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.

Treatment 52

Treatment Clinical Pharmacology Drugs Clinical Development 52

The Pharma Data

NOVEMBER 8, 2020

9, 2020 00:00 UTC. HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 Limited (Stock Code: 300759.SZ/3759.HK)

Clinical Pharmacology 40

Clinical Pharmacology Laboratories Science Pharmaceuticals 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

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]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Metabolite Tales Blog

JULY 5, 2023

APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). link] [13] A user’s guide to lorlatinib. Nagasaka et al., Critical Reviews in Oncology/Hematology, 151, 102969, [link]. [16]

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). link] [13] A user’s guide to lorlatinib. Nagasaka et al., Critical Reviews in Oncology/Hematology, 151, 102969, [link]. [16]

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

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

Agency IQ

JULY 28, 2023

During the COVID-19 pandemic, the number of opioid-involved deaths climbed sharply, with mortality rates increasing by 38% between 2019 and 2020. In 2020, the agency awarded a contract to “establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection.”

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

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

The Premier Consulting Blog

JUNE 18, 2023

Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials. BMC Bioinformatics 2020, 21(Suppl 17):527 [link]

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

JULY 31, 2024

Pancreatic cancer, for example, does not affect all populations equally and, between 2000 and 2020 , African Americans in the United States persistently had a 19% higher incidence of pancreatic cancer when compared with other racial groups.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Treatment 52

Agency IQ

OCTOBER 6, 2023

Under the 351(k) pathway, 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. See AgencyIQ’s analysis of these changes here.

FDA 52

FDA Biosimilars Science Production 52

Eye on FDA

JANUARY 5, 2022

And speaking of divergent outcomes – one of the most notable occurrences in 2020 was the number of resignations that occurred in the wake of FDA’s decision to approve Aduhelm for Alzheimer’s Disease after an overwhelming committee vote recommending the agency decline to approve. Taking Care of AdComm Vacancies.

FDA 76

FDA Clinical Pharmacology Vaccine Production 76

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020. Circuit vacated the final rule in 2021.

Regulations 40

Regulations FDA Science 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

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

The Pharma Data

OCTOBER 15, 2020

Assembly Biosciences – Former Gilead Sciences CEO John McHutchison, currently president and CEO of Assembly, was named the recipient of the Advance 2020 Global Impact award. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. Farrell Simon joins Trevi as head of U.S.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. supplemental oxygen, mechanical ventilation). Like the first version, the updated guidance was issued as direct-to-final.

FDA 40

FDA Clinical Trials Vaccine Trials 40

Agency IQ

SEPTEMBER 29, 2023

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 Regulations Production 40

The Pharma Data

FEBRUARY 8, 2021

[v] ERLEADA ® is being studied in five Phase 3 clinical trials. Accessed December 11, 2020. iv] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Prostate Cancer V.3.2020. Accessed December 2020. [v] Accessed February 2020. [vi] Prescribing Information, October 2020.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

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

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

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

Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. Available from: [link] Bakker E, Hendrikse NM, Ehmann F, et al. 174-177.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

Agency IQ

JULY 12, 2024

Fall 2023 July 2024 Final Rule Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices Fall 2022 July 2024 Final Rule Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail (..)

Regulations 40

Regulations FDA Science Production 40