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

APRIL 16, 2021

for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. Lilly’s chief scientific officer and president of Lilly Research Laboratories. variant, present in these other countries and remain an important treatment option.

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The Pharma Data

NOVEMBER 9, 2020

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).

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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

AUGUST 15, 2021

inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. WELIREG is the first HIF-2? inhibitor therapy approved in the U.S.

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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

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

JANUARY 26, 2021

In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine.

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The Pharma Data

SEPTEMBER 21, 2020

MSD (Merck) and Eisai have revealed new data from two trials under the LEAP clinical programme evaluating the combination of MSD’s PD-1 inhibitor Keytruda and Eisai’s oral tyrosine kinase inhibitor Lenvima. In another phase II trial, Keytruda plus Lenvima demonstrated an ORR between 9.7-32.3% Source link.

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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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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

SEPTEMBER 28, 2021

Recommendation supported Data From Phase 3 KEYNOTE-355 Trial. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. Importantly, this treatment regimen are often utilized in combination with different chemotherapy agents.

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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

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.

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The Pharma Data

JUNE 7, 2023

These results add to the emerging picture of how individualized neoantigen therapy may advance melanoma treatment and the promise it may hold for other types of cancer. Rubin, senior vice president, global clinical development, Merck Research Laboratories.

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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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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

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

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

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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The Pharma Data

NOVEMBER 11, 2021

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.

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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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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

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

JUNE 7, 2022

Li, president, Merck Research Laboratories. Results from the Phase 3 MOVe-OUT study demonstrated the efficacy benefit of LAGEVRIO treatment was generally consistent across patients infected with SARS-CoV-2 variants of concern, Delta, Gamma and Mu. About Merck.

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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

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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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.

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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. Females of reproductive potential: Exclude pregnancy before the start of treatment. In the EU, VERQUVO (2.5

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The Pharma Data

NOVEMBER 5, 2021

s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Grown-ups With a Positive SARS-CoV-2 Diagnostic Test and Who Have at Least One Threat Factor for Developing Severe Illness. Li, administrative vice chairman and chairman, Merck 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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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

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.

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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

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

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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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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