Microsoft Access

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

Retrieved on: 
Wednesday, March 6, 2024

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.

CELEBRATING 25 YEARS: A Q&A WITH CEO GUNTHER EYSENBACH

Retrieved on: 
Thursday, March 7, 2024

TORONTO, March 6, 2024 /PRNewswire/ -- Join Gunther Eysenbach, the founder, CEO, and executive editor of JMIR Publications, in this new video as he reflects on the company's 25th anniversary and its remarkable journey in the scholarly publishing industry.

Key Points: 
  • TORONTO, March 6, 2024 /PRNewswire/ -- Join Gunther Eysenbach, the founder, CEO, and executive editor of JMIR Publications, in this new video as he reflects on the company's 25th anniversary and its remarkable journey in the scholarly publishing industry.
  • Eysenbach discusses the inception of the Journal of Medical Internet Research and the driving forces behind creating an open access eHealth journal.
  • Eysenbach shares memorable success stories, notably the pivotal role of JMIR Publications during the COVID-19 pandemic, where digital health solutions gained unprecedented prominence.
  • Eysenbach highlights JMIR Publications' initiatives like the JMIRx series, which pioneers new approaches to peer review and publication.

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Retrieved on: 
Wednesday, February 21, 2024

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

Caliway Received U.S. FDA Fast Track Designation for CBL-514 for the Treatment of Dercum's Disease

Retrieved on: 
Thursday, February 15, 2024

NEW TAIPEI CITY, Feb. 14, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first drug to receive Fast Track designation for Dercum's disease treatment.

Key Points: 
  • - CBL-514 is the first drug to receive Fast Track designation for Dercum's disease treatment.
  • NEW TAIPEI CITY, Feb. 14, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment.
  • "We are very pleased to see the FDA's decision on granting Fast Track designation to CBL-514," said Vivian Ling, CEO of Caliway.
  • The Expanded Access Program is a program recognized by the FDA as a follow-on to their Fast Track Designation.

Rezolute Reports Second Quarter Fiscal 2024 Results and Provides Business Update

Retrieved on: 
Tuesday, February 13, 2024

REDWOOD CITY, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the second quarter of fiscal 2024 ended December 31, 2023, and provided an update on recent business developments and outlook.

Key Points: 
  • REDWOOD CITY, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the second quarter of fiscal 2024 ended December 31, 2023, and provided an update on recent business developments and outlook.
  • Rezolute initiated sunRIZE, a global, pivotal, Phase 3 clinical study in participants with cHI, in Europe and other geographies outside of the U.S.
  • Innovation and Licensing Application Passport (ILAP) designation awarded to RZ358 for the treatment of cHI by the U.K.
  • Topline results expected in the second quarter of 2024.

Anavex Life Sciences Provides an Update on Rett Syndrome Program

Retrieved on: 
Tuesday, January 2, 2024

NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders today reported topline results from the randomized, double-blind, placebo-controlled, Phase 2/3 EXCELLENCE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 30 mg ANAVEX®2-73 in 92 pediatric patients with Rett syndrome (RTT) between the ages of 5 through 17 years. Participants were randomized 2:1 (ANAVEX®2-73 [62 patients] to placebo [30 patients]) for 12 weeks, followed by a week 16 safety visit. As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.

Key Points: 
  • As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.
  • After 12 weeks, the study showed improvement on the key co-primary endpoint Rett Syndrome Behaviour Questionnaire (RSBQ), which is a detailed 45-item questionnaire for assessing multiple Rett syndrome characteristics by the patients’ caregivers.
  • As of today, some patients with Rett syndrome have been on ANAVEX®2-73-treatment for over 4 years, combined OLE and Compassionate Use Program.
  • In addition to Rett syndrome, Anavex is evaluating ANAVEX®2-73 in other neurodevelopmental disorders, including Fragile X syndrome, and in neurodegenerative disorders like Parkinson’s disease.

Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab in Multiple Sclerosis

Retrieved on: 
Tuesday, December 19, 2023

NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA ) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS).

Key Points: 
  • NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA ) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS).
  • Six investigational centers have been recruited for this double-blind, placebo-controlled trial, with up to 18 patients per treatment arm.
  • The primary endpoint of the trial will be the change in microglial activation based on PET scans.
  • I believe the study results will reveal important aspects for optimizing clinical management of na-SPMS - particularly the potential for a reduction in MFIS scores.”

United States Open Access Journal Publishing 2023-2027: Research Integrity a Rising Challenge - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 27, 2023

The "United States Open Access Journal Publishing 2023-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "United States Open Access Journal Publishing 2023-2027" report has been added to ResearchAndMarkets.com's offering.
  • This report explains the origins of the open access movement, gives a timeline for its development, but most importantly, the analyst quantifies open access' position as a fast growing subsegment of scholarly journal publishing.
  • The analyst used the information it gathered through primary and secondary research to develop a financial outlook for open access journal publishing including leading competitors' performance through 2023 and market projections through 2027.
  • Open Access Journal Publishing 2023-2027 contains separate chapters covering the market, key competitors, and issues and forecast that include:
    A breakdown of players in the open access ecosystem including public and private research funders.

United States Open Access Journal Publishing 2023-2027: Opportunities in Open Data and Preprints

Retrieved on: 
Friday, December 22, 2023

DUBLIN, Dec. 22, 2023 /PRNewswire/ -- The "United States Open Access Journal Publishing 2023-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 22, 2023 /PRNewswire/ -- The "United States Open Access Journal Publishing 2023-2027" report has been added to ResearchAndMarkets.com's offering.
  • This report explains the origins of the open access movement, gives a timeline for its development, but most importantly, the analyst quantifies open access' position as a fast growing subsegment of scholarly journal publishing.
  • The analyst used the information it gathered through primary and secondary research to develop a financial outlook for open access journal publishing including leading competitors' performance through 2023 and market projections through 2027.
  • Open Access Journal Publishing 2023-2027 contains separate chapters covering the market, key competitors, and issues and forecast that include:
    A breakdown of players in the open access ecosystem including public and private research funders.

TFF Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 14, 2023

FORT WORTH, Texas, Nov. 14, 2023 (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 third quarter of 2023 and provided a corporate update.

Key Points: 
  • FORT WORTH, Texas, Nov. 14, 2023 (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 third quarter of 2023 and provided a corporate update.
  • For the quarter ended September 30, 2023, compared to quarter ended September 30, 2022
    Cash Position: as of September 30, 2023, TFF Pharmaceuticals reported cash and cash equivalents of $9.7 million.
  • Net Loss: TFF Pharmaceuticals reported a net loss for the third quarter of 2023 of $4.4 million, compared to a net loss of $7.3 million for the comparable period in 2022.
  • The Company will host a conference call today, Tuesday, November 14, 2023, at 4:30 PM Eastern Time, to discuss third quarter 2023 financial results and the corporate update.