ASPET

OCTOBER 23, 2024

Neither nimodipine nor NP10679 alter each other's pharmacokinetic profile, suggesting no obvious drug-drug interactions. In addition, we observed an unexpected reduction in SAH-induced luminal narrowing of the middle cerebral artery.

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PPD

NOVEMBER 9, 2023

However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.

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PPD

NOVEMBER 21, 2023

The drug development industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drug development industry experienced setbacks during the COVID-19 pandemic, the field  is again gaining momentum reminiscent of its pre-pandemic pace.

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Clinical Development Clinical Trials Trials Clinical Research 52

The Pharma Data

DECEMBER 14, 2020

AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia.

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PPD

NOVEMBER 11, 2024

It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drug development. As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients.

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Drug Development Clinical Trials Drugs Small Molecule 95

Drug Hunter

JUNE 5, 2023

Macrocyclic molecules, containing 12 or more atoms in a ring system, are increasingly prevalent in drug discovery, with over 67 macrocyclic drugs approved so far and several notable examples of clinical success highlighted on Drug Hunter recently, including MK-0616 , repotrectinib , and pacritinib.

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Process Chemistry Drugs Production Clinical Development 206

Fierce BioTech

OCTOBER 21, 2024

Carl Sailer is Vice President of Full Service Solutions at Syneos Health®, a leading fully integrated biopharmaceutical solutions organization providing clinical development and commercialization s | In this conversation with Fierce Biotech, we explore the ever-evolving biotech landscape.

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The Pharma Data

NOVEMBER 29, 2020

(HKEX:1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announced today that Melissa Palmer , MD, an internationally renowned Hepatologist, will join the Company as Chief Medical Officer, effective December 1, 2020. Wu , Founder, Chairman and CEO of Ascletis. ” About Ascletis.

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Drug Discovery Today

JANUARY 20, 2022

Cambridge and Wetherby, UK, 18 January 2022: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms announces that the next pre|CISION™ drug candidate, AVA3996, has been selected for pre-clinical development (..)

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Clinical Trials Clinical Development Drugs Therapies 113

The Pharma Data

NOVEMBER 30, 2020

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

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Clinical Development Vaccine Clinical Trials Immune Response 52

BioPharma Drive: Drug Pricing

NOVEMBER 4, 2024

As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.

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Production Clinical Development Drug Development Marketing 52

Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture. At Worldwide, we understand that every program is different, which means every drug development path forward will be unique.

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Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

Alta Sciences

MAY 29, 2024

How to Optimize Your Early-Phase Drug Development Program pmjackson Wed, 05/29/2024 - 20:32 The Challenges With Outsourcing Drug Development In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.

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Drug Development Drugs Clinical Development 52

Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

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Drugs FDA Approval Organic Chemistry Small Molecule 69

Cytel

NOVEMBER 8, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director, Blackstone Life Sciences When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities.

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Clinical Trials Trials Clinical Development Science 59

The Pharma Data

SEPTEMBER 29, 2021

Food and Drug Administration (FDA) supported the positive results of the FIDELIO-DKD phase III clinical trial study for patients with CKD and T2D. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

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Clinical Development Disease Clinical Trials Trials 52

PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. . SUZHOU, China and ROCKVILLE, Md. ,

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Clinical Development Disease Treatment Licensing 40

ASPET

FEBRUARY 26, 2024

FXR-targeted drugs have shown promise in late-stage clinical trials for non-alcoholic steatohepatitis. Cilofexor is one of few remaining FXR agonists in clinical development. The farnesoid X receptor (FXR) is a nuclear receptor that controls bile acid, lipid, and cholesterol metabolism.

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Disease Treatment Clinical Trials Clinical Development 100

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. This means that we are not doing something right.

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Drug Development Drugs Clinical Development Pharmaceutical Companies 98

PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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Trials Clinical Trials Clinical Development Clinical Research 98

Drug Hunter

JULY 21, 2023

With the popular success of diabetes and weight-loss peptide drugs from Novo (e.g. semaglutide/Ozempic), this month features a pair of ultra-hot non-peptide oral GLP-1R modulators in clinical development. The post Molecules of the Month – June 2023 appeared first on Drug Hunter. Not a member?

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Structure Based Drug Design (SBDD) Targeted Protein Degradation Clinical Trials Trials 227

Cytel

JANUARY 23, 2023

This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:

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Clinical Development Trials Clinical Research Treatment 52

The Pharma Data

JULY 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1.

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Clinical Development Therapies Laboratories Treatment 52

Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

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Drug Development Clinical Trials Drugs Vaccine 59

Drug Target Review

APRIL 22, 2024

What are the primary methods used for bioconjugation in antibody drug-conjugate (ADC) development, and how do they influence the stability and efficacy of the resulting ADCs? Site-specific conjugation methods are primarily utilised for a significant portion of ADCs in clinical developments.

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Pharmacokinetics Organic Chemistry Drugs Engineering 75

The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated product).

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Small Molecule DNA Drugs Clinical Development 52

Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

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Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

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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Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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Clinical Research Clinical Development Pharmaceutical Companies Drug Development 98

DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

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Drug Development Clinical Trials Drugs Therapies 74

Cytel

SEPTEMBER 1, 2023

Data is the cornerstone of any clinical trial, driving the decision-making process of drug development, and is a fundamental requirement for approval of new therapies by regulatory agencies like the FDA or EMA.

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Clinical Development Clinical Trials FDA Drug Development 64

FDA Law Blog: Biosimilars

AUGUST 8, 2023

Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs that may be nitrosamines, even having a deviation in pH of an Active Pharmaceutical Ingredient that might conceivably contribute to the formation of nitrosamines in a finished drug product.

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FDA Organic Chemistry Drugs Production 74

Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 64

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? The pipeline currently includes five drug candidates, all of which have the potential to revolutionise the treatment of PD. IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025.

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Disease Drugs Treatment Drug Development 52

PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

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International Clinical Development Clinical Trials Clinical Research 52

Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

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