FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e.,

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. IND, CTA, NDA, BLA). “If

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PPD

DECEMBER 14, 2023

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD ® FSP solutions utilize different regions to drive more efficient clinical development operations.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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Labcorp Drug Development

APRIL 17, 2023

The association between excessive alcohol consumption and liver disease is well documented. In fact, the effect on alcohol consumption levels during the COVID-19 pandemic has more recently been investigated.

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The Pharma Data

DECEMBER 9, 2020

Our lead candidate, ibrexafungerp (formerly known as SCY-078), is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, in late stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients. Forward Looking Statement.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025. At IRLAB we are well prepared to meet this future.

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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. guidance documents) fell short of answering the questions that they had.

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Agency IQ

SEPTEMBER 22, 2023

While this provision generally codified FDA practice on accelerated approval, it allowed the agency more flexibility in the types of evidence it can collect for new drugs and biologics in regulatory submissions. FDA is clear that this does not intend to serve as an exhaustive list. ( When should this occur? at the end-of-phase 2 meeting).

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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The Premier Consulting Blog

OCTOBER 26, 2022

The varying groups that generate or summarize the information that comprises the MPD over the course of development are called the sending unit , and the group that utilizes the information to manufacture the drug substance or drug product is call the receiving unit. It may also be used for the development of sections 3.2.S

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.

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The Pharma Data

OCTOBER 26, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

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The Pharma Data

OCTOBER 25, 2020

The Richmond Agitation–Sedation Scale was developed in a collaborative effort with practitioners representing critical care physicians, nurses, and pharmacists and its validation and reliability is well documented. On one end of the RASS score, +4 represents a very combative, violent patient, who is dangerous to the staff.

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Agency IQ

JUNE 26, 2023

In effect, CDx are IVDs (and therefore medical devices) that are specifically intended for use with an accompanying drug or biological product and specifically when the IVD is “essential” for safe and effective use of that drug. Implementing the pilot and a shift in LDT policy As noted above, the pilot is open immediately.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

In our experience with INTERACT meetings prior to their formalization as part of PDUFA, these meetings were often limited to very early development where there were novel CMC/manufacturing issues. In responding to meeting requests, FDA still reserves the right to determine what format is most appropriate.

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LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us. Don’t get me wrong. I know we all haven’t exactly been coasting this summer.

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The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.

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Agency IQ

JULY 21, 2023

An earlier report highlighted three key areas for international regulatory consideration when employing AI in drug development. EMA notes in the paper that many learnings and best practices from areas such as model informed drug development and biostatistics also can be applied to AI. image refinement).

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

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Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.

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Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. At the start of the year, FDA published a guidance document, not specific to oncology, on the use of external controls. What’s ahead?

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The Pharma Data

NOVEMBER 24, 2020

In ILLUMINATE-A, the efficacy and safety of Oxlumo were evaluated in 39 patients ages six and older with relatively preserved renal function (estimated glomerular filtration rate [eGFR] at or above 30 mL/min/1.73m 2 ) and a documented diagnosis of PH1. Visit OXLUMO.com for more information, including full Prescribing Information.

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The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. it is a single document for submission). P) is per the specific IMPD guidance.

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Agency IQ

AUGUST 2, 2024

EHR/health IT vendors weighed in on the draft guidance document to express interest in improving secondary use of data generated from their offerings as fit-for-purpose RWD. Instead, the authors write that upon DHCoE review, “early AI standards documents… lack specific details.” NIST, a division of the U.S.

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The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Christophe Le Tourneau, M.D.,

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Agency IQ

AUGUST 16, 2024

In this analysis, AgencyIQ has combed through the newly released final guidance document to tease out what’s new and what’s the same. Another addition to FDA’s general advice is a recommendation for sponsors to engage early with the FDA “early in clinical development” (as opposed to “at relevant milestone meetings”).

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PPD

JULY 11, 2023

Patient diversity in clinical research requires a multi-faceted approach. While race and ethnicity are certainly driving factors behind diversifying clinical trials, they are not the only qualities drug developers should keep in mind. Document and track reasons for screen failure.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD. 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

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Agency IQ

JUNE 28, 2024

In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. That said, FDA has not done nothing in 2024 related to clinical trial diversity. Read AgencyIQ’s full analysis of that draft guidance document here. ] Read AgencyIQ’s full analysis of that draft guidance document here. ]

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