PPD

MARCH 13, 2024

Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy. Whether this is via an allogeneic (healthy donors) or autologous (patient) approach, the material collected is then manufactured and returned to patients for infusion therapy.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. Tags Bioanalysis Weight 15

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Therapies DNA RNA Laboratories 52

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. Complexity: PAH trial sites are complex and require highly experienced clinicians, researchers and support staff.

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Clinical Trials Trials Clinical Research Disease 98

Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. Integrating SolveBio’s technology with QuartzBio’s existing portfolio helps us accomplish that.”

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Clinical Research Research Clinical Development Engineering 40

PPD

SEPTEMBER 25, 2023

The PPD clinical research business of Thermo Fisher Scientific has surveyed more than 150 drug developers around the globe to gather annual data on trends in pharmaceutical research and development. In Asia , personalized and precision medicine has become the driving force behind transformative clinical trials.

Drug Development 104

Drug Development Clinical Trials Drugs Trials 104

The Pharma Data

SEPTEMBER 21, 2020

in patients with unresectable or advance melanoma who had previously progressed on an anti-PD-1/L1 therapy. The results, presented at the 2020 European Society for Medical Oncology (ESMO) virtual congress, showed that Keytruda (pembrolizumab) plus Lenvima (lenvatinib) demonstrated an objective response rate (ORR) of 21.4%

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Research Laboratories Laboratories Trials Therapies 52

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. In June 2023, the U.S.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. 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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Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

The Pharma Data

NOVEMBER 9, 2020

These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy,” said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. Source link.

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Research Laboratories Laboratories Treatment Therapies 52

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].

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Data on the efficacy of deucravacitinib, no matter prior psoriasis treatment (Presentation FC03.06), were featured as an public speaking today from 2:30 – 3:30 p.m.

Disease 52

Disease Laboratories Clinical Pharmacology Treatment 52

Precision for Medicine

JUNE 26, 2023

Unraveling the complexity of manufacturing next-gen biologics is critical to the shared mission of accelerating patient access to new therapies,” said Chad Clark, President of Precision for Medicine. This convergence is driving faster clinical development and approval. Bethesda, Md., For more information, visit projectfarma.com.

Science 40

Science Small Molecule Clinical Research Engineering 40

Drug Target Review

SEPTEMBER 28, 2023

An area where high throughput synthetic DNA and next-generation sequencing can have a large impact is in clinical research. Often, DNA technology is used in the development of new therapies. We’re moving away from a time when everyone was prescribed the same drug and into the eras of precision medicine and personalised medicine.

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DNA Organic Chemistry Science Virus 116

Precision for Medicine

MAY 24, 2023

CRO Leadership Awards recognize companies judged by customers as exceeding expectations BETHESDA, MD, May 25, 2023 – Precision for Medicine, the first biomarker-driven clinical research organization (CRO), announces its wide recognition in the 2023 CRO Leadership Awards.

Clinical Trials 40

Clinical Trials Clinical Research Science Trials 40

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

The Pharma Data

AUGUST 30, 2021

There is currently a lack of therapies for ARDS associated with COVID-19. The study is a prime example of collaboration between basic and clinical researchers.

Clinical Trials 52

Clinical Trials Drugs Trials Hospitals 52

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.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

The Pharma Data

NOVEMBER 17, 2020

” Tony Anderson , DHSc, ELD is a multi-site laboratory director for Aspire Fertility as well as the founder of EmbryoDirector IVF Academy USA. Anderson started his career in the bovine laboratory in 1990 at Granada Biosciences and made it to the human laboratory in 1992 at IVF America in Livingston New Jersey.

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Laboratories Nurses Doctors International 52

The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Thérin is the president of Advanced Therapies at Siemens Healthineers. Prior to SpringWorks, Smith was the executive vice president of Gene Therapy at Bamboo Therapeutics. Previously he was CFO of Voyager Therapeutics.

Small Molecule 52

Small Molecule Clinical Development Engineering Pharmaceuticals 52

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?,

Treatment 52

Treatment Disease Clinical Trials Therapies 52

Vial

FEBRUARY 26, 2024

The pharmaceutical and biotechnological landscape is constantly evolving and a key partner within the drug development process is contract research organizations (CROs) , who are at the forefront with sponsors to drive innovation in clinical research.

Clinical Trials 52

Clinical Trials Trials Clinical Research Pharmaceuticals 52

The Anticancer Fund

JANUARY 12, 2022

The key finding is that women who receive progestin and metformin therapy have lower disease relapse than those receiving progestin alone. Combined therapy was not associated with significantly different remission rates or with different pregnancy and live birth rates. You can easily subscribe to this newsletter by clicking here.

Drugs 40

Drugs Clinical Trials Trials Small Molecule 40

The Pharma Data

NOVEMBER 10, 2020

This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field.”. Parexel is focused on supporting the development of innovative therapies to improve patient health. NEW YORK and LONDON, Nov.

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Clinical Trials Science Disease Trials 40

Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

MAY 28, 2024

Representatives on both sides of the aisle took full advantage of their floor time to probe FDA leadership on its spending, performance and specific regulatory policies – including its recent Laboratory Developed Test final rule. If you don’t have the staff to do this, how are you going to have the staff to do that?”

FDA 40

FDA Production Science Clinical Trials 40

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.

Clinical Research 52

Clinical Research Science Research Research Laboratories 52

PPD

APRIL 14, 2025

This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. Expertise that accelerates your clinical development success The PPD clinical research business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials.

Clinical Trials 52

Clinical Trials Trials Clinical Development Disease 52

Precision for Medicine

MAY 14, 2024

Now with 125,000 square feet of state-of-the-art capability, the facility offers significantly increased capacity and scale across both biorepository and laboratory services, with particular focus on cell and gene therapy, oncology and viral research. This convergence is driving faster clinical development and approval.

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Laboratories Research Clinical Research Clinical Trials 49

Precision for Medicine

APRIL 7, 2023

The custom-designed laboratory accommodates the growth in demand for advanced digital pathology and imaging capabilities, expertise in molecular sciences and a wide array of sequencing technologies. The expansion significantly increases the sample processing capacity of the laboratory.

Laboratories 52

Laboratories Clinical Research Clinical Trials Cell Biology 52

The Pharma Data

APRIL 8, 2021

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. In the U.S.

Therapies 52

Therapies Disease Research Laboratories Treatment 52

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. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

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

FDA Approval 52

FDA Approval FDA Treatment Therapies 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. Merck has the industry’s largest immuno-oncology clinical research program.

FDA 52

FDA Therapies Treatment Clinical Research 52

The Pharma Data

JUNE 25, 2021

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Merck has the industry’s largest immuno-oncology clinical research program. In the U.S. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

Disease 52

Disease Therapies Treatment Medical Schools 52

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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Doctors Treatment Hospitals Clinical Trials 52

The Pharma Data

OCTOBER 22, 2020

Conclusive Evidence from Rigorous Clinical Trials Nine months later, results from the randomized, controlled trials of Veklury involving thousands of patients have been published in peer-reviewed journals, conclusively demonstrating the clinical benefits of treatment with Veklury. Adverse reactions.

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Science Clinical Trials Hospitals Trials 52