PPD

OCTOBER 31, 2024

As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.

Drug Development

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.

Drug Development

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.

Drug Development

BioPharma Drive: Drug Pricing

JUNE 2, 2025

Genetic research is driving progress in kidney disease drug discovery.

Disease

Drug Patent Watch

DECEMBER 11, 2024

This article outlines key considerations and strategies for developing a sustainable generic drug development strategy. Pfizer, for example, has been applying green chemistry principles in drug development for over two decades to reduce waste, minimize resource use, and develop energy-efficient manufacturing processes.

Drug Development

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.

Clinical Trials

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.

Drug Development

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.

Drug Development

PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years.

Drug Development

Fierce BioTech

JULY 15, 2025

For biotech companies advancing oncology therapies, regulatory speed can be critical to achieving key milestones and getting new therapies to patients faster. Regulatory expert shares how early planning and FDA engagement can speed oncology approval

FDA

Drug Patent Watch

MARCH 27, 2025

Revolutionizing Generic Drug Development: The Power of Digital Transformation As the pharmaceutical industry continues to evolve, one thing is clear: digital transformation is no longer a luxury, but a necessity. So, what does this mean for the future of generic drug development? Share your thoughts in the comments below!

Drug Development

Drug Patent Watch

MAY 27, 2025

"Unlock Hidden Profits in Pharmaceutical R&D: A recent analysis of top-selling medications reveals that companies that closely monitor their competitors' patent portfolios are 3x more likely to achieve a higher return on investment in drug development. link] #pharmaceuticalinnovation #drugdevelopment #patentportfolio"

Drug Development

Drug Patent Watch

DECEMBER 4, 2024

These methods have the potential to revolutionize the drug discovery process by enhancing the efficiency and accuracy of identifying and developing new drug candidates. This article will explore how machine learning can be leveraged to optimize generic drug development… Source

Drug Development

Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development. The generic drug development process involves several stages, from patent research to regulatory approvals.

Drug Development

Drug Patent Watch

DECEMBER 11, 2024

Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.

Pharmaceutical Companies

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.

Clinical Development

The Pharma Data

JUNE 24, 2025

However, breakthroughs in recent years—most notably the approval of KRASG12C inhibitors—have opened new doors for drug development, and Revolution Medicines is at the forefront of efforts to expand this therapeutic frontier.

Drug Development

Drug Target Review

MARCH 24, 2025

Promising areas for AI implementation When discussing the most transformative AI applications in drug discovery, Sujeegar identifies a particularly ambitious goal: developing AI models that can simulate human pharmacokinetics and pharmacodynamics (PK/PD) using only preliminary laboratory data.

Clinical Trials

thought leadership

JULY 20, 2025

Launching a clinical trial in Europe is a complex but rewarding endeavor, requiring careful navigation of regulatory frameworks, ethical requirements, and submission processes.

Clinical Trials

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development. who intend to evaluate a drug, biologic, medical device, or food for medical purposes that targets a rare disease in a clinical trial.

Clinical Development

Drug Patent Watch

MARCH 4, 2025

The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. But have you ever stopped to think about the unsung heroes of generic drug development?

Drug Development

Drug Target Review

DECEMBER 6, 2024

For more: [link] ; [link] ; [link] ; [link] Nina Truter Nina Truter is a translational scientist with a deep focus on understanding mechanisms of action in drug development and leveraging disparate datasets in biotech. In 2003, he was selected by EE Times as one of the top 13 most influential people in the semiconductor industry.

RNA

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.

Drugs

Drug Patent Watch

MARCH 3, 2025

Breaking Down Barriers: The Power of Global Research Collaborations in Generic Drug Development As the world grapples with the complexities of healthcare, one thing is clear: the need for innovative solutions has never been more pressing. The benefits of international collaborations in generic drug development are multifaceted.

International

Fierce BioTech

JUNE 30, 2025

We’re in the midst of a paradigm shift in biomarker science. | The right biomarker signature can de-risk trials, guide decisions, and survive real-world complexity. Here’s how.

Drug Development

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.

Drugs

Crown Bioscience

JULY 1, 2025

Highly targeted antibody-drug conjugates (ADCs) combine an antibody with a cytotoxic payload, covalently attached via a chemical linker. These “ biological missiles ” represent an exciting new advance in anti-cancer therapies and are one of the fastest-growing segments in oncology drug development.

Drugs

Crown Bioscience

JULY 24, 2025

The Patient’s Journey: An Emotional and Scientific Challenge At the heart of drug resistance lies a deeply personal story - each slide of a patient’s tissue sample represents an individual’s journey of courage and hope in navigating a challenging chapter of their life.

Drug Development

Drug Patent Watch

DECEMBER 9, 2024

This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?

Drugs

Crown Bioscience

JULY 21, 2025

In the complex landscape of oncology research and drug development, reliable preclinical models are crucial. Among various available platforms, cell line-derived xenografts (CDX) stand out as a robust and highly valuable model system, offering unique advantages for understanding tumor biology, drug efficacy, and therapeutic potential.

Drugs

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Despite these advancements, analysing biologically derived targets remains a formidable challenge due to interference from endogenous molecules.

International

Drug Patent Watch

DECEMBER 11, 2024

These guidances are designed to streamline the development process and help ensure that generic drugs meet the same high standards of safety and efficacy as their brand-name counterparts. They offer guidance on formulation development and manufacturing considerations.

Drug Development

Chemical Biology and Drug Design

MAY 10, 2025

With ongoing research pushing the boundaries of its potential, carprofen remains a promising candidate for innovation in drug development and treatment strategies.

Small Molecule

Drug Patent Watch

FEBRUARY 13, 2025

The Unsung Heroes of Generic Drug Development: The Power of Partnerships As we navigate the complex landscape of pharmaceuticals, it's easy to overlook the crucial role that partnerships play in bringing affordable, life-saving medications to market. So, what can we learn from the role of partnerships in generic drug development?

Drug Development

Fierce BioTech

JUNE 23, 2025

Leveraging Machine Learning to Accelerate Drug Development Discover how CDMOs are using machine learning to speed up drug development, cut costs, and improve quality. mcottam Mon, 06/23/2025 - 14:54 Discover how CDMOs are using machine learning to speed up drug development, cut costs, and improve quality.

Drug Development

Drug Target Review

JUNE 9, 2025

A personal journey to Alltrna Michelle Werner’s career has spanned over 20 years in the pharmaceutical industry, where she developed her expertise in oncology drug development at leading companies such as Bristol Myers Squibb, AstraZeneca, and Novartis.

Disease

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.”

Therapies