Phase III-IV

Uniting clinical research, healthcare can benefit both: Biofourmis

17-Aug-2021 By Jenni Spinner

An executive from the digital therapeutics specialist discusses the clinical trial landscape, and how clinical care can yield a number of important benefits.

Trial complexity, info explosion driving data management evolution

17-Aug-2021 By Jenni Spinner

A leader from Veeva Systems shares perspective on what factors are impacting clinical trial data management, and how the industry can adapt to the changes.

Tech Innovations: August 2021

17-Aug-2021 By Jenni Spinner

This month’s roundup of equipment, decentralized technology, partnerships and other items includes news from Medidata, PerkinElmer, Syneos and other firms.

Alzheimer’s research tool targets underrepresented groups

16-Aug-2021 By Emily Jarecki

The National Institute on Aging has launched Outreach Pro, an online tool aimed to help connect with underrepresented populations for Alzheimer’s trials.

Accenture survey reflects changing patient experiences

16-Aug-2021 By Jenni Spinner

The check-in with nearly 1,800 US healthcare consumers reflects how COVID-19 and other factors have impacted patient access, equity, experience and trust.

WHO COVID-19 trial moves ahead with three drug candidates

12-Aug-2021 By Jenni Spinner

The World Health Organization’s Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.

TriNetX, Marshfield Clinic Research Institute partner to improve trial access

12-Aug-2021 By Emily Jarecki

The clinical study network is partnering with the Wisconsin-based health system to increase the reach of trials into a largely rural patient population.

Importance of achieving true patient centricity in clinical trials

09-Aug-2021 By Jenni Spinner

A leader from Longboat by Advarra outlines what it really means for a study to be patient centric, and how to succeed in achieving patient-centric trials.

Understanding placebo response, patient personality vital

09-Aug-2021 By Jenni Spinner

A representative from Tools4Patient discusses how grasping the ties between the two can help in reducing the impact of the placebo response in trials.

Artificial intelligence stands to ‘revolutionize’ research: Bioclinica

05-Aug-2021 By Jenni Spinner

A leader from the clinical research tech specialist explains how the use of AI is increasing and outlines the many ways it could change the field.

cphi north america 2021

Pharma event welcomes industry professionals ‘keen to meet’

04-Aug-2021 By Jenni Spinner

Producers of CPhI North America 2021 offer a glimpse at programming, including sessions on COVID-19 challenges, supply chain issues, and more key topics.

Psychedelics research institute launches in Australia

03-Aug-2021 By Jenni Spinner

The Psychae Institute, established by a global team of scientists, will conduct pre-clinical and clinical research around psychedelic medicine development.

AstraZeneca lupus treatment Saphnelo obtains FDA approval

02-Aug-2021 By Jenni Spinner

The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.

Arcturus Therapeutics lines up Phase 1/2/3 trial for next-generation mRNA COVID-19 vaccine

02-Aug-2021 By Rachel Arthur

Arcturus Therapeutics and its Vietnam partner Vinbiocare will take ARCT-154, a next-generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, into a Phase 1/2/3 trial. The companies will also establish a vaccine manufacturing centre in Vietnam....

FDA grants Breakthrough Device designation to digital therapeutic

29-Jul-2021 By Jenni Spinner

The BiovitalsHF, from Biofourmis, is intended to augment decision-making in clinical environments, and to supplement traditional pharmaceutical therapies.

Pharma industry, CROs adapting to COVID-19 impacts: survey

27-Jul-2021 By Jenni Spinner

A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges.

BMS, BridgeBio partner to study drug combo for lung cancer

27-Jul-2021 By Jenni Spinner

The two pharma firms will partner to study the efficacy of Opdivo, paired with a SHP2 inhibitor, to treat non-small cell lung cancer with KRAS mutations.

Recent FDA actions and responses on COVID-19 pandemic

26-Jul-2021 By Jenni Spinner

The US Food and Drug Administration has stayed on top of developments around the pandemic, including research into potential vaccines and treatments.

Personalized medicine requires complex supply chains: Marken

26-Jul-2021 By Jenni Spinner

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

Merck, Evidation join forces on Alzheimer’s data solutions

22-Jul-2021 By Jenni Spinner

The health data specialist and pharma firm are partnering on solutions around remote collection of digital data for detection and monitoring of treatments.

Next-level tech elevates clinical data management: AiCure

22-Jul-2021 By Jenni Spinner

A leader from the artificial intelligence solutions firm discusses how advanced analytical tools can help researchers make the most of mountains of data.

Novartis inks 10-year pledge to improve equity in research, care

20-Jul-2021 By Jenni Spinner

The pharma firm's partnership with 26 US Black colleges includes a $13.7m investment in trial and research centers at Morehouse School of Medicine.

Statins may reduce risk of COVID-19 death: researchers

19-Jul-2021 By Jenni Spinner

A recent study indicates patients taking the cholesterol-lowering drugs prior to COVID hospitalization are far less likely to die as a result of the virus.

WHO issues position statement on TB clinical trial design

19-Jul-2021 By Jenni Spinner

The World Health Organization hopes to encourage the development of novel therapies for tuberculosis by spotlighting key clinical study characteristics.

COTA, MedStar Health partnership to use RWD in cancer research

15-Jul-2021 By Jenni Spinner

The oncology-centered analytics firm will work with the DC-area healthcare provider to delve into discovery and development of novel cancer treatments.

Lilly and Banner Alzheimer’s Institute in strategic research collaboration for donanemab trial

15-Jul-2021 By Rachel Arthur

Eli Lilly and Company and Banner Alzheimer’s Institute have announced a strategic research collaboration as part of the planned Phase 3 study for donanemab in participants at risk from cognitive and functional decline related to Alzheimer’s disease.

