DrugBank

FEBRUARY 9, 2023

disease genes) generated from patients inflicted with both obesity and type 2 diabetes, were mapped to tissue-specific protein–protein interactome and gene coexpression network to generate tissue-specific disease modules. DrugBank Powered Research: The differentially expressed genes (i.e., Dutta et al. Dutta et al.

Clinical Pharmacology 52

Clinical Pharmacology Molecular Biology DNA Licensing 52

The Pharma Data

NOVEMBER 1, 2020

Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of kidney disease, neurodegenerative disease, rare mitochondrial diseases and fibrosis. The Company is managed by a team with broad international, commercial and clinical-science experience. Source link.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. For more information, please visit www.sagerx.com.

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Treatment Clinical Pharmacology Drugs Clinical Development 52

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. There’s also a requirement for the FDA to “promptly” post this information publicly.

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Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

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The Pharma Data

DECEMBER 17, 2020

. The newly established subsidiary, InspirMed, will focus on inhalable liposomal treatments in both acute and chronic lung diseases. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Cautionary Note on Forward-Looking Statements. Source link.

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Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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The Pharma Data

FEBRUARY 8, 2021

In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”. v] ERLEADA ® is being studied in five Phase 3 clinical trials. ERLEADA ® IMPORTANT SAFETY INFORMATION.

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Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Garcia Jimenez et al.,

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Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Garcia Jimenez et al.,

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Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.”

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Agency IQ

JUNE 2, 2023

We’re expecting that there are a lot of companies that aren’t aware of this requirement, but we’re also expecting that this information will be hugely helpful to the FDA and its ability to even know what it regulates. government’s way of informing stakeholders of the regulations that are under active development.

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Agency IQ

DECEMBER 1, 2023

However, the revision provided much more detail given the amount of information on Covid-19 that was gained between May 2020 and February 2021. For instance, if the product is intended to prevent hospitalization, patients at a high risk of progression to severe disease should be enrolled in the trial.

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Agency IQ

FEBRUARY 23, 2024

Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.” We need to factor those in to think about whether a PRO outcome in a small trial is going to be informative or not.”

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Science FDA Trials Clinical Pharmacology 40

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

JUNE 16, 2023

Another addition is an advanced notice of proposed rulemaking that seeks to “obtain information related to recalls of products subject to the jurisdiction of the FDA.” For proposed and final rules with near-term planned actions, the FDA is generally more likely to release regulations when it says it plans to.

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The Anticancer Fund

JUNE 7, 2022

In the therapeutic study in patients with recurrent and/or metastatic disease (n=12), treatment was shown to be tolerable but there was no signal of efficacy, with median PFS less than two months in 9 evaluable patients. Subscription Would you like to stay informed about the latest news on drug repurposing in oncology?

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Clinical Trials Drugs Trials Treatment 40

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. FDA provided information on the comparative sales of cold medicines in the U.S. The communication strategy should include clear information on alternatives, according to the panel.

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Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

FEBRUARY 12, 2024

to analyze data, generate summaries of certain information, or other tasks of interest to companies in the interest of efficiencies. A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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FDA Science Biosimilars Clinical Trials 40

Agency IQ

MARCH 1, 2024

District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires. Deadline FDA must submit to OMB and post publicly a plan to achieve consistency with OMB’s AI memorandum.

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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read it now. The Altascientist : Issue No.

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The Pharma Data

NOVEMBER 9, 2020

He is a German trained expert in biopharmaceutics with a focus on oral and inhalable nanoparticles for the treatment of cancer and infectious disease and is the former president of the Canadian Society for Pharmaceutical Sciences and vice chair of the United States Pharmacopeia Dietary Supplement Expert Committee. XPhyto Therapeutics Corp.

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires. Note: If a link no longer works, it is likely because OIRA has since deleted it.)

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FDA Science Clinical Trials Regulations 40

Alta Sciences

JULY 25, 2024

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Shifting from pharmacology, the draft guidance offers input on design of toxicology studies.

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Therapies FDA Production Disease 59

Conversations in Drug Development Trends

JANUARY 6, 2025

BioA plays a pivotal role in therapeutic development, facilitating progress in our understanding and treatment of complicated diseases through PK/PD, immunogenicity studies, and biomarker discovery. This precision aligns with the growing demand for therapies that target disease mechanisms while accounting for individual differences.

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Clinical Trials Trials Drug Development Therapies 52

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

Patient and population-specific considerations include an understanding of the background rates of specific long-term neurodevelopmental outcomes in the population of interest, and disease-specific characteristics that may increase the risk for adverse neurodevelopmental outcomes.

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Production FDA Therapies Clinical Pharmacology 64

Drug Target Review

NOVEMBER 27, 2024

5 Alzheimer’s disease: driving advancements with precision medicine In contrast, advanced technologies like MSD and LC-MS/MS offer enhanced precision and sensitivity for biomarker analysis. Agencies like the FDA and EMA welcome comprehensive information from the outset, as it facilitates a smoother and more efficient review process.

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Drug Development Regulations Laboratories FDA 52

Drug Target Review

JANUARY 20, 2025

Genetic predispositions, such as BRCA mutations in hereditary cancers, influence treatment options and inform preventive measures. Advanced statistical approaches : Modern statistical approaches utilising Bayesian and other methods enable efficient analysis of complex dose-response data helping developers make informed decisions about dosing.

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Clinical Trials Trials Drugs Drug Development 52

Alta Sciences

JULY 31, 2024

Why Diversity in Clinical Trials Matters A wide variety of factors, from age or biological sex to environmental conditions and lifestyle choices (e.g., substance abuse, sexual activity), can influence the risk and likelihood of developing a disease or other long-term health issues—as well as the way an individual responds to treatment.

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Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

Agency IQ

JULY 12, 2024

Specifically, FDA is proposing to classify blood irradiators intended for the prevention of transfusion-associated graft versus host disease into Class II and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery into Class III. and the E.C.

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