The Pharma Data

AUGUST 31, 2021

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. Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. Source link: [link].

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The Pharma Data

JUNE 7, 2023

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.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. Lilly ‘s chief scientific officer and president of Lilly Research Laboratories.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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The Pharma Data

SEPTEMBER 28, 2021

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 , 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. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88];

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The Pharma Data

MARCH 13, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. “Tau has become increasingly validated as a predictive biomarker for Alzheimer’s disease progression, as shown again in this trial,” said Liana G. Patients with treatment discontinuations were allowed to continue in the trial.

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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. indication, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

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The Pharma Data

NOVEMBER 22, 2020

The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations. Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S. The data was based on the Phase III KEYNOTE-355 trial. On October 14, Liquidia announced the U.S.

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The Pharma Data

JUNE 29, 2021

KEYTRUDA is First Anti-PD-1 Therapy Approved in Europe in Combination With Chemotherapy for First-Line Treatment of Advanced Esophageal or GEJ Cancer, Regardless of Histology. KENILWORTH, N.J.–(BUSINESS Data Supporting the European Approval. About Esophageal Cancer in Europe.

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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.

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The Pharma Data

OCTOBER 23, 2021

KEYTRUDA Is the First Anti-PD-1 Therapy in Combination With Chemotherapy to Demonstrate Statistically Significant Overall Survival in These Patients; Based on Results From the Phase 3 KEYNOTE-355 Study. In this trial, 38 of enrolled cases had excrescences expressing PD-L1 with CPS ? Data Supporting the European Blessing.

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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. inhibitor therapy approved in the U.S. WELIREG is the first HIF-2? As an inhibitor of HIF-2?,

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The Pharma Data

APRIL 11, 2021

” 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.

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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. First Anti-PD-1 Regimen Approved in China for First-Line Treatment of Advanced Esophageal or GEJ Cancer, Regardless of Histology or PD-L1 Expression. About KEYNOTE-590.

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The Pharma Data

JUNE 7, 2022

Based on a post hoc analysis, fewer LAGEVRIO-treated participants in the MITT population required respiratory interventions (including conventional oxygen therapy, a high-flow heated and humidified device, noninvasive mechanical ventilation, or invasive mechanical ventilation) versus placebo-treated participants, with a RRR of 34.3% [95% CI, 4.3%

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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

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The Pharma Data

JULY 18, 2021

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted. VAXNEUVANCE previously received Breakthrough Therapy designation from the FDA for the prevention of IPD in adults 18 years of age and older. pneumoniae serotypes contained in the vaccine.

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The Pharma Data

JULY 21, 2021

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. In the EU, VERQUVO (2.5 VERQUVO is being jointly developed by Merck and Bayer AG. mg, 5 mg and 10 mg).

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The Pharma Data

APRIL 16, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. who require oxygen therapy due to COVID-19, OR. who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

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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.

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Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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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.

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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

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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.

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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.

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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 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.

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The Pharma Data

OCTOBER 25, 2021

Week 48 Data Met Safety and Efficacy Endpoints in Adults with HIV-1 Infection Currently on Antiretroviral Therapy. At 48 weeks, both trials met their primary efficacity endpoint of chance of actors with HIV-1 RNA situations ? Merck Research Laboratories. “ PIFELTRO and DELSTRIGO.

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The Pharma Data

JANUARY 26, 2021

percent) in patients taking therapy and 36 events (7.0 Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution. INDIANAPOLIS, Jan. have reached record highs.

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Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Read A one-time gene therapy injection for spinal muscular atrophy. Gene Therapy. ” Clinical trials are underway. Nature Neuroscience. Trends in Biotechnology.

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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.

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The Pharma Data

AUGUST 30, 2021

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. months [95% CI, 5.4-32.4]

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The Pharma Data

JANUARY 26, 2021

Eli Lilly expanded its ongoing BLAZE-4 study to include Vir’s monoclonal antibody in the trial. Data published last week showed that bamlanivimab significantly reduced COVID-19 risk for nursing home residents in a Phase III trial. . Food and Drug Administration to treat mild-to-moderate COVID-19 patients.

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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. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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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 About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

NOVEMBER 9, 2020

Lilly’s chief scientific officer and president of Lilly Research Laboratories. “We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19. who require oxygen therapy due to COVID-19, OR. See Limitations of Authorized Use.

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