Clinical Development, Licensing and Pharmacy

Clinical Development

Licensing

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

Roche Invests $5.3B in Zealand’s Petrelintide, an Obesity Drug Candidate

XTalks

MARCH 17, 2025

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4

Hormones

Hormones Drugs Sales Insulin

Join 21,000+

Insiders

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

Trending Sources

Orvacabtagene autoleucel by Bristol-Myers Squibb for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities.

Pharmacy

Pharmacy Production Development Clinical Trials

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

Danicamtiv, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities.

Drugs

Drugs Development Production Pharmacy

Innovations in Biosimilars: Insights and Trends from Samsung Bioepis

XTalks

NOVEMBER 28, 2023

Ilsun Hong VP and Product Evaluation Team Leader, Samsung Bioepis To have a biologic product ready for launch, it takes years of commitment from planning, early-stage development, clinical development, regulatory approval to supply readiness.

Production

Production Marketing Development Pharmacy

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

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

Production

Production Antibody Manufacturing 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

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

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 Clinical Development

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

The Pharma Data

NOVEMBER 20, 2020

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Merck will not receive any milestone payments for the development of lonafarnib for the treatment of Progeria, and has waived royalty obligations from Eiger for a specified quantity of lonafarnib.

FDA Approval

FDA Approval Genetics Clinical Trials Clinical Trials

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). R&D: Up-front payments related to license and collaboration agreements. (85).

Sales

Sales Production Manufacturing Antibody

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

The Pharma Data

DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

Antibody

Antibody Trials Production Clinical Trials

Clinical Research Informer

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Roche Invests $5.3B in Zealand’s Petrelintide, an Obesity Drug Candidate

Webinars

Trending Sources

Orvacabtagene autoleucel by Bristol-Myers Squibb for Relapsed Multiple Myeloma: Likelihood of Approval

Webinars

Danicamtiv, what is the likelihood that the drug will be approved?

Innovations in Biosimilars: Insights and Trends from Samsung Bioepis

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

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

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

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

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

Regeneron Reports Third Quarter 2020 Financial and Operating Results

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

Stay Connected