BioPharma Drive: Drug Pricing

OCTOBER 8, 2023

Mirati shareholders could also receive another $1 billion should an experimental cancer drug the biotech is developing make it to U.S. regulators’ desks.

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Drug Target Review

DECEMBER 20, 2024

Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development. who intend to evaluate a drug, biologic, medical device, or food for medical purposes that targets a rare disease in a clinical trial.

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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

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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The Premier Consulting Blog

OCTOBER 30, 2024

To support this, the Innovative Technologies and Advanced Manufacturing Hub (I-TEAM Hub) was created. As outlined earlier in this blog, innovative manufacturing techniques are key for producing superior quality medicine, as improvement in quality manufacturing can limit drug shortages due to quality-related issues.

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Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Perficient: Drug Development

NOVEMBER 19, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Drug Patent Watch

DECEMBER 11, 2024

Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.

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Perficient: Drug Development

DECEMBER 18, 2023

Legal Obligations and Regulatory Frameworks It is well-known that financial institutions operate within a complex web of laws and regulations. By streamlining processes and ensuring compliance with regulations, banks can reduce the likelihood of errors, fraud, and other operational inefficiencies that could threaten their stability.

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PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success.

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Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

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Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles.

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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.

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ProRelix Research

MAY 10, 2025

Herbal clinical trials in […] The post Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA appeared first on ProRelix Research. With the increasing popularity of herbal products for both preventive care and therapeutic intervention, the demand for rigorous scientific validation is stronger than ever.

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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

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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. EU, and other regions. ” Scientific Research Publishing , 2024.

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Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Institutions must invest in secure housing, specialised veterinary care and rigorous training for handlers.

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Conversations in Drug Development Trends

DECEMBER 19, 2024

As regulatory frameworks like the General Data Protection Regulation (GDPR) have heightened the emphasis on data privacy and individual rights, Europe is leading the way in terms of privacy and data. In-Vitro Diagnostic Regulation and The FDAs Final Rule The WODC U.S.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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ASPET

JUNE 10, 2024

Interleukin (IL)-33 has been shown to centrally regulate, among other processes, inflammation and fibrosis. Both intracellular full-length (FLIL33) precursor and extracellular mature cytokine (MIL33) forms exert such regulation, albeit differentially.

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Drug Patent Watch

FEBRUARY 26, 2025

Understanding the Patent Landscape Biologic drugs are often protected by a combination of patents, including composition of matter patents, method of use patents, and formulation patents. However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA).

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PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

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Drug Target Review

APRIL 7, 2025

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions. References Sun D, et al. doi:10.1016/j.apsb.2022.02.002.

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Drug Target Review

SEPTEMBER 25, 2024

Classically, rational drug combinations are designed to target two nodes in the same oncogenic signalling pathway. BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example.

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KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times.

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Drug Target Review

APRIL 30, 2025

The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT. From precise target identification to optimised gene-editing techniques and streamlined clinical trial designs, AI has the capacity to transform every stage of the drug development pipeline.

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PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. In regulated domains, every step must be documented, auditable and reproducible to meet stringent regulatory requirements.

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Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering. Cancer Cell [Internet].

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey.

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Drug Target Review

JUNE 17, 2025

The dynamic behaviour of RNA transcripts, the regulation and modification of proteins, the lipid composition of membranes, the structural organisation of cells and the spatial context of tissues all play critical roles in disease progression and therapeutic response.

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Conversations in Drug Development Trends

APRIL 29, 2025

On the last day of February every year is Rare Disease Day , a dedicated day to celebrate the rare disease community, including patients, families, caregivers, clinicians, researchers, regulators, and more. For any collaboration inquiries or questions about the 2025 Rally for Rare event, reach out to rare@worldwide.com.

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