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What are the main challenges currently faced in the treatment of chronic liver diseases, and how does Resolution Therapeutics aim to address these challenges? Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years.
First-line treatments for patients with ovarian cancer are designed to delay the disease’s progression for as long as possible to help achieve long-term remission. The PAOLA-1 trial showed that the combination of Lynparza with bevacizumab as a maintenance treatment reduced the risk of disease progression or death by 67%.
“While the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,” said Dr. Scot Ebbinghaus, vice president, clinicalresearch, Merck ResearchLaboratories. “We
Previously, Baffa was Therapeutic Area Head of Oncology, Global ClinicalDevelopment for Shire. Gelbman most recently served as the founding CEO of FDNA, a digital health startup that develops advanced AI tools to help diagnose patients with rare diseases.
Results included global public and private financing from regenerative medicine and advanced therapy developers, and highlighted a 120 per cent increase over the first half of 2019. The ARM report also showcased robust pipelines of therapies targeting indications in cancers, infectious diseases and inherited disorders. Dr. Francis S.
PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries that can cause right heart failure and eventual death. The drug also received Rare Pediatric Disease Designation for these indications. It was granted Priority Review. with LEPR deficiency obesity. Featured Jobs on BioSpace.
This collaboration with the Lieber Institute further expands our innovative neuropsychiatric research program, a key focus area at Boehringer Ingelheim, with a first-in-class mechanism that may have the potential to address these symptoms,” said Dr. Hugh Marston, Ph.D., Head of Department CNS DiseasesResearch at Boehringer Ingelheim. “By
“We are pleased to offer two potential new treatment options with KEYTRUDA for patients in Japan based on compelling data from our clinical trial program,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories. months (95% CI, 7.6-11.3)
Under her leadership, Pfizer advanced into clinicaldevelopment or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile. Dr. Anderson joined Pfizer via Wyeth in 2007.
Cadavid will be responsible for the strategy, direction and execution of the company’s clinicaldevelopment programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinicaldevelopment group. He spent 27 years at Merck & Co.
In the Phase 2, patients are enrolled across various cohorts, depending on disease type and prior therapy. Loxo Oncology at Lilly was created in December 2019, combining the Lilly ResearchLaboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The primary endpoint for Phase 2 is ORR.
Results from the PROpel trial showed a statistically significant and clinically meaningful 34% reduction in the risk of radiographic disease progression or death with Lynparza plus abiraterone with prednisone or prednisolone, versus abiraterone alone in patients with mCRPC (hazard ratio [HR] 0.66; 95% confidence interval [CI] 0.54-0.81;
50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. 15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). Retevmo is an U.S.
VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and make recommendations on the use of VAXNEUVANCE in adults.
Baynes, head of Global ClinicalDevelopment (GCD) and Chief Medical Officer, Merck ResearchLaboratories (MRL), will be retiring from Merck in July. Li, president, Merck ResearchLaboratories, until his retirement. He also led the expansion of Merck’s research and development in China and Japan. “It
First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting. 41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; KENILWORTH, N.J.–(BUSINESS
Since its first approval in renal cell carcinoma nearly two years ago, KEYTRUDA has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories.
“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At About Molnupiravir. About Ridgeback Biotherapeutics.
0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result. EFS was defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinicaldevelopment program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. In patients with chronic kidney disease, also assess serum phosphorus.
“We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinicaldevelopment, infectious diseases, Merck ResearchLaboratories. “We Source link:[link].
Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories.
FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]
The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. “It
The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinicalresearch, Merck ResearchLaboratories. In the U.S.,
Many patients with mCRPC are only able to receive one line of therapy, as the disease can progress quickly. and an investigator in the trial, said, “Preventing or delaying radiographic progression is an important clinical endpoint in assessing cancer treatment and is very important to patients, their caregivers and their families.
All clinical studies provide important learnings to help us in the fight against HIV, and we are grateful to the patients and investigators for their contributions.”. mg daily (DOR/ISL) in HIV-1 virologically suppressed participants. Source link: [link].
“There remains a significant unmet need for patients diagnosed with advanced prostate cancer, who have a poor prognosis after not responding to initial therapy,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories. Source link: [link].
Results from the PROpel trial showed a statistically significant and clinically meaningful 34% reduction in the risk of radiographic disease progression or death with LYNPARZA plus abi/pred (HR=0.66 [95% CI, 0.54-0.81]; We look forward to the outcome of the FDA’s review of the application.” months versus 16.6 months, respectively.
For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. Forward-Looking Statement of Merck & Co., Kenilworth, N.J.,
“This announcement reflects another important regulatory milestone in the development of this medicine,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories. Forward-Looking Statement of Merck & Co., Kenilworth, N.J.,
10) and who haven’t received prior chemotherapy for metastatic disease. Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinicalresearch, Merck ResearchLaboratories. Source link: [link].
0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; We are committed to putting patients first and continuing our research to help advance new approaches to potentially extend the lives of people with cancer. Ninety-one percent had M1 disease, and 9% had M0 disease.
We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories. Forward-Looking Statement of Merck & Co., Kenilworth, N.J.,
Patients were treated until disease progression or unacceptable toxicity. Thirty-seven percent of patients had upper tract disease. Patients in the dose escalation cohort (n=5), Cohort A (n=40), and Cohort K (n=76) received enfortumab vedotin 1.25 A total of 121 patients received KEYTRUDA in combination with enfortumab vedotin.
Gregory Lubiniecki, Vice President, Global ClinicalDevelopment, Merck ResearchLaboratories. Senior Vice President, ClinicalDevelopment, Oncology at Eisai Inc. It is estimated there will be nearly 100,000 new cases of melanoma diagnosed and approximately 8,000 deaths resulting from the disease in the U.S.
Rubin, senior vice president, global clinicaldevelopment, Merck ResearchLaboratories. “Patients with stage III and IV melanoma can be at high risk of having their cancer recur or metastasize to other sites,” said Dr. Eric H.
Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. Kenilworth, N.J.,
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