Daiichi Sankyo

Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer or HR Positive, HER2 Negative Breast Cancer

Retrieved on: 
Monday, March 4, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Breast cancer, AstraZeneca, EMA, Doctor of Philosophy, MAA, MD, News, Cancer, Lung, Daiichi Sankyo, ADC, IHC, HER2, HR, DXD, European Medicines Agency, Patient, Maas, Medicine, Lung cancer, Congress, Breast

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) datopotamab deruxtecan (Dato-DXd) in two types of cancer.

Key Points: 
  • The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) datopotamab deruxtecan (Dato-DXd) in two types of cancer.
  • One MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment.
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
  • “The EMA validation is an important first step toward bringing this TROP2 directed antibody drug conjugate to eligible patients in Europe with nonsquamous lung cancer and HR positive, HER2 negative breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer

Retrieved on: 
Monday, February 19, 2024
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Metabolism, Immunotherapy, AstraZeneca, News, Daiichi Sankyo, National Cancer Institute, Lung cancer, Triple-negative breast cancer, Immunology, Patient, Cleavage, Biopharmaceutical, Social media, Progression-free survival, Treatment, BLA, Docetaxel, IHC, DXD, Pharmacotherapy, NSCLC, Breast cancer, Gefitinib, PD-1, Safety, Lung, Pemetrexed, PFS, American Cancer Society, Pircher, Observational study, MD, Sapporo Medical University, Food, Cancer, ADC, OS, Immunoglobulin G, Death, Medicine, Pharmaceutical industry

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

Key Points: 
  • AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.
  • In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favorable OS trend.
  • Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 19, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, NSCLC, Breast cancer, Progression-free survival, PFS, AstraZeneca, Docetaxel, Doctor of Philosophy, MD, News, Food, BLA, PDUFA, Lung, Daiichi Sankyo, ADC, OS, IHC, HER2, Lung cancer, DXD, Patient, Congress, Pharmaceutical industry

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

Key Points: 
  • Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca.
  • In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favorable OS trend.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

QuantHealth Appoints Dr. Adam Petrich, MD, As Its First Chief Medical Officer and Adam Goldberger As First Chief Financial Officer

Retrieved on: 
Wednesday, February 7, 2024
Research, Technology, Clinical Trials, Software, Biotechnology, Pharmaceutical, Health, Science, Artificial Intelligence, Other Science, Multimedia, Daiichi Sankyo, MD, Clinical trial, Therapy, Patient, AbbVie, Series

QuantHealth , an AI-powered clinical trial design company that simulates clinical trials, today announced the appointment of Dr. Adam Petrich, MD, as the company’s inaugural Chief Medical Officer and Adam Goldberger as Chief Financial Officer.

Key Points: 
  • QuantHealth , an AI-powered clinical trial design company that simulates clinical trials, today announced the appointment of Dr. Adam Petrich, MD, as the company’s inaugural Chief Medical Officer and Adam Goldberger as Chief Financial Officer.
  • Prior to that, he was a full-time faculty member at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago.
  • As QuantHealth’s first Chief Financial Officer, Adam Goldberger will partner with the executive team to help drive innovation and reach critical financial milestones as the company continues commercializing its platform and expanding its roster of industry partners.
  • Most recently, he acted as Chief Business Officer at RenalSense and CFO/Group Executive at MedHealth.

Susan G. Komen® Orlando MORE THAN PINK Walk Raises Funds for Breast Cancer Patient Care Services

Retrieved on: 
Friday, February 2, 2024
Bank of America, Daiichi Sankyo, WFTV, Tears, La Croix, THAN, Breast cancer, Research, Breast, WOW, Patient, Internet, Laughter, Federation, Disease, Radio, State, Bank, National Airlines, Opening ceremony, Nightclub

ORLANDO, Fla., Feb. 2, 2024 /PRNewswire/ -- Susan G. Komen ®, the world's leading breast cancer organization, will hold the annual Orlando MORE THAN PINK Walk on Saturday, March 2, 2024, at Cranes Roost Park in Altamonte Springs, FL.

