EnvisionOne Insights: Transforming data management in life sciences
Envision Pharma Group, a global leader in technology solutions for the life sciences industry, has unveiled its latest innovation, EnvisionOne Insights.
Transparency on trial
Incorporating behavioral science: A new approach to patient-focused drug development?
Is it time to incorporate behavioral science into early drug design and development, in pursuit of a truly patient-focused approach from day one?
Women in Science: Dr Laura Trotta – ‘I joined CluePoints because of the research but also the mindset’
Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president of research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess...
Interview: The evolution of data management in clinical development
Gen Li is president and founder of Phesi, and OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and...
Five decentralized clinical trial organizations raising big VC cash
Decentralized clinical trials (DCTs) are gaining increasing interest as they have the potential to make clinical trial operations quicker, more efficient and more accessible to patients. Check out five DCT organizations that have raised big venture...
The key pharmaceutical trends from 2023 according to industry leaders
The pharmaceutical industry in 2023 has seen many investments, partnerships, acquisitions and more. As the year ends, industry leaders give the biggest trends to look for in 2024, with artificial intelligence being a hot topic.
FDA approval expands Welireg to patients with renal cell carcinoma
The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).
Phesi's free service to identify 'zombie trials' during a time of 'chronic challenge'
A free of charge service to help sponsors identify any ‘zombie trials’ has been launched by Phesi in a bid to save sponsors time and money.
Interview: EDETEK's Munther Baara on the paradigm shift in clinical trials
Munther Baara has worked in the life sciences arena for more than 30 years. He has always been completely committed.
CymaBay launches study into drug for liver scarring in patients with compensated cirrhosis
A study to evaluate the effect of seladelparm, a small molecule treatment by CymaBay Therapeutics, Inc. on patients with cirrhosis was announced this month (September 21).
Women in Science: UCB’s Iris Loew-Friedrich: ‘patients are what get me out of bed every morning’
Iris Loew-Friedrich is the executive vice president and chief medical officer at global biopharma company UCB.
Minority participation doubles average with Columbia Uni diversity drive
Columbia University is running three separate efforts to improve diversity within clinical trials, and it released data showing that early improvements could be seen.
Greenphire Study: Unified technology ‘essential’ for patient experience in clinical trials
Greenphire, provider of clinical trial financial solutions, has released its global 2023 State of Clinical Trial Patient Convenience Market Trends survey.
DIA Global
Curavit: Tackling underrepresentation with the right balance of patient care, science and business
New guidelines have been issued by the FDA called Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. Curavit was ahead of the game with its plans, find out how.
Breakthrough for liver disease patients with ascites that could eliminate needle paracentesis
Sequana Medical has just announced additional data on safety, quality of life and survival from its North American alfapump study, called Poseidon which could signal an end to manual draining of ascites.
FDA requests draft guidance feedback in bid to modernize clincal trials
The US Food and Drug Administration (FDA) has announced this month (June) it is requesting feedback on draft recommendations and how they should be applied to increasingly diverse trial types and data sources.
Karyopharm encouraged by interim study results of blood cancer treatment, eltanexor
A single-agent treatment for patients with relapsed or refractory myelodysplastic neoplasms has shown promising results, including overall survival, in a study.
'Compelling results from Karyopharm study using combination of drugs to treat myelofibrosis
Symptom improvements have been hailed as ‘very compelling’ after results from a phase 1 study into a combination of drugs to treat myelofibrosis prove positive.
Hutchmed 's rare gastric cancer drug accepted for review in China
A drug to treat a rare cancer that grows where the esophagus and stomach join has been accepted for review by the China National Medical Products Administration (NMPA).
A toxicologist’s perspective on good laboratory practice (GLP) standards versus non-GLP testing
Since 1978, the US Food and Drug Administration has had in place the guidance for good laboratory practices (GLP) regulations.
University becomes Freenome's study partner for multi-cancer screening approach
The Institute for Population and Precision Health (IPPH) at the University of Chicago has joined private biotech company, Freenome, to become its partner as part of a study.
