Drug Patent Watch

FEBRUARY 26, 2025

In this article, we'll delve into the world of drafting drug patent applications for biologic drugs. Understanding the Patent Landscape Biologic drugs are often protected by a combination of patents, including composition of matter patents, method of use patents, and formulation patents.

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Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions. ” Scientific Research Publishing , 2024.

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KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times. Read the Article The post #ScienceSaturday: January 13, 2024 appeared first on KIF1A.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry. Fill out the form to read the full article.

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The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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Perficient: Drug Development

JANUARY 30, 2025

Regulations like the General Data Protection Regulation (GDPR) in the EU, the California Consumer Privacy Act (CCPA) in California, and other global privacy laws mandate that businesses protect the privacy of individuals and ensure their data is stored and processed securely.

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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. Lisa also suggests talking about your studies early on.

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Drug Target Review

JULY 4, 2023

In this article, Petra Dieterich, Ian Glassford, and Jeff Mocny, Scientific Leaders at Abzena discuss real-world data that is challenging traditional scientific thinking on the ADC therapeutic window. Antibody drug conjugated with cytotoxic payload. The therapeutic window of antibody drug conjugates: A dogma in need of revision.

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Perficient: Drug Development

AUGUST 19, 2024

Banks have silos, these silos have been created due to mergers, regulations, entities, risk types, chinese walls, data protection, land laws or sometimes just technological challenges over time. This is a 2021 article, also published here – Risk Management Data Strategy – Insights from an Inquisitive Overseer | LinkedIn

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KIF1A

JUNE 3, 2023

In this week’s article, researchers in Japan investigated the genetics of hereditary spastic paraplegia in a retrospective study : this means they went back and analyzed existing data, in this case the genetics and clinical profiles of 37 children diagnosed with HSP.

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Agency IQ

JUNE 26, 2023

Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. regulators. In the U.S., Recently, U.S.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.

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Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. There are several high-level takeaways from these updates for drug developers.

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Drug Target Review

JULY 13, 2023

In recent years, a novel approach known as condensate biology has emerged, revolutionising the way researchers think about drug discovery and development. Dewpoint Therapeutics, a platform drug discovery company founded in 2018, has been at the forefront of this exciting field.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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The Pharma Data

JANUARY 27, 2021

regulators have allowed emergency use of some Lilly and Regeneron antibodies for mild or moderate COVID-19 cases that do not require hospitalization as research on the treatments continued. Now, both companies are asking regulators to expand authorization of their drugs based on the new findings, the AP said. © 2021 HealthDay.

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Agency IQ

NOVEMBER 3, 2023

BY LAURA DIANGELO, MPH | OCT 30, 2023 9:38 PM CDT FDA’s new proposed rule on the regulation of laboratory developed tests An incredibly quick background : Laboratory developed tests (LDTs) are considered a subset of in vitro diagnostics (IVDs). IVDs are regulated as medical devices in the U.S., Quick intro: QSR, QMSR.

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Agency IQ

FEBRUARY 12, 2024

In terms of organization, the playbook starts with an introduction to the BGTC, provides an overview of the playbook’s development, and offers advice on it can be used. Although the document briefly touches on the technical aspects of drug development, most of the content in the playbook focuses on early touchpoints between sponsors and FDA.

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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.

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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. over this period.

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Agency IQ

JANUARY 19, 2024

The work could represent early steps toward modernizing one part of FDA’s regulation of this complicated product class. BY AMANDA CONTI | JAN 16, 2024 7:43 PM CST Regulatory background: complex generics Unlike new drug products, generic drugs do not require extensive clinical evidence to demonstrate safety or efficacy.

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Perficient: Drug Development

DECEMBER 27, 2023

Once published by regulators, Perficient’s Risk and Regulatory CoE will be here to walk our clients through the changes. YOU MAY ENJOY: Regulatory Reporting in Financial Services Modernizing CRA Regulations Managing compliance risk frameworks in alignment with existing risk profiles is crucial as customer needs evolve.

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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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Agency IQ

FEBRUARY 12, 2024

As the FDA has previously acknowledged : “Many complex drug products did not exist” when the Hatch-Waxman Amendments were first passed into law. “As As drugs have increased in complexity in recent years, the scientific and regulatory roadmaps for drug development and approval may not be as well-established for more complex generics.”

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Agency IQ

JULY 7, 2023

regulators have previously discussed , using RWE “for regulatory decision-making is already a reality, and there is increasing interest in using big data and advanced analytics as a complementary source of evidence.” Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect. Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement.

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Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. This concept is crucial in early drug discovery because it challenges traditional methods of drug development, where the focus is often on the PK.

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Perficient: Drug Development

OCTOBER 3, 2023

Blog articles that include your physicians’ bylines and consumer-friendly, understandable language help position your team of physicians as thought-leaders in their fields of expertise. On top of that, you can use physician-written blog articles to improve your physician search results. That’s where your physicians come in.

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Agency IQ

DECEMBER 11, 2023

So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans. Per Roy, “it’s basically a work in progress,” as the plans are being developed and translated into practice, and the company is still receiving iterative feedback from the FDA.

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Drug Target Review

MARCH 4, 2025

GLP-1 receptor agonists are a class of medications that mimic glucagon-like peptide-1 (GLP-1), a hormone that helps regulate blood sugar and appetite. These drugs slow digestion, reduce hunger and promote feelings of fullness, making them effective for both type 2 diabetes and weight loss.

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Perficient: Drug Development

DECEMBER 1, 2023

Despite this proactive approach, federal banking regulators either neglected to review the same documents or did so without taking necessary action before the bank failed. Contact us today to navigate the evolving landscape of risk and regulation successfully.

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Agency IQ

DECEMBER 1, 2023

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. As before, the guidance provides recommendations on drug development for COVID-19 across five domains: population, trial design, efficacy endpoints, safety considerations and statistical considerations.

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Perficient: Drug Development

JANUARY 16, 2024

Background On October 19 th , 2023, the Office of the Comptroller of the Currency (OCC) published an article highlighting new enforcement actions and clarifying explicit rules regarding misconduct, particularly as it relates to financial abuse by senior-level management.

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Nvidia Developer: Drug Discovery

JULY 21, 2021

The research , from scientists at the University of Washington (UW), holds promise for faster drug development, which could unlock solutions for treating diseases like cancer. Made from long chains of amino acids that interact to form a folded three-dimensional structure, the shape of a protein determines its function.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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