MSD

Oncoinvent Announces Changes to its Board of Directors and Formation of Scientific and Clinical Advisory Board

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, Clinical Trials, Radiology, Pharmaceutical, Biotechnology, MSD, Ovarian cancer, Mirati Therapeutics, London Business School, University of Coimbra, GSK, BMS, Doctor of Philosophy, Therapy, Algeta, Colorectal cancer, International, Pharmacy, Radiopharmaceutical, Radium-223, Agios Pharmaceuticals, Amgen, Cubist Pharmaceuticals, Takeda Pharmaceutical Company, Bristol Myers Squibb, University, Private sector, The central science, Drug development, Sanofi, Psychiatry, BASF, Master of Science, M.B.A, Science, GE HealthCare, Pharmaceutical industry

“We are excited to welcome an internationally renowned group of industry leaders as new members of our Board of Directors.

Key Points: 
  • “We are excited to welcome an internationally renowned group of industry leaders as new members of our Board of Directors.
  • “We are also pleased to announce the formation of a Scientific and Clinical Advisory Board, consisting of our highly distinguished founders who are uniquely positioned to support Oncoinvent in our clinical programs.
  • Dr. O’Bryan-Tear has been an adviser to several US and European biotech companies and has held board positions at Fusion Pharmaceuticals and Clarity Pharmaceuticals.
  • In addition, Oncoinvent founding scientists Roy Larsen, Ph.D., and Øyvind Bruland, M.D., Ph.D., previously board members, will lead a newly established Scientific and Clinical Advisory Board.

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.

Merck to Hold First-Quarter 2024 Sales and Earnings Conference Call April 25

Retrieved on: 
Monday, April 1, 2024
Biotechnology, Pharmaceutical, Health, MSD, Webcast, MRK, News

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m.
  • Investors, journalists and the general public may access a live audio webcast of the call via this weblink .
  • A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com .
  • All participants may join the call by dialing (888) 847-9708 (U.S. and Canada Toll-Free) or (630) 395-0358 and using the access code 4164932.

PharmaJet Announces Scientific Advisory Boards and Presentation at World Vaccine Congress in Washington on April 1

Retrieved on: 
Monday, April 1, 2024
Oncology, Health, Medical Devices, Infectious Diseases, Health Technology, Pharmaceutical, Biotechnology, MSD, Research, Clinical research, Government, Congress, Global health, Policy, Cancer, University, Infection, Former, Injection, Emerita, SAB, Immune system, Therapy, Use, Multimedia, Vaccine, Chiron, Medical director

The Boards will provide strategic guidance and expertise to help PharmaJet advance its vision to better activate the immune system with its unique technology and accelerate its partnering strategy with vaccine and pharmaceutical companies.

Key Points: 
  • The Boards will provide strategic guidance and expertise to help PharmaJet advance its vision to better activate the immune system with its unique technology and accelerate its partnering strategy with vaccine and pharmaceutical companies.
  • View the full release here: https://www.businesswire.com/news/home/20240401778401/en/
    In the countries highlighted, PharmaJet has commercial and development partners for prophylactic vaccines for the prevention of infectious diseases as well as cancer treatments.
  • To date, more than 10 million vaccinations have been made and PharmaJet has over 80 global development partners.
  • To find out how this innovative technology can help your vaccine or therapeutic program, schedule a meeting with one of our company experts by clicking here .

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.

FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)

Retrieved on: 
Tuesday, March 26, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, MSD, FC, Exercise, Breakthrough therapy, Blood, Risk, Patient, Orthostatic hypertension, MRK, World Health Organization, Heart, WHO, Multimedia, PAH, Food, Pharmaceutical industry

“The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.

Key Points: 
  • “The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.
  • In the WINREVAIR treatment group, the placebo-adjusted median increase in 6MWD was 41 meters (95% CI: 28, 54; p
  • The median treatment difference in PVR between WINREVAIR and placebo was -235 dynes*sec/cm5 (95% CI: -288, -181; p
  • The median treatment difference in NT-proBNP between WINREVAIR and placebo was -442 pg/mL (95% CI: -574, -310; p

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.