ESMO

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.

Purple Biotech Reaches Recommended Phase 2 Dose for NT219

Retrieved on: 
Thursday, February 1, 2024

REHOVOT, Israel, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced it has determined 100mg/kg is the recommended Phase 2 dose (RP2D) for NT219 in combination with cetuximab in the treatment of head and neck cancer based on its Phase 1/2 dose escalation study (NCT04474470).

Key Points: 
  • REHOVOT, Israel, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced it has determined 100mg/kg is the recommended Phase 2 dose (RP2D) for NT219 in combination with cetuximab in the treatment of head and neck cancer based on its Phase 1/2 dose escalation study (NCT04474470).
  • The Company recently reported that NT219, in combination with cetuximab, demonstrated a dose dependent anti-tumor activity with confirmed partial responses.
  • The Company is now advancing its upcoming Phase 2 Proof of Concept study of NT219 for the treatment of R/M SCCHN.
  • “We look forward to treating more patients with NT219 in a Phase 2 study.”

Median Technologies Reports 2023 Revenue and Summarizes 2024 Strategic Outlook

Retrieved on: 
Monday, January 29, 2024

Median Technologies (FR0011049824, ALMDT, PEA/SME eligible) announces its 2023 revenue, outlining both its strategic outlook and key milestones for 2024.

Key Points: 
  • Median Technologies (FR0011049824, ALMDT, PEA/SME eligible) announces its 2023 revenue, outlining both its strategic outlook and key milestones for 2024.
  • Fredrik Brag, Chief Executive Officer and Founder of Median Technologies, commented: "In Q4 2023, our iCRO1 business achieved record-high order intake, which increased significantly our backlog.
  • We expect to return to growth in 2024 on the back of a decline in 2023 revenue due to soft order intake in China caused by the Covid lockdowns in 2022 and H1 2023."
  • The Standalone study will be finalized in Q2 2024 and the MRMC study in Q3 2024.

OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook

Retrieved on: 
Friday, January 19, 2024

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024.
  • Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement.
  • Thus, from Q1 2024, the Company could have validated doses and therapeutic regimens to consider the implementation of possible other clinical trials.

Analyze the Clinical Trial Landscape Through the Pharma Competitive Intelligence Monitoring Services by DelveInsight

Retrieved on: 
Thursday, January 18, 2024

LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services. Through this service, clients can easily monitor developmental assets, clinical trials, regulatory milestones, commercial news, and receive high-priority alerts in real time as well as assess updates via an online dashboard. 

Key Points: 
  • LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services .
  • Competitive intelligence monitoring enables companies to swiftly adjust to market fluctuations, comprehend patient needs, address developmental challenges, enhance their overall decision-making processes, and leverage competitive advantage.
  • Demonstrating proficiency in Competitive Intelligence Monitoring, DelveInsight assists clients in fortifying their brand's market standing and company's overall positioning, staying abeam of prevailing industry trends.
  • Leverage our Competitive Intelligence Monitoring Services for precise and effective results:
    Monitor competitors extensively; who are in product development, or those already in the market
    Ask for a proposal to find out how DelveInsight's pharma Competitive intelligence monitoring solutions can assist you.

Analyze the Clinical Trial Landscape Through the Pharma Competitive Intelligence Monitoring Services by DelveInsight

Retrieved on: 
Thursday, January 18, 2024

LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services. Through this service, clients can easily monitor developmental assets, clinical trials, regulatory milestones, commercial news, and receive high-priority alerts in real time as well as assess updates via an online dashboard. 

Key Points: 
  • LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services .
  • Competitive intelligence monitoring enables companies to swiftly adjust to market fluctuations, comprehend patient needs, address developmental challenges, enhance their overall decision-making processes, and leverage competitive advantage.
  • Demonstrating proficiency in Competitive Intelligence Monitoring, DelveInsight assists clients in fortifying their brand's market standing and company's overall positioning, staying abeam of prevailing industry trends.
  • Leverage our Competitive Intelligence Monitoring Services for precise and effective results:
    Monitor competitors extensively; who are in product development, or those already in the market
    Ask for a proposal to find out how DelveInsight's pharma Competitive intelligence monitoring solutions can assist you.

Dignitana signs OncoMedical for distribution in Switzerland and Liechtenstein

Retrieved on: 
Monday, January 15, 2024

LUND, Sweden, Jan. 15, 2024 /PRNewswire/ -- Scalp cooling innovator Dignitana AB has signed OncoMedical AG as the exclusive distributor for The DigniCap Scalp Cooling System in Switzerland and Liechtenstein.

Key Points: 
  • LUND, Sweden, Jan. 15, 2024 /PRNewswire/ -- Scalp cooling innovator Dignitana AB has signed OncoMedical AG as the exclusive distributor for The DigniCap Scalp Cooling System in Switzerland and Liechtenstein.
  • Switzerland is a strong market for scalp cooling with many options for quality private healthcare in addition to the public sector clinics.
  • The distribution agreement with OncoMedical seeks to expand that footprint in Switzerland and Liechtenstein, while also upgrading current Dignitana customers to the advanced technology offered by the next generation DigniCap Delta system.
  • "OncoMedical shares our commitment to excellence in technology, customer service and patient care," said Catarina Löwenadler, CEO of Dignitana.

TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Tuesday, January 9, 2024

The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.

Key Points: 
  • The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.
  • The safety profile of TIVDAK in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.
  • In October 2023, results from the innovaTV 301 study were presented during a Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress.
  • The accelerated approval is based on tumor response and durability of response from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer.

TIVDAK® (tisotumab vedotin-tftv) Supplemental Biologics License Application Accepted for Priority Review by U.S. Food and Drug Administration for Patients with Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Tuesday, January 9, 2024

The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024.

Key Points: 
  • The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024.
  • The safety profile of tisotumab vedotin-tftv in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.
  • In October 2023, results from the innovaTV 301 study were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress.
  • “The FDA acceptance of our sBLA for review is important progress toward continuing to offer an option that can extend the lives of more adults with cervical cancer.”