The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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Drug Discovery World

APRIL 10, 2024

iECURE has been given the go-ahead to begin US trials of its investigational gene editing-based therapy in newborn males with neonatal onset Ornithine Transcarbamylase (OTC) deficiency. The post FDA approves first in vivo gene insertion programme in infants appeared first on Drug Discovery World (DDW).

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. The decision makes Benlysta the first lupus therapy authorized to treat this potentially life-threatening complication of the disease.

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The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

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Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Often, medical innovations are first explored in oncology research (e.g.,

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Drug Discovery World

AUGUST 10, 2022

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Developing the first CAR T cell therapy. Training T cells to target tumours.

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). Session Title: Targeted Therapy and Ovarian Cancer Trials. Session Type: Clinical Trials Plenary Session.

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The Pharma Data

JANUARY 22, 2021

Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ Lupkynis TM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care.

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The Pharma Data

JUNE 24, 2021

The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

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The Pharma Data

MARCH 26, 2021

“The positive CHMP opinion for ponesimod is testament to nearly a decade of cumulative clinical research which ultimately showed the treatment offers RMS patients superior efficacy on the primary endpoint of reduced annualised relapse rate compared to an established therapy, as well as a proven safety profile.”. 6]. ###.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1.

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The Pharma Data

MARCH 23, 2023

Dupixent is the first and only biologic to demonstrate a clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms), while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

This improvement stems from several factors, including the FDA’s emergency use authorization (EUA) of a number of therapies found to be safe and effective for COVID-19. Therapeutics Clinical Working Group : Prioritizes therapeutic agents for testing within an adaptive master protocol strategy for clinical research.

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The Pharma Data

OCTOBER 22, 2020

With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today. ii] The ACTT-1 study sets a high bar for clinical evidence that must be considered as new data emerge. Posted: October 2020.

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The Anticancer Fund

JUNE 23, 2023

While other regimens have shown similar promising results, the authors note that in low and middle income countries this simple and low-cost treatment may be suitable as a maintenance therapy in high-risk LGG patients. They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells.

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The Pharma Data

JANUARY 17, 2021

The service is expected to become operational in 2021 and will be available for clinical research and clinical care — starting with private patients, followed by expansion into the public healthcare system over time. “We Guardant Health has achieved CE mark approval as well as U.S. This press release features multimedia.

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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

JULY 29, 2021

Our flagship HIV therapy, Biktarvy, saw continued growth and gains in market share, despite the ongoing impact of the pandemic,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “The Cell Therapy product sales increased 39% to $219 million for the second quarter 2021 compared to the same period in 2020.

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The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Presentation Topic: Disease Modifying Therapies – Risk Management. Presentation Topic: Disease Modifying Therapies – Mechanism of Action.

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Advarra

AUGUST 8, 2023

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. We also discuss how a centralized biosafety review process can benefit this type of research.

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NIH Director's Blog: Drug Development

JULY 20, 2017

But today the outlook is far brighter for her and so many others, thanks to recent advances that build upon NIH-supported basic research. Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. After a median follow-up of 13.4

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Historically, the available drugs and U.S. None offers a cure for PAH.

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Conversations in Drug Development Trends

MAY 30, 2024

A condition of approval is the completion of a Phase 3 study designed to evaluate pheno-conversion in SOD1 mutation carriers (ATLAS study) to confirm clinical benefit. An area of interest has been deciphering ALS’s genetic underpinnings and delivering functional copies of dysfunctional genes to the patient.

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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.

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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Fountzilas et al. Satam et al.

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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 About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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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

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. This marks the first time an anti-PD-1 therapy has been approved in combination with anantibody-drug conjugate in the U.S.

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The Pharma Data

MARCH 23, 2021

Because esophageal cancer generally has poor survival rates, new first-line therapies are urgently needed for these patients,” said Dr. Peter Enzinger, Director, Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center. Merck has the industry’s largest immuno-oncology clinical research program.

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Drug Target Review

AUGUST 3, 2023

Doctors and other healthcare professionals have very little time to devote to signposting patients to research, so we have to explore other ways to find participants and, crucially, keep them engaged. That needs to change. Could you provide insights into the process of developing the at-home DNA tests used by Sano?

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The Anticancer Fund

OCTOBER 18, 2023

The results show that enoxacin, an FDA approved antibiotic, was able to slow tumour growth compared to untreated controls and compared to etoposide alone. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund.

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The Pharma Data

SEPTEMBER 8, 2020

In addition, over 170,000 people have been treated with OCREVUS, our first-in-class B-cell therapy, and we are incorporating years of clinical trial data and real-world evidence to optimise its potential to improve outcomes for patients with MS.”. Until the FDA approval of OCREVUS, there had been no FDA approved treatments for PPMS.

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Advarra

SEPTEMBER 30, 2022

Is the clinical research industry winning or failing at innovation? In the past decade, trials have evolved to include not just traditional drugs and medical devices, but also innovations like cell and gene therapies, wearables, and more. It probably depends on who you ask and likely full of nuance. Of course not.

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The Pharma Data

JUNE 26, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring. EINSTEIN-Jr is the largest pediatric study completed to date for the treatment of VTE.

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