Reprocell

NOVEMBER 1, 2022

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. And while animal testing has progressed thousands of therapeutics that we use today, it is not without its experimental and ethical downfalls.

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biobide

JUNE 8, 2023

The in silico method represents an increasing role in drug discovery as technology becomes more sophisticated. It is fast becoming a cost-effective and efficient alternative to animal testing. It can be used in all stages of drug discovery, from screening to pre-clinical trials and greatly reduces drug development time.

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Crown Bioscience

APRIL 12, 2023

The development of new drugs and biological products has traditionally mandated animal testing, but the FDA Modernization Act 2.0 allows for alternative non-clinical testing, allowing reliable alternatives for drug discovery and biological product applications.

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Drug Target Review

SEPTEMBER 26, 2023

These cells demonstrate considerable promise for uncovering drug-induced perturbations to neuronal function such as seizure, and their use extends further to sedation, anti-epileptic drug discovery and modelling of neurological diseases.

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Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

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Predictive Oncology

AUGUST 8, 2024

Most drug failures occur in Phase II and Phase III clinical trials when drugs move from immortalized cell lines and animal testing to human patients. By combining these two assets, this offering represents an opportunity to de-risk drug discovery and accelerate pipeline development.

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Drug Target Review

MARCH 18, 2024

How do recent advancements in bioprinting technology promise to revolutionise the traditional drug development process, in terms of cost and timeline? Recent advancements in bioprinting technology are setting the stage for a major transformation in the drug development process, primarily through cost reduction and accelerated timelines.

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Reprocell

MARCH 6, 2023

A recent law passed in the USA means that new drugs do not need to be tested on animals before human studies. expands the range of models that can be used to test a compound before clinical trials. With support from over 200 organizations, the "FDA Modernization Act 2.0"

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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. What are nonclinical studies and when are they conducted in drug development?

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Drug Target Review

MARCH 11, 2024

How can this finding potentially reduce the reliance on animal testing in the field of cancer drug testing? 3D printing allows innovators to produce complex structures and intricate organ models, which can be used to study diseases and test new therapies in a more realistic and efficient manner.

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Vial

MAY 20, 2024

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. What is a Pre-Clinical CRO?

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Drug Target Review

OCTOBER 3, 2024

Since the 1970s, when hybridoma technology enabling the generation of monoclonal antibodies (mAbs) was first developed, 1 antibody-based therapeutics have become one of the most rapidly growing drug categories, with applications across cancer indications, immune disorders and infections.

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Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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The Pharma Data

JANUARY 11, 2021

CAMBRIDGE, England–( BUSINESS WIRE )– CN Bio , a leading developer of single and multi organ-on-chip microphysiological systems (MPS) that improve the accuracy and efficiency of drug discovery, today announced the publication of co-authored research with the U.S. Food and Drug Administration (FDA) 1.

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Typical clinical development timelines for anticancer drugs average an estimated 6.7 This thereby proves the drug is also clinically meaningful or beneficial.

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The Pharma Data

MAY 15, 2023

Leveraging human model systems, the institute aims to accelerate drug discovery and development by improving the understanding of how organs function and how diseases develop. These efforts will also enable early testing of which drug candidates are safe and which molecules would work best for each patient.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).

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Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

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Agency IQ

JANUARY 26, 2024

Further, other types of coatings or surface modifications are outside of the scope of the guidance – although, notably, the guidance may be able to provide some recommendations about coatings that contain a drug or biologic, but doesn’t “discuss drug or biologic characterization recommendations” – solely the coating material itself.

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Agency IQ

JANUARY 12, 2024

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. BY PATRICIA ISCARO, ESQ. |

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biobide

JANUARY 5, 2024

The Food and Drug Administration (FDA) Modernization Act 2.0 At its core lies a pivotal stride toward more humane and scientifically advanced practices through the authorization for the use of certain alternatives to animal testing in Drug safety and efficacy investigations.

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The Premier Consulting Blog

APRIL 25, 2023

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. As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models.

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Broad Institute

JUNE 27, 2024

Therapy search Vallabh, along with her husband Eric Minikel, leads a lab at Broad focused on developing drugs to prevent and treat prion diseases. From tool to drug Led by Neumann and Bertozzi, the researchers began engineering a new epigenome editor.

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biobide

JUNE 8, 2023

Animal testing has had an influential role in almost every medical breakthrough in the last 100 years. Further, animals are essential in assessing drugs and vaccine safety. Approximately 26 million animals are used in the USA every year for research purposes.

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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. Nonclinical studies encompass much more than just animal studies.

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Codon

JULY 21, 2024

With a little encouragement, these animals develop preconditions towards cancer, Huntington's, Rheumatoid arthritis, Parkinson’s, sleep and memory disorders, addiction, and more. Their not being human is critical here—as there exists a massive double standard when it comes to protocols for human and animal experimentation.

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Agency IQ

MARCH 7, 2024

Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates Congressional appropriators this week released the text of the legislation that is set to provide FY2024 funding for the FDA, following a short-term continuing resolution (CR) to fund the agency and related Departments through date.

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PLOS: DNA Science

APRIL 4, 2024

Among the barrage of drug ads for cancer, diabetes, weight loss and more are those for Lume , a “doctor-developed whole body deodorant.” It’s also a precursor to many drugs. Perhaps that’s why the recipe doesn’t include an antiperspirant, which would place it in the drug category.

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Codon

MARCH 14, 2023

After reading dozens of papers on this topic, I can’t help but feel that I wasted part of my life injecting chubby mice with drugs. Mice and rats account for 95 percent of all animals used in biomedical research. For every 5,000 drug compounds tested in mice, five move into human studies.

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Codon

JUNE 2, 2024

Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments. While fundamental research is often productive in mice, translational drug research tends to be relatively intolerant to biological differences.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Instead, this guidance highlights questions about species, animal model, and product selection for nonclinical programs as well as several aimed at helping to understand the purpose and importance of POC, toxicity, and biodistribution studies.

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Drug Target Review

APRIL 9, 2025

In the fast-moving world of drug discovery and vaccine development, the most transformative breakthroughs often emerge where cutting-edge science meets bold innovation. Rademacher explained that their approach bypasses the need for traditional animal testing: Everybody asks us why we don’t test our vaccines in monkeys and rabbits.

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Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

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The Pharma Data

OCTOBER 27, 2020

27, 2020 — Testing of Eli Lilly’s antibody drug for hospitalized COVID-19 patients has been halted because the treatment doesn’t help them recover from their infection. Food and Drug Administration while late-stage studies continue. The antiviral drug remdesivir has received full approval from the U.S.

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Codon

NOVEMBER 1, 2024

Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. growing drugs in 1,000-liter bioreactors), regulatory limits, and ethical quandaries. Subscribe to Asimov Press.

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Drug & Device Law

JULY 21, 2022

Joining all other courts to have considered habeas petitions filed on behalf of (non-human) animals, a divided New York Court of Appeals, the state’s highest court, denied the petition, holding that the writ is “intended to secure the liberty rights of human beings who are unlawfully restrained, not nonhuman animals.” Nonhuman Rts.

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