Fierce BioTech

SEPTEMBER 19, 2023

To predict whether new therapeutics will be safe and effective for humans, drug developers first test them in animal- and cell-based models as well as computational tools that are designed to appro | An introduction to Organ-on-a-Chip technology and how it can improve the quality of drugs entering the clinic.

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Drug Development Drugs 115

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 Development Drugs Pharmaceuticals Research 98

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 Development Drugs Marketing 105

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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Drug Development Drugs Pharmaceuticals 105

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.

Molecular Biology 100

Molecular Biology Drug Development Drugs Therapies 100

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 Development Drugs 129

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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Drug Development Pharmaceuticals Drugs 108

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 Development Drugs Pharmaceuticals 153

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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Drug Development Drugs Pharmaceuticals 98

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. Improved Return on Investment (ROI) Industry-academic partnerships can enhance the financial return on drug development investments.

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Drug Development Clinical Trials Drugs Therapies 81

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.

Drug Development 116

Drug Development Treatment Production Drugs 116

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 Development Drugs Marketing 105

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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Biosimilars Drug Development Drugs Pharmaceuticals 115

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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Drug Development Drugs FDA Production 111

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 Development Compliance Pharmaceutical Companies Drugs 52

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 Development Drugs Pharmaceuticals 105

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.

Clinical Trials 95

Clinical Trials Trials Drug Development Treatment 95

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 Development Pharmaceutical Companies Drugs Pharmaceuticals 105

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. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.

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Drug Development Metabolic Stability Clinical Trials Drugs 71

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 52

Drug Development Clinical Trials Trials Drugs 52

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 Development Pharmacokinetics Compliance Drugs 52

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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Drug Development Compliance Drugs Pharmaceuticals 52

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

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 Development Drugs 82

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 Development Drugs Pharmaceuticals 104

BioPharma Drive: Drug Pricing

DECEMBER 20, 2023

Still, the complexities of the disease and of drug development have brought hard-felt losses. The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists.

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Research Doctors Treatment Drug Development 142

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 Development Clinical Research Treatment Research 111

BioPharma Drive: Drug Pricing

FEBRUARY 21, 2024

The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.

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Disease Drug Development Therapies Drugs 126

BioPharma Drive: Drug Pricing

NOVEMBER 26, 2024

The brain drug developer is letting go of around 41 of its 238 employees, in a move the company says will help “align resources” with its strategic priorities.

Drugs 108

Drugs Drug Development 108

Fierce BioTech

NOVEMBER 13, 2024

| Discover how minimal residual disease (MRD) assessment is accelerating multiple myeloma drug development through FDA's latest guidance.

FDA 101

FDA Drugs Drug Development Disease 101

BioPharma Drive: Drug Pricing

MARCH 21, 2024

The job cuts at the cancer drug developer will primarily impact manufacturing roles, but will touch on several other parts of the organization, the company said.

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Research Drug Development Drugs 115

BioPharma Drive: Drug Pricing

OCTOBER 6, 2023

The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

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Research Drugs Drug Development 126

Fierce BioTech

AUGUST 20, 2024

Alzheimer’s disease research and drug development is evolving at a rapid pace. Decades of research has led to the approval of the first disease-modifying drugs and new pathological discoveries. |

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Disease Drug Development Research Drugs 116

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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Drugs Drug Development 111

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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Drugs Drug Development Pharmaceuticals 111

BioPharma Drive: Drug Pricing

DECEMBER 8, 2023

The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.

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Trials Drug Development Drugs 115

Science Daily: Pharmacology News

JUNE 18, 2024

Tests, in mice, of a drug developed by the researchers showed that regulatory T cells can be attracted to specific body parts, boosted in number, and activated to suppress immune response and rebuild tissue.

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Treatment Disease Immune Response Clinical Trials 124