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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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. Your review article discussed the need to study genetically diverse patient samples. Can you expand on that?

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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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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 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. With support from pharmaceutical companies, ultimately, the answer to this question should be yes.

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Drug Patent Watch

JANUARY 30, 2025

Maximizing Patent Protection: Strategies for Pharmaceutical Marketers As a pharmaceutical marketer, you know how crucial it is to protect your patented drug's market share. This exclusivity is a result of the patent protection granted to the drug's developer. Read the full article here: [link]

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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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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.

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Alta Sciences

MARCH 4, 2025

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. I have spent the better part of my career working to make drugs safer.

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Clinical Trials FDA Drug Development Trials 52

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. In this article, we share our hard-earned insights into overcoming these critical challenges.

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The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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Drug Target Review

JULY 4, 2023

In this article, Petra Dieterich, Ian Glassford, and Jeff Mocny, Scientific Leaders at Abzena discuss real-world data that is challenging traditional scientific thinking on the ADC therapeutic window. Antibody drug conjugated with cytotoxic payload. The therapeutic window of antibody drug conjugates: A dogma in need of revision.

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Alta Sciences

APRIL 10, 2025

Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS pmjackson Thu, 04/10/2025 - 19:59 As a leading partner in ocular therapy, Altasciences has been at the forefront of ophthalmic drug development for over 30 years, having completed more than 100 ocular studies to assess the safety of new drug products intended for human use.

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Drug Target Review

DECEMBER 16, 2024

Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drug development. Opportunities in clinical research and drug development were not always easy to come by.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Food and Drug Administration (FDA).

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Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. This has sparked the development of a new approach to treating neuropsychiatric disorders.

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Treatment Licensing Licensing Science 52

Alta Sciences

JUNE 12, 2024

Altasciences’ scientists have formulated and developed countless molecules using various advanced technologies. Our full range of pharmaceutical formulation services can improve the quality and performance of your product, for a seamless transition from discovery to clinical trials to market. LEARN MORE Ready to start?

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Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement. The facts are detailed in the complaint.

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Production FDA Licensing Licensing 59

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. The average annual growth in non-orphan pharmaceutical expenditure in the same period was only 3%. member states.

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Vial

MAY 20, 2024

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. over this period.

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Agency IQ

FEBRUARY 12, 2024

Per the document’s prologue, the playbook has been intentionally prepared in plain language to “serve AAV drug developers of all backgrounds, but primarily those who could benefit from simplified language, guidelines, and templates for this complex process (e.g.,

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Agency IQ

JUNE 26, 2023

Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. In the U.S.,

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Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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The Pharma Data

SEPTEMBER 15, 2020

The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric. He has worked for a number of partner research organizations in clinical development, including Biotrial, Celerion and Parexel.

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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

More than 90 percent of that contributory research was basic—that is, related to the discovery of fundamental biological mechanisms, rather than actual development of the drugs themselves. Previous attempts to quantify the contribution of federal funding to new drug development had looked primarily at patents.

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Vial

FEBRUARY 15, 2024

Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. This article discusses current challenges in managing clinical trials and elucidates the pivotal role that CROs play in overcoming these obstacles. over the forecast period (2022-2030).

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Alta Sciences

SEPTEMBER 13, 2023

Clinical pain models also serve as useful translational tools for analgesic drugs that progress from preclinical to clinical stages of drug development, and can simulate similar paradigms often used in preclinical evaluations. At Altasciences , we have extensive experience testing various pain models.

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Vial

FEBRUARY 26, 2024

The pharmaceutical and biotechnological landscape is constantly evolving and a key partner within the drug development process is contract research organizations (CROs) , who are at the forefront with sponsors to drive innovation in clinical research.

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Clinical Trials Trials Clinical Research Pharmaceuticals 52

The Pharma Data

JANUARY 11, 2021

The publication substantiates the Company’s position as a leader in the field with reliable and robust cutting-edge technology, ready for widespread adoption across the pharmaceutical industry. ‘Impact of organ-on-a-chip technology on pharmaceutical R&D costs’ [link]. View source version on businesswire.com: [link].

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. Check out this article for insights on selecting the right CRO for you.

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Clinical Trials Trials Clinical Research Research 52

Vial

MARCH 25, 2024

Evolution of the Sponsor-CRO Relationship Clinical research and drug development have transformed in recent years with the emergence of big data analytics, advanced trial technologies, and rapid advances in precision therapies. The need for closer and more strategic partnerships between sponsors and CROs is in line with these changes.

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Perficient: Drug Development

JANUARY 25, 2024

And 32% rated their interactions as “Poor” (the third-highest in that category, trailing only pharmaceutical companies and nursing homes). Payers at least didn’t drop as far in their consumer rankings as many in the industry, particularly pharmaceutical companies, physicians and hospitals. Quite frankly … not much.

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The Pharma Data

JANUARY 6, 2021

The complete text of the article titled, “Neuronal Delivery of Antibodies has Therapeutic Effects in Animal Models of Botulism,” can be found h e re. The approach used to turn botulinum toxin into a kind of Trojan horse that delivers a cargo into neurons has enormous potential for future drug development,” noted Thomas C.

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