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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Collaborative Drug

AUGUST 1, 2023

Streamlining Collaborations and Drug Development using CDD Vault and ELN

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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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Chemical Biology and Drug Design

MARCH 18, 2025

The review provides a comprehensive analysis of non-hydroxamate inhibitors for IspC, an enzyme crucial in the MEP pathway, highlighting its structural diversity and improved drug development potential.

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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.

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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 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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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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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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BioPharma Drive: Drug Pricing

JANUARY 13, 2025

Intra-Cellular has had success selling Caplyta, a brain-rebalancing drug that's approved to treat schizophrenia and bipolar depression.

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Drug Patent Watch

NOVEMBER 24, 2024

Here, we will explore the best practices in patient centricity for generic drug development… Source This approach focuses on understanding and addressing the needs and preferences of patients to ensure that the medications they receive are safe, effective, and easy to use.

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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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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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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.

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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.

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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.

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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?

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BioPharma Drive: Drug Pricing

JUNE 20, 2023

The deal adds to recent M&A activity as well as signals pharma’s continued interest in pills for inflammatory conditions, which are meant to approach the potency of injectable therapies.

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BioPharma Drive: Drug Pricing

AUGUST 25, 2023

Neumora’s filing late Friday, along with that of radiopharmaceutical startup RayzeBio earlier this week, could be an important test of the biotech IPO market.

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BioPharma Drive: Drug Pricing

AUGUST 23, 2023

The funding for Rapport Therapeutics saw participation from a series of so-called crossover investors, many of which have pulled back from biotech startups in recent years.

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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!

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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

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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Drug Patent Watch

NOVEMBER 18, 2024

This growth is driven by several factors, including the increasing prevalence of chronic diseases, cost-effectiveness, and patent expirations of branded drugs. The future of generic drug development in emerging markets looks promising, with technological advancements… Source

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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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BioPharma Drive: Drug Pricing

JULY 16, 2024

The Merck KGaA spinout has a tau-regulating medicine it claims could be an “ideal therapy” for Alzheimer’s. The pitch has intrigued both healthcare investors and pharma venture arms.

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BioPharma Drive: Drug Pricing

OCTOBER 14, 2024

Choosing the right clinical outcome assessments (COAs) is an important part of successfully advancing drug development and securing regulatory approval.

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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?

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Drug Patent Watch

APRIL 14, 2025

"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies.

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BioPharma Drive: Drug Pricing

MAY 29, 2024

An acquisition of EyeBio will hand Merck a treatment for diabetic macular edema and age-related macular degeneration that’s ready for pivotal testing.

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Drug Patent Watch

JANUARY 14, 2025

.”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?

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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.

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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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BioPharma Drive: Drug Pricing

JANUARY 8, 2024

The proposed takeout follows a spate of dealmaking around antibody-drug conjugates, targeted cancer medicines that have lured AbbVie, Pfizer, Merck and Gilead.

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BioPharma Drive: Drug Pricing

DECEMBER 22, 2023

The deal would hand Bristol Myers, which has newly made neuroscience a therapeutic focus, an experimental treatment for schizophrenia.

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BioPharma Drive: Drug Pricing

AUGUST 14, 2023

Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.

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BioPharma Drive: Drug Pricing

MARCH 25, 2024

Worth about $138 million upfront, the deal is another example of pharma interest in new drugs for inflammatory conditions like Crohn’s.

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