Mixed results from latest study of BenevolentAI's dermatitis ointment
An ointment for patients with mild to moderate skin disease, atopic dermatitis (AD), has had mixed results from its phase 2a study.
UK agency opens future of clinical trials to the public
The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.
Europe launches initiative to transform clinical trials
Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
Pharma industry, CROs adapting to COVID-19 impacts: survey
A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges.
Most patients confident in personalized medicine: survey
A recent survey conducted by dosing technology firm found that the vast majority (85%) of patients think that personalized medicine stands to improve care.
COTA, MedStar Health partnership to use RWD in cancer research
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
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
A representative from the medication management solutions company suggests patient behavior data can be used to improve adherence to trial drug regimens.
Biden executive order could impact pharmaceutical industry
US President Joe Biden singled out the pharmaceutical industry in his recently issued Executive Order on Promoting Competition in the American Economy.
FDA lead calls for independent inquiry into Biogen drug approval
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.
DIA 2021 Annual Meeting
‘Magic happens’ when pharma pros meet to share ideas: DIA
A leader with the association discusses the value in attending events like the DIA 2021 Annual Meeting gather to tackle COVID-19 and other challenges.
Cancer drug developer aims to elevate treatment
A leader from clinical-stage pharma firm NuCana shares promising results for its ProTides therapies and hopes the drugs can elevate outcomes for patients.
Tapping into ePRO yields cost, accuracy benefits: Phastar
A leader from the CRO talks about increased use of electronic patient-reported outcomes in research, challenges of adoption, and how ePRO benefits trials.
FHIR can help tackle daunting digital challenges in research
A leader from digital health solutions firm CitiusTech suggests use of fast healthcare interoperability resources is useful in the face of evolving tech.
SCOPE 2021
SCOPE 2021 to take on tough clinical trial challenges
The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics.
World Cancer Day
Lung cancer community severely impacted by COVID: report
A report from the World Economic Forum and Lung Ambition Alliance outlines the impacts the pandemic is having on lung cancer diagnoses and treatment.
Oracle, Cognizant alliance aims to accelerate study startups
The two companies are integrating their technologies in a move designed to help hasten trial launches, and get promising new treatments to market faster.
Lancet study: Work needed to minimize exposure of ethnic minority groups to coronavirus
The clear evidence of increased risk of COVID-19 infection amongst ethnic minority groups, people from Black and Asian backgrounds, is of urgent public health importance, according to the authors of a paper published today by The Lancet.
CRAACO 2020
IQVIA: tap the right talent to lead digital transformation
In order to effectively handle collection and analysis of huge volumes of vital data, a leader from IQVIA advises bringing on people up to the challenge.
CRAACO 2020
Inteliquet: COVID-19 transforming oncology trial landscape
A leader from the cancer patient matching and analysis solutions firm discusses how and other forces are pushing innovation in the oncology research space.
BBK Worldwide survey reveals patients want trial innovation
The latest iteration of BBK Worldwide's Study Voices survey reveals thoughts on decentralized studies, telehealth and other trial technology.
First patient dosed in long-term Alzheimer’s trial
Neurotrope has kicked off its ongoing Phase II study of Bryostatin-1 for treatment of Alzheimer’s disease, with the help of a $2.7m NIH grant.
Parexel: improving trial diversity can elevate outcomes
A representative from the pharma services firm discusses how increasing diversity of clinical trial populations can improve research effectiveness.
EPS taps CluePoints for trial management solution
The Japanese pharma development firm will harness risk-based quality management solutions to help sponsors improve trial quality and safety.
FDA update on COVID-19 actions and advisements
Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.
TrialAssure offers academics free trial reporting tool
The software company is offering institutions no-cost access to its registry clinical trial disclosure reporting application.
Veeva Data Cloud promises innovative, open approach
The company’s Data Cloud platform is designed to increase the innovation, openness and flexibility of using patient and prescriber data.
BioData free video conferencing enables COVID-19 collaboration
The company has integrated a video conferencing and documentation tool to its Labguru electronic laboratory notebook at no charge during the pandemic.
Judge: Feds must open trial data access
A judge has ruled in favor of parties seeking to broaden access to federal clinical trial information, helping close a long-standing loophole.