Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings.

FDA 40

FDA Science Clinical Trials Trials 40

Drug Target Review

SEPTEMBER 25, 2024

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. 2023 Apr 4 [cited 2024 Sep 4];83(7_Supplement):3907–7. Cancer Research [Internet].

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Alta Sciences

AUGUST 21, 2023

Choosing the Best Bioanalytical Platform for Your Program aasimakopoulos Mon, 08/21/2023 - 20:50 Choosing the right bioanalytical platform for your molecule’s intended use and program segment is crucial to obtaining reliable, robust data in a timely manner. Why Partner With Altasciences for Your Bioanalytical Projects?

Assay Development 52

Assay Development Pharmacokinetics Drug Development Drugs 52

DrugBank

MARCH 7, 2024

Market Dynamics and Growth Projections The year 2023 witnessed an unprecedented surge in the popularity of weight loss drugs, with patients experiencing significant weight loss, despite facing the challenges of high drug costs and limited insurance coverage. Let’s delve into what lies ahead in the coming year.

Pharmaceutical Companies 81

Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 81

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.”

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. The drug development industry is undoubtedly in a season of change.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 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. In January 2023, the White House announced that the federal Covid-19 national emergency and PHE would officially end on May 11, 2023.

FDA 40

FDA Clinical Trials Vaccine Trials 40

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Drug Discovery. nM vs. 24.0

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

FDA Law Blog: Drug Discovery

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Marketing 59

Marketing FDA Regulations Pharmacokinetics 59

Agency IQ

JULY 28, 2023

Physiologically-based pharmacokinetic (PBPK) models are defined by FDA as drug development tools that mathematically integrate physiological, physicochemical, and drug-dependent preclinical and clinical information to predict an investigational drug’s absorption, distribution, metabolism, excretion (ADME), and pharmacokinetics (PK).

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

Science 40

Science FDA Drugs Production 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

BY LAURA DIANGELO, MPH | DEC 4, 2023 2:46 PM EST Diversity in clinical research: Guidance and statute In April 2022, the FDA issued a new draft guidance document on diversity in clinical research programs. The Food and Drug Omnibus Reform Act (FDORA) gave FDA new statutory authority and responsibilities.

FDA 40

FDA Research Clinical Trials Trials 40

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. FDA will accept comments on the draft guidance until December 18, 2023. What’s next?

FDA 40

FDA Science Trials Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

OCTOBER 20, 2023

BY KARI OAKES, CHELSEY MCINTYRE, PHARMD | OCT 16, 2023 9:28 PM CDT Background: Diabetic foot infections Diabetes mellitus, a disease that occurs when blood glucose levels are too high , is highly prevalent. The docket for comments on this guidance will be open until December 18, 2023.

FDA 40

FDA Treatment Trials Therapies 40

Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? On June 2, 2023, FDA published the final version of its guidance on nonclinical evaluation of immunotoxicity.

FDA 40

FDA Small Molecule Science Immune Response 40

The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars.

FDA 52

FDA Animal Testing Pharmacokinetics Small Molecule 52

Agency IQ

FEBRUARY 12, 2024

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Watch the video. Listen here. Watch it now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

AUGUST 16, 2024

In January 2023, FDA’s work on dose optimization made the leap from research to policy , starting with the release of OCE’s long-awaited guidance on dose optimization for oncology products. Read the analysis of the comments submitted here] Since then, this topic has continued to be a priority for the FDA.

Production 40

Production FDA Science Clinical Trials 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

FEBRUARY 15, 2024

We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. New on CDRH’s guidance agenda. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

FEBRUARY 23, 2024

Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development.

Drugs 40

Drugs Clinical Trials Pharmacokinetics Drug Development 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease.

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

JUNE 28, 2024

At a high level, the guidance laid out a policy whereby sponsors of certain products would voluntarily submit a Race and Ethnicity Diversity Plan as part of their development program that would outline and justify their approach to recruiting and retaining a “representative” research population.

FDA 40

FDA Science Clinical Trials Production 40