Clinical Development, Containment and Pharmacy

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations. To accomplish this, we pay careful attention to both dosing and sample collection.

Clinical Trials

Clinical Trials Clinical Trials Pharmacy Trials

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

APRIL 24, 2023

For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program. This is important since not all pharmacies and sites are eligible to prepare and administer gene therapy due to biosafety and technical reasons.

Gene Therapy

Gene Therapy Gene Trials Clinical Trials

Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

XTalks

NOVEMBER 9, 2023

XTALKS WEBINAR: The Evolution of the Cardiovascular Clinical Development Landscape and Potential Role of GLP-1 RAs Live and On-Demand: Wednesday, December 6, 2023, at 11am EST (4pm GMT/UK) Register for this free webinar to learn about successful study outcomes in developing GLP1s to new therapeutic areas within cardiovascular medicine and more.

FDA Approval

FDA Approval Manufacturing Drugs Pharmacy

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

Drugs

Drugs Containment Development Sales

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

Clinical Trials

Clinical Trials Clinical Trials Production Medicine

MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

Clinical Trials

Clinical Trials Clinical Trials Development Trials

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

OCTOBER 30, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

Production

Production Antibody Manufacturing Trials

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

NOVEMBER 20, 2020

This press release contains “forward-looking” statements that involve substantial risks and uncertainties. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. NOTE REGARDING FORWARD-LOOKING STATEMENTS.

FDA Approval

FDA Approval Genetics Clinical Trials Clinical Trials

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

Antibody

Antibody Medicine Production Trials

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Antibody

Antibody Production Trials Medicine

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. . “We will submit detailed results from this trial for publication in order to share insights with the public health and medical communities,” said David Weinreich, M.D.,

Antibody

Antibody Trials Production Clinical Trials

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. . “We appreciate the continued support of patients and investigators around the world who are working to advance Regeneron’s antibody cocktail trials under very challenging circumstances,” said David Weinreich , M.D.,

Antibody

Antibody Trials Production Clinical Trials

COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months.

Vaccination

Vaccination Vaccine Antibody Life Science

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). Non-GAAP net income per share – diluted (1). $. Business Highlights.

Sales

Sales Production Manufacturing Antibody

TLC Announces Full Patient Enrollment in EXCELLENCE Trial of TLC599 for Osteoarthritis PainOn-schedule completion of enrollment despite COVID-19 pandemic; unique trial design evaluates safety and efficacy of single & repeat doses

The Pharma Data

DECEMBER 27, 2020

The US Department of Justice announced in October that opioid maker Purdue Pharma would plead guilty to fueling the nation’s opioid crisis in a $8 billion settlement, and sued Walmart recently for unlawfully dispensing controlled substances through its pharmacies, certifying the gravity of the opioid crisis. About TLC599. Source link.

Trials

Trials Clinical Trials Clinical Trials Containment

Clinical Research Informer

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

Trending Sources

Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

European Commission vs Big Pharma, or profit vs access?

MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

COVID-19 Pandemic Coverage

Regeneron Reports Third Quarter 2020 Financial and Operating Results

TLC Announces Full Patient Enrollment in EXCELLENCE Trial of TLC599 for Osteoarthritis PainOn-schedule completion of enrollment despite COVID-19 pandemic; unique trial design evaluates safety and efficacy of single & repeat doses

Stay Connected