Clinical Development and Drugs - Clinical Research Informer

Partnering for success in early phase clinical development

Bio Pharma Dive

FEBRUARY 24, 2025

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

Clinical Development

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Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

OCTOBER 28, 2022

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Robots can improve drug discovery and development. Remote-controlled robotic labs.

Development

Development Drugs Pharma Companies Life Science

FDA grants orphan drug designation to MAIA’s glioblastoma agent

Pharmaceutical Technology

NOVEMBER 13, 2023

As per the company, the candidate THIO, is the only direct telomere-targeting agent currently in clinical development.

Clinical Development

Clinical Development Drugs Development

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Ablaze Pharmaceuticals to develop drug candidate for liver cancer

Pharmaceutical Technology

APRIL 3, 2023

Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China.

Development

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. A recent draft from the FDA provides valuable insight.

Clinical Research

Adcentrx raises funds to advance ADCs into clinical development

Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. ADRX-070 is the company’s lead candidate and is anticipated to enter a first-in-human Phase I clinical trial in the second half of 2023.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Production

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Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development

pharmaphorum

MARCH 7, 2024

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development Mike.Hammerton Thu, 07/03/2024 - 09:43 Bookmark this

Clinical Development

Clinical Development Manufacturing Development Drugs

Researchers develop CRISPR-based drug candidate for microbiome targeting

Pharmaceutical Technology

MAY 12, 2023

The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. The US Food and Drug Administration has granted fast-track designation to SNIPR001, which is currently in clinical development.

Development

Development Bacteria Research Drugs

Vivace closes $35m in Series D for cancer drug development

Pharmaceutical Technology

MARCH 13, 2025

Vivace Therapeutics has closed $35m in a Series D financing round to support the clinical development of its cancer drug VT3989.

Development

Development Drugs Clinical Development

US companies drive 2023 drug launches positioned for blockbuster success by 2028

Pharmaceutical Technology

MAY 30, 2023

According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Genmab AS’s epcoritamab presents as the top European drug launch and only oncological therapy.

Drugs

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BioMed X and Sanofi partner to leverage AI for drug development

Pharmaceutical Technology

OCTOBER 25, 2022

BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drug development. This team will focus on creating a versatile computational platform that can precisely forecast the first-in-class drug candidates’ efficacy in virtual patient groups.

Development

Development Drugs In-Vivo Engineer

How Can You Manage the Complexity of Early Phase Clinical Development?

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations.

Clinical Development

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The Power of Personalization Amid the Changing CRO Landscape

Worldwide Clinical Trials

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.

Clinical Development

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Acute lymphocytic leukaemia leads in cell therapy clinical development

Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.

Clinical Development

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Centers of excellence or product-centric BizDevOps managed services?

Bio Pharma Dive

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.

Production

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The future of pain medication: are cannabinoids the solution to the opioid epidemic?

Pharmaceutical Technology

JUNE 12, 2023

The North American opioid epidemic highlights limitations in opioid use, such as the potential for drug abuse and overdose. Nevertheless, opioid-based painkillers remain the primary approach for pain management, creating a need for effective drugs with alternative targets.

Drugs

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Sosei to regain rights to IBD drug after GSK discontinues programme

Pharmaceutical Technology

NOVEMBER 24, 2023

The Sosei Heptares oral IBD drug was first licensed to GSK in 2020 and is currently in Phase I clinical development.

Licensing

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Why Should Companies Use Digital Endpoints Across Clinical Development?

XTalks

MAY 28, 2024

These daunting figures highlight the necessity for innovative solutions that can accelerate the journey of new drugs from the lab to patients. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research.

Clinical Development

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Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Worldwide Clinical Trials

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. Rigorous procedures to ensure that drugs are effective and safe.

Clinical Trials

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Abzena, Alira Health and Oncodesign launch DRIVE Biologics to support access to specialist services from discovery to clinical development for oncology and inflammation

Pharma Mirror

FEBRUARY 25, 2022

This joint service offering, DRIVE™-Biologics, will leverage Abzena’s strength in design and developability, and cell line development through to commercial manufacturing.

Clinical Development

Clinical Development Development Manufacturing Medicine

BST-2123 by Bostal Drug Delivery Co for Diabetes: Likelihood of Approval

Pharmaceutical Technology

JUNE 18, 2024

BST-2123 is under clinical development by Bostal Drug Delivery Co and currently in Phase I for Diabetes.

