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The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.
The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinicaltrials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinicaltrials to combat Covid-19.
This came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the recommendation based on a positive opinion of the PAOLA-1 Phase 3 trial which was published in The New England Journal of Medicine. .
Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. This indication was approved under accelerated approval based on tumor response rate and duration of response.
The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020. About the BRUIN Phase 1/2 Trial.
KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. 0.80; p=0.0002) and doubled median PFS (16.5 months [95% CI, 5.4-32.4] months [95% CI, 6.1-10.2])
Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S. DAXI was evaluated in three Phase III trials, with the median time to loss of none or mild wrinkle severity was 24 weeks and the median time to return to baseline wrinkle severity was about 28 weeks. On October 14, Liquidia announced the U.S.
In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. The Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation. 0.81; p<0.001).
” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR.
We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories.
Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months. “We Phase 1 Implant Study Results for Investigational Anti-HIV agent Islatravir.
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. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.
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).
At the recommendation of the eDMC, Merck is stopping dosing in the trial, with continued monitoring of study participants. The company has notified investigators and paused development of MK-8507. Merck recently announced positive topline results from the ILLUMINATE SWITCH A and ILLUMINATE SWITCH B Phase 3 clinicaltrials.
and Canada, announced along with Eisai today that it has new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307). The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC).
This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) These approvals were based on the data from the Phase 3 PROfound trial.
An overview of the islatravir treatment and prevention development program is available here , which includes our two Phase 3 IMPOWER trials evaluating islatravir as once-monthly oral PrEP across diverse populations of people who may benefit from additional HIV-1 prevention options. KENILWORTH, N.J.–(BUSINESS
Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. KENILWORTH, N.J.–(BUSINESS
As previously announced , the trial will continue to evaluate OS, a key secondary endpoint. Merck has the industry’s largest immuno-oncology clinicalresearch program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. KENILWORTH, N.J.–(BUSINESS
The application is based on overall response data from Cohorts D and K of the KEYNOTE-158 trial, which will be presented for the first time at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract #795P). Continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinicaltrials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.
Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted. After sequential administration with PNEUMOVAX 23, OPA GMTs were numerically similar between the two vaccination groups for all 15 serotypes contained in VAXNEUVANCE.
In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.
The trial’s other dual primary endpoint, radiographic progression free survival (rPFS), was evaluated at an earlier interim analysis and did not demonstrate improvement compared to the control arm. In collaboration with AstraZeneca, Merck is evaluating LYNPARZA in combination with abiraterone in the Phase 3 PROpel trial.
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.
Gilead Lores, and Merck, known as MSD outside the United States and Canada, moment blazoned the launch of a Phase 2 clinical study assessing an investigational formerly-daily oral combination treatment authority of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral remedy.
“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.
Recommendation supported Data From Phase 3 KEYNOTE-355 Trial. 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. About Triple-Negative carcinoma.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The approval is based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen and Astellas.
Reclamation for the VICTOR trial has begun. Like the VICTORIA trial, Merck and Bayer AG will serve asco-sponsors for the VICTOR trial. VICTOR is anticipated to take 39 months to complete, and the trial will include cases from 34 countries at roughly 500 spots around the world. The study will be executed by Merck.
The approval of Verquvo by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. Verquvo (vericiguat) 2.5
The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.
“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. Obtain a pregnancy test before the start of treatment.
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. The safety profile of KEYTRUDA was consistent with findings from previous studies.
Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck ResearchLaboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinicaltrials to support its development as a once-monthly oral PrEP agent. About Islatravir (MK-8591).
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