The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). v] ERLEADA ® is being studied in five Phase 3 clinical trials. Accessed December 11, 2020. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Metabolite Tales Blog

JULY 5, 2023

A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury. Figure 2 Human metabolism of glecaprevir Involvement of gut bacteria Grazoprevir (MK5172) is also used as part of combination therapy to treat chronic hepatitis C. link] [13] A user’s guide to lorlatinib. Nagasaka et al.,

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury. Figure 2 Human metabolism of glecaprevir Involvement of gut bacteria Grazoprevir (MK5172) is also used as part of combination therapy to treat chronic hepatitis C. link] [13] A user’s guide to lorlatinib. Nagasaka et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. However, the record for the highest number of AAs in one year is 16, from FY 2020. CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics.

FDA 52

FDA Biosimilars Science Production 52

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.

Science 40

Science Biosimilars FDA Production 40

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” The FDA’s effort to restrict the use of personalized genomics testing gets new challenge To contact the author of this piece, please email Alec Gaffney (agaffney@agencyiq.com)

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

FDA finalized a ban on these devices in 2020, but the D.C. FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” Circuit vacated the final rule in 2021. With FDA’s LDT rule under development, we wonder if HPM could receive a response soon.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 15, 2023

However, the Coronavirus Aid, Relief, and Economic Security (CARES) Act) of 2020 included provisions to overhaul OTC drug regulation. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. The two sides saw nearly every finding in a different light.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

NOVEMBER 9, 2020

VANCOUVER, BC / ACCESSWIRE / November 10, 2020 / XPhyto Therapeutics Corp. He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

Agency IQ

DECEMBER 1, 2023

FDA finalized a ban on these devices in 2020, but the D.C. FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” Circuit vacated the final rule in 2021. With FDA’s LDT rule under development, we wonder if HPM could receive a response soon.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” With FDA’s LDT rule under development, we wonder if HPM could receive a response soon.

FDA 40

FDA Science Clinical Trials Regulations 40

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

This Guidance explicitly excludes gene therapies (a change from the draft guidance), but instead makes reference to a separate guidance that has been in place since 2020 titled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.

Production 64

Production FDA Therapies Clinical Pharmacology 64

Drug Target Review

NOVEMBER 27, 2024

As precision medicines, including RNA interference (RNAi) and oligonucleotide therapies, become more prominent, the importance of advanced techniques in streamlining biomarker validation and expediting the regulatory review process becomes even clearer. Clinical Pharmacology & Therapeutics. 2022 Mar 5;112(1):69–80.

Drug Development 52

Drug Development Regulations Laboratories FDA 52