Key Points: 
  • ORLANDO, Fla., Feb. 2, 2024 /PRNewswire/ -- Susan G. Komen ®, the world's leading breast cancer organization, will hold the annual Orlando MORE THAN PINK Walk on Saturday, March 2, 2024, at Cranes Roost Park in Altamonte Springs, FL.
  • This signature event enables Komen to raise critical funds that provide direct support to breast cancer patients, fund groundbreaking research, and advocate for change at both the state and federal government levels.
  • "We are excited to create a community for those impacted by breast cancer during this year's Orlando MORE THAN PINK Walk.
  • Register today and join us as we celebrate survivors, those living with breast cancer, and honor loved ones lost to the disease.

ENHERTU® Granted Priority Review in the U.S. for Patients with Metastatic HER2 Positive Solid Tumors

Retrieved on: 
Monday, January 29, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Orbis, HER2, Immunohistochemistry, Neoplasm, Patient, IHC, MD, ADC, Daiichi Sankyo, Survival, Breakthrough therapy, Medicine, Cancer, Food, Safety, Priority review, Doctor of Philosophy, Breast, AstraZeneca, PDUFA, Pharmaceutical industry

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
  • The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in August 2023 for ENHERTU in metastatic HER2 positive solid tumors.
  • Data from other supporting trials in patients with HER2 positive IHC 3+ tumors in the ENHERTU clinical development program, including DESTINY-Lung01 and DESTINY-CRC02 , also were included in the submission.
  • We will continue working closely with the FDA to bring this potential first tumor agnostic HER2 targeted medicine to patients as quickly as possible.”

U.S. Patent Office Invalidates Seagen Patent in Dispute between Daiichi Sankyo and Seagen

Retrieved on: 
Wednesday, January 17, 2024
Biotechnology, Health, Patent Law, Professional Services, Pharmaceutical, Daiichi Sankyo, District court, PGR, General counsel, Title, Patent, Pharmaceutical industry

Daiichi Sankyo Co., Ltd. (TSE: 4568) (hereinafter, Daiichi Sankyo) announced today that the U.S. Patent and Trademark Office (U.S. PTO) rendered a Final Written Decision invalidating all claims of Seagen Inc.’s U.S. patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR).

Key Points: 
  • Daiichi Sankyo Co., Ltd. (TSE: 4568) (hereinafter, Daiichi Sankyo) announced today that the U.S. Patent and Trademark Office (U.S. PTO) rendered a Final Written Decision invalidating all claims of Seagen Inc.’s U.S. patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR).
  • “We are pleased that the U.S. PTO invalidated all challenged claims of the ’039 patent,” said Naoto Tsukaguchi, Corporate Officer and General Counsel, Daiichi Sankyo.
  • On December 23, 2020, Daiichi Sankyo filed a PGR petition with the U.S. PTO contesting the patentability of certain claims of the ’039 patent.
  • On April 7, 2022, the U.S. PTO granted Daiichi Sankyo’s request to institute the PGR.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

ReAlta Life Sciences Strengthens Board of Directors with Appointment of Three Accomplished Biotechnology Executives

Retrieved on: 
Wednesday, January 3, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Kite Pharma, Engineering management, Tufts University, Marketing, Lilly, Migraine, Johnson & Johnson, Amgen, Sale, AstraZeneca, Daiichi Sankyo, Eli Lilly, Jan Vansina, Business administration, Engineering, WebMD, MBA, Chemical engineering, Doctor of Philosophy, Roivant Sciences, Therapy, Eli Lilly and Company, Consumer service, University, Washington State University, Worcester Polytechnic Institute, Iowa State University, SVP, Corporation, Pharmaceutical industry

ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announced the appointment of three seasoned biotechnology executives, Christi Shaw, Mert Aktar, and David Marek, to its Board of Directors, effective immediately.

Key Points: 
  • ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announced the appointment of three seasoned biotechnology executives, Christi Shaw, Mert Aktar, and David Marek, to its Board of Directors, effective immediately.
  • “We are delighted to welcome Christi Shaw, Mert Aktar and David Marek, and the tremendous expertise and wise counsel they represent, to our Board of Directors,” said Buzz Heidt, Chairman of ReAlta's Board of Directors.
  • Prior to Kite, Ms. Shaw served as an executive officer of Eli Lilly and Company (Lilly), a global healthcare company, and president of Lilly Bio-Medicines.
  • Mr. Aktar is an accomplished life sciences industry executive with over twenty years of multinational experience bridging science and business in pharmaceuticals and biotechnology.