Savvy solutions can elevate medication adherence: AARDEX

14-Jul-2021 By Jenni Spinner

A representative from the medication management solutions company suggests patient behavior data can be used to improve adherence to trial drug regimens.

Ongoing training fills data management knowledge gaps: TriTiCon

14-Jul-2021 By Jenni Spinner

A leader from the clinical tech consultancy shares advice on how to employ training to help keep up with the rapidly evolving field of data management.

ACD/Labs, Science Data Experts establish AI partnership

14-Jul-2021 By Jenni Spinner

The two companies will work together to come up with solutions that use machine learning and artificial intelligence to help accelerate innovation in R&D.

From hesitancy to reliance: journey to real-world data acceptance

14-Jul-2021 By Jenni Spinner

According to a leader from CRO Quanticate, the research industry’s increased use of real-world data is leading to a broad range of benefits in trial work.

The right questions and tools key to clinical data: Daelight

14-Jul-2021 By Jenni Spinner

A leader from life-sciences IT consultancy Daelight Solutions shares how the clinical trial data landscape has changed and offers advice on how to keep up.

FDA lead calls for independent inquiry into Biogen drug approval

12-Jul-2021 By Jane Byrne

Acting US FDA commissioner, Janet Woodcock, has called for an independent federal review of interactions between officials at her agency and representatives of Biogen, prior to the recent approval of the pharma company’s treatment for Alzheimer’s disease....

Rare disease specialists talk resources, research and hope

09-Jul-2021 By Jenni Spinner

During the Rare/Orphan Diseases, Special Patient Population webinar, a group of industry experts discussed challenges and opportunities faced in the field.

Pharma SAAS solutions must balance safety, efficiency: IQVIA

09-Jul-2021 By Jenni Spinner

A leader from IQVIA suggests what to look for when seeking ways to automate drug safety processes, while maintaining security and customer satisfaction.

Medicenna takes on deadly brain cancer in clinical trial

08-Jul-2021 By Jenni Spinner

The immunotherapy firm is conducting a Phase III trial centered on an innovative approach to treating recurrent glioblastoma, an aggressive brain cancer.

CRO Parexel to be acquired by Goldman Sachs in $8.5b deal

08-Jul-2021 By Jenni Spinner

The global contract research organization has announced it will be purchased by Goldman Sachs Asset Management and EQT Private Equity.

People on the Move: July 2021

08-Jul-2021 By Jenni Spinner

This month’s news on hires, promotions, acquisitions, and expansions includes items about Javara, Elligo, Lonza, Yourway, Medable, and other notable firms.

Duke University, HumanFirst partner to assess digital clinical measuring tools

06-Jul-2021 By Jenni Spinner

The two entities will work together to evaluate digital sensors and other tools used in clinical research, checking the items for accuracy and equity.

BMS, GRYT Health collaborate on patient advocacy platform

06-Jul-2021 By Jenni Spinner

The two organizations have joined to create the Advocacy Exchange, a virtual platform designed to bring together patients, advocates and industry leader.

Experts to talk rare and orphan diseases, patient experience at webinar

01-Jul-2021 By Jenni Spinner

On July 7, a group of seasoned industry leaders will offer insights at Rare/orphan diseases, special patient population, a focused, free online event.

Brace yourselves for clinical trial guideline update: Remarque Systems

01-Jul-2021 By Jenni Spinner

A leader from the trial management specialist says sites and sponsors prepare for International Council for Harmonization guideline changes on the horizon.

Mobile optometry service expands clinical trial support

01-Jul-2021 By Jenni Spinner

Thanks in part to the recent completion of an $8m investment, 2020 On-site plans to expand its services, including the mobile support of vision research.

Scleroderma Foundation increases research funding by more than 100%

29-Jun-2021 By Jenni Spinner

The organization, focused on building awareness and finding therapies for the rare disease, is boosting its annual research funding to more than $2.7m USD.

Signify Health partners on decentralized trials for children’s cancer

29-Jun-2021 By Jenni Spinner

The trial solutions firm is working with Children’s Oncology Group to expand in-home research and care options for investigational immune-oncology therapy.

Formedix launches cloud-based clinical metadata repository

28-Jun-2021 By Jenni Spinner

The company’s ryze technology combines a clinical MDR and study automation platform, designed to accelerate and optimize design and execution of trials.

Recent FDA COVID-19 actions and updates

25-Jun-2021 By Jenni Spinner

The agency has been busy with actions related to the virus behind the pandemic, keeping an eye on vaccinations, emerging variants, and other concerns.

Cancer patient survey shows COVID's impact on care decisions

25-Jun-2021 By Jenni Spinner

The survey, conducted by Ai-powered study matching company TrialJectory, indicates more patients than ever are interested in clinical trial participation post-pandemic.

Takeda reports promising results for potential lung cancer treatment

22-Jun-2021 By Jenni Spinner

The pharmaceutical company reports favorable results in a recent study exploring mobocertinib in treating certain non-small cell lung cancer patients.

Gilead shares positive findings for potential COVID-19 treatment

22-Jun-2021 By Jenni Spinner

The pharma firm reports its Veklury (remdesivir) led to a reduction in mortality rate among hospitalized patients in three analyses of real-world data.

Mobile patient engagement solution lands industry award

18-Jun-2021 By Jenni Spinner

United BioSource received the 2021 Healthiverse Heroes Award for Life Sciences in recognition of its automated clinical trial patient outreach technology.