The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Abstract 1914.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

Drug Development 52

Drug Development Treatment Drugs FDA Approval 52

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. Roche is continuing to advance the science in MS and is exploring the investigational medicine fenebrutinib. P15: MS Clinical Trials and Therapeutics.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

Biosimilars 40

Biosimilars Science FDA Production 40

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

Science 40

Science FDA Production Drugs 40

PPD

MAY 11, 2023

Having the protocol endorsed by an ethics committee with pediatric expertise or ensuring it takes advice in clinical, ethical and psychosocial problems in pediatrics. Placing the interests of the patient over those of science and society. Prohibiting any additional incentives or financial inducements beyond compensation.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. .

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer.

Research 40

Research Clinical Trials Small Molecule Trials 40

The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. The secondary outcome involves pharmacokinetic endpoints.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

Treatment 52

Treatment Disease Small Molecule Production 52

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Treatment 52

Treatment Disease Therapies Pharmaceuticals 52

The Pharma Data

DECEMBER 5, 2020

Senior Vice President, Translational & Clinical Sciences, Hematology at Regeneron. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. Andres Sirulnik , M.D.,

Production 40

Production Trials Treatment Disease 40

The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

Drug Target Review

OCTOBER 16, 2024

I’ve always been drawn to the early stages of scientific discovery, where hypotheses are formed and developed into something tangible that can benefit patients. Being involved in these formative stages allows you to not only understand the challenges ahead but also shape the science to ensure it addresses patient needs.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 52

Agency IQ

DECEMBER 11, 2023

The notice described FDA’s search for a vendor to “provide analyses in the development of physiologically-based pharmacokinetic (PBPK) models to determine the optimal safe and appropriate dose of oncology drugs for pregnant women with cancer.” In July, a new contract notice indicated that this is an area of interest for FDA as well.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product.

FDA 40

FDA Science Small Molecule Immune Response 40

Agency IQ

SEPTEMBER 22, 2023

The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinical development process. When should this occur? at the end-of-phase 2 meeting).

FDA 40

FDA Science Trials Clinical Trials 40

The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”. About Gilead Sciences in Liver Disease. About Gilead Sciences. Gilead Sciences, Inc.

Disease 52

Disease Clinical Trials Treatment Science 52

The Pharma Data

JANUARY 3, 2021

The pharmacokinetics of nasally administered Foralumab will also be evaluated. Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected. About Tiziana Life Sciences. NEW YORK and LONDON, Jan. +44 (0)20 7495 2379.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. representative population.

FDA 40

FDA Science Clinical Trials Production 40

The Pharma Data

MARCH 16, 2021

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Neuroscience is a major focus of research and development at Roche. and 10%, respectively), nasopharyngitis (21.7% and 16.7%, respectively), pyrexia (13.3% and 10%, respectively), vomiting (11.7%

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

Agency IQ

AUGUST 16, 2024

Another addition to FDA’s general advice is a recommendation for sponsors to engage early with the FDA “early in clinical development” (as opposed to “at relevant milestone meetings”).

Production 40

Production FDA Science Clinical Trials 40

The Pharma Data

SEPTEMBER 15, 2020

I am proud of the truly transformational science that our research and clinical teams are bringing to the fight against disease, as well as the unprecedented speed with which we are advancing our clinical programs in the battle against COVID-19. About Pfizer: Breakthroughs That Change Patients’ Lives.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 27, 2020

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. About Roche in Neuroscience Neuroscience is a major focus of research and development at Roche. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

FDA Approval 52

FDA Approval Pharmacokinetics Treatment Clinical Trials 52

The Pharma Data

MARCH 30, 2021

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Neuroscience is a major focus of research and development at Roche. Evrysdi has been approved in 38 countries and submitted in a further 33 countries. About FIREFISH. The study met its primary endpoint.

Treatment 52

Treatment Clinical Trials Pharmacokinetics Trials 52

The Pharma Data

APRIL 7, 2022

Sisunatovir significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. Food and Drug Administration (FDA).

Virus 52

Virus Vaccine Clinical Development Hospitals 52

The Pharma Data

MAY 7, 2021

About the Sotrovimab Clinical Development Program. GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us. About Vir Biotechnology.

Treatment 40

Treatment Virus Vaccine Trials 40

The Pharma Data

SEPTEMBER 1, 2020

“Alongside our industry-leading collaborators, we are investigating novel endpoints, brain volume and cognition, which may help to further our understanding of the safety and efficacy profile of Zeposia and can advance transformational science for multiple sclerosis patients experiencing this unpredictable, debilitating disease.”.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

Drug Target Review

APRIL 25, 2025

19 Multi-organ CIVMs provide several new opportunities in ADME including in vitro bioavailability predictions, assessment of the effect of gut microbiome on hepatic drug metabolism, and prediction of the pharmacokinetic (PK) profile in humans in early pre-clinical stage. Toxicological Sciences 203 (2024) 7987. AAPS J 24 (2022).

Clinical Development 52

Clinical Development Small Molecule Drugs FDA Approval 52

The Premier Consulting Blog

FEBRUARY 11, 2025

Given the low patient numbers in rare diseases, sponsors may find themselves forced to consider specifically when, and for what purpose, patients can best be utilized in the clinical development program. Innovative approaches and FDA initiatives In addition to the special designations available (e.g.,

Drug Development 52

Drug Development Disease Drugs FDA 52