Pharmaceutical Technology

NOVEMBER 13, 2023

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

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Clinical Development Drugs Development 278

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

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 115

Clinical Development Manufacturing Development Drugs 115

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.

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Clinical Development Development Clinical Trials Clinical Trials 110

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 130

Clinical Development Development Production Sales 130

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Shilling was appointed to represent the company on the steering committee of the BGTC.

Gene Therapy 242

Gene Therapy Gene Development Manufacturing 242

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.

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Clinical Development Clinical Trials Clinical Trials Trials 341

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 116

Clinical Development Development Clinical Trials Clinical Trials 116

Pharmaceutical Technology

JUNE 12, 2023

Accordingly, the development of non-opioid painkillers is experiencing a surge in activity and despite numerous novel targets receiving high levels of attention, cannabinoids have emerged as strong favourites to replace opioid-related medications. However, along with other painkiller alternatives, doubts have been cast over their efficacy.

Drugs 358

Drugs Development Clinical Development Sales 358

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.

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Development Drugs FDA Approval Clinical Development 162

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.

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Clinical Development Development Manufacturing Medicine 130

Pharmaceutical Technology

FEBRUARY 20, 2023

Other lines of research look at the genetic overlap between FTD and amyotrophic lateral sclerosis (ALS), which could be used in the development of treatments for both conditions. This is also one of the major challenges that slow the development of effective treatments for FTD, he adds. Do we develop a single treatment for all three?

Development 246

Development Gene Therapy Protein Gene 246

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.

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Clinical Trials Clinical Trials Drugs Trials 195

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.

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Production Clinical Development Development Marketing 204

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.

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Development Drugs Licensing Licensing 130

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.

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Development Drugs Bioavailability Production 130

Camargo

DECEMBER 20, 2021

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). The initiative reflects the FDA’s recognition of this sector as a growing and increasingly important area of drug development.

Gene Therapy 184

Gene Therapy Gene Development Production 184

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 59

Clinical Development Development Life Science Clinical Trials 59

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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Development Drugs Clinical Trials Clinical Trials 147

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.

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Licensing Licensing Drugs Clinical Development 147

Pharmaceutical Technology

FEBRUARY 13, 2023

SOPHiA GENETICS is expanding its collaboration with AstraZeneca to include multimodal approaches for developing cancer drugs. The post SOPHiA GENETICS and AstraZeneca partner for oncology drugs development appeared first on Pharmaceutical Technology.

Genetics 130

Genetics Development Drugs Genome 130

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 130

Drug Delivery Drugs Clinical Development Development 130

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,…

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Drugs Clinical Development Development 130

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.

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Trials Protein Clinical Development Drugs 104

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.

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Immune Response Clinical Trials Clinical Trials Antibody 273

Pharmaceutical Technology

DECEMBER 14, 2022

GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.

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Life Science Development Gene Therapy Genetics 162

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2024

A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials.

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Clinical Trials Clinical Trials Trials Production 81

Pharma Times

AUGUST 29, 2023

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

Drugs 123

Drugs Clinical Development Development 123

Pharmaceutical Technology

NOVEMBER 30, 2022

The latest development is based on data obtained from an open-label clinical trial of Biktarvy. Merging three therapies, Biktarvy is the smallest available three-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR).

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Marketing FDA Approval Clinical Trials Clinical Trials 246

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 279

Genetics Life Science Trials Clinical Development 279

Pharmaceutical Technology

AUGUST 4, 2022

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year.

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Development Clinical Trials Clinical Trials Gene Therapy 147

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 130

Antibody Drugs Clinical Development Licensing 130

Pharmaceutical Technology

OCTOBER 3, 2022

Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. The post Indonesia grants EUA for US-developed Covid-19 vaccine appeared first on Pharmaceutical Technology.

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Vaccine Vaccination Development Production 130

Pharmaceutical Technology

DECEMBER 6, 2022

MEI Pharma and Kyowa Kirin have announced plans to discontinue the international development of investigational cancer therapy, zandelisib, for B-cell malignancies outside of Japan. The latest development comes after the companies received guidance from a meeting held with the US Food and Drug Administration (FDA) in November.

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Development Trials Clinical Trials Clinical Trials 147

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 131

Drugs Clinical Development Marketing Genome 131

Pharmaceutical Technology

MAY 19, 2023

SiteOne Therapeutics has received a $15m grant from the National Institute on Drug Abuse (NIDA) to develop the investigational selective NaV1.8 Titled ‘Development of a potent and selective Nav1.8 The company stated that the grant from NIDA will support the clinical development of its NaV1.8

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Development Clinical Development Regulation Drugs 130

Worldwide Clinical Trials

NOVEMBER 21, 2023

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis.

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Clinical Trials Clinical Trials Clinical Development Drugs 195