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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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. The key problem is that there appear to be many different underlying mechanisms that lead to depression.

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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

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Drug Patent Watch

JULY 25, 2024

Developing a competitive edge in generic drug development is crucial for companies to gain a significant market share and dominate the market. Here are some key strategies and insights from industry…

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Drug Discovery Today

NOVEMBER 24, 2022

Over the last decade, co-crystallization has become an attractive alternative to improve the physiochemical properties of drugs without affecting their pharmacology. As a result of the pharmaceutical benefits co-crystals exhibit, industrial interest is on the rise.

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Drug Patent Watch

SEPTEMBER 11, 2024

This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients. One of the most promising applications of nanotechnology is in generic drug development, where it offers unparalleled opportunities to enhance efficacy, safety… Source

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Chemical Biology and Drug Design

JUNE 19, 2024

Exploring the transformative impact of large language models (LLMs) in molecular biology and drug development, discussing potential areas of applications and breakthroughs in personalized therapies. While enhancing molecular biology aspects, we also address ethical concerns ensuring responsible application of these models.

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BioPharma Drive: Drug Pricing

NOVEMBER 13, 2023

How can these increase the probability of success or efficiency in a pre-clinical and clinical drug development program? Regulatory agencies have set the framework and use cases for RWE.

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BioPharma Drive: Drug Pricing

FEBRUARY 2, 2024

The California biotech is the third this year to go public, following stock offerings from CG Oncology and Arrivent Biopharma.

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Drug Patent Watch

JULY 31, 2024

The journey of a generic drug developer is a complex and multifaceted one, involving rigorous research, meticulous development, and stringent […] Source

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Drug Patent Watch

DECEMBER 10, 2024

This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers. Reshaping drug development through CRO/CDMO integration. Integrated CDMO and CRO Services Creates Innovation in Early-Stage Drug Development.

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Drug Patent Watch

OCTOBER 16, 2024

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

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Drug Target Review

AUGUST 19, 2024

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Drug Patent Watch

SEPTEMBER 10, 2024

The generic drug market has experienced significant growth over the past few decades, driven by the passage of the Hatch-Waxman Act in 1984 and subsequent legislation. Today, the market is more competitive than ever, with generic drugs accounting for over 90% of all prescriptions in the United States.

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Drug Patent Watch

OCTOBER 23, 2024

The pharmaceutical industry has faced significant challenges in recent years, including the loss of patents, increased regulatory scrutiny, and rising research and development costs. Patient centricity involves designing… Source

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Drug Patent Watch

OCTOBER 14, 2024

Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy.

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DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. UCSD, with its world-renowned Center for Microbiome Innovation , provides expertise in microbial genomics and drug discovery platforms.

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PPD

SEPTEMBER 6, 2023

Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. LEARN HOW The post How to Optimize Drug Development by Combining FSO and FSP Models appeared first on PPD Inc.

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LifeSciVC

JANUARY 3, 2024

There is clear precedent for such a complex-directed therapeutic approach in drug discovery. At HotSpot, we believe our proprietary Smart Allostery TM drug discovery platform affords us a unique understanding of how nature controls proteins through signaling pathways, including at the intricacies of complex formation.

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BioPharma Drive: Drug Pricing

OCTOBER 14, 2024

The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.

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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. This means that we are not doing something right.

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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. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

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Chemical Biology and Drug Design

MAY 23, 2023

Lanosterol 14α-demethylase (CYP51) responsible for oxidative removal of 14α-methyl group of sterol precursors, lanosterol, and 24(28)-methylene-24,25-dihydrolanosterol in ergosterol biosynthesis; essential component of fungal life cycle and prominent target for antifungal drug development.

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Drug Patent Watch

JULY 28, 2024

Patient advocacy groups have become increasingly influential in the pharmaceutical industry, particularly in the development of generic drugs. These groups, […] Source

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Drug Patent Watch

NOVEMBER 24, 2024

Patient centricity has become a crucial aspect of the pharmaceutical industry, particularly in the development of generic drugs. Here, we will explore the best practices in patient centricity for generic drug development… Source

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DrugBank

OCTOBER 17, 2024

Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drug development lifecycle.

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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.

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Quanticate

SEPTEMBER 13, 2024

With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.

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BioPharma Drive: Drug Pricing

SEPTEMBER 13, 2023

The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.

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DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

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BioPharma Drive: Drug Pricing

OCTOBER 30, 2023

The venture firm has supported a number of approved medicines with its co-development strategy, including Pfizer’s Besponsa and Apellis’ Empaveli.

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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.

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Drug Patent Watch

DECEMBER 11, 2024

Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs).

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BioPharma Drive: Drug Pricing

OCTOBER 21, 2024

Launched by PureTech and backed by well-known venture capital firms, the startup has raised $325 million since its debut this spring.

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Drug Patent Watch

SEPTEMBER 5, 2024

This alarming trend has led to a growing need for sustainable practices in the industry, particularly in the development of generic drugs. The pharmaceutical industry is a significant contributor to global carbon emissions, with a projected increase of over 300% by 2050 if left unchecked.

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Drug Patent Watch

APRIL 23, 2024

Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs. This book chapter provides a… Source

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Drug Patent Watch

NOVEMBER 19, 2024

The pharmaceutical industry is undergoing significant transformations, particularly in the realm of generic drug development. Recent trends and advancements in technology, research, and collaboration are reshaping the landscape of generic drug development, leading to new opportunities and challenges for pharmaceutical companies.

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