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

MARCH 8, 2021

We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At About Molnupiravir. About Ridgeback Biotherapeutics.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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The Pharma Data

MARCH 13, 2021

Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer’s disease. Lilly’s chief scientific officer and president of Lilly Research Laboratories. Apostolova, M.D.,

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The Pharma Data

SEPTEMBER 11, 2020

In the Phase III OSTRO trial, Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score (NPS) and the nasal blockage score (NBS) compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care, the firm said.

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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

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. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity.

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The Pharma Data

AUGUST 31, 2021

Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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The Pharma Data

JUNE 2, 2023

This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) These approvals were based on the data from the Phase 3 PROfound trial.

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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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Elrig

APRIL 29, 2025

Understanding the role of neuroimmune interactions has become increasingly important in tackling complex neurological diseases. Matthew Fell, Forum Director and Executive Director of Neuroimmunology,MSD ,is responsible for leading a team of scientists focused on the discovery of neuroimmune based therapies for neurodegenerative diseases.

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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 Head and Neck Squamous Cell Cancer.

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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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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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PPD

OCTOBER 12, 2023

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

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 17, 2020

Lilly ‘s chief scientific officer and president of Lilly Research Laboratories. This is yet another example of the ways our industry is closely collaborating to combat this devastating disease and help patients around the world access new therapies.”

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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? 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.

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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. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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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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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 Kenilworth, N.J.,

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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 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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The Pharma Data

SEPTEMBER 21, 2020

This came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the recommendation based on a positive opinion of the PAOLA-1 Phase 3 trial which was published in The New England Journal of Medicine. . It also improved progression-free survival by a median of 37.2 months versus 17.7

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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. 1)] as determined by a U.S. Head and Neck Squamous Cell 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. in patients with VHL disease-associated RCC.

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The Pharma Data

NOVEMBER 22, 2020

PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries that can cause right heart failure and eventual death. Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S. The drug also received Rare Pediatric Disease Designation for these indications.

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The Pharma Data

AUGUST 30, 2021

KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. It is an aggressive type of breast cancer that has a high risk for disease recurrence.

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The Pharma Data

JUNE 25, 2021

First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting. 41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; KENILWORTH, N.J.–(BUSINESS

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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). “The Merck has the industry’s largest immuno-oncology clinical research program. In the U.S.,

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The Pharma Data

JANUARY 24, 2021

We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings. About Merck.

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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

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 Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation. 0.81; p<0.001).

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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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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 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. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.

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The Pharma Data

MARCH 8, 2021

Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months. “We Our Commitment to Infectious Diseases. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.

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