Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. For instance, CAPA in good manufacturing practices (GMP) addresses manufacturing deviations and quality deficiencies.

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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.

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Clinical Development Clinical Trials Clinical Trials Development 97

VirTrial

DECEMBER 8, 2023

If you missed Signant’s November 15 webinar about utilizing EDC for modern clinical trials, there is still time. Webinar Takeaways  With increasing decentralization in several aspects of trial , conduct, and management, are EDC systems still relevant? You can watch the  recorded webinar here  and below.

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XTalks

JANUARY 17, 2024

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health , and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center.

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Clinical Trials Clinical Trials Trials Life Science 52

Drug Discovery World

JANUARY 30, 2023

Dominic Elliston , Managing Director of Evoke Galliard and Evoke Incisive Health, shares his take on how effective clinical trial communications is the key to expediting the delivery of new and extraordinary treatments. What’s that got to do with clinical trials? Tell us about yourself, Dominic.

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Clinical Trials Clinical Trials Trials Development 52

pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. Personal approach. About the author.

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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.

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Clinical Trials Clinical Trials Trials Life Science 98

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Regulation Vaccination Vaccine Trials 52

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Clinical Trials Clinical Trials Trials Vaccination 105

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

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

Pharmaceutical Technology

NOVEMBER 28, 2022

According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinical trial. . on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.

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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

Drug Discovery World

SEPTEMBER 12, 2022

We are hopefully nearing the tail-end of a pandemic that made the whole world become participants in that deep learning experience of what clinical development is. I think never before did we have families sit on the couch and talk about Phase I, II and III clinical trials. appeared first on Drug Discovery World (DDW).

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Clinical Trials Clinical Trials Trials Gene Therapy 52

Outsourcing Pharma

MAY 4, 2023

Sam Whittaker is founder, and CEO of multiple clinical trial technology companies, including Greenphire and Mural Health.

Clinical Development 52

Clinical Development Clinical Trials Clinical Trials Development 52

Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Gene Therapy Gene Development Genetics 264

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Clinical Trials Clinical Trials Trials Clinical Research 111

The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.

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Clinical Development Development Clinical Trials Clinical Trials 52

BioPharma Reporter

MARCH 3, 2021

Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines.

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Clinical Development Vaccination Vaccine Development 52

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.

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XTalks

OCTOBER 7, 2020

Not only did this baby survive to do all these things, but he became a poster child for gene therapy with the regulators at the U.S. The Xtalks White Paper, The Intersection of Rare Disease and Advanced Therapies: What it Means for Clinical Development , is available for free download. Partnering with regulators early.

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Development Gene Therapy Clinical Trials Clinical Trials 98

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. We’re already seeing biotechs making breakthroughs with AI in this area, with more than 150 small molecule drugs discovered and 15 already in clinical trials.

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Genome Genomics Life Science Gene Therapy 139

Drug Discovery World

OCTOBER 3, 2023

The US Food and Drug Administration (FDA) has announced a pilot programme with the aim of accelerating the development of novel drug and biological products for rare diseases.

Clinical Trials 52

Clinical Trials Clinical Trials Production Regulation 52

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). 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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Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). 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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Contract Manufacturing Dermatology Hormones Production 100

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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Drug Discovery World

APRIL 13, 2023

In 2018, the US Food and Drug Administration (FDA) introduced a policy for accepting real-world data (RWD) and real-world evidence (RWE) in addition to traditional clinical trial data in new drug applications. With RWD, fewer patients require direct enrolment in randomised clinical trials.

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Clinical Trials Clinical Trials Trials Marketing 52

pharmaphorum

NOVEMBER 11, 2022

Understanding commercial and market access risks and opportunities at an early stage in biopharmaceutical product development is essential for optimizing commercial success. Several decisions are made in the early stages of clinical development that have key implications for entering markets successfully.

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Clinical Development Marketing Regulation Packaging 52

Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Metastatic Colorectal Cancer. 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.

Drugs 100

Drugs Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Gastroesophageal (GE) Junction Carcinomas. 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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Drugs Clinical Trials Clinical Trials Development 100

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

Drug Discovery World

NOVEMBER 10, 2023

Topline results from a Phase I/II clinical trial have shown that Kiora’s light-restoring small molecule KIO-301 has the potential to meaningfully improve vision in patients with retinitis pigmentosa (RP). Once inside the cell, KIO-301 localises within specific voltage-gated ion channels involved in regulating neural signalling.

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Clinical Trials Clinical Trials Trials Clinical Development 52

pharmaphorum

DECEMBER 4, 2020

Results from Pfizer’s clinical trial also took longer than expected to materialise and caused further delays, the spokesperson added. The first shipments of the vaccine are reportedly in the UK following approval by the country’s medicines regulator. million doses.

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Vaccination Vaccine Production Regulation 125

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway.

Drugs 100

Drugs Pharmacy Production Development 100

Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway.

Drugs 100

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Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+

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Clinical Research Research Clinical Trials Clinical Trials 52