Clinical Pharmacology, FDA Approval and Information

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Clinical Development

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

. “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA).

Clinical Trials

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Alta Sciences

SEPTEMBER 20, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Virus

Virus Clinical Pharmacology Drugs FDA Approval

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

The Premier Consulting Blog

SEPTEMBER 11, 2024

Unlike the traditional 505(b)(1) pathway, which requires extensive original investigations, the 505(b)(2) pathway allows developers to rely on information contained in published literature and/or from studies not conducted by the applicant, which can significantly reduce development time and cost.

Drugs

Drugs Clinical Pharmacology Packaging Small Molecule

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. Data on these novel approvals is published throughout the year by both CDER and CBER. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

FDA

FDA Biosimilars Science Drugs

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Garcia Jimenez et al.,

Drugs

Drugs Metabolic Stability FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Garcia Jimenez et al.,

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process. MAM technology (e.g.,

Science

Science Biosimilars FDA Production

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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.

FDA

FDA Science Regulations Production

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. About one year after its initial publication, FDA updated the guidance in February 2021. supplemental oxygen, mechanical ventilation).

FDA

FDA Clinical Trials Trials Vaccine

Janssen Presents Results from Phase 3 ACIS

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. vi] Since its first approval in the U.S.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Therapies

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

FDA now intends to release that regulation in August 2023 – just two months from now, indicating that this effort was proceeding apace behind-the-scenes for some time since these types of regulations often take years to develop.

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.

Science

Science FDA Clinical Trials Clinical Pharmacology

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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.

FDA

FDA Science Regulations Production

Drug Discovery Digest

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Eplontersen

Trending Sources

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Janssen Presents Results from Phase 3 ACIS

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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