Language in FDA Decisions Could Signal Increased Scrutiny in Approval Decision-making
The wording in the US Food and Drug Administration’s (FDA) recent decision not to approve Pfizer and Myovant’s endometriosis application [...]
Webinar Series: ResearchX Season ’22
This years’ Flatiron ResearchX series has focused on the impact of evidence generation innovations on oncology research and care. Previous [...]
Investment in Vivosense Software to Promote Wearable Sensor Data in Clinical Trials
The wearable sensor consulting and data analysis firm Vivosense has just announced the closing of a $25 million investment to [...]
Amazon Teams Up with Thread to Advance Decentralized Clinical Trials Platform
Amazon Web Services has announced a new partnership with the US-based tech company Thread to promote and expand a digital [...]
FDA Oncology Chief Denies Claims that Rejection of Lilly and Innovent Cancer Drug is Politically Motivated
On the heels of the FDA’s rejection of Eli Lilly and Innovent Biologics’ low-cost lung cancer immunotherapy drug sintilimab, the [...]
ISPOR 2022: Short Morning Course Sessions
Five short course morning sessions are being offered at ISPOR 2022 on Sunday, May 15th. The courses span a range [...]
RWE Software to Improve Clinical Trial Recruitment of Underrepresented Groups
The success and health outcomes stemming from clinical trials are hampered by difficulties in recruiting patient populations who are representative [...]
Free Cytel E-book – The Fundamentals of Real World Evidence in Oncology Drug Development
As real-world evidence (RWE) is increasingly utilized for drug pricing and reimbursement decision, the potential for RWE to drive drug [...]
Reuters Events: Pharma Clinical 2022
Reuters Events is hosting Pharma Clinical 2022, a virtual meeting where over 500 clinical innovators will collaborate to discuss new [...]
Advancing Real World Evidence Under FDA Commissioner Califf
As part of his new role as FDA Commissioner, Robert Califf has pledged to promote the use of real-world evidence [...]
Final Clinical Cancer Trial Guidances Issued By FDA
Three new final guidances for cancer trials have been released by the US Food and Drug Administration (FDA), which build [...]
Russia’s Invasion of Ukraine Puts Over 200 Clinical Trials in Jeopardy
The war in Ukraine may impact a substantial amount of clinical trials, adding greater uncertainty to the growing humanitarian crisis. [...]
White Paper: Connecting Patient-level Clinical Trial Data to Real World Data
Gaps between real world data (RWD) and data from clinical trials slow progress by obfuscating long-term outcomes and efficacy. A [...]
Safety and Efficacy of Brolucizumab in DME Backed by 3 Studies
Three recent clinical trials have found Brolucizumab 6 mg to have a positive benefit-risk ratio for treating diabetic macular edema. [...]
Lancet Neurology Study Finds Riluzole Ineffective for SCA2
Riluzole was not found to improve patient outcomes living with spinocerebellar ataxia type 2 in a study published in the [...]
FDA and Pfizer Step Away From COVID-19 Vaccine Expedited Review
The US Food and Drug Administration (FDA) and Pfizer are backing down from initial plans to fast-track approval of their [...]
Tralokinumab Improves Quality of Life for Teens with Atopic Dermatitis
New data released from Leo Pharma indicates that their biologic drug tralokinumab-ldrm improved quality of life, anxiety, itching, depression and [...]
Whitepaper: What the New FDA Guidelines Mean for Patient-Reported Outcomes in Oncology Trials
The FDA has just released its draft guidance on oncology clinical trials using patient reported outcome measures (PROMS). The guidance [...]
Balancing Market Access and Regulatory Requirements
Bringing a clinical product or service to market requires a careful strategy that ensures regulatory approval and value for payers. [...]
Lark Health Among Recent Push Towards Decentralized Clinical Trials
Lark Health and Curavit are teaming up for a decentralized clinical for their new chronic disease prevention and management app. [...]
White Paper: Model-Based Approach for Better Enrollment Forecasting
According to the Clinical Trials Database, low recruitment rates were the largest factor determining whether a trial would terminate in [...]
Overcoming Patient Recruitment Projection Challenges
According to the Tufts Center for the Study of Drug Development, 37% of clinical trials miss enrollment targets. This is [...]
Reuters white paper: Building a Framework for Decentralized Clinical Trials in a Hybrid Future
The future of clinical trials is moving towards a field with decentralized, site-based, and hybrid trials that combine elements of [...]
Biogen Will Ensure Increased Diversity in Aduhelm Trials
Biogen has just promised that Black and Latinx people will account for at least 18% of participants in Aduhelm’s mandated [...]
Infographic: The Power of the Digital Thread in Life Sciences
A new infographic shows how the digital thread can empower life sciences product development. The digital thread unifies product design, [...]