The Pharma Data

MARCH 16, 2021

This NDA is based on data from the Phase 2 Study-004 trial, in which belzutifan showed a confirmed overall response rate of 36.1% (n=22/61) (95% CI: 24.2-49.4) In fact, up to 70% of patients with VHL develop renal cell carcinoma during their lifetime,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

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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. In this trial, the median duration of exposure to KEYTRUDA was 10 months (range, 1 day to 2.2

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The Pharma Data

JUNE 25, 2021

As previously announced , the trial will continue to evaluate OS, a key secondary endpoint. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. KENILWORTH, N.J.–(BUSINESS

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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. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. KEYTRUDA is now approved for eight indications across five different types of cancer in China. “In

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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.

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PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

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The Pharma Data

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; Data Supporting the Approval.

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The Pharma Data

AUGUST 15, 2021

The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity. WELIREG is the first HIF-2? of patients.

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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).

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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 Esophageal Cancer.

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The Pharma Data

JULY 6, 2021

“While there remains an unmet need for heavily pre-treated patients with advanced gastric cancer, we recognize that the treatment landscape has evolved and we respect the FDA’s efforts to continually evaluate accelerated approvals,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

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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.

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Codon

JULY 21, 2024

In an effort to continue this cycle, researchers at UBC also try to get their animals adopted at the end of their studies. According to Weary, the “recognition that the animal is an individual that has a life beyond this particular trial” positively influences their treatment at the hands of researchers.

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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.

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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). Continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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The Pharma Data

APRIL 4, 2023

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.

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. About IMPOWER Clinical Trials Program.

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