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 agreement allows Ablaze to clinically develop and commercialise the drug in Greater China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio.

Development 246

Development Drugs Clinical Development Licensing 246

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

Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. This includes an upfront payment of $2m from AstraZeneca.

Development 264

Development Gene Expression Licensing Licensing 264

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Under […]

Clinical Trials 184

Clinical Trials Clinical Trials Trials Clinical Research 184

Pharmaceutical Technology

NOVEMBER 30, 2022

However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development. Nonetheless, the increased focus on the development of PPMS treatment is a welcome game-changer for patients.

Development 246

Development Clinical Trials Clinical Trials Trials 246

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

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. And that has a lot of downstream consequences.”

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. 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 9, 2023

Upstream Bio will use the funds to advance its UPB-101 into Phase II trials to treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). It is also preparing for a swift transition to Phase III development. It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.

Clinical Development 147

Clinical Development Development Life Science Clinical Trials 147

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

Medical Xpress

APRIL 26, 2023

A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa.

Clinical Development 133

Clinical Development Gene Therapy Development Gene 133

Pharmaceutical Technology

FEBRUARY 20, 2023

Different approaches that are studied include antisense oligonucleotides (ASOs), and gene therapies, which are in early clinical trials. 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.

Development 246

Development Gene Therapy Protein Gene 246

Worldwide Clinical Trials

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

Genetics 189

Genetics Trials Clinical Trials Clinical Trials 189

XTalks

NOVEMBER 1, 2023

Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. She also spoke about clinical trials in the space, including Allergan Aesthetics’ commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard.

Life Science 105

Life Science Clinical Trials Clinical Trials Clinical Development 105

Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

Trials 189

Trials Clinical Trials Clinical Trials Clinical Development 189

Pharmaceutical Technology

JULY 1, 2022

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. Furthermore, findings from the final trial report showed a relative risk decline of 86%.

HR 264

HR Clinical Development Trials Vaccination 264

Pharmaceutical Technology

MARCH 23, 2023

The deal gives Biohaven global rights for the development of BHV-8000, excluding regions of China. BHV-8000’s mechanistic proof of concept was showed in several pre-clinical models. This year, Biohaven is expecting to advance the TYK2/JAK1 inhibitor into a Phase I trial.

Licensing 263

Licensing Licensing Clinical Development Development 263

Pharmaceutical Technology

SEPTEMBER 26, 2023

The funding will support the clinical development of the oral SK ion channel inhibitor that was recently evaluated in a Phase II trial.

Development 130

Development Clinical Development Trials 130

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. Six cannabinoids have recently completed or are undergoing Phase II trials.

Drugs 358

Drugs Development Clinical Development Sales 358

Pharmaceutical Technology

DECEMBER 1, 2022

Rebyota’s safety and efficacy were analysed in the largest trial programme in the microbiome-based therapeutics field, including five trials enrolling over 1,000 subjects. The latest development is based on the findings from the clinical programme including the double-blind, randomised, placebo-controlled Phase III PUNCH CD3 trial.

FDA Approval 264

FDA Approval Trials Clinical Development Development 264

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.

Development 147

Development Trials Clinical Trials Clinical Trials 147

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). Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.

Gene Therapy 184

Gene Therapy Gene Development Production 184

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. It decreased vitamin A dimerization by more than 80% and prevented blindness in a genetic animal model of the disease in preclinical trials.

Genetics 279

Genetics Life Science Trials Clinical Development 279

Worldwide Clinical Trials

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.”

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

MAY 26, 2023

HanAll Biopharma and Daewoong Pharmaceutical have entered into a co-development deal with NurrOn Pharmaceuticals to develop therapy for Parkinson’s disease (PD) and other neurodegenerative disorders. They will help to progress ATH-399A towards a Phase I trial.

Development 130

Development Clinical Trials Clinical Trials Protein 130

Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

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.

Development 147

Development Clinical Trials Clinical Trials Gene Therapy 147

Pharmaceutical Technology

OCTOBER 18, 2022

Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.

Antibody 130

Antibody Development Sales Clinical Trials 130

Pharmaceutical Technology

MAY 19, 2023

Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. The financing will help to fast-track the development of other in vivo programming candidates into clinical trials.

In-Vivo 246

In-Vivo Gene Therapy Gene RNA 246

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 69

Production Clinical Development Development Regulation 69

Pharmaceutical Technology

NOVEMBER 30, 2022

The latest development is based on data obtained from an open-label clinical trial of Biktarvy. According to the trial findings, the treatment was demonstrated to be effective and well-tolerated through 24 weeks in adolescents who are virologically suppressed and children with HIV infection.

Marketing 246

Marketing FDA Approval Clinical Trials Clinical Trials 246

Pharmaceutical Technology

MARCH 10, 2023

It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials.

FDA Approval 246

FDA Approval Pharmacy Trials Clinical Development 246

Worldwide Clinical Trials

JUNE 13, 2024

The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

Trials 130

Trials Clinical Trials Clinical Trials Clinical Development 130

Pharma Mirror

JUNE 8, 2022

The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine. According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Development 130

BioPharma Reporter

DECEMBER 13, 2021

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

Antibody 140

Antibody Clinical Trials Clinical Trials Clinical Development 140

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.

Life Science 162

Life Science Development Gene Therapy Genetics 162

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. Novaliq’s CyclASol (0.1%

Development 147

Development Drugs Clinical Trials Clinical Trials 147