Chemical Biology and Drug Design

JULY 3, 2025

Computationally guided modifications of centaureidin led to the development of CA4, demonstrating enhanced antioxidant and antitumor activities. Molecular docking and in vitro assays confirm improved binding affinity and cytotoxicity, highlighting CA4's potential as a promising drug candidate for cancer therapy.

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Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

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Drug Patent Watch

APRIL 30, 2025

"Game Changers in Generic Drug Development: What's Next? As the pharmaceutical industry continues to evolve, one thing is clear: the future of generic drug development is about to get a whole lot more interesting. Read the full article here: [link] #GenericDrugs #PharmaInnovation #FutureOfPharma"

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Drug Development Drugs Pharmaceuticals 68

Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Quanticate

AUGUST 2, 2024

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences.

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Drug Patent Watch

NOVEMBER 20, 2024

Generic drug development is a complex process that involves rigorous scientific research and regulatory assessments. Food and Drug Administration (FDA) plays a crucial role in ensuring the quality and efficacy of generic drugs through various programs and guidelines.

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PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. RWE is transforming rare disease drug development, providing the insights needed to overcome unique challenges.

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Perficient: Drug Development

JULY 2, 2024

If you use ServiceNow as your knowledge management platform, you might want to make your knowledge articles searchable and accessible from Microsoft Search. By connecting your ServiceNow knowledge articles to Microsoft Search, you can enable your users to find and request them directly from the Microsoft 365 apps.

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Production 118

Chemical Biology and Drug Design

MAY 10, 2025

The review focused on English-language original research and review articles, examining carprofen and its derivatives in terms of their synthesis methods as well as their use as small molecules in various therapeutic applications, both human and veterinary.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Drug Patent Watch

OCTOBER 16, 2024

As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems. This article delves into the impact of biosimilars on biologic drug… Source

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Perficient: Drug Development

SEPTEMBER 26, 2023

We’re excited to introduce you to two illuminating articles recently featured on CMSWire.com, “The Heart of Composable Architecture,” and “Navigating the Long Tail of Composable in the Martech Landscape” Both articles were penned by Perficient’s own David San Filippo, Sitecore Principal and Sitecore Technology MVP.

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Drug Target Review

DECEMBER 20, 2024

Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.

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Clinical Trials Trials Pharmaceuticals Drug Development 128

Drug Patent Watch

DECEMBER 11, 2024

In this article, we will delve into the key criteria for selecting a CDMO, highlighting the essential factors to consider and the importance of effective communication and cultural fit. Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO.

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Drug Patent Watch

OCTOBER 14, 2024

The Food and Drug Administration (FDA) and other regulatory bodies have implemented various measures to ensure that generic drugs are equivalent to their brand-name counterparts in terms of quality, safety, and efficacy. This article will delve… Source

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Drug Development Drugs FDA Production 107

Drug Patent Watch

MARCH 10, 2025

The Future of Generic Drugs: How Technology is Revolutionizing the Industry As we continue to navigate the ever-changing landscape of healthcare, one thing is clear: technology is playing an increasingly important role in shaping the future of generic drug development. Read the full article here: [link]

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Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. Your review article discussed the need to study genetically diverse patient samples. Can you expand on that?

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Crown Bioscience

JUNE 23, 2025

Drug resistance remains one of the most pressing challenges in oncology drug development, as it is the leading cause of treatment failure. As researchers look to understand and overcome drug resistance, they need precise, controllable, and scalable models that allow them to isolate and study resistance mechanisms effectively.

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Drugs Drug Development Therapies Treatment 52

Crown Bioscience

JULY 1, 2025

These “ biological missiles ” represent an exciting new advance in anti-cancer therapies and are one of the fastest-growing segments in oncology drug development.

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Drugs Drug Development Therapies Research 52

Quanticate

SEPTEMBER 13, 2024

In our article, we cover the key trends that have been shaping clinical trials so far in 2024, and those that are predicted to continue into 2025.

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Drug Patent Watch

MARCH 18, 2025

This is where generic drug development comes in a game-changer for millions of people around the world. The Growing Importance of Generic Drug Development As the global demand for affordable medications continues to rise, the importance of generic drug development cannot be overstated.

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Drug Development Marketing Pharmaceutical Companies Drugs 52

FDA Law Blog: Drug Discovery

MARCH 19, 2023

s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s

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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 Target Review

MARCH 24, 2025

Sujeegar Jeevanandam, an expert with 13 years of experience in life sciences R&D, offers valuable insights into the current state and future trajectory of artificial intelligence in drug discovery. This breakthrough could fundamentally change how drugs are developed and tested.

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Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

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Drug Target Review

JUNE 6, 2025

Image credit: Crystal Eye Media / Shutterstock The role of SPICA and manufacturing capabilities Drug development in the radiopharmaceutical space is particularly resource intensive. He stresses the importance of recognising organisational strengths and weaknesses: “No single company is fully expert in all aspects of drug development.”

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Drug Patent Watch

JUNE 20, 2024

In the high-stakes world of pharmaceuticals, patents play a pivotal role in safeguarding intellectual property and ensuring a return on investment for drug developers. The journey of a drug patent is a complex and intricate one, spanning from the initial filing to its eventual expiry.

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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Animal Testing FDA Drug Development Production 52

FDA Law Blog: Drug Discovery

APRIL 21, 2025

One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a leadership vacuum at the Center for Drug Evaluation and Research (CDER).

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Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-. 113:9861002.

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Chemical Biology and Drug Design

JANUARY 21, 2025

ABSTRACT Infectious diseases, including bacterial, fungal, and viral, have once again gained urgency in the drug development pipeline after the recent COVID-19 pandemic. Compound 26 was identified as a promising antiproliferative hit. Tuberculosis (TB) is an old infectious disease for which eradication has not yet been successful.

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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. ” Scientific Research Publishing , 2024. ” U.S.

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Drug Development Compliance Drugs Regulations 52

Drug Patent Watch

SEPTEMBER 24, 2024

Recent advancements in analytical technologies have significantly impacted the development of generic drugs, enabling more accurate and efficient analysis of complex drug products. This article will explore the latest developments in… Source

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Drug Development Drugs Production 59

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.

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Drug Patent Watch

FEBRUARY 26, 2025

In this article, we'll delve into the world of drafting drug patent applications for biologic drugs. To draft a strong patent application, you need to understand the nuances of biologic drug development, including the production process, stability, and formulation. Read the full article here: [link]

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