

Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2

Key Points: 
  • Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2
    This press release features multimedia.
  • Common adverse reactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, and rash.
  • Increased blood alkaline phosphatase, hepatic enzymes, alanine aminotransferase, aspartate aminotransferase and blood bilirubin were also common.
  • Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.2
    Rezafungin may cause increased risk of phototoxicity.

Introducing the Gentle & Clear Collection from Colleen Rothschild Beauty: Specialized Care for Blemish-Prone and Sensitive Skin

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星期二, 一月 16, 2024
Gentle, Health, Collection, Salicylic acid, Environment, Skin, Mitt, Cosmetics

Colleen Rothschild herself has meticulously guided the creation of the Gentle & Clear Collection, infusing each product with her dedication to empowering individuals through exceptional skincare.

Key Points: 
  • Colleen Rothschild herself has meticulously guided the creation of the Gentle & Clear Collection, infusing each product with her dedication to empowering individuals through exceptional skincare.
  • Gentle & Clear focuses on maintaining the skin's natural equilibrium and building resilience, ensuring your skin achieves and maintains optimal health.
  • The Gentle & Clear Collection features a signature blend, including Salicylic Acid, Lactobacillus Ferment, and Niacinamide, specifically formulated to address the unique challenges of blemish-prone and sensitive skin.
  • With the Gentle & Clear Collection, we provide a trusted solution designed to help UNVEIL YOUR COMPLEXION CONFIDENCE.

Cellectar Biosciences Announces Positive Topline Data Achieving Primary Endpoint in Pivotal Clinical Study of Iopofosine I 131 in Waldenstrom’s Macroglobulinemia

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星期一, 一月 8, 2024
Sequela, Quality of life, Febrile neutropenia, WM, Death, Anemia, International, IWMF, Disease, Neutropenia, NDA, WAM, News, Cancer, Thrombocytopenia, SCR, Macroglobulinemia, MCI, MRR, Mayo Clinic, Mitt, Patient, Safety, Medicine, Cytopenia, Immunoglobulin M, Pharmaceutical industry

The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value

Key Points: 
  • The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value
  • Notably, iopofosine monotherapy achieved an 8% stringent complete remission (sCR) in this highly refractory WM population.
  • “The results from this pivotal study utilizing just four doses of iopofosine monotherapy in heavily pretreated patients are very compelling, demonstrating deep and durable remissions.
  • “Iopofosine’s high major response rate and achievement of the study’s primary endpoint in highly refractory, Waldenstrom’s macroglobulinemia patients exhibits its potentially practice-changing clinical profile.

Athira Pharma Announces Encouraging Results from SHAPE Phase 2 Clinical Trial of Fosgonimeton for the Treatment of Parkinson's Disease Dementia and Dementia with Lewy Bodies

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星期二, 十二月 12, 2023
Dementia, Athira Pharma, Death, Hepatocyte growth factor, HGF, ADAS, Three-body problem, Doctor of Philosophy, Mitt, Central nervous system, Patient, ERP, SHAPE, Pharmaceutical industry

BOTHELL, Wash., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced findings from the exploratory SHAPE Phase 2 clinical trial to evaluate fosgonimeton (ATH-1017) in patients with Parkinson’s disease dementia and dementia with Lewy Bodies.

Key Points: 
  • Fosgonimeton is a potentially first-in-class, investigational, small molecule designed to positively modulate the hepatocyte growth factor (HGF) system, which can activate neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system.
  • In addition, directional improvements in other cognitive, functional and biomarker measurements were observed in the fosgonimeton 40 mg treatment group.
  • The most common adverse event in the treatment groups was injection site reactions.
  • “More broadly, we are encouraged by the clinical and preclinical evidence that support the potential therapeutic effects of HGF system positive modulation across a wide range of neurodegenerative diseases.”

More Real-World Data and New Analyses of Data for REBYOTA® (fecal microbiota, live – jslm) Presented at IDWeek 2023

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星期三, 十月 11, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Ferring Pharmaceuticals, Multimedia, Food, Life, Bacteroidales, Bacteria, CKD, Insurance, Safety, Gammaproteobacteria, MHI, Recurrence, Kidney disease, Chronic kidney disease, Clostridioides difficile infection, Infection, Electronic health record, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mitt, Observation, PUNCH, Patient, Urinary tract infection, Clostridioides difficile, Pharmaceutical industry, Bacilli

Electronic health records, administration records and internal databases were reviewed for patient demographics, setting of care, time from order to treatment, logistics from order to administration and payor details.

Key Points: 
  • Electronic health records, administration records and internal databases were reviewed for patient demographics, setting of care, time from order to treatment, logistics from order to administration and payor details.
  • Early experience with REBYOTA showed an administration time of six minutes followed by 15 minutes of observation.
  • No one was denied insurance coverage for REBYOTA or the instillation procedure.
  • Within a modified intent-to-treat (mITT) population (n=402), 98 had renal comorbidity, including chronic kidney disease (CKD) (n=29) and end-stage renal failure (n=5).