The Pharma Data

JULY 29, 2021

About Kumquat Biosciences Kumquat Biosciences is a privately held drug discovery and development company committed to creating breakthrough medicines for the treatment of cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

Small Molecule 52

Small Molecule Immune Response Research Laboratories Laboratories 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

MARCH 5, 2021

” “While covalent BTK inhibitors and venetoclax have transformed the treatment of CLL, we now see many patients needing new therapeutic alternatives,” said Brian Koffman, MDCM (retired), chief medical officer of the CLL Society. chief medical officer of Loxo Oncology at Lilly. About Loxo Oncology at Lilly.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. He spent 27 years at Merck & Co.

Small Molecule 52

Small Molecule Clinical Development Engineering Pharmaceuticals 52

The Pharma Data

JUNE 1, 2022

Anderson most recently served as Vice President and Chief Scientific Officer for Bacterial Research and Hospital within the Vaccine R&D organization. Prior to Pfizer, Dr. Anderson worked at Merck Research Laboratories where she founded its prokaryotic bio-combinatorial engineering laboratory and initiated a bacterial vaccine program.

Vaccine 40

Vaccine Research Laboratories Doctors 40

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.

Research 52

Research Treatment Therapies Trials 52

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.

Clinical Trials 52

Clinical Trials Treatment Trials RNA 52

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? Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years.

Therapies 116

Therapies Disease Engineering Medical Schools 116

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.

Treatment 52

Treatment Clinical Trials Clinical Development Trials 52

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. Photo by D Wells. months versus 35.3 months with bevacizumab.

Research Laboratories 52

Research Laboratories Treatment Trials Laboratories 52

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.

Treatment 52

Treatment FDA Approval FDA Therapies 52

The Pharma Data

APRIL 8, 2021

Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC.

Therapies 52

Therapies Disease Treatment Research Laboratories 52

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. months [95% CI, 5.4-32.4]

Treatment 52

Treatment Trials Research Laboratories Clinical Trials 52

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.

FDA 52

FDA Licensing Licensing Treatment 52

The Pharma Data

AUGUST 10, 2021

The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. Source link: [link].

FDA 52

FDA Therapies Treatment Clinical Research 52

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. There were no serious drug-related AEs in people who received islatravir.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

The Pharma Data

APRIL 28, 2023

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. Preventing or delaying radiographic progression is an important clinical endpoint in assessing oncologic treatment and is very relevant to patients, their caregivers and their families.

FDA 40

FDA Trials Treatment Research Laboratories 40

The Pharma Data

JULY 15, 2021

Given the high rates of recurrence within the first five years of diagnosis, patients with high-risk early-stage TNBC need new treatment options,” said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. KEYTRUDA is currently approved under accelerated approval in the U.S.

Therapies 52

Therapies Treatment Trials FDA 52

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).

FDA 40

FDA FDA Approval Trials Treatment 40

The Pharma Data

JUNE 25, 2021

We hope to build on this important research and provide new treatment options to kidney cancer patients.”. “As The late-breaking results will be presented in the Plenary session of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA5) on Sunday, June 6, 2021. of patients in the placebo arm.

Disease 52

Disease Therapies Treatment Medical Schools 52

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.

Trials 52

Trials Clinical Trials Research Laboratories Pharmacokinetics 52

The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

Treatment 40

Treatment FDA Approval FDA Therapies 40

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

Treatment 52

Treatment Production Disease FDA Approval 52

The Pharma Data

MARCH 15, 2022

Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About LYNPARZA® (olaparib).

DNA 52

DNA Clinical Trials Trials Therapies 52

The Pharma Data

APRIL 7, 2023

LEAP-003: Merck and Eisai are discontinuing the Phase 3 LEAP-003 trial evaluating KEYTRUDA plus LENVIMA for the first-line treatment of adults with unresectable or metastatic melanoma. Merck and Eisai are informing study investigators of the decision and advising them to reach out to patients in the study regarding treatment.

Trials 40

Trials Clinical Trials Treatment Therapies 40

The Pharma Data

SEPTEMBER 28, 2021

Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. This positive CHMP opinion is a crucial breakthrough in bringing a replacement immunotherapy treatment option with KEYTRUDA to appropriate patients in Europe with metastatic triple-negative carcinoma. About Triple-Negative carcinoma.

Research Laboratories 52

Research Laboratories Clinical Research Treatment Disease 52

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.

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

The Pharma Data

NOVEMBER 11, 2021

Joerg Koglin, vice chairman, Global Clinical Development and Therapeutic Area Head, Cardiovascular for Merck Research Laboratories. Ladies of reproductive implicit Exclude gestation before the launch of treatment. Gain a gestation test before the launch of treatment. each time,” saidDr.

Clinical Trials 40

Clinical Trials Trials Hospitals Treatment 40

The Pharma Data

JUNE 7, 2023

Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology. 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. The safety profile of KEYTRUDA was consistent with findings from previous studies.

Clinical Trials 40

Clinical Trials Therapies Research Laboratories Vaccine 40

The Pharma Data

NOVEMBER 22, 2020

The study, IMPOWER 22, will evaluate the efficacy and safety of islatravir — Merck’s novel investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation for both treatment and prevention — and is anticipated to begin by early 2021.

Trials 52

Trials Clinical Trials International Production 52