Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. New Drug Application (NDA) : Needed for marketing approval of new drugs. Freyr Solutions.

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Drug Target Review

JUNE 9, 2025

To do this, Alltrna leverages the unique biology of tRNA and its AI-enabled platform to design engineered tRNAs that can restore full-length protein production in diseases caused by shared genetic mutations, such as premature termination codons. Alltrna focuses on a mutation-driven approach.

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Drug Patent Watch

DECEMBER 11, 2024

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). Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. ” – Dr.

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Drug Target Review

APRIL 30, 2025

Faster time-to-market and reduced costs. This not only improved product consistency but also shortened the manufacturing timeline – getting the therapy to patients faster and more reliably. This not only enhances productivity but also fosters a culture of continuous learning and innovation within CGT. The result?

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Chemical Biology and Drug Design

MAY 10, 2025

Although it has long been employed in veterinary medicine as an anti-inflammatory agent, its use in humans was discontinued shortly after its market launch due to costly raw materials, complex synthesis, and labor-intensive production processesfactors that made it less competitive compared with other NSAIDs.

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The Pharma Data

JULY 3, 2025

Sunshine Biopharma Launches NIOPEG® Biosimilar in Canada, Targeting $10B Biologics Market Sunshine Biopharma Inc. and marks Sunshine Biopharma’s entry into the rapidly expanding global biologics and biosimilars market. The global market for NEULASTA® and its biosimilars is substantial. In 2024, it was valued at approximately $4.5

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Drug Target Review

JULY 1, 2025

His expertise spans business development, strategic planning, product management and marketing, with a focus on sustainable growth and portfolio expansion. He has held senior roles at WCG, Bioclinica, ERT, Icon Development Solutions, Covance, MDS Pharma Services and Inveresk Research.

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Drug Target Review

FEBRUARY 10, 2025

Over the years, Ive had the privilege of working on more than 25 different products, Bock shared. His experience has played a key role in shaping a more capital-efficient model for bringing cell therapies to market. My focus has always been on advancing novel medicines from research to clinical development.

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The Pharma Data

JUNE 24, 2025

One of the principal concerns in biologics manufacturing is product consistency—ensuring that every batch meets stringent criteria for purity, identity, charge, and molecular size. These attributes not only determine a drug’s safety and efficacy but also influence its regulatory approval and post-market success.

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The Pharma Data

JUNE 9, 2025

This milestone marks a significant step forward in their collaboration, originally initiated in December 2023, and signifies the beginning of domestic manufacturing for VISEN’s flagship product in China. VISEN Pharmaceuticals expects to obtain regulatory approval for lonapegsomatropin in China by 2025.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

The brain drug developer is now saying that its two marketed products could ultimately bring in $2 billion annually, and its pipeline may one day add another $12 billion in sales each year.

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Drug Target Review

APRIL 7, 2025

Investigational products with novel mechanisms of action are also assessed for safety in unique ways, creating complexities that can be more dynamically and effectively monitored using biologically relevant biomarkers.

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PPD

MARCH 11, 2025

It involves addressing the specificity of research questions, the clinical and investigational product context, and underlying causal frameworks; selection of a suitable data source; and a deep understanding of RWD provenance, granularity, completeness, structure and curation.

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The Pharma Data

JUNE 18, 2025

The company’s lead candidate, NCX-L2 , is specifically designed to slow or even halt the progression of Parkinson’s disease—a neurodegenerative condition that currently has no disease-modifying therapies on the market.

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The Pharma Data

JULY 2, 2025

WuXi Biologics sets a new standard in the formulation of biologics by enabling concentration levels up to 230 mg/mL , a significant leap beyond the previous high mark of 200 mg/mL seen in FDA-approved products. This seamless transition capability minimizes technical transfer risks and shortens time-to-market for biologic candidates.

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PPD

JANUARY 15, 2025

Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time. As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster.

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FDA Law Blog: Biosimilars

APRIL 13, 2025

Echoes from Past Warnings The disclaimers included on the website were likely derived from FDA commentary on previously submitted marketing pieces. According to the Untitled Letter, the FDA previously pointed out concerns about Taihos marketing messages, particularly regarding the selective presentation of efficacy data.

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Perficient: Drug Development

MAY 27, 2025

Shopaholic another powerful plugin with extensible architecture and marketing features. Both plugins allow product management, order processing, payment integration, and customer management. It facilitates clean code management, quick development, and the production of unique plugins.

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The Pharma Data

JUNE 24, 2025

The strategic funding arrangement is designed to support the continued advancement and global commercialization of Revolution Medicines’ RAS(ON) inhibitor portfolio, including its lead candidate daraxonrasib, as the company scales its operations independently across the international oncology market.