Drug Delivery

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Safinamide mesylate by Zambon Co for Drug-Induced Dyskinesia: Likelihood of Approval

Pharmaceutical Technology

SEPTEMBER 8, 2024

Safinamide mesylate is under clinical development by Zambon Co and currently in Phase II for Drug-Induced Dyskinesia. According to GlobalData,…

Drugs

Drugs Clinical Development Development

Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

XTalks

DECEMBER 10, 2024

By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production. The drug also reduced the need for emergency rescue therapies by 52 percent and delivered significant improvements in patient-reported fatigue scores.

Trials

Trials Protein Clinical Development Drugs

Innovating Immune-Modulating Therapies in Autoimmune Disorders ft. Dr. Mario Marcondes, VP Head of Clinical Development, Nektar Therapeutics

XTalks

FEBRUARY 5, 2025

In this episode, Ayesha spoke with Mario Marcondes, MD, PhD, VP Head of Clinical Development at Nektar Therapeutics , a company focused on the discovery and development of novel therapies for autoimmune disorders and cancer. Dr. Marcondes is a licensed and trained physician, specializing in oncology and immune oncology.

Clinical Development

Clinical Development Development Life Science Clinical Trials

FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML

Pharma Times

AUGUST 29, 2023

The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme - News - PharmaTimes

Drugs

Drugs Clinical Development Development

Pfizer seeks approval from US FDA for Covid-19 treatment

Pharmaceutical Technology

JULY 1, 2022

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally.

HR

HR Clinical Development Trials Vaccination

China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

Immune Response

Immune Response Clinical Trials Clinical Trials Antibody

Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

JUNE 6, 2023

Gildeuretinol is the first and only medicine in clinical development to treat Stargardt disease by reducing vitamin A dimerization in the eye, without affecting normal vision. The therapy has also received orphan drug designation and breakthrough therapy designation from the US Food and Drug Administration.

Genetics

Genetics Life Science Trials Clinical Development

Pharma’s spend on AI in drug discovery ‘could top $3bn by 2025’

pharmaphorum

JULY 8, 2022

The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. The post Pharma’s spend on AI in drug discovery ‘could top $3bn by 2025’ appeared first on.

Drugs

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Corbus and CSPC Megalith sign licence agreement for antibody drug conjugate

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

Antibody

Antibody Drugs Clinical Development Licensing

US FDA launches lupus consortium to confront drug development challenges

Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Asian, Hispanic, and Native American women are also at higher risk.

Development

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TORL scores $158m in Series B2 to advance ADC cancer therapies

Pharmaceutical Technology

APRIL 10, 2024

TORL plans to use the funds to advance the clinical development of its antibody-drug conjugate (ADC) pipeline.

Clinical Development

Clinical Development Antibody Development Drugs

Eli Lilly’s Tirzepatide Shows Promise for Keeping Prediabetic Patients Diabetes-Free

XTalks

NOVEMBER 21, 2024

The drug also alleviated heart failure symptoms and improved patients’ physical limitations compared with placebo. Based on this data, Lilly said it plans a data submission to the US Food and Drug Administration (FDA) and other regulatory bodies before the end of the year. In contrast, only 29.7 billion.

Sales

Sales Insulin Drugs Trials

ImmunoForge expands agreement with Duke University for drug development

Pharmaceutical Technology

MAY 19, 2023

ImmunoForge has expanded its licence agreement with Duke University in North Carolina, US, to jointly improve research and drug development opportunities. ImmunoForge chief technology officer Dr Jim Balance pioneered the clinical development of peptide drugs genetically fused to ELPs.

Development

Development Drugs Licensing Licensing

Teijin and Axcelead sign deal for drug discovery research JV

Pharmaceutical Technology

FEBRUARY 21, 2023

Japanese firm Teijin has announced its basic agreement on a capital and business alliance with Axcelead to establish a drug discovery research joint venture (JV) company. In addition to supporting drug discovery research, the new company will investigate and acquire candidate compounds for new drugs.

Research

Research Drugs Clinical Development Development

Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug

Outsourcing Pharma

OCTOBER 10, 2024

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

Clinical Trials

Clinical Trials Clinical Trials Clinical Development Drugs

Zerion and Insud to develop Dispersome formulations of drugs

Pharmaceutical Technology

AUGUST 30, 2022

Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.

