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.

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The Pharma Data

JANUARY 21, 2021

Eli Lilly reported yesterday that its monoclonal antibody bamlanivimab (LY-CoV555) significantly lessened the risk of contracting COVID-19 among nursing home residents and staff, according to findings from a phase 3 trial. James Miessler. Source link.

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Drug Target Review

NOVEMBER 1, 2023

I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre. The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials.

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The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. 0.96]; non- BRCA subgroup OS HR=0.92 [95% CI, 0.74-1.14]),

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The Pharma Data

MARCH 13, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. Donanemab has the potential to become a very important treatment for Alzheimer’s disease. As early as nine months (36 weeks) after initiation of treatment, a significant difference in decline by iADRS was observed. Apostolova, M.D.,

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The Pharma Data

MARCH 30, 2021

In Europe, KEYTRUDA is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a Combined Positive Score (CPS) ? Merck has the industry’s largest immuno-oncology clinical research program.

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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

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. An overview of the islatravir treatment and prevention development program is available here. Abstract 2361. Hillier et al.

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The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events.

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PPD

OCTOBER 12, 2023

These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type. 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.

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The Pharma Data

SEPTEMBER 17, 2020

Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Lilly ‘s chief scientific officer and president of Lilly Research Laboratories. Lilly ‘s chief scientific officer and president of Lilly Research Laboratories.

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The Pharma Data

NOVEMBER 18, 2021

A review by the external Data Monitoring Committee (eDMC) determined that this effect was related to treatment with the combination of ISL08507; the greatest decreases were seen in the arms of the study receiving the highest doses of MK-8507 (200 mg and 400 mg). The company has notified investigators and paused development of MK-8507.

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The Pharma Data

OCTOBER 25, 2021

At 48 weeks, both trials met their primary efficacity endpoint of chance of actors with HIV-1 RNA situations ? The safety and tolerability profile of DOR/ ISL during the trials to date are harmonious with the preliminarily reported Phase 2 studies. Merck Research Laboratories. “ PIFELTRO and DELSTRIGO.

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The Pharma Data

JULY 8, 2021

KEYTRUDA Is Now Approved for the Treatment of Patients With Recurrent or Metastatic or Locally Advanced cSCC That Is Not Curable by Surgery or Radiation. The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ? About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

JULY 21, 2021

Islatravir is currently being evaluated across a variety of dosing regimens, for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. Results from this study support the safety profile of oral islatravir PrEP regimen through 24 weeks versus placebo.

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Alta Sciences

APRIL 4, 2025

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me pmjackson Fri, 04/04/2025 - 18:01 By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services. How Clinical Research Saved My Life I was born in 2000.

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Drug Target Review

AUGUST 28, 2024

What are the main challenges currently faced in the treatment of chronic liver diseases, and how does Resolution Therapeutics aim to address these challenges? Dr Brass has published over 85 peer reviewed articles and more than 200 abstracts, primarily in the field of hepatology, in both the areas of clinical and basic science research.

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The Pharma Data

SEPTEMBER 21, 2020

AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation across the European Union for the first-line maintenance treatment with bevacizumab for patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. Conor Kavanagh. Source link.

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The Pharma Data

MARCH 23, 2021

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression. We are committed to putting patients first and continuing our research to help advance new approaches to potentially extend the lives of people with cancer.

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The Pharma Data

OCTOBER 27, 2021

– This Clinical Study is the First from Merck and Gilead’s Collaboration to Develop Potential Long-Acting HIV Treatment Options –. Joan Butterton, vice chairman, global clinical development, contagious conditions, Merck Research Laboratories. There’s presently no cure for HIV or AIDS. About Gilead Lores Gilead Lores,Inc.

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The Pharma Data

APRIL 8, 2021

The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC. About KEYNOTE-564.

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The Pharma Data

AUGUST 30, 2021

KEYTRUDA Now Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer. KEYTRUDA Also Approved for the Treatment of Patients With Unresectable, Advanced or Recurrent High Microsatellite Instability (MSI-H) Colorectal Cancer.

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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. About the Phase 2 Study-004 Trial.

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The Pharma Data

NOVEMBER 22, 2020

The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments. It holds the rights for the drug in the rest of the world.

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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 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 ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.

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The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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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

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

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

JUNE 29, 2021

KEYTRUDA is Now Approved in Combination With Platinum- and Fluoropyrimidine-Based Chemotherapy As First-Line Treatment for Certain Patients With Locally Advanced Unresectable or Metastatic Esophageal Carcinoma or HER2-Negative GEJ Adenocarcinoma Whose Tumors Express PD-L1 (CPS ?10). Data Supporting the European Approval.

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The Pharma Data

MARCH 8, 2021

Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated across a variety of doses, formulations and frequencies for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a single agent.

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The Pharma Data

SEPTEMBER 7, 2021

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. This new indication was granted approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-590 trial. 0.86]; p<0.0001).

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The Pharma Data

JUNE 25, 2021

As previously announced , the trial will continue to evaluate OS, a key secondary endpoint. We hope to build on this important research and provide new treatment options to kidney cancer patients.”. “As Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC.

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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. When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. ” Clinical trials are underway. The Lancet HIV.

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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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