Edema

Endonovo Launches SofPulse® into the Veterans Administration

Retrieved on: 
tisdag, maj 2, 2023

As was previously announced, Academy Medical will be reselling SofPulse® medical devices to the Veterans Health Administration (VHA) healthcare facilities, thereby ensuring its availability to the country’s military, veterans and their families.

Key Points: 
  • As was previously announced, Academy Medical will be reselling SofPulse® medical devices to the Veterans Health Administration (VHA) healthcare facilities, thereby ensuring its availability to the country’s military, veterans and their families.
  • This sales launch meeting marks the beginning of the partnership between Endonovo and Academy Medical.
  • With the launch of SofPulse® into the Federal marketplace Endonovo, along with Academy Medical, have the potential to significantly improve access to SofPulse® to military personnel and veterans.
  • “The partnership between Academy Medical and Endonovo provides veterans an opportunity to benefit from the device’s unique PEMF technology,” according to CEO, Tory Crawford, Army veteran.

Tiziana Life Sciences Announces Findings from Intranasal Anti-CD3 mAb Treatment in Intracerebral Hemorrhage at the Annual American Academy of Neurology Conference

Retrieved on: 
torsdag, april 27, 2023

NEW YORK, April 27, 2023 (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 broad-based findings on the utility of nasal anti-CD3 mAb in the treatment of intracerebral hemorrhage (ICH).

Key Points: 
  • NEW YORK, April 27, 2023 (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 broad-based findings on the utility of nasal anti-CD3 mAb in the treatment of intracerebral hemorrhage (ICH).
  • The data using a mouse model of collagenase-induced ICH was presented at the Annual American Academy of Neurology conference.
  • Our research studied the effect of an intranasal anti-CD3 antibody in a mouse model of induced ICH.
  • “These exciting findings may allow Tiziana to explore additional intranasal foralumab neuroinflammatory indications to help patients with unmet needs and create further shareholder value”.

Ubie signs a broad collaboration agreement with Takeda Pharmaceuticals to promote digital transformation

Retrieved on: 
torsdag, april 27, 2023

NEW YORK, April 27, 2023 /PRNewswire/ -- Ubie Inc. has signed a comprehensive collaboration agreement with Takeda Pharmaceutical Co., Ltd. to promote digital transformation, which aims to guide people to appropriate medical care for rare diseases and gastrointestinal diseases.

Key Points: 
  • NEW YORK, April 27, 2023 /PRNewswire/ -- Ubie Inc. has signed a comprehensive collaboration agreement with Takeda Pharmaceutical Co., Ltd. to promote digital transformation, which aims to guide people to appropriate medical care for rare diseases and gastrointestinal diseases.
  • Since April 2021, Ubie and Takeda Pharmaceutical Co., Ltd. have been promoting digital transformation for the early detection of diseases and guidance for appropriate medical examinations using Ubie Symptom Checker, a service for general public with disease concerns, and Ubie Patient Intake Form, a service for medical institutions.
  • (*2,3,4) If it lodges in the throat, it can block the airway, causing difficulty breathing and the elevating risk of suffocation.
  • Ubie, in collaboration with Takeda, will contribute to the health of as many patients as possible by supporting patient journeys through the active use of technology.

BioArctic: New lecanemab-data presented at the AD/PD™ 2023 conference

Retrieved on: 
måndag, april 3, 2023

Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.

Key Points: 
  • Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
  • In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine .
  • His presentation concluded that lecanemab has a unique binding profile, with strong selectivity for protofibrils over monomers and fibrils of Aβ.
  • The information was released for public disclosure, through the agency of the contact person below, on April 3, 2023, at 08:00 a.m. CET.

BioArctic: New lecanemab-data presented at the AD/PD™ 2023 conference

Retrieved on: 
måndag, april 3, 2023

Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.

Key Points: 
  • Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
  • In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine .
  • His presentation concluded that lecanemab has a unique binding profile, with strong selectivity for protofibrils over monomers and fibrils of Aβ.
  • The information was released for public disclosure, through the agency of the contact person below, on April 3, 2023, at 08:00 a.m. CET.

Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting

Retrieved on: 
fredag, mars 31, 2023

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer’s Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.

Endonovo Announces Binding Letter of Intent to Sell SofPulse® Assets to Spin-Off Company

Retrieved on: 
onsdag, mars 29, 2023

As previously announced, Endonovo hired Ocean Tomo to value its medical IP assets for an anticipated Spin-Off.

Key Points: 
  • As previously announced, Endonovo hired Ocean Tomo to value its medical IP assets for an anticipated Spin-Off.
  • Endonovo will retain its non-medical PEMF assets and the future telehealth division.
  • Ocean Tomo is a leading provider of expert opinion and consulting services for IP and intangible assets.
  • The last valuation report issued for Endonovo’s SofPulse® IP and assets, completed in 2018, stated that these assets were worth $75 million.

Endonovo’s SofPulse® Nears Final Stages to Receive Taiwan FDA License to Distribute in Taiwan

Retrieved on: 
torsdag, mars 23, 2023

With its launch in Taiwan on the horizon, Sofpulse® is poised to help more patients experience the benefits of this revolutionary technology.

Key Points: 
  • With its launch in Taiwan on the horizon, Sofpulse® is poised to help more patients experience the benefits of this revolutionary technology.
  • With newly obtained U.S. State Department certification of Certificate of Foreign Government (CFG) distribution, final Taiwan FDA approval for medical device license is months away from obtaining final distribution license for its medical market.
  • "We are so close to receiving the rights to distribute the SofPulse® device in Taiwan.
  • This technology has already received certification from the U.S. FDA and has the potential to provide safe, effective and affordable solutions for patients in Taiwan and beyond," Weisberg concluded.

Poxel Reports Financial Results for Full Year 2022 and Provides Corporate Update

Retrieved on: 
torsdag, mars 23, 2023

POXEL SA (Euronext: POXEL - FR0012432516) (Paris:POXEL), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its results for the year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516) (Paris:POXEL), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its results for the year ended December 31, 2022 and provided a corporate update.
  • Based on recent sales trends, Sumitomo has increased its fiscal year 20223 forecast by 20% to JPY 1.8 billion6 (EUR 12.8 million)5.
  • For the Sumitomo fiscal year 2023 (ending March 31, 2024), as a conservative assumption, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • Beyond 2024, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Business Update

Retrieved on: 
onsdag, mars 22, 2023

BURLINGTON, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2022 and provided a business update. 

Key Points: 
  • Entered into $100 million secured debt financing agreement with funds managed by Oaktree Capital Management in October 2022.
  • scPharmaceuticals ended the fourth quarter 2022 with $118.4 million in cash, cash equivalents, restricted cash and investments, compared to $75.5 million as of December 31, 2021.
    scPharmaceuticals reported a net loss of $9.2 million for the fourth quarter of 2022, compared to $7.3 million for the fourth quarter of 2021.
  • Research and development expenses were $2.3 million for the fourth quarter of 2022, compared to $4.5 million for the fourth quarter of 2021.
  • General and administrative expenses were $7.2 million for the fourth quarter of 2022, compared to $2.2 million for the fourth quarter of 2021.