The Pharma Data

NOVEMBER 18, 2021

At the recommendation of the eDMC, Merck is stopping dosing in the trial, with continued monitoring of study participants. In light of the findings from the MK-8507-013 study, Merck conducted a review of trends in total lymphocyte and CD4+ T-cell counts in company-sponsored clinical trials of ISL across all indications and dosing regimens.

Clinical Trials 52

Clinical Trials Treatment Trials RNA 52

The Pharma Data

JULY 18, 2021

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.

Disease 52

Disease Immune Response Vaccine FDA Approval 52

The Pharma Data

JUNE 25, 2021

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

Disease 52

Disease Therapies Treatment Medical Schools 52

The Pharma Data

SEPTEMBER 21, 2020

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. . It also improved progression-free survival by a median of 37.2 months versus 17.7

Research Laboratories 52

Research Laboratories Treatment Trials Laboratories 52

The Pharma Data

SEPTEMBER 11, 2020

In the Phase III OSTRO trial, Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score (NPS) and the nasal blockage score (NBS) compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care, the firm said.

Research Laboratories 52

Research Laboratories Laboratories Treatment Hospitals 52

The Pharma Data

JULY 21, 2021

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 Kenilworth, N.J.,

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

The Pharma Data

JULY 12, 2021

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 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. About Molnupiravir.

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

The Pharma Data

MARCH 16, 2021

inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), not requiring immediate surgery. in patients with VHL disease-associated RCC.

FDA 52

FDA Disease Trials Drugs 52

The Pharma Data

SEPTEMBER 1, 2021

Study Now Enrolling Participants Who Live in the Same Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. MOVe-AHEAD Study.

Laboratories 52

Laboratories Clinical Trials Virus Trials 52

The Pharma Data

AUGUST 15, 2021

WELIREG Approved for Adult Patients With VHL Disease Who Require Therapy for Associated Renal Cell Carcinoma, Central Nervous System Hemangioblastomas, or Pancreatic Neuroendocrine Tumors, Not Requiring Immediate Surgery. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity.

Treatment 52

Treatment Disease Clinical Trials Therapies 52

The Pharma Data

SEPTEMBER 28, 2021

Recommendation supported Data From Phase 3 KEYNOTE-355 Trial. 10) and who haven’t received prior chemotherapy for metastatic disease. Merck has the industry’s largest immuno-oncology clinical research program. There are currently quite 1,600 trials studying KEYTRUDA across a good sort of cancers and treatment settings.

Research Laboratories 52

Research Laboratories Clinical Research Treatment Disease 52

The Pharma Data

MARCH 15, 2022

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. About Merck.

DNA 52

DNA Clinical Trials Trials Therapies 52

The Pharma Data

MARCH 17, 2021

This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88];

Therapies 52

Therapies Treatment Disease Trials 52

The Pharma Data

AUGUST 31, 2021

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.

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

The Pharma Data

NOVEMBER 22, 2020

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. Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S. The drug also received Rare Pediatric Disease Designation for these indications.

FDA 52

FDA Licensing Licensing Treatment 52

The Pharma Data

AUGUST 30, 2021

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. It is an aggressive type of breast cancer that has a high risk for disease recurrence.

Treatment 52

Treatment Trials Research Laboratories Clinical Trials 52

The Pharma Data

AUGUST 10, 2021

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). “The Merck has the industry’s largest immuno-oncology clinical research program. In the U.S.,

FDA 52

FDA Therapies Treatment Clinical Research 52

The Pharma Data

APRIL 7, 2023

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.

Trials 40

Trials Clinical Trials Treatment Therapies 40

The Pharma Data

JUNE 2, 2023

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.

FDA Approval 52

FDA Approval FDA Therapies Treatment 52

The Pharma Data

MARCH 5, 2021

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.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

MARCH 30, 2021

KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We Head and Neck Squamous Cell Cancer.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

The Pharma Data

JULY 8, 2021

This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

The Pharma Data

JULY 6, 2021

Food and Drug Administration (FDA)-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. 1)] as determined by a U.S. Head and Neck Squamous Cell Cancer.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

The Pharma Data

JUNE 29, 2021

This approval is based on results from the Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with 5-FU and cisplatin alone in all pre-specified study populations.

Therapies 52

Therapies Treatment Disease Clinical Research 52

Codon

JULY 21, 2024

Of course, AA and P-line rats are not the only research animals bred for the study of disease. The most famous of these is the Oncomouse , engineered in 1984 for the express purpose of developing tumors so that researchers could study cancer in living organisms, rather than in petri dishes. 1 Subscribe to Asimov Press.

Research 123

Research Engineering Disease Science 123

The Pharma Data

OCTOBER 19, 2020

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 clinical development, chief medical officer, Merck Research Laboratories.

Vaccine 52

Vaccine Immune Response Disease Clinical Trials 52

The Pharma Data

SEPTEMBER 7, 2021

This new indication was granted approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-590 trial. KEYTRUDA plus 5-FU and cisplatin reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; The median OS was 12.4 months (95% CI, 10.5-14.0) months (95% CI, 8.8-10.8)

Treatment 52

Treatment Research Laboratories Packaging Laboratories 52

The Pharma Data

APRIL 28, 2023

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).

FDA 40

FDA Trials Treatment Research Laboratories 40

The Pharma Data

JULY 12, 2021

There will also be updates from the Phase 3 DRIVE-AHEAD trial evaluating DELSTRIGO (doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg) in previously untreated participants with HIV-1. Islatravir Safety Analysis Through Week 96 from a Phase 2 Trial in Treatment Naïve Adults with HIV-1 Infection. Abstract 2361.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

JULY 22, 2021

Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation.

Therapies 52

Therapies Treatment Disease Trials 52

The Pharma Data

MARCH 11, 2021

In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. Lilly’s chief scientific officer and president of Lilly Research Laboratories. Bamlanivimab alone. patients who recovered from COVID-19.

Hospitals 40

Hospitals Trials Long-Term Care Facilities Treatment 40

The Pharma Data

FEBRUARY 12, 2022

Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. ” The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. “With the emergence of variants such as Omicron, treatment options remain limited.

Treatment 40

Treatment Hospitals FDA Clinical Trials 40

The Pharma Data

OCTOBER 23, 2021

10) and Who Have Not Received Prior Chemotherapy for Metastatic Disease. In this trial, 38 of enrolled cases had excrescences expressing PD-L1 with CPS ? Vicki Goodman, vice chairman, clinical exploration, Merck Research Laboratories. “ Triadic-negative bone cancer is an aggressive type of bone cancer.

Treatment 52

Treatment Research Laboratories Trials Laboratories 52

The Pharma Data

JULY 15, 2021

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).

Therapies 52

Therapies Treatment Trials FDA 52

The Pharma Data

MARCH 23, 2021

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.

Treatment 52

Treatment FDA Approval FDA Therapies 52

The Pharma Data

APRIL 28, 2023

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.

FDA 40

FDA FDA Approval Trials Treatment 40

The Pharma Data

JANUARY 20, 2021

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

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52