Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ). patient and product characteristics).

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FDA Law Blog: Drug Discovery

JUNE 12, 2024

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA. Tobolowsky — Much has changed since the long-gone days of 2017.

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Cytel

SEPTEMBER 1, 2023

Data is the cornerstone of any clinical trial, driving the decision-making process of drug development, and is a fundamental requirement for approval of new therapies by regulatory agencies like the FDA or EMA.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. 16 This concludes our exploration of metabolism of last year’s FDA approved small molecule drugs.

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The Pharma Data

AUGUST 13, 2020

The US Food and Drug Administration (FDA) has accepted Roche’s application for a new self-administration option for Xolair (omalizumab) across all approved US indications. Its use in these settings is supported by a rigorous clinical development programme, including eight Phase III studies. Source link.

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Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus.

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The Pharma Data

APRIL 24, 2023

Quizartinib NDA Review for Patients with Newly Diagnosed FLT3- ITD Positive AML Extended by FDA Daiichi Sankyo (TSE: 4568) today announced that the U.S. No additional efficacy or safety data has been requested. “We

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Agency IQ

FEBRUARY 12, 2024

Far from just an outline of the work completed by Consortium members to date, the Playbook is a thoughtfully organized “how-to-guide” which walks readers through some of the major milestones of early clinical development in just over one hundred pages.

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Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. References Iversen et al., Front Pharmacol.,

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The Pharma Data

SEPTEMBER 29, 2021

Food and Drug Administration (FDA) supported the positive results of the FIDELIO-DKD phase III clinical trial study for patients with CKD and T2D. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion and $86.01

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Zai Lab is leading clinical development in its territory. “We Although much of the U.S.

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The Premier Consulting Blog

OCTOBER 21, 2024

The FDA defines a serious condition as “a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning.” To address these delays, the FDA has required certain confirmatory trials to be underway before granting accelerated approval.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

MAY 16, 2022

Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). (Nasdaq: GILD) today announced the U.S.

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Cytel

JUNE 20, 2023

Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has been relatively scarce. How might this affect pediatric drug development?

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The Pharma Data

JULY 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. The FDA’s Fast Track designation of LX9211 reflects the serious unmet medical need of people suffering from diabetic peripheral neuropathic pain,” said Praveen Tyle, Ph.D., THE WOODLANDS, Texas, Dec. Safe Harbor Statement.

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Agency IQ

SEPTEMBER 22, 2023

BY AMANDA CONTI, ALEXANDER GAFFNEY, MS, RAC SEP 18, 2023 9:24 PM CDT Background: FDA’s standards for evidence When seeking approval from the FDA, companies are required to demonstrate that their product is safe and effective when used as intended. In one landmark case, Warner-Lambert Co.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

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Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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The Pharma Data

MAY 31, 2022

FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. The target action date for the FDA decision is September 30, 2022. The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

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The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. FDA, underscoring the value it brings to patients, providers, and health systems alike.” NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S.

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.

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Agency IQ

JANUARY 4, 2024

In new report, FDA sketches out ideas for improving how it publishes guidance documents In a long-anticipated draft report, the FDA has offered a vision for a series of potential improvements to the way it currently publishes guidance documents. For the FDA, guidance documents come in a variety of different forms and formats.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. This is a question that sponsors have been struggling with for quite some time.

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The Pharma Data

AUGUST 24, 2020

The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. In a paper published in Molecular Therapy: Methods & Clinical Development , the team discussed why they choose this type of gene therapy to treat HIV. Air Force photo by Kemberly Groue.

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The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. Taigexyn ® is already on the market in the mainland China and Taiwan , TG-3000 has completed Phase 2 clinical studies, and Furaprevir is currently in Phase 3 clinical development.

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The Pharma Data

NOVEMBER 22, 2020

Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. The FDA approved it under the brand name Gavreto on September 4. In addition to RET-altered NSCLC, it is being developed for RET-altered thyroid cancer and other solid tumors. Here’s a look at the upcoming week.

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The Pharma Data

NOVEMBER 8, 2020

Food and Drug Administration (FDA) in terms of PDUFA dates. Here’s a look at some of the upcoming target action dates on the FDA’s calendar. . The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We

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The Pharma Data

JANUARY 13, 2021

NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. SOUTH SAN FRANCISCO, Calif., About the Phase 1/2 Trial for HPN217.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. Bayer today announced that the U.S.

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The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. VTX-801 is a novel investigational gene therapy for Wilson Disease, which has been granted Orphan Drug Designation (ODD) by the Food and Drug Administration (FDA) and the European Commission (EC) and Fast Track designation by the FDA.

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Agency IQ

JUNE 26, 2023

While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g.,

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