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Tiziana Life Sciences Announces Additional Clinical Improvements Among Multiple Sclerosis Patients in its Expanded Access Program

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月曜日, 4月 22, 2024
EAP, Mass, Hospital, EDSS, Patient, MFIS, Fatigue, Neurology, Harvard Medical School, Multiple sclerosis, Central nervous system, Microsoft Access, Nursing

NEW YORK, April 22, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients.

Key Points: 
  • NEW YORK, April 22, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients.
  • The data demonstrate multiple improvements in foralumab-treated patients, with 70% showing an improvement in fatigue after six months of follow-up.
  • Fatigue is a debilitating symptom for many MS patients and is measured by the Modified Fatigue Impact Scale (MFIS).
  • The findings, which are summarized in Table 1 below, show broad-based six-month improvements across various key measures for multiple sclerosis.

Tiziana Life Sciences Announces New Quantitative PET Imaging Data on Foralumab at the Annual Meeting of the American Academy of Neurology

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木曜日, 4月 18, 2024
American Academy, Mass, Hospital, Stabilizer, White matter, PET, EDSS, Human, Patient, MFIS, Fatigue, DSM-IV codes, Harvard Medical School, Biomarker, Annual general meeting, Associate, Microsoft Access, Neuro, PIRA, Medical imaging

The presentation includes new, encouraging quantitative imaging data from foralumab’s intermediate- size patient population Expanded Access Program.

Key Points: 
  • The presentation includes new, encouraging quantitative imaging data from foralumab’s intermediate- size patient population Expanded Access Program.
  • Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, commented, “Tiziana is taking a leadership role in focusing on this subset of progressive MS where there are no effective treatments.
  • The study is designed to be open-label and part of the Expanded-Access Program evaluating foralumab in na-SPMS patients that is currently underway.
  • This trial ( NCT06292923 ) is important because if the potential to slow disease progression is demonstrated this would align with early treatment intervention.

Feinstein Institutes’ Daniel A. Grande Named President-Elect of the International Cartilage Regeneration & Joint Preservation Society (ICRS)

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木曜日, 4月 18, 2024
Health, Hospitals, Other Health, Other Science, General Health, Research, Science, Education, FDA, Rheumatology, EVS, Microsoft Exchange Server, Intervertebral disc, Regenerative medicine, Seminal vesicles, Cartilage, Doctor of Philosophy, B cell, Meniscus, ICRS, Patient, Tissue engineering, Molecular medicine, 3D bioprinting, Medical research, Microsoft Access, Multimedia, Regeneration, Stem cell, Credit, Journal, Medical device

The International Cartilage Regeneration & Joint Preservation Society (ICRS) has named Daniel A. Grande, PhD, assistant vice president of research services and professor of molecular medicine and orthopedic surgery at The Feinstein Institutes for Medical Research , its new President-Elect.

Key Points: 
  • The International Cartilage Regeneration & Joint Preservation Society (ICRS) has named Daniel A. Grande, PhD, assistant vice president of research services and professor of molecular medicine and orthopedic surgery at The Feinstein Institutes for Medical Research , its new President-Elect.
  • View the full release here: https://www.businesswire.com/news/home/20240418363701/en/
    Feinstein Institutes’ Dr. Daniel A. Grande has been named the new president-elect of International Cartilage Repair Society.
  • (Credit: Feinstein Institutes)
    Dr. Grande, renowned for his significant contributions to cartilage repair and regeneration, will lead the ICRS in its mission to advance science and education in preventing and treating cartilage injuries.
  • "I am honored and excited to serve as the President-Elect of the International Cartilage Regeneration & Joint Preservation Society.

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

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木曜日, 3月 28, 2024
Narcolepsy, Exercise, Somnolence, New Drug Application, Patient, Visual analogue scale, Sale, NDA, G&A, Arimoclomol, Nature, IND, Bank statement, Microsoft Access, Investment, Therapy, Priority review, Corporation, Audit committee, Research, Niemann–Pick disease, Medical science liaison, Sleep disorder, Brain, Trial of the century, Safety, Interim, Food, Sleep, QuickStart, Disease, FY, Acquisition, Emetine, UCD, COL3A1, Celiprolol, Syndrome, FDA, Marketing, Conference call, Conference, EAP, SDX, NPC, Epworth Sleepiness Scale, Idiopathic hypersomnia, Physician, PDUFA, Pharmaceutical industry

CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.

TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

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木曜日, 3月 28, 2024
Research, TFF, Administration, Conference, Patient, IPA, EAP, Mortality, G&A, Lung transplantation, Insurance, AAAM, Microsoft Access, Research and development, Infection, Safety, FDA, Heart, Corporation, Pharmaceutical industry

FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.

Key Points: 
  • FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.
  • For TFF TAC, the Company presented data showing that eight out of eight patients successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • In the fourth quarter 2023, the Company announced the appointment of three new members of its Board of Directors, including Thomas B.

