Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 95

Clinical Trials Clinical Trials Regulation Trials 95

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.

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FDA Approval Pharmacy Trials Clinical Development 246

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. Integrating DHTs Across Drug Development Phases Dr.

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Clinical Development Development Clinical Trials Clinical Trials 116

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.

Development 264

Development Gene Expression Licensing Licensing 264

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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Regulation Development Drugs Clinical Trials 105

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.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Vaccine Vaccination Trials Protein 104

pharmaphorum

SEPTEMBER 24, 2020

The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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Vaccine Vaccination Trials Immune Response 98

pharmaphorum

MARCH 12, 2021

COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research.

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Trials Research Pharma Companies Clinical Trials 132

XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Trials 52

pharmaphorum

DECEMBER 2, 2022

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. With a fresh take on a data-driven trial strategy, sponsors can create a new path for trials that also accounts for potential risks.

Trials 98

Trials Clinical Trials Clinical Trials Clinical Research 98

pharmaphorum

NOVEMBER 11, 2022

The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. Both groups were poorly represented however in oncology trials. for Hispanics.

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Clinical Trials Clinical Trials Trials Pharma Companies 97

pharmaphorum

SEPTEMBER 3, 2020

UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms. Another was hospitalised with suicidal ideation. The post Compass plans $100m IPO to fund magic mushroom depression drug appeared first on.

Drugs 116

Drugs Life Science Clinical Development Regulation 116

Pharmaceutical Technology

DECEMBER 6, 2022

The latest development comes after the companies received guidance from a meeting held with the US Food and Drug Administration (FDA) in November. Based on findings from the MIRAGE and TIDAL trials, the company also plans to make a submission seeking marketing authorisation from the health authorities in Japan.

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Development Trials Clinical Trials Clinical Trials 147

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.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Clinical Research 101

Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

Vaccine 89

Vaccine Vaccination Recombinant DNA Technology Trials 89

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.

Development 98

Development Gene Therapy Clinical Trials Clinical Trials 98

XTalks

MARCH 17, 2025

The partnership also outlines development milestones of $1.2 billion, primarily linked to initiating Phase III trials for petrelintide as a stand-alone therapy, with sales-based milestones that could push the total value to $5.3 Under the deal, Zealand Pharma will receive an upfront cash payment of $1.65 billion $1.4

Hormones 59

Hormones Drugs Sales Insulin 59

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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Vaccine Vaccination Production Regulation 125

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

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.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

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.

Clinical Development 52

Clinical Development Development Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. Pfizer and BioNTech are running a parallel trial in Germany and plan to announce further results from that in the “near future”.

Vaccine 122

Vaccine Vaccination Antibody Regulation 122

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

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

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.

Clinical Trials 87

Clinical Trials Clinical Trials Trials Clinical Development 87

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.

Compliance 52

Compliance Clinical Development Development Clinical Trials 52

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

Clinical Trials 98

Clinical Trials Clinical Trials Trials In-Vitro 98

Pharmaceutical Technology

JULY 26, 2022

Several drugs in the pipeline have novel mechanisms of action (MOAs), including novel calcium channel regulator acetylleucine and cyclodextrin therapies, adrabetadex and Trappsol Cyclo. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

Marketing 306

Marketing Gene Branding Clinical Development 306

pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The pharma company will use the technology known as accelerateIQ to collect data across its clinical studies through a variety of wearable biosensors.

Licensing 72

Licensing Licensing Trials Clinical Trials 72

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. In addition, 43.4 percent were using or piloting omics data.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Regulation 105

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Valneva is paying 30% of development costs and in return Pfizer will pay tiered royalties starting at 19% and will lead late-stage development.

Vaccine 119

Vaccine Vaccination Bacterium Protein 119

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.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Clinical Research 111

Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).

Marketing 147

Marketing Trials Development Protein 147