Development

Development Drugs Bioavailability Production

Gilead receives EC marketing authorisation for HIV treatment in children

Pharmaceutical Technology

NOVEMBER 30, 2022

Merging three therapies, Biktarvy is the smallest available three-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR). Through the Gilead Global Pediatric Center of Excellence, we are committed to applying our decades of antiviral expertise to drive innovation in paediatric HIV research.”.

Marketing

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Repurposed Drugs by Luminous Mind for Depression: Likelihood of Approval

Pharmaceutical Technology

JANUARY 22, 2024

Repurposed Drugs is under clinical development by Luminous Mind and currently in Phase I for Depression.

Drugs

Drugs Clinical Development Development

Kronos downsizes workforce by 19% to funnel funds into cancer drugs

Pharmaceutical Technology

NOVEMBER 3, 2023

Kronos Bio joins other pharma companies in workforce reductions, cutting 19% of its employees to support clinical development.

Pharma Companies

Pharma Companies Clinical Development Drugs Development

BioInvent receives Investigational New Drug approval for monoclonal antibody BI-1910

Pharma Times

JUNE 2, 2023

BI-1910 is now the second of the company's anti-tumour necrosis factor receptor 2 programmes to enter clinical development - News - PharmaTimes

Antibody

Antibody Clinical Development Drugs Development

Repurposed Drugs by Luminous Mind for Anxiety Disorders: Likelihood of Approval

Pharmaceutical Technology

JANUARY 22, 2024

Repurposed Drugs is under clinical development by Luminous Mind and currently in Phase I for Anxiety Disorders.

Drugs

Drugs Clinical Development Development

FibroGen and Fortis sign exclusive licence deal for mCRPC drug candidate

Pharmaceutical Technology

MAY 9, 2023

FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is a natural fit with our research and development capabilities and expertise.

Drugs

Drugs Clinical Development Antibody Protein

Partnering for success in early phase clinical development

Cloud robotics labs are accelerating drug discovery and development

Webinars

Trending Sources

FDA grants orphan drug designation to MAIA’s glioblastoma agent

Webinars

Ablaze Pharmaceuticals to develop drug candidate for liver cancer

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Adcentrx raises funds to advance ADCs into clinical development

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development

Researchers develop CRISPR-based drug candidate for microbiome targeting

Vivace closes $35m in Series D for cancer drug development

US companies drive 2023 drug launches positioned for blockbuster success by 2028

BioMed X and Sanofi partner to leverage AI for drug development

How Can You Manage the Complexity of Early Phase Clinical Development?

The Power of Personalization Amid the Changing CRO Landscape

Acute lymphocytic leukaemia leads in cell therapy clinical development

Centers of excellence or product-centric BizDevOps managed services?

The future of pain medication: are cannabinoids the solution to the opioid epidemic?

Sosei to regain rights to IBD drug after GSK discontinues programme

Why Should Companies Use Digital Endpoints Across Clinical Development?

Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Abzena, Alira Health and Oncodesign launch DRIVE Biologics to support access to specialist services from discovery to clinical development for oncology and inflammation

BST-2123 by Bostal Drug Delivery Co for Diabetes: Likelihood of Approval

Safinamide mesylate by Zambon Co for Drug-Induced Dyskinesia: Likelihood of Approval

Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

Innovating Immune-Modulating Therapies in Autoimmune Disorders ft. Dr. Mario Marcondes, VP Head of Clinical Development, Nektar Therapeutics

FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML

Pfizer seeks approval from US FDA for Covid-19 treatment

China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharma’s spend on AI in drug discovery ‘could top $3bn by 2025’

Corbus and CSPC Megalith sign licence agreement for antibody drug conjugate

US FDA launches lupus consortium to confront drug development challenges

TORL scores $158m in Series B2 to advance ADC cancer therapies

Eli Lilly’s Tirzepatide Shows Promise for Keeping Prediabetic Patients Diabetes-Free

ImmunoForge expands agreement with Duke University for drug development

Teijin and Axcelead sign deal for drug discovery research JV

Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug

Zerion and Insud to develop Dispersome formulations of drugs

Gilead receives EC marketing authorisation for HIV treatment in children

Repurposed Drugs by Luminous Mind for Depression: Likelihood of Approval

Kronos downsizes workforce by 19% to funnel funds into cancer drugs

BioInvent receives Investigational New Drug approval for monoclonal antibody BI-1910

Repurposed Drugs by Luminous Mind for Anxiety Disorders: Likelihood of Approval

FibroGen and Fortis sign exclusive licence deal for mCRPC drug candidate

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