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs

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水曜日, 3月 27, 2024
Principal, Annual, Fungal infection, TFF, COVID, Intubation, International Society, Part, Patient, Biomarker, IPA, Spirometry, EAP, Mortality, Lung transplantation, Microsoft Access, Potential, Safety, Kidney, Heart, Pharmaceutical industry

FORT WORTH, Texas , March 27, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

Key Points: 
  • “Based on the totality of these clinical data, we believe TFF TAC and TFF VORI have the potential to establish a new and significantly improved form of delivery for these two life-saving medicines.
  • The updated safety and efficacy data are based on the cutoff date of March 8, 2024.
  • The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity.
  • The Company will host a conference call today at 4:30 pm Eastern Time, to discuss updated data for the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

TFF Pharmaceuticals Announces Update on Clinical Programs

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水曜日, 3月 20, 2024
Health, TFF, P-value, Acceleration, Partnership, Patient, IPA, EAP, KOL, Mortality, Clinical research associate, Microsoft Access, Calendar, Potential, Safety, Voriconazole, Pharmaceutical industry

FORT WORTH, Texas, March 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, is announcing data updates and strategic prioritization of its clinical programs. Based on positive data from the ongoing Phase 2 study of TFF TAC, the potential to address a significant unmet need in lung transplant medicine, and substantial market opportunity, the Company has made the decision to prioritize the TFF TAC program and focus resources on the acceleration of its clinical pathway towards registration.

Key Points: 
  • “However, after a rigorous assessment of our pipeline, including the significant capital and resources required to progress both clinical development programs, we will focus our clinical development efforts and financial resources on TFF TAC.
  • In summary, for TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • The Company will host a conference call on Wednesday, March 27, 2024, at 4:30 PM Eastern Time, to discuss updated clinical data for the TFF TAC and TFF VORI.

Pharming Group reports fourth quarter and full year 2023 financial results

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木曜日, 3月 14, 2024
Patient, Health care, Epidemiology, Executive Committee, Laboratory, Microsoft Access, Lymphocyte, Clinical trial, European Commission, APDS, MHLW, AEG, Welfare, Ageing, Committee, EMA, Trial of the century, PID, CTLA4, Safety, Pharmacokinetics, Ministry, CHMP, ODD, U.S. FDA, Prevalence, PTEN, Disease, HAE, Immunodeficiency, VUS, Literature, PIK3R1, PMDA, FDA, DSM-IV codes, Diagnosis, Civil service commission, IRP, Haploinsufficiency, Genetic testing, MAA, Autoimmunity, World Games, Iberian languages, Marketing, MHRA, Euronext Amsterdam, PIK3CD, Physician, Pharmaceutical industry

The U.S. market contributed 97% of 2023 revenues, while the EU and Rest of World contributed 3%.

Key Points: 
  • The U.S. market contributed 97% of 2023 revenues, while the EU and Rest of World contributed 3%.
  • Revenues increased to US$7.9 million in the fourth quarter of 2023, driven by the continued increase in patients on paid therapy, and revenues were US$18.2 million for 2023.
  • Pharming made continued progress in the fourth quarter of 2023 on leniolisib regulatory filings for APDS patients 12 years of age and older in key global markets.
  • Pharming filed regulatory submissions in Canada and Australia in the third quarter of 2023, and Israel in the second quarter.

Arrowhead Pharmaceuticals Initiates Expanded Access Program for Plozasiran and Announces Upcoming Presentation of Clinical Data

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月曜日, 3月 25, 2024
Infectious Diseases, Diabetes, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Oncology, Arrowhead, Diagnosis, PALISADE, Patient, Hypertriglyceridemia, EAP, Science, Microsoft Access, American College, Clinical trial, RNA interference, FCS, Therapy, Physician, Pharmaceutical industry

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.
  • Arrowhead will also present new final Phase 2 clinical data from the double-blind portion of the SHASTA-2 study of plozasiran in a late-breaking oral presentation at the upcoming American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24), being held in Atlanta on April 6-8, 2024.
  • “Arrowhead is committed to supporting patients living with various lipid disorders and the physicians who treat them.
  • “Our Phase 3 PALISADE study of plozasiran in patients with FCS is nearing completion and we are further supporting the patient community by initiating an expanded access program for patients and physicians interested in receiving treatment with plozasiran outside of a clinical trial.

Rezolute Reports Validation of the Potential Use of RZ358 for Treatment of Non-Islet Cell Tumor Hypoglycemia (NICTH)

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水曜日, 3月 6, 2024
Pharmacology, FDA, Hormone, Food, Microsoft Access, Hypoglycemia, Ligand, Patient, Insulin, Hyperinsulinism, Information and communications technology, EAP, Human, Cancer, Pharmaceutical industry

Tumor hyperinsulinism (HI) may be caused by a variety of different tumor types, resulting in islet cell tumor hypoglycemia (ICTH) and NICTH.

Key Points: 
  • Tumor hyperinsulinism (HI) may be caused by a variety of different tumor types, resulting in islet cell tumor hypoglycemia (ICTH) and NICTH.
  • The Company previously reported on the successful use of RZ358 under its Expanded Access Program (EAP) to treat patients with insulin-producing pancreatic islet cell tumors (ICTs), or insulinomas, causing severe and uncontrolled hypoglycemia.
  • The therapeutic potential of RZ358 in this setting was anticipated given that ICTH is mediated by insulin and that RZ358 is known to work at the insulin receptor to decrease excess insulin binding and activity.
  • The inclusion of NICTH patients in a potential addressable market for RZ358 in tumor HI would more than double the population.