Lancet

FRUZAQLA™ (fruquintinib) Now Available from Onco360 for the Treatment of Adult Patients with Metastatic Colorectal Cancer (mCRC)

Retrieved on: 
Tuesday, November 21, 2023

Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.

Key Points: 
  • Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.
  • Colorectal cancer is the fourth most frequent diagnosed cancer and second leading cause of death in the U.S.
  • Fruquintinib vs Placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicenter, randomized double blind, phase 3 study.
  • Effect of fruquintinib vs Placebo on overall survival in patients with previously treated metastatic colorectal cancer.

GRAIL To Initiate REACH Study To Evaluate Clinical Impact Of GalleriⓇ Multi-Cancer Early Detection (MCED) Test Among The Medicare Population

Retrieved on: 
Monday, November 20, 2023

With age being the most significant risk factor for cancer, Medicare beneficiaries face the highest unmet need for early cancer detection.

Key Points: 
  • With age being the most significant risk factor for cancer, Medicare beneficiaries face the highest unmet need for early cancer detection.
  • View the full release here: https://www.businesswire.com/news/home/20231120057874/en/
    The Galleri-Medicare study is a first-of-its-kind real-world study designed to further evaluate the clinical impact of the Galleri® multi-cancer early detection (MCED) test among Medicare beneficiaries, including racial and ethnic minorities, and seniors from historically under-served communities.
  • Medicare will cover the costs of Galleri and related and routine items and services for study participants.
  • “The Galleri-Medicare study demonstrates our commitment to provide broad, equitable access to early cancer detection that is representative of the U.S. population, including groups that are often under-represented in clinical research.

Cardiawave Announces the Publication in The Lancet of First-In-Human Clinical Studies Results With 40 Aortic Stenosis Patients Treated With Its Innovative Non-invasive Ultrasound Therapy (NIUT)

Retrieved on: 
Wednesday, November 15, 2023

The patients were treated with Cardiawave’s NIUT investigational device in one session.

Key Points: 
  • The patients were treated with Cardiawave’s NIUT investigational device in one session.
  • “Clinically, the patients experienced a considerable improvement in their clinical status suggesting a better quality of life.
  • These early findings can represent a change in the paradigm of CAS treatment especially for patients who have no other options.
  • In July 2023, Cardiawave successfully completed the patient enrolment with no procedure or device-related mortality up to 30 days.

CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

Retrieved on: 
Thursday, December 14, 2023

KING OF PRUSSIA, Penn., Dec. 14, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the submission for CSL's Marketing Authorization Application (MAA) for garadacimab. If approved, garadacimab would become the first treatment for HAE in the U.S. and EU to target activated Factor XII (FXIIa).

Key Points: 
  • The company also announced the European Medicines Agency (EMA) has accepted the submission for CSL's Marketing Authorization Application (MAA) for garadacimab.
  • If approved, garadacimab would become the first treatment for HAE in the U.S. and EU to target activated Factor XII (FXIIa).
  • Orphan-drug designation for garadacimab as a therapy for hereditary angioedema has been granted by both the FDA and the EMA.
  • The ongoing open-label extension of the VANGUARD study evaluates the long-term safety and efficacy of garadacimab (200 mg monthly) in patients with HAE.

GN and Soundly Presents "Inside the Ear", Digital Art Campaign Aiming to Transform Hearing Health Awareness

Retrieved on: 
Thursday, November 30, 2023

BALLERUP, Denmark, Nov. 30, 2023 /PRNewswire/ -- GN, the global leader in hearing aid innovation, and Soundly, a consumer education resource for hearing wellness, have joined forces once again to present "Inside the Ear," a digital art campaign aimed at demystifying hearing loss and hearing health. The campaign, launching today, showcases a series of fascinating and educational videos created by award-winning digital artist, Design Cells, which beautifully illustrate the complex inner workings of the ear.

Key Points: 
  • The campaign explores the inner workings of the ear through vibrant visuals, empowering consumers with a deeper understanding of their hearing health.
  • BALLERUP, Denmark, Nov. 30, 2023 /PRNewswire/ -- GN, the global leader in hearing aid innovation, and Soundly, a consumer education resource for hearing wellness, have joined forces once again to present "Inside the Ear," a digital art campaign aimed at demystifying hearing loss and hearing health.
  • GN and Soundly unite with a shared vision to cultivate greater awareness and education surrounding the crucial significance of maintaining optimal hearing health.
  • Explore the complete "Inside the Ear" digital art collection and delve into the significance of hearing health by clicking here .

ConcertAI's TeraRecon Enhances its Eureka Clinical AI Platform with AI-Based Prostate Cancer Diagnostic Solutions from Lucida Medical

Retrieved on: 
Wednesday, November 15, 2023

CAMBRIDGE, Mass., Nov. 15, 2023 /PRNewswire/ -- ConcertAI's TeraRecon, the advanced visualization and clinical AI SaaS company, today announced the addition of Lucida Medical to its Eureka Clinical AI Platform ecosystem.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 15, 2023 /PRNewswire/ -- ConcertAI's TeraRecon, the advanced visualization and clinical AI SaaS company, today announced the addition of Lucida Medical to its Eureka Clinical AI Platform ecosystem.
  • Pi™ (Prostate Intelligence™), Lucida Medical's AI-machine learning software, is designed to help radiologists detect prostate cancer lesions from MRI, enabling faster and more accurate prostate cancer detection.
  • Prostate cancer diagnosis using MRI represents a major step forward compared to earlier methods but remains prone to human error.
  • Learn more about the Eureka Clinical AI platform capabilities and algorithms that span across neurology, radiology, cardiology, oncology, and more:

HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Thursday, November 9, 2023

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announced that its partner Takeda received approval from the U.S. Food and Drug Administration (“FDA”) for FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (“CRC”) who have been previously treated with fluoropyrimidine-, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (“VEGF”) therapy, and, if RAS wild‑type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy. FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated metastatic CRC regardless of biomarker status.1,2 This approval was received under Priority Review more than 20 days ahead of the scheduled Prescription Drug Users Fee Act (PDUFA) date of November 30, 2023.

Key Points: 
  • The FDA approval of FRUZAQLA triggers a US$35 million milestone payment from Takeda.
  • Fruquintinib is developed and marketed in China by HUTCHMED following approval in September 2018, under the brand name ELUNATE™, in partnership with Eli Lilly and Company.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • A submission to the Japan Pharmaceuticals and Medical Devices Agency (“PMDA”) also took place in September 2023 .

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Wednesday, November 8, 2023

"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.

Key Points: 
  • "There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.
  • “For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • “Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized.

VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Thursday, November 9, 2023

VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2

Key Points: 
  • VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2
    The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet .
  • The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%).
  • QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation.
  • Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

Marinus Pharmaceuticals Initiates Global Access Program for ZTALMY® (ganaxolone) Oral Suspension CV

Retrieved on: 
Tuesday, November 7, 2023

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the initiation of the Marinus Access Program, a global managed access program for ZTALMY® (ganaxolone) oral suspension CV.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the initiation of the Marinus Access Program, a global managed access program for ZTALMY® (ganaxolone) oral suspension CV.
  • The new program enables physicians to request ZTALMY for eligible patients with seizures associated with CDKL5 deficiency disorder (CDD) in geographies where the product is not commercially available and as supported by local regulatory requirements.
  • The Marinus Access Program will be managed by Durbin, a leader in the international distribution of specialized pharmaceuticals.
  • “Consistent with our company mission, we are committing appropriate resources to help facilitate broader access to ZTALMY for patients with critical unmet medical needs,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus.