Reprocell

NOVEMBER 27, 2024

In recent years, the pharmaceutical industry has increasingly harnessed artificial intelligence (AI) to make clinical trials more efficient and effective. By making patient selection and recruitment processes more targeted, AI-driven tools not only improve trial outcomes but also accelerate the journey of new drugs to market.

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Clinical Trials Trials Pharmaceuticals Marketing 64

Drugs.com

MARCH 11, 2024

MONDAY, March 11, 2024 -- Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market.In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a.

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ProRelix Research

MAY 31, 2023

Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared (..)

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PPD

NOVEMBER 11, 2024

By accelerating timelines, anticipating challenges and alleviating bottlenecks, pharmaceutical companies and combined CDMO and CRO partners together can help ensure those potential treatments reach the patients who need them as efficiently as possible.

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Drug Development Clinical Trials Drugs Small Molecule 97

Drug Hunter

SEPTEMBER 17, 2023

III clinical trials such as Vertex’s sodium channel inhibitor for acute pain and Denali Therapeutics’ CNS-penetrant eIF2B activator for ALS. selective inhibitor developed by Vertex Pharmaceuticals for acute pain in Phase III clinical trials. Several of the molecules making the August list are in Ph.

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PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs.

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Clinical Trials Trials Clinical Research FDA 98

BioPharma Drive: Drug Pricing

JUNE 4, 2024

Longer follow-up results from a mid-stage trial indicate the company’s treatment for a genetic cause of dwarfism may be competitive to an approved therapy from BioMarin Pharmaceutical.

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Drug Patent Watch

DECEMBER 12, 2024

This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics.

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Licensing Licensing Drugs Biosimilars 92

Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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ProRelix Research

APRIL 17, 2025

andIndianregulations,ethicalconcerns,andinternationalstandardsincross-borderclinical trials. How clinicaltrialoutsourcingtoIndiaimpactsglobalpharmaresearch.ExploreU.S. Indian,andinternationalregulatorychallengesandethicalimplicationsof conductingclinicalresearchacrossborders.

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Clinical Trials Regulations Trials Pharmaceuticals 52

Drug Discovery Today

MAY 28, 2020

Cambridge Cognition Holdings plc (AIM: COG), which develops and markets digital solutions to assess brain health, is pleased to announce that the Company has recently won several new contracts to support pharmaceutical clients in delivering virtual clinical trials, including two contracts collectively worth over £1 million - the majority of which is (..)

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Clinical Trials Trials Pharmaceuticals Marketing 100

New Drug Approvals

APRIL 11, 2025

2] History The efficacy and safety of fitusiran were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male participants with either hemophilia A or hemophilia B. [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1] Fitusiran 1711.0g/mol,

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Clinical Trials FDA FDA Approval Trials 107

DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. Intellectual Property Valuation Valuing intellectual property (IP) assets is a critical component of pharmaceutical M&A, as these assets often represent a significant portion of a company's value.

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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

PPD

JUNE 7, 2023

The need for pediatric pharmaceuticals and biologics to treat the disease is urgent: Estimates project roughly one in 10 children will be afflicted by NAFLD. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

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Trials Clinical Trials Clinical Research Disease 98

Chemical Biology and Drug Design

OCTOBER 13, 2024

This review also highlights the challenges in this field which need to be addressed for further successes in pharmaceutical applications. This review focuses on the different AI and machine learning (ML) techniques with their applications mainly focused on the pharmaceutical industry.

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Pharmaceuticals Science Clinical Trials Trials 100

PPD

OCTOBER 8, 2024

With FSO, all clinical trial tasks (e.g., In a hybrid model, one or more FSP offerings are added to a new or existing FSO arrangement to optimize clinical trial operations or address unforeseen circumstances and changing demands. study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.)

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Drug Patent Watch

DECEMBER 9, 2024

In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. “Pharmacognosy is the bridge between traditional medicine and modern pharmaceutical science, offering a treasure trove of potential new drugs waiting to be discovered.”

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Drugs Drug Development Pharmaceuticals Production 96

PPD

OCTOBER 31, 2024

As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape.

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Drug Development Clinical Trials Trials Drugs 52

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

BioPharma Drive: Drug Pricing

AUGUST 17, 2023

The German pharmaceutical company is launching three Phase 3 trials of an obesity drug called survodutide, which like Wegovy targets the GLP-1 receptor

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Pharmaceutical Companies Pharmaceuticals Trials Drugs 130

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Many of these patients’ conditions are disabling.

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Drug Patent Watch

OCTOBER 8, 2024

The research, conducted by a team from the University of Cambridge and AstraZeneca, explores how AI can be leveraged to enhance various aspects of pharmaceutical research, from target identification to clinical trials.

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Clinical Trials Drugs Pharmaceuticals Trials 120

Antidote

JULY 29, 2022

In 2019 alone, research and development spending totaled $186 billion for the global pharmaceutical industry. Between 2009 and 2018, U.S. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8 billion to bring a new therapy to market.

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Clinical Trials Trials Therapies Pharmaceuticals 96

Drug Target Review

JUNE 5, 2024

We have several international trials ongoing or being initiated in a range of indications. About the author James Graham, CEO of Recce Pharmaceuticals Recce Pharmaceuticals. James Graham is the CEO of Recce Pharmaceuticals. Could you tell us how the development of the R435 and R529 candidates is progressing?

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Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.

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H1 Blog

DECEMBER 4, 2023

As the pharmaceutical and biotech industries continue to push for faster drug development, the importance of equity and diversity in clinical trial recruitment cannot be overlooked. Data is a powerful tool in identifying and reaching vulnerable populations for clinical trials.

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Clinical Trials Trials Pharmaceutical Companies Drug Development 59

Quanticate

SEPTEMBER 6, 2024

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in clinical trial design is beginning to reshape the pharmaceutical and medical research industries.

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Clinical Trials Trials Pharmaceuticals Research 52

Conversations in Drug Development Trends

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

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Clinical Trials Trials Clinical Development Drug Development 52

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

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Treatment Trials Clinical Trials Drugs 69

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Clinical Trials Trials Clinical Research Treatment 52

ProRelix Research

JUNE 10, 2024

of the country’s gross domestic product (GDP), and the presence of several multinational pharmaceutical and biopharmaceutical companies in […] The post Why is India Becoming a Hot Destination for Global Clinical Trials? With a population of approximately 1.4 billion people, healthcare expenditure of 2.6%

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Clinical Trials Trials Pharmaceuticals Production 52

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] The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.

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FDA Therapies Trials Treatment 62

Drug Target Review

JULY 4, 2023

2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. Whilst no trials have been performed directly comparing small molecules with their ADC counterparts, it is possible to contrast data from trials with ADCs to those performed with analogous small molecules.

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Drug Target Review

FEBRUARY 10, 2025

In just two years, CTMC has advanced eight therapies into clinical trials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. Bock explained that the supply chain for clinical trials typically follows a linear model for traditional therapies, where manufacturing is separate from the clinic.

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Therapies Treatment Engineering Clinical Trials 64

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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Drug Development Clinical Trials Compliance Trials 52

The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region.

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Clinical Development Pharmaceuticals Clinical Trials Trials 52

Antidote

APRIL 20, 2023

When contract research organizations and pharmaceutical sponsors need to recruit patients for clinical trials, they often work with clinical trial marketing and advertising companies to reach the right candidates. For organizations in need of clinical trial recruitment support, here are some of our best outreach suggestions.

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