Merck & Co.

DIA 2024 Global Annual Meeting Welcomes Life Sciences Leaders to Confront Emerging Challenges in Healthcare

Retrieved on: 
Tuesday, April 2, 2024
Medical Devices, FDA, Health, Health Technology, General Health, Pharmaceutical, Eli Lilly, Combination, DCT, Microsoft Research, Artificiality, Trust (social science), GSK, Novartis, Patient, Food and Drug Administration, Artificial intelligence, USS Midway, AI, EMA, Merck & Co., Medicine, European Medicines Agency, Johnson & Johnson, Ecosystem, Drug development, Pharmacovigilance, Food, DIA, Student, Diamond, DEI, Medical device

The ethical use of artificial intelligence (AI) in healthcare, the development of advanced therapies, and other emerging regulatory and scientific challenges demand in-depth discussion as DIA , a global organization of life sciences professionals, accepts registrations for the DIA 2024 Global Annual Meeting , to be held June 16-20 in San Diego.

Key Points: 
  • The ethical use of artificial intelligence (AI) in healthcare, the development of advanced therapies, and other emerging regulatory and scientific challenges demand in-depth discussion as DIA , a global organization of life sciences professionals, accepts registrations for the DIA 2024 Global Annual Meeting , to be held June 16-20 in San Diego.
  • Thousands of industry representatives, regulators, government officials, academics, innovators, and patients will convene for the world's preeminent neutral life sciences forum — and the only thing missing is you.
  • "This year marks the 60th anniversary of DIA and the Global Annual Meeting, and we're celebrating by continuing to forge a bold future marked by innovation and impact," said Marwan Fathallah, DIA's President and Global Chief Executive.
  • — An interactive forum featuring U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) representatives discussing today's regulatory, scientific, and communication challenges.

REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer

Retrieved on: 
Wednesday, April 3, 2024
Pharmaceutical, Health, Oncology, Clinical Trials, MSD, DXD, CDH6, Survival, Glomus tumor, Patient, Merck & Co., SGO, MD, Society, Senior, MRK, Safety, Gynecologic Oncology (journal), Recurrence, ADC, Daiichi Sankyo, Annual general meeting, Pharmaceutical industry

The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.

Key Points: 
  • The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.
  • Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck.
  • “Raludotatug deruxtecan has shown promising activity in a phase 1 trial of patients with advanced ovarian cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.
  • “We look forward to working with our colleagues at Daiichi Sankyo to further evaluate the potential of raludotatug deruxtecan to provide a new treatment option for patients with platinum-resistant ovarian cancer.”

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable Non-Small Cell Lung Cancer (NSCLC) at High Risk of Recurrence in Adults

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Civil service commission, OS, Lung cancer, Survival, Disease, Risk, Patient, Committee, Neoplasm, EFS, Merck & Co., Cancer, Death, MRK, European Commission, Recurrence, PD-L1, Marketing, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
  • For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen.
  • The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen.
  • KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU.

Cornerstone Building Brands Appoints Dr. Marcia Avedon to its Board of Directors

Retrieved on: 
Tuesday, March 26, 2024
Architecture, Residential Building & Real Estate, Manufacturing, Commercial Building & Real Estate, Construction & Property, Building Systems, Other Manufacturing, Anheuser-Busch, Ingersoll Rand, Growth, Generac, Merck & Co., Saint-Gobain, Merck, Communication, Corporate Affairs, Lincoln National Corporation, Marketing, Trane Technologies, Honeywell, Human resources, Acuity Brands, Management

Cornerstone Building Brands, Inc., a leading manufacturer of exterior building products in North America, has appointed Marcia Avedon, Ph.D., as a member of its board of directors (the “Board”), effective April 1, 2024.

Key Points: 
  • Cornerstone Building Brands, Inc., a leading manufacturer of exterior building products in North America, has appointed Marcia Avedon, Ph.D., as a member of its board of directors (the “Board”), effective April 1, 2024.
  • View the full release here: https://www.businesswire.com/news/home/20240326897081/en/
    Dr. Marcia Avedon will serve as a member of the Cornerstone Building Brands board of directors, effective April 1, 2024.
  • “Marcia’s depth and breadth of both corporate leadership and board experience in leadership development, talent and succession management, executive compensation, organizational development, corporate governance, brand building, operations and sustainability make her a particularly strong addition to our Cornerstone Building Brands board of directors,” said Rose Lee, President and Chief Executive Officer, Cornerstone Building Brands.
  • Marcia previously served on the board of directors of GCP Applied Technologies and Lincoln National Corporation.

Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, March 21, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, OS, Pemetrexed, Chemotherapy, NSCLC, Progression-free survival, Patient, Carboplatin, Merck & Co., MRK, PARP, Cisplatin, PFS, Pharmaceutical industry

In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).

Key Points: 
  • In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).
  • The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies.
  • “These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer.
  • We sincerely thank the patients and investigators for their important contributions to this study.”

Koneksa Announces Merck Joins Data Syndication Partnership Program Around Parkinson’s Digital Biomarkers Observational Study

Retrieved on: 
Wednesday, March 20, 2024
Mobile, Wireless, Hardware, Data Management, Biometrics, Consumer Electronics, Technology, Health Technology, Clinical Trials, Nanotechnology, Neurology, Biotechnology, Wearables, Mobile Technology, Health, MSD, Observational study, IPhone, Biomarker, Merck & Co., Drug development, Translational medicine

Koneksa , a healthcare technology company pioneering evidence-based digital biomarkers, announced that Merck, known as MSD outside of the United States and Canada, has joined its Data Syndication Partnership program for the LEARNS observational study, which seeks to develop digital biomarkers in neurodegenerative disorders from smart phone-based assessments and wearable technologies.

Key Points: 
  • Koneksa , a healthcare technology company pioneering evidence-based digital biomarkers, announced that Merck, known as MSD outside of the United States and Canada, has joined its Data Syndication Partnership program for the LEARNS observational study, which seeks to develop digital biomarkers in neurodegenerative disorders from smart phone-based assessments and wearable technologies.
  • As a member, Merck researchers will have real-time access to data and results from the ongoing study.
  • The high-precision longitudinal data and in-clinic data from the LEARNS study will guide future development of digital biomarkers of disease progression in Parkinson’s disease.
  • Data syndication gives partners immediate and continuous access to data and results as the study progresses, and access to the study dashboard from Koneksa’s proprietary platform for real-time study monitoring, enabling syndication partners to learn from the study as it progresses.

Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Retrieved on: 
Tuesday, March 19, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Emory University, Antigen, Streptococcus, International Society, HIV, Risk, Global health, Patient, Cohort, Hospital, Merck & Co., Aes, OPA, Epidemiology, Training school (United States), PCV20, Immunoglobulin G, Attenuated vaccine, MRK, Pediatrics, CDC, Vaccination, PPSV23, Community-acquired pneumonia, Food, FDA, PDUFA, Medicine, Vaccine

V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

Key Points: 
  • V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23.
  • V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116.

Avenacy Announces New Product Launches and Participation in DCAT Week 2024

Retrieved on: 
Monday, March 18, 2024
Biotechnology, General Health, FDA, Health, Pharmaceutical, HER2, Combination therapy, Fulvestrant, Growth, AstraZeneca, Entrepreneurship, DCAT, Merck, Merck & Co., Woman, Syringe, Breast cancer, Safety, Multimedia, Food, Injection, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240318415023/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240318415023/en/
    “Avenacy has had a strong start to 2024, with two product launches already executed and two more newly announced additions to our rapidly expanding portfolio.
  • Avenacy will begin shipping Fosaprepitant for Injection and Fulvestrant Injection to wholesale partners this week.
  • To learn more about Avenacy’s products or the Company’s exciting growth plans for 2024, please see the Avenacy management team at DCAT Week 2024 taking place in New York City from March 18-21st.
  • To request a meeting with a member of the Avenacy team, please reach out to [email protected] .

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival (OS) Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

Retrieved on: 
Friday, March 15, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, MSD, OS, Chemoradiotherapy, CRT, Obstetrics, Congress, Gynaecology, CPS, Survival, Disease, Progression-free survival, Data monitoring committee, Cervical cancer, Patient, Neoplasm, Merck & Co., Overalls, Humanitas University, Bevacizumab, MRK, Cancer, ESMO, PFS, FIGO, PD-L1, Food, Pharmaceutical industry

At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone.

Key Points: 
  • At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone.
  • The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
  • Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
  • As previously reported , KEYNOTE-A18 met its other primary endpoint of progression-free survival (PFS) in 2023.