Incidence

BioCryst Presents New Real-world Data Showing Rapid, Substantial and Sustained HAE Attack Rate Reductions After Beginning ORLADEYO® (berotralstat) Treatment

Retrieved on: 
Friday, February 23, 2024

“These additional analyses of real-world use of ORLADEYO show that any person living with HAE has the potential to experience a rapid, substantial and sustained reduction in their monthly attack rate with ORLADEYO.

Key Points: 
  • “These additional analyses of real-world use of ORLADEYO show that any person living with HAE has the potential to experience a rapid, substantial and sustained reduction in their monthly attack rate with ORLADEYO.
  • These analyses present the overall attack rate progression and attack rate progression stratified by severity (i.e., number of attacks at baseline), prior prophylaxis and C1-INH level and function.
  • These findings further demonstrate that ORLADEYO can help maintain disease control in patients with lower baseline attack rates and further reduce attack rates in patients with more active disease.
  • Berotralstat Prophylaxis Reduces HAE Attack Rates Regardless of Baseline Attacks: Real-World Outcomes; Poster #012; Friday, February 23, 3:15-4:15 p.m.

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 22, 2024

WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

Rhythm Pharmaceuticals Announces Clinical Development Plan of Setmelanotide for Hypothalamic Obesity in Japan

Retrieved on: 
Thursday, February 22, 2024

BOSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced plans to add a cohort of patients with hypothalamic obesity in Japan to its ongoing global Phase 3 clinical trial of setmelanotide, with dosing expected to begin in the third quarter of 2024.

Key Points: 
  • “Following constructive discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), we are pleased to have developed a clear and efficient plan to support the potential approval of setmelanotide for hypothalamic obesity in Japan,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm.
  • The condition most frequently follows the growth and surgical removal or other treatment of craniopharyngioma, astrocytoma, or other rare brain tumors.
  • These individuals often experience rapid weight gain, a reduction in energy expenditure, and an increase in hunger leading to severe obesity within six to 12 months following the hypothalamic lesions.
  • Rhythm also announced today that it completed enrollment in the pivotal, 120-patient cohort in its global Phase 3 trial of setmelanotide in hypothalamic obesity with patients, aged 4 years or older with hypothalamic obesity randomized 2:1 to setmelanotide therapy or placebo for a total of 60 weeks, including up to eight weeks for dose titration.

Coherus Announces U.S. Launch of UDENYCA ONBODY™ a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv

Retrieved on: 
Wednesday, February 21, 2024

REDWOOD CITY, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the launch of UDENYCA ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), is successfully underway, with a broad distribution of accounts nationwide ordering this innovative device, and patients now accessing its benefits. UDENYCA is a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

Key Points: 
  • UDENYCA is a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
  • “The ONBODY device is the third presentation in the UDENYCA franchise, which also includes a prefilled syringe and autoinjector.
  • Where a cancer diagnosis takes empowerment away from patients, UDENYCA gives it back.”
    UDENYCA ONBODY is available through existing full-line and specialty distributors.
  • More details regarding UDENYCA ONBODY, including video instructions for ONBODY preparation and application, can be found at https://udenyca.com/hcp/onbody/ .

IR-MED Reports 92% Efficacy for PressureSafe™ in Early, Non-Invasive, Skin Color Agnostic Detection of Pressure Injuries

Retrieved on: 
Tuesday, February 20, 2024

The objective of the study was to evaluate the sensitivity, specificity, and usability of PressureSafe to detect early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage, compared to standard of care.

Key Points: 
  • The objective of the study was to evaluate the sensitivity, specificity, and usability of PressureSafe to detect early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage, compared to standard of care.
  • PressureSafe detected biomarkers and changes in tissue structures under the skin’s surface as they relate to pressure injuries.
  • The 14-day efficacy portion of the single arm, bi-center study evaluated 38 patients at high risk of pressure injury development.
  • Based on these data, the study concluded that PressureSafe is a safe, efficient, and valuable method for early detection of pressure injuries.

NMDP Announces Enrollment of First Patient in OPTIMIZE Clinical Trial

Retrieved on: 
Tuesday, February 20, 2024

The trial is sponsored by NMDP through the Center for International Blood and Marrow Transplant Research (CIBMTR®).

Key Points: 
  • The trial is sponsored by NMDP through the Center for International Blood and Marrow Transplant Research (CIBMTR®).
  • The OPTIMIZE trial hypothesizes that a reduced PTCy dosage could reduce these risks while still effectively guarding against GvHD.
  • The OPTIMIZE trial’s goals include:
    Improve patient survival and quality of life by decreasing acute and long-term toxicities associated with standard dose PTCy.
  • This trial recently completed enrollment in its adult arms ahead of schedule and is continuing to enroll within its pediatric arm.

Cloudflare Doubles Down on Middle East; Expands Presence and Team to Support Growing Customer Demand

Retrieved on: 
Friday, March 8, 2024

The investment includes a new office in Dubai Internet City and growing team focused on partner enablement, innovation, and customer success.

Key Points: 
  • The investment includes a new office in Dubai Internet City and growing team focused on partner enablement, innovation, and customer success.
  • Cloudflare announced its first office in the Middle East nearly two years ago.
  • Cloudflare’s Dubai-based team, led by Bashar Bashaireh, Head of Middle East Sales, continues to grow in the region, signaling the company’s ongoing commitment to its customers and partners.
  • To learn more about Cloudflare Middle East, please check out the resources below:

Asia-Pacific Organ Transplant Diagnostics Market Report 2024: Analysis and Forecast, 2023-2033 - Market to Grow by $2.2 Billion, Driven by Advancements in Human Leukocyte Antigen (HLA) Typing Tests - ResearchAndMarkets.com

Retrieved on: 
Friday, March 8, 2024

The "Asia-Pacific Organ Transplant Diagnostics Market: Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Asia-Pacific Organ Transplant Diagnostics Market: Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.
  • In 2023, the Asia-Pacific organ transplant diagnostics market was valued at $1.25 billion and is expected to reach $3.45 billion by 2033, with a CAGR of 10.73% during the forecast period 2023-2033.
  • The Asia-Pacific (APAC) organ transplant diagnostics market is experiencing significant growth, propelled by various factors.
  • The key players in the APAC organ transplant diagnostics market analyzed and profiled in the study involve established and emerging players that offer different products and services for organ transplant diagnostics.

Janux Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Friday, March 8, 2024

“2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.

Key Points: 
  • “2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.
  • RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
    Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in February 2024.
  • Janux plans to deploy these funds to expand development of clinical programs, advance additional preclinical programs and extend corporate runway.
  • FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:
    Cash and cash equivalents and short-term investments: As of December 31, 2023, Janux reported cash and cash equivalents and short-term investments of $344.0 million compared to $327.0 million at December 31, 2022.

Thermo Fisher Scientific Launches CorEvitas Clinical Registry in Generalized Pustular Psoriasis

Retrieved on: 
Friday, March 8, 2024

Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).

Key Points: 
  • Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).
  • This registry, which is open to enrollment, is CorEvitas’ 10th syndicated disease registry and addresses an unmet need for real-world evidence (RWE) related to the clinical and patient-reported outcomes of patients with GPP.
  • Thermo Fisher acquired CorEvitas, a leading provider of gold-standard real-world evidence solutions, in August 2023.
  • The registry was launched with clinical guidance from two leading GPP clinical experts who serve as scientific advisors: Dr. Mark Lebwohl, dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai; and Dr. Bruce Strober, clinical professor, Department of Dermatology at Yale University.