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Drug Target Review

MAY 14, 2025

This isnt about hype or grand promises its about identifying low-hanging fruit and achievable productivity gains. Recently, we’ve been pursuing AI product initiatives that have made me consider why people might be resistant to AI tools, what AI tools are capable of in drug discovery, and their limitations.

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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market. With trials facing a median delay of 12.2

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Perficient: Drug Development

MARCH 25, 2025

They unify Finance, Engineering, and Product teams around shared goals, fostering a mindset where cost efficiency and value creation go hand in hand. Are Finance, Product, and Engineering collaborating on goals, reporting, and forecasting? Does it feel like there has to be a better way to do this?

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Perficient: Drug Development

APRIL 30, 2025

From customer service and sales to product development, marketing, finance, training, and operationsour commitment to customer satisfaction is embedded in every part of the business. Perficient stepped in as a strategic partner to lead a comprehensive cloud transformation, designing and deploying a future-ready contact center solution.

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The Pharma Data

JUNE 15, 2025

The mutations within the calreticulin (CALR) gene — predominantly in exon 9 — enable the production of mutant forms of calreticulin (mutCALR) that promote the abnormal growth of hematopoietic cells, fueling the progression of the disease.

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Drug Target Review

JUNE 19, 2025

Still, Bazan says “Vertex’s work has been so important for the pain field – to get eyes on the large market size that matches the significant societal and clinical need for pain innovation.” It produces a harmful by-product, NAPQI, which can cause serious hepatic and renal damage. Unlike the newly approved NaV1.8

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The Pharma Data

JUNE 13, 2025

This includes support from specialized chemists, biologists, toxicologists, and other scientific and business-development professionals who can aid them in designing their products, navigating the complex process toward clinical trials, securing intellectual property, and preparing for eventual market authorization.

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The Pharma Data

JUNE 11, 2025

This decision represents a pivotal moment in the evolution of treatment convenience for patients with certain B-cell malignancies, while reinforcing BRUKINSA’s stronghold in the BTK inhibitor market. Notably, BRUKINSA has emerged as the market leader in new CLL patient starts across all lines of therapy in the U.S. for the first time.

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Drug Channels

DECEMBER 9, 2024

During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. The Humira biosimilar market just took another step forwardbut remains far from its ideal state. As you will see below, CVS Healths formulary actions led to rapid uptake of a low-list-price biosimilar.

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The Premier Consulting Blog

OCTOBER 30, 2024

In this blog, we explore the concept of advanced manufacturing and outline the FDA programs that play a critical role in promoting innovation while ensuring product quality. Continuous manufacturing, by contrast, integrates all steps of drug production into a seamless, ongoing process. What is advanced manufacturing?

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Drug Target Review

MAY 21, 2025

At the forefront of this mission is Senior Vice President of Vitalant, Becky Butler Cap, whose career has been long defined by a passion for building new services and treatment options in emerging markets. It allows clinicians to focus on patient care, while developers can remain centred on the unique requirements of their products.

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The Pharma Data

JUNE 13, 2025

Continuing Clinical Development JNJ-4496 forms a key component of Johnson & Johnson’s growing pipeline of cellular therapies for B-cell malignancies and is a product of its ongoing collaboration with AbelZeta Inc. formerly Cellular Biomedicine Group, Inc.).

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The Pharma Data

JUNE 25, 2025

BeOne Medicines Receives Positive CHMP Opinion for New Film-Coated Tablet Formulation of BRUKINSA® (zanubrutinib), Paving the Way for European Market Approval BeOne Medicines Ltd. This dual regulatory progress signals strong global confidence in the new formulation and sets the stage for expanded availability in key markets.

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Drug Target Review

JUNE 11, 2025

If it’s not mixable, the data value chain (from R&D phase to production phase) is neither interpretable or reproducible. He holds a master’s degree from University of Salerno in political sciences and marketing. His focus on the human element of technology applications has led to high rates of solution implementation.

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Drug Patent Watch

JANUARY 13, 2025

As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 from 2020 to 2025[1].

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The Premier Consulting Blog

APRIL 13, 2025

This pathway allows novel drug products to leverage data from other approved drugs (in the US and abroad), greatly reducing and sometimes altogether avoiding animal testing for approval. from approved products in other countries) to inform doses and development.

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Perficient: Drug Development

MARCH 18, 2025

Introduction to Copilot Agents In today’s fast-paced digital landscape, efficiency and productivity are paramount. Here are some key advantages: Increased Efficiency : By automating repetitive and time-consuming tasks, these agents free up employees to focus on more strategic and creative activities, boosting overall productivity.

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Drug Patent Watch

FEBRUARY 11, 2025

Behind the scenes, companies are employing clever tactics to protect their intellectual property and block competitors from entering the market. By securing patents for their products, companies can limit access to their technology and prevent others from developing similar treatments. But at what cost?

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