Checkmate

Bitcoin and Ethereum on the Road to Recovery, While Furrever Token (FURR) Emerges as New Crypto Darling with Impressive ROI Opportunities

Retrieved on: 
Tuesday, April 9, 2024

However, amidst this volatility, a new contender has emerged on the crypto scene, capturing the attention of investors seeking high returns.

Key Points: 
  • However, amidst this volatility, a new contender has emerged on the crypto scene, capturing the attention of investors seeking high returns.
  • Furrever Token (FURR) has generated significant excitement with its promising ROI offers, diverting the spotlight from the more established cryptocurrencies like Bitcoin and Ethereum.
  • Historically, Bitcoin tends to linger near cycle peaks for about 1-2 months before price movements resume.
  • Furrever Token (FURR) has swiftly risen to prominence in the crypto landscape, alluring investors with its promise of high returns and adorable charm.

Check Point Announces a New Collaboration with Microsoft to Supercharge Infinity AI Copilot with Microsoft Azure OpenAI Service

Retrieved on: 
Tuesday, March 26, 2024

REDWOOD CITY, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Check Point Software Technologies Ltd. (NASDAQ: CHKP), a leading AI-powered, cloud-delivered cyber security platform provider, has announced a collaboration with Microsoft that utilizes the Microsoft Azure OpenAI Service to enhance Check Point Infinity AI Copilot, marking a significant advancement in cyber security AI applications.

Key Points: 
  • REDWOOD CITY, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Check Point Software Technologies Ltd. (NASDAQ: CHKP), a leading AI-powered, cloud-delivered cyber security platform provider, has announced a collaboration with Microsoft that utilizes the Microsoft Azure OpenAI Service to enhance Check Point Infinity AI Copilot, marking a significant advancement in cyber security AI applications.
  • Infinity AI Copilot is a generative AI service that uses automation to accelerate security administration up to 90% and increase security effectiveness through faster incident mitigation and response.
  • The collaboration with Azure OpenAI Service is a key part of Check Point’s strategy to produce generative AI cyber security products and services.
  • "Our collaboration with Microsoft Azure OpenAI Service represents a significant leap forward in our mission to offer the most advanced AI-driven security solutions," said Eyal Manor, VP of Product Management at Check Point.

Novotech Publishes Precision Oncology Landscape Whitepaper Identifying Current Trends and Opportunities in Targeted Therapies

Retrieved on: 
Wednesday, March 13, 2024

Precision oncology, or personalized medicine, involves the use of biomarker testing to identify the driver mutations of a patient’s cancer and actionable biomarkers for targeted therapy treatment.

Key Points: 
  • Precision oncology, or personalized medicine, involves the use of biomarker testing to identify the driver mutations of a patient’s cancer and actionable biomarkers for targeted therapy treatment.
  • The Precision Oncology - Global Clinical Trial Landscape whitepaper is designed for researchers, clinicians, pharmaceutical, biopharma and biotech firms.
  • It presents a thorough analysis of healthcare, technology, macroeconomic, regulatory trends, SWOT analysis, funding, and innovative research developments in precision oncology.
  • The report provides a detailed review of the current precision oncology landscape including standout trials, important trends around FDA approvals, funding initiatives, and ongoing insights impacting research and development.

Natera and Alliance for Clinical Trials in Oncology Announce Activation of Alliance A032103 (MODERN): A Randomized, Phase II/III Adjuvant Trial in Urothelial Cancer

Retrieved on: 
Monday, April 1, 2024

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI), part of National Institutes of Health, today announced the launch of Alliance A032103 ( MODERN ), a randomized, phase II/III, biomarker-integrated trial.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI), part of National Institutes of Health, today announced the launch of Alliance A032103 ( MODERN ), a randomized, phase II/III, biomarker-integrated trial.
  • Alliance A032103 (MODERN) will utilize Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to help guide personalized treatment based on molecular status in patients diagnosed with muscle-invasive urothelial cancer (MIUC) after radical cystectomy.
  • Patients will be divided into two cohorts based on an initial assessment of MRD status.
  • “We are grateful to collaborate with the Alliance on this important study.”

Bristol Myers Squibb Announces CheckMate -9DW Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Meets Primary Endpoint of Overall Survival for the First-Line Treatment of Advanced Hepatocellular Carcinoma

Retrieved on: 
Wednesday, March 20, 2024

The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib.

Key Points: 
  • The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib.
  • The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.
  • “Advanced stage liver cancer patients remain in need of additional treatment options that may help improve survival,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb.
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -9DW clinical trial.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, February 7, 2024

Bristol Myers Squibb (NYSE: BMY) today announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).
  • "Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence.
  • The study also showed benefits in key secondary endpoints including pathologic complete response (pCR) and major pathologic response (MPR).
  • Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 6, 2024

In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.

Key Points: 
  • In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2023, Exelixis earned $40.7 million and $148.5 million, respectively, in royalty revenues.
  • In October 2023, detailed results were presented from the phase 3 CABINET pivotal trial at the 2023 ESMO Congress.
  • Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year of 2023 and provide a general business update during a conference call beginning at 5:00 p.m.

Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial

Retrieved on: 
Saturday, January 27, 2024

In addition, subcutaneous nivolumab displayed noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo.

Key Points: 
  • In addition, subcutaneous nivolumab displayed noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo.
  • PFS: Median PFS by BICR with subcutaneous nivolumab was 7.23 months and 5.65 months with IV Opdivo.
  • Among patients treated with subcutaneous nivolumab (n=247), grade 3-4 adverse events (AEs) occurred in 35.2% of patients vs. 40.8% of patients treated with IV Opdivo (n=245).
  • “We are thrilled to present this research for the first time evaluating subcutaneous nivolumab, demonstrating noninferiority compared to intravenous Opdivo and supporting subcutaneous nivolumab as a potential new option to improve healthcare efficiency.

Eight-Year Data for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Continue to Demonstrate Longest Survival Benefit vs. Sunitinib Reported in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Retrieved on: 
Monday, January 22, 2024

Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.

Key Points: 
  • Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.
  • DOR: Median DOR was 82.8 months for patients treated with Opdivo plus Yervoy compared to 19.8 months with sunitinib.
  • ORR: ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib (42% vs. 27%).
  • DOR: For patients treated with Opdivo plus Yervoy, median DOR was 76.2 months compared to 25.1 months with sunitinib.