The Pharma Data

SEPTEMBER 21, 2020

in patients with unresectable or advance melanoma who had previously progressed on an anti-PD-1/L1 therapy. However, the combo treatment performed better in certain cancers compared to others, reporting a response in 32.3% In another phase II trial, Keytruda plus Lenvima demonstrated an ORR between 9.7-32.3% Source link.

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Conversations in Drug Development Trends

DECEMBER 12, 2022

This enables us to recruit patients ​quickly​​ ​and pinpoint optimal study locations to help our sponsors uncover new and potentially lifesaving treatments for people suffering from rare diseases. What is the difference between a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory vs a research laboratory?

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. 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.

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The Pharma Data

MARCH 16, 2021

Head of Department CNS Diseases Research at Boehringer Ingelheim. “By By combining our expertise, we hope to make significant steps forward to finding solutions for patients for which there currently is no treatment.”. Our mission is to create breakthrough therapies that change lives. Hugh Marston, Ph.D., Boehringer Ingelheim.

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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. Liquidia Technologies has a target action date of November 24 for its NDA for LIQ861 for treatment of pulmonary arterial hypertension (PAH). The FDA approved it under the brand name Gavreto on September 4.

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The Pharma Data

OCTOBER 12, 2021

The Award recognizes the research that has the highest translational potential Translational medicine is an interdisciplinary branch in the biomedical field that aims to combine benchside, bedside and community to promote enhancement in prevention, diagnosis, and treatment. This year, Prof. Boehringer Ingelheim.

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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. The primary endpoint for Phase 2 is ORR.

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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. months [95% CI, 5.4-32.4]

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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. KEYTRUDA Is Now Approved for Eight Indications Across Five Different Types of Cancer in China. KEYTRUDA Is Now Approved for Eight Indications Across Five Different Types of Cancer in China.

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The Pharma Data

JUNE 1, 2022

Anderson has led the team of infectious disease biologists that validated and delivered to an emergency use authorization PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), Pfizer’s novel COVID-19 oral treatment. Dr. Anderson joined Pfizer via Wyeth in 2007.

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The Pharma Data

JANUARY 26, 2021

Vir Chief Executive Officer George Scangos said they believe VIR-7831 has significant potential as a single agent and noted the company is optimistic about pending interim data from two Phase III studies evaluating its potential for early treatment and in hospitalized patients. “As

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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

DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies.

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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. Nature Neuroscience. Read You love to see it! Nature Communications. ” Max Bayer.

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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.

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Codon

JULY 21, 2024

As the biotechnologist Alex Telford writes , “Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.” Another part of providing research animals with a good life is granting them a good death.

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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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Codon

JUNE 18, 2024

. ” However, studies over the last six decades have repeatedly affirmed that ultrasound is safe , at least when used in the short durations common to medical imaging and treatment. Arash Farhadi (left) and Mikhail Shapiro (right) setting up an ultrasound experiment in their Caltech laboratory.

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The Pharma Data

DECEMBER 22, 2020

In vitro studies have provided compelling evidence supporting the view that Tmod-based cell therapy can distinguish tumor cells from normal cells, across multiple tumor targets,” said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. “We About A2 Biotherapeutics.

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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. in these patients.

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The Pharma Data

APRIL 8, 2021

Since its first approval in renal cell carcinoma nearly two years ago, KEYTRUDA has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” 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

JUNE 25, 2021

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. Median DFS was not achieved in either treatment arm based on event accrual.

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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. In the U.S., In the U.S.,

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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 ?1)] 1)] as determined by a U.S.

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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. Twenty-two percent received one or more prior lines of therapy; 63% received prior radiation therapy. KENILWORTH, N.J.–(BUSINESS After a median follow-up of 13.4

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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) ? About KEYTRUDA ® (pembrolizumab) Injection, 100 mg. Non-Small Cell Lung Cancer.

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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

NOVEMBER 9, 2020

The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC). The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. Merck , also known as MSD outside of the U.S.

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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

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

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

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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

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). About Esophageal Cancer in Europe.

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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. Doravirine is approved for the treatment of grown-ups with HIV-1 in combination with other antiretrovirals, as a single agent (PIFELTRO) and a element of a single- tablet authority (DELSTRIGO; DOR/ 3TC/ TDF).

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The Pharma Data

OCTOBER 23, 2021

KEYTRUDA Is Now Approved in Combination With Chemotherapy as First-Line Treatment for Patients With Locally Recurrent Unresectable or Metastatic TNBC Whose Tumors Express PD-L1 (CPS ?10) This blessing is an important corner for applicable cases with metastatic TNBC who are in need of new treatment options,” saidDr.

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The Pharma Data

MARCH 15, 2022

The safety profile of KEYTRUDA in combination with LYNPARZA in this trial was consistent with that observed in previously reported studies for the individual therapies; however, the combination was associated with a higher incidence of grade 3-5 adverse events and drug-related serious adverse events, compared to the control arm.

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