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?

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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.

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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).

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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.

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Drug Discovery World

JANUARY 20, 2023

This paid-for advertorial by CN Bio appeared in the SLAS 2023 Supplement, Volume 24 – Issue 1, Winter 2022/2023 Despite advancements, the drug development process remains inefficient. OOC systems represent the next generation platform for predicting drug effects in humans. In a study by Long et al.,

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Drug Discovery World

APRIL 12, 2023

This paid-for advertorial by CN Bio appeared in DDW Volume 24 – Issue 2, Spring 2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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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.

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Drug Discovery World

AUGUST 22, 2023

For instance, the development team would have to perform a deep characterisation study to understand the goalpost and which formulation might be successful or which characteristics might influence the pharmacokinetic (PK) study while determining how the body handles the substance. Other significant challenges include: 1.

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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.

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Drug Discovery World

AUGUST 3, 2023

Therefore, I hope for a future that offers a voice to all the variety of effects experienced when using cannabis, supported by a public education that informs recreational users and aligns with guidelines for safe prescribing of medicinal cannabis.” More recently in February 2023, Wellcome awarded Oxford’s Department of Psychiatry £16.5

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Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. It is proposed that the decreased clearance of the drug observed in patients may be due to depletion of GSH in this population [10]. Drug Metab Dispos. 2023; 51(7):873-883. Clin Pharmacokinet.

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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).

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

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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.

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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.,

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Image Social media_e-bulletin Ethnobridging.jpg Tags Clinical Trials Weight 1

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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. ].

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Drug Discovery World

APRIL 11, 2024

On the final day of AACR, the plenary session of the Annual Meeting put artificial intelligence at the forefront and featured a stellar lineup of AI and data science experts who discussed AI and topics such as imaging, precision medicine, and drug development.

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Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s We are proud to support Ischemix in advancing this vital new therapy.”

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Alta Sciences

AUGUST 7, 2023

[NEW EBOOK] Safety Assessment for Ophthalmic Products tchichekian Mon, 08/07/2023 - 19:08 HTML Excellence in Ophthalmic Safety Testing Altasciences has been conducting ophthalmic safety testing for decades, with all global regulatory submissions from our studies approved for design, conduct, and data integrity. Let’s get you started!

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.”

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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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.

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