The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. marketing and diagnostics. BeyondSpring – BeyondSpring Inc. Additionally, Parag V. Katherine S.

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The Pharma Data

NOVEMBER 9, 2020

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. Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S. XPhyto Therapeutics Corp.

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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. Amanda Conti, AgencyIQ What kind of biologic products entered the market? Industry has historically struggled to fulfill (or be incentivized to fulfill) post-market requirements (PMRs) in general.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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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. . ‡ Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted. percent in the control arm.

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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 clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

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Agency IQ

DECEMBER 11, 2023

The side effects of some anticancer treatments can result in dose interruptions or de-escalations, or even outright discontinuation of an efficacious therapy. subsequent superior/inferior supportive care, lifestyle changes, or use of additional therapies).

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

OCTOBER 27, 2023

the drug and device) of the combination product.

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Agency IQ

FEBRUARY 15, 2024

Priority A List.

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Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

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Agency IQ

MARCH 1, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes Request for Information February 29 (Extended) Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments Draft Guidance March 11 Advanced Manufacturing Technologies Designation Program Draft Guidance March (..)

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Agency IQ

DECEMBER 1, 2023

The final rule takes into account the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices. the drug and device) of the combination product.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application.

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Alta Sciences

MARCH 27, 2025

We are grateful for the opportunity to partner with esteemed sponsors from around the globe, providing them with integrated solutions that not only support groundbreaking therapeutic progress but also contribute meaningfully to getting those therapies to those who need them, faster.

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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.

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Conversations in Drug Development Trends

JANUARY 6, 2025

Transforming Drug Development with Biomarkers and Streamlined Regulatory Pathways The growing focus on addressing unmet medical needs has prompted regulatory agencies to streamline pathways to expedite access to transformative therapies. As a cornerstone of the 4P model, PGx plays a transformative role in advancing personalized care.

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Drug Target Review

NOVEMBER 27, 2024

The global biomarker discovery outsourcing service market was estimated at $2.7 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.

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