The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. Summary of New PXL770 Phase 2a Study Results. About NASH.

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The Pharma Data

SEPTEMBER 1, 2021

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” said Gustavo Alva*, M.D., DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

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Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. intended use population. population demographics. population in light of the U.S. role in global health.

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. More specifically: “The estimated prevalence or incidence of the disease or condition by demographic characteristics in the U.S.

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The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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The Pharma Data

AUGUST 9, 2021

The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases.

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The Pharma Data

DECEMBER 23, 2020

The company said the new knowledge to be generated from the extended collaboration will help further de-risk and accelerate development of Ilya’s pipeline of advanced therapies based on modified lactic acid bacteria expressing human chemokines beyond acute skin wounds to diabetic wounds and inflammatory bowel disease.

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Agency IQ

FEBRUARY 2, 2024

after ischemic heart disease and stroke. The guideline is supported by four appendices: 1) methodological considerations for use of progression-free or disease-free survival , 2) use of patient-reported outcomes , 3) summary of product characteristics and 4) condition specific guidance. were from cancer.

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The Pharma Data

OCTOBER 14, 2020

VBL has recently demonstrated ex-vivo activity of anti-MOSPD2 antibodies in patients with relapsing-remitting and progressive multiple sclerosis (MS), as well as in animal models of rheumatoid arthritis (RA), nonalcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD). Inventiva – The U.S. Axol Bioscience – Based in the U.K.,

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. In effect, not all individual studies in a research program need to reflect the U.S.

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