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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. Medical Misinformation : FDA Commissioner ROBERT CALIFF has been heavily focused for much of the last two years on what he calls the negative health effects of medical misinformation.

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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. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

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Agency IQ

JUNE 2, 2023

Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)

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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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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. Food & Drug Administration.

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The Pharma Data

FEBRUARY 15, 2022

Vice President, Medical Sciences-Oncology, Astellas. The initial findings from EV-103 Cohort H are encouraging, and we look forward to learning more from the Phase 3 studies evaluating enfortumab vedotin in muscle-invasive bladder cancer in combination with the anti-PD-1 therapy pembrolizumab,” said Marjorie Green, M.D.,

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The Pharma Data

NOVEMBER 8, 2020

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 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,

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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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The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. At therapeutic doses, deucravacitinib doesn’t inhibit JAK1, JAK2 or JAK3.

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The Pharma Data

NOVEMBER 9, 2020

Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada. Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S.

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Drug Discovery World

NOVEMBER 8, 2023

On Day 1, Tuesday 14 November 2023, the tracks include: Display of biologics, antibody-based cancer therapies, safety and efficacy of bispecific antibodies, modulating the tumour microenvironment, optimisation and developability, and cell line and systems engineering. from engineered peptide and antibody libraries’.

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Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. James Cooke, PhD, Associate Director, Bicycle Therapeutics, on: ‘Engineering bicyclic peptides for precision targeted medicine’.

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FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. LILLIAN SIU, an oncologist and clinical trialist at Toronto’s Princess Margaret Cancer Centre, was a panelist on the day’s second session.

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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 Looking downstream, a shift toward biologics could have ripple effects for the life sciences industry.

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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 (..)

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Agency IQ

DECEMBER 1, 2023

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. This is already proving to be one of the FDA’s most-opposed actions in years.

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Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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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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Drug Discovery World

AUGUST 15, 2023

Specifically, we propose the hypothesis that whole-heart pacing studies are more likely than standard reductionist methods to recapitulate the biology of cardiac therapy (or toxicity) in human patients and hence have higher predictive validity than conventional methods. Clinical Pharmacology & Therapeutics. 12(3): 197-202.

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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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The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. In particular this study focuses on the role of the arginine-ornithine-polyamine axis, which is highly upregulated in GBM.

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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. . ‡ Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent of patients in the combination arm versus 56.2 10 months.

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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. The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Additionally, Parag V.

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