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. This is the storm that we find ourselves in the midst of.”

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Clinical Development Development Clinical Trials Clinical Trials 110

pharmaphorum

MAY 27, 2021

Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. Access to finding the right patients to participate in trials is often cited as the number one obstacle for completing a clinical trial on time and within budget.

Clinical Trials 119

Clinical Trials Clinical Trials Trials Life Science 119

Pharmaceutical Technology

NOVEMBER 28, 2022

Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). This includes an upfront payment of $2m from AstraZeneca. This includes an upfront payment of $2m from AstraZeneca.

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Development Gene Expression Licensing Licensing 264

pharmaphorum

JANUARY 14, 2022

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.

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Clinical Trials Clinical Trials Trials Development 98

Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

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Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

NOVEMBER 30, 2022

While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development.

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Development Clinical Trials Clinical Trials Trials 246

XTalks

JULY 29, 2024

Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Research 105

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

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Clinical Research 101

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.

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Trials Clinical Trials Clinical Trials Development 242

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. GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

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Clinical Trials Clinical Trials Trials Clinical Development 87

Pharmaceutical Technology

AUGUST 18, 2022

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?

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Gene Therapy Gene Genotype In-Vivo 246

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Data security: The clinical trial data is backed-up and secure.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Worldwide Clinical Trials

APRIL 15, 2024

Worldwide Clinical Trials recently conducted a comprehensive research study, where we included 140 key industry-decision makers from biotech and pharmaceutical companies of all sizes. The Advantages of Midsize CROs In contrast to large CROs, midsize CROs like Worldwide Clinical Trials offer a unique value proposition to the market.

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Clinical Trials Clinical Trials Clinical Development Clinical Research 130

Worldwide Clinical Trials

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” The post Trends in Oncology Study Design, from Optimus to Endpoints appeared first on Worldwide Clinical Trials.

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Trials Clinical Trials Clinical Trials Drugs 208

World of DTC Marketing

NOVEMBER 19, 2021

government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinical development. SUMMARY: The U.S. Additionally, Moderna used patents and non-exclusive rights that the U.S.

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Vaccination Vaccine Allergies Production 44

XTalks

NOVEMBER 21, 2024

Additionally, over a 176-week period, weekly injections of tirzepatide (marketed as Zepbound and Mounjaro) using pooled doses of 5 mg, 10 mg and 15 mg, significantly reduced the risk of disease progression to type 2 diabetes by 94 percent compared with placebo in adult prediabetes patients who were obese or overweight.

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Sales Insulin Drugs Trials 105

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. That mission is really important to me because I think it’s the only way we’re going to accelerate drug development in rare disease.

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Clinical Trials Clinical Trials Trials Development 97

BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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Clinical Development Development Clinical Trials Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Generic Pharmaceutical 172

Generic Pharmaceutical Dermatology Clinical Trials Clinical Trials 172

Pharmaceutical Technology

FEBRUARY 24, 2023

(LAI-287 + semaglutide) is under clinical development by Novo Nordisk and currently in Phase III for Type 2 Diabetes. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Insulin Hormones Drugs Clinical Trials 182

Outsourcing Pharma

JULY 24, 2023

Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

Clinical Development 80

Clinical Development Clinical Trials Clinical Trials Development 80

Pharmaceutical Technology

AUGUST 4, 2022

According to the deal, Poseida will offer either exclusive rights or options to Roche for developing and marketing various allogeneic CAR-T programmes in its portfolio targeting hematologic malignancies. Furthermore, Roche will oversee the late-stage clinical development and worldwide marketing of all products under the alliance.

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Development Clinical Trials Clinical Trials Gene Therapy 147

Pharmaceutical Technology

SEPTEMBER 23, 2022

While Restasis and Xiidra have been in use in the US market for a long time, both treatments have been associated with patient satisfaction issues such as a non-favorable tolerability profile and a slow onset of action. This gap in the market is what the late-stage pipeline therapies are currently targeting. Novaliq’s CyclASol (0.1%

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Development Drugs Clinical Trials Clinical Trials 147

XTalks

JANUARY 7, 2025

These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. The deal was valued at approximately $25 billion and strengthened Abbotts presence in the cardiovascular devices market.

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Life Science Manufacturing Production Clinical Development 105

pharmaphorum

JANUARY 31, 2022

Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The post Daiichi makes play for share of Japan’s COVID booster market appeared first on.

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Marketing Vaccination Vaccine Antibody 96

XTalks

JULY 9, 2024

In the dynamic landscape of clinical trials, ensuring compliance and maintaining high-quality standards are paramount. The field of quality and compliance in clinical trials is undergoing significant transformations driven by technological advancements, regulatory changes and evolving industry practices.

Compliance 59

Compliance Clinical Trials Clinical Trials Trials 59

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

Pharmaceutical Technology

JULY 7, 2022

While just two gene therapy products have been approved by the FDA, a number of companies are nearing the market with therapies targeting rare diseases, including 14 candidates in Phase III plus three in the pre-registration phase, according to GlobalData. A new frontier in cancer research.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

pharmaphorum

MAY 7, 2021

It’s illegal in most countries including the US and UK but Small Pharma is convinced of its potential as a therapeutic medicine for depression and has already begun clinical development. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

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Drug Trials Trials Marketing Drugs 98

Pharmaceutical Technology

MAY 10, 2023

XinThera’s therapy targeting MK2 is expected to enter clinical trials later in 2023. Gilead Sciences stated that the two programmes have the potential to address a number of indications and to provide development opportunities both alone and along with its wider portfolio.

Immune Response 130

Immune Response DNA Clinical Trials Clinical Trials 130

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

Worldwide Clinical Trials

FEBRUARY 22, 2023

Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. Rob: When I was diagnosed, my mother was adamantly against a clinical trial.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Pharmaceutical Technology

JULY 21, 2022

A clinical-stage speciality biopharmaceutical firm, ZyVersa uses advanced technologies for developing product candidates to address unmet medical needs in renal and inflammatory disease areas. Its development pipeline comprises a cholesterol efflux mediator, VAR 200 and a new inflammasome ASC inhibitor, IC 100.

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Production Development Clinical Trials Clinical Trials 147