DARWIN EU Real-World Evidence Studies Begin
The first real-world evidence (RWE) studies have begun in the DARWIN EU initiative of the European Medicines Agency (EMA). The project is a collaboration between the European Commission and the health technology assessment bodies of 27 member countries. Through the project, members hope to support and optimize the use of RWE in regulatory decision-making.
Real-World Data Shows Lucid Diagnostics’ EsoCheck is Well-tolerated
Newly presented data at a special conference of the American Association for Cancer Research shows that Lucid Diagnostics’ EsoCheck medical device is well tolerated when used in the early detection of esophageal precancer. The study used data taken from 687 patients, finding that 98% of patients completed the procedure. Moreover, DNA was successfully extracted from 90% of patients.
Eisai and Biogen’s Alzheimer’s Drug Surrounded by Cost and Safety Worries
As Eisai and Biogen’s novel Alzheimer's drug lecanemab inches closer to the finish line, many worry that the high price of the antibody-based therapeutic may lower patient access. A primary concern is whether payers will cover lecanemab, especially after the aduhelm controversy over the past few years. In addition, recent adverse events, including a second patient death, have engendered worry for many.
No Word from US FDA on Orphan Drug Exclusivity
The US Food and Drug Administration (FDA) is maintaining silence after losing a case last year over exclusivity of an orphan drug. In the case, and appeals court ruled the agency was wrong in approving a rare disease drug that shared its main ingredient with an existing orphan drug with exclusivity. As the silence continues, industry leaders worry about orphan drug exclusivity going forward, especially with the impending drug pricing reform from the Inflation Reduction Act.
Twist Biosciences Unveils Factory It Says Could Make Biologic Prices Competitive
Twist Biosciences, a biotech specializing in DNA synthesis, has revealed details of its new, state-of-the-art facilities the company says may drive competitive pricing in nucleic acid biologics. The facility, set in Oregon, US, is equipped with four DNA manufacturing devices and has room to grow, up to a total of 12. In addition, the upgrades will help speed production in other ways.
Pharma Skeptical of US FDA Plan for OTC Indications of Prescription Drugs
A group of pharma industry organizations have banded together and leveled their complaints and concerns at the US Food and Drug Administration’s recent plans to make a pathway for prescription drugs to receive over-the-counter (OTC) status for certain indications. A key sticking point was that insurers are likely to end coverage of prescriptions of these medications, complicating patient access and drugmakers’ earnings.
Study Finds Closed-Loop Insulin Delivery Systems Reduce Diabetes Impact on Young Children
A newly published real-world data study in Diabetic Medicine found that children under 12 who use a closed-loop insulin system to manage their diabetes had a reduced disease burden. The researchers used data from 251 patients 18 years or younger and found that patients on closed loop systems had a significantly reduced baseline glycated hemoglobin (A1C), a measure of long-term glucose control.
Verana Health Announces New Real-World Data and Qdata Modules in AWS Data Exchange
The digital health company Verana Health has announced the release of new real-world data (RWD) and Qdata™ modules in Amazon’s AWS Data Exchange. These expanded offerings will allow researchers and other clients from the life sciences industry to access Verana’s vast RWD resources in a platform already used by the majority of the company’s existing clients.
Insurance Coverage Reduces Cigarette Use in People Living with Mental Illness and Substance Use Disorders
An article recently published in Addiction found that insurance coverage is associated with reduced cigarette use in people living with mental illness or substance use disorder. People within this demographic are at increased risk of cigarette use, especially when they are under- or uninsured. The study examined data from nearly 450,000 respondents of the US National Survey of Drug Use and Health Surveys from 2009-2019.
Community Care Hubs as an Avenue to Improve Health Outcomes
The US Department of Health and Human Services (HHS) has prioritized the need to address social determinants of health to improve health outcomes for marginalized people. In this month’s issue of Health Affairs¸ authors discuss the use of community care hubs to help improve community health outcomes.
Mathematical Modeling of HIV/AIDs – Accounting for Social Determinants of Health
While research has established that social determinants of health (SDoH) play a major role in outcomes for people living with HIV/AIDS, most mathematical models fail to account for them in a meaningful capacity. In a newly published article in Nature, authors describe the development and application of a mathematical model that incorporates SDoH into its analysis.
Using Real-World Evidence to Investigate COVID-19 Breakthrough Infections
Real-world evidence (RWE) has been essential for the public health, pharma, and biotech response to the COVID-19 pandemic. In a new interview with Med Ad News, Matthew W. Reynolds, IQVIA’s vice president of scientific affairs and real world solutions, speaks about the use of RWE in studying COVID-19 breakthrough infections to prepare for the next outbreak.
Aetion Announces Launch of RWE Oncology Initiative
Aetion has announced a new initiative to help companies across the oncology-related industries better understand the use of real-world evidence (RWE) in regulatory decision-making and clinical trials. The team-up