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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. Could you describe the platform of macrophage biology and cell engineering used by Resolution Therapeutics in developing their cell therapies?
today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].
As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.
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.
While peripherally acting COMT inhibitors are currently used as an adjunctive therapy in the treatment of neurological conditions, including Parkinson’s disease, this new collaboration is investigating centrally acting COMT inhibitors in neuropsychiatric disorders. “We Our mission is to create breakthrough therapies that change lives.
Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition.
The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations. In addition to RET-altered NSCLC, it is being developed for RET-altered thyroid cancer and other solid tumors. The FDA approved it under the brand name Gavreto on September 4.
today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA Also Approved for the Treatment of Patients With Unresectable, Advanced or Recurrent High Microsatellite Instability (MSI-H) Colorectal Cancer.
Anderson most recently served as Vice President and Chief Scientific Officer for Bacterial Research and Hospital within the Vaccine R&D organization. Prior to Pfizer, Dr. Anderson worked at Merck ResearchLaboratories where she founded its prokaryotic bio-combinatorial engineering laboratory and initiated a bacterial vaccine program.
Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. 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.
Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. Perlmutter, President, Merck ResearchLaboratories. “We About A2 Biotherapeutics.
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
Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories. KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. In the U.S.
Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinicaldevelopment program, which includes over 20 clinical studies and more than 4,000 patients.
The trial investigated neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC).
These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy,” said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. Source link.
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. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.
Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. prostate cancer is the second most common cancer in men, and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low. 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59])
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. If appropriate, initiation of anti-HBV therapy may be warranted.
That’s why we set out to develop a conjugate vaccine that includes pneumococcal serotypes that pose the greatest threat and elicits a strong immune response to each serotype covered,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories.
The safety profile of KEYTRUDA in combination with LYNPARZA in this trial was consistent with that observed in previously reported studies for the individual therapies; however, the combination was associated with a higher incidence of grade 3-5 adverse events and drug-related serious adverse events, compared to the control arm.
Consider the potential for drug interactions prior to and during PREVYMIS therapy; review concomitant medications during PREVYMIS therapy; and monitor for adverse reactions associated with PREVYMIS and concomitant medications. See additional Selected Safety Information below. Source link: [link]
Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. in these patients.
We strongly believe in the results of the PROpel trial, which demonstrated a clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.” indication, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For that U.S.
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. About IMAGINE-DR.
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. Importantly, this treatment regimen are often utilized in combination with different chemotherapy agents.
mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. VERQUVO is being jointly developed by Merck and Bayer AG. In the EU, VERQUVO (2.5 mg, 5 mg and 10 mg).
In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo.
Because esophageal cancer generally has poor survival rates, new first-line therapies are urgently needed for these patients,” said Dr. Peter Enzinger, Director, Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center. For more information, see “Selected Important Safety Information” below.
“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.
Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis, thus these results showing a reduction in the risk of distant recurrence underscore the potential of neoantigen therapy,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.
“The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”. This approval builds upon Merck’s proud history of developingtherapies for the treatment of patients with cardiovascular disease.”. Therapy was initiated at Verquvo 2.5
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.
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