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.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

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. Developing effective ECs requires more than just matching clinical trial inclusion and exclusion criteria within the RWD source.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

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.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Compliance Pharmaceuticals Drug Development 98

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.

Drug Development 98

Drug Development Pharmacokinetics Compliance Drugs 98

Drug Patent Watch

DECEMBER 9, 2024

High-Throughput Screening: Modern Technology Meets Natural Products Advanced technologies now allow researchers to rapidly test thousands of natural compounds against specific disease targets. This approach has led to the discovery of numerous potential drug candidates.

Drugs 97

Drugs Drug Development Pharmaceuticals Production 97

PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. The adoption of new innovations, strategies and technologies offers opportunities to address persistent challenges and develop suitable approaches for the future.

Drug Development 104

Drug Development Clinical Trials Drugs Trials 104

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.

Drug Development 98

Drug Development Clinical Trials Drugs Therapies 98

Perficient: Drug Development

MARCH 11, 2024

AI (Artificial Intelligence) Powered Product People Have you ever wondered how artificial intelligence can transform not only our lives but also our professions? As someone passionate about technology and digital product development, I have always been intrigued by new tools and how they can improve our lives and careers.

Production 105

Production Government Marketing 105

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.

Drug Development 111

Drug Development Drugs FDA Production 111

Drug Target Review

DECEMBER 9, 2024

Baker’s model could revolutionise drug development, synthetic biology, and nanotechnology, opening possibilities for new medical treatments, vaccines, nanomaterials, and sensors.

Engineering 105

Engineering International Drug Development Science 105

Perficient: Drug Development

MARCH 12, 2024

Drucker defined knowledge workers as high-level workers who analyze data and apply theoretical/analytical knowledge to develop insights, trends, products, and services. He noted that knowledge workers would be the most valuable assets of a 21 st -century organization because of their high level of productivity and creativity.

Production 104

Production Packaging Engineering Science 104

PPD

JANUARY 15, 2025

As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. 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.

Clinical Trials 95

Clinical Trials Trials Clinical Research Drug Development 95

Perficient: Drug Development

SEPTEMBER 4, 2024

Similar is the situation of an IT professional during a production deployment call. It is always a hassle when it comes to production deployment. It is simply your code for a service that will run as you developed it but in a different organization or environment. Also, it can cause recurring problems in production.

Production 105

Production 105

Perficient: Drug Development

MARCH 29, 2024

As Paulo spoke about the dedication, strategic thinking, and adaptability necessary to thrive in the world of competitive gaming, we couldn’t help but draw parallels to our experiences in product development. Our product development teams remain with you throughout the life of your product.

Production 104

Production Marketing 104

Drug Patent Watch

DECEMBER 17, 2024

Today, they’re strategic partners in drug development and manufacturing, offering end-to-end solutions that can make or break a pharmaceutical company’s success. This shift reflects the increasing complexity of drug development and the need for specialized expertise at every stage of the process.

Pharmaceuticals 90

Pharmaceuticals Therapies Production Pharmaceutical Companies 90

DrugBank

SEPTEMBER 12, 2024

At DrugBank we’re committed to improving your daily research and drug development operations. Not only is this best practice, it ensures we are always delivering you the highest integrity products.

Production 98

Production Government Packaging Research 98

Perficient: Drug Development

AUGUST 29, 2024

To properly capitalize on this opportunity, companies must ensure their product information is accurate, consistent, and compelling across all channels. This is where Product Information Management (PIM) systems come into play. This includes product descriptions, prices (MSRP), images, and specifications.

Production 98

Production Marketing Engineering 98

LifeSciVC

JANUARY 3, 2024

NF-kB is a key mediator of inflammatory responses, playing a crucial role in the regulation of cytokine production, as well as in the activation and proliferation of immune cells. The post Signaling Complexes: A Ripe Opportunity for Drug Development appeared first on LifeSciVC.

Drug Development 96

Drug Development Drugs Small Molecule Disease 96

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. To qualify as endpoints, biomarkers used in early phases must be relevant to later stages of drug development.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Plenge Gen

SEPTEMBER 27, 2023

I titled my presentation “ Bullseye.Aim.Fire ” and then renamed it “ Increasing R&D Productivity to Deliver Transformational Medicines ” so the topic would be more obvious. … The post Increasing R&D productivity: “Bullseye, Aim, Fire!” ” appeared first on Plenge Gen @rplenge.

Production 81

Production Research Drug Development Drugs 81

Conversations in Drug Development Trends

JANUARY 21, 2025

Bioanalysis during clinical development of a drug is an indispensable process where trials obtain critical data pertinent to pharmacokinetics (PK) and pharmacodynamics (PD) and as readouts that are crucial for assessing the safety and efficacy of the drugs.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

Licensing 96

Licensing Licensing Drugs Clinical Trials 96

Covalent Modifiers

FEBRUARY 1, 2024

link] Proteins labelled site-specifically with small molecules are valuable assets for chemical biology and drug development. Nat Commun 15 , 859 (2024). The unique reactivity profile of the 1,2-aminothiol moiety of N -terminal cysteines ( N -Cys) of proteins renders it highly attractive for regioselective protein labelling.

Biophysical Assays 200

Biophysical Assays Small Molecule Drug Development Production 200

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.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

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.

Drug Development 52

Drug Development Compliance Drugs Regulations 52

thought leadership

FEBRUARY 27, 2025

Discover the importance of early signal detection and management in drug development and post-marketing to ensure safer, more effective medicinal products.

Production 52

Production Drug Development Marketing Drugs 52

Drug Patent Watch

SEPTEMBER 24, 2024

The development of generic drugs has become increasingly complex, requiring advanced analytical technologies to ensure the quality and efficacy of these products. This article will explore the latest developments in… Source

Drug Development 59

Drug Development Drugs Production 59

Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

Drug Development 98

Drug Development Production Clinical Trials Pharmaceutical Companies 98

Drug Patent Watch

JUNE 24, 2024

The 505(b)(2) regulatory pathway provides an attractive avenue for drug developers to bring new products to market by leveraging existing data on approved drugs.

Drugs 105

Drugs Drug Development Production Marketing 105

Drug Patent Watch

JANUARY 30, 2025

In this post, we'll explore effective strategies for maximizing patent protection and exclusivity, ensuring your product remains a leader in the market. This exclusivity is a result of the patent protection granted to the drug's developer. Share your experiences and insights in the comments below!

Marketing 59

Marketing Drugs Production Pharmaceuticals 59

Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company. Financing and recruitment of the best people has been more challenging work than I had expected.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

DS in Pharmatics

NOVEMBER 14, 2024

If you are searching for a way to accelerate your drug product development timelines, it is recommended you speak with a consultant. Discover why here!

Production 52

Production Drugs Drug Development 52

LifeSciVC

AUGUST 5, 2024

We are constantly reminded how we are in the midst of an artificial intelligence revolution of the drug development process which promises to completely transform how we develop drugs with increases in productivity of an order of magnitude or more. a company with the strongest pipeline in the entire industry.”

Molecular Biology 90

Molecular Biology Production Drug Development Small Molecule 90

Drug Patent Watch

FEBRUARY 26, 2025

To draft a strong patent application, you need to understand the nuances of biologic drug development, including the production process, stability, and formulation. This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

Drugs 59

Drugs Government Regulations Compliance 59

Perficient: Drug Development

DECEMBER 13, 2024

Q Developer is evolving beyond just code generation and is timing its maturity well alongside the rise of agentic workflows with dedicated agents playing specific roles within a process a familiar metaphor for enterprise developers. Customer code is not used to train models using the Pro Tier but requires opt-out using Free version.

Production 52

Production Engineering Research 52

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement.

Production 59

Production FDA Licensing Licensing 59