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 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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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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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.

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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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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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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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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 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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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

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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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 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

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 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 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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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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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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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

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 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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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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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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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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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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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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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.

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thought leadership

DECEMBER 18, 2024

On November 27,2024, FDA released a draft guidance intended to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the in vitro bacterial reverse mutation (Ames) test of a drug (active ingredient) or its metabolites and to provide recommendations on follow-up in vitro and (..)

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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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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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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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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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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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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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Fierce BioTech

NOVEMBER 13, 2024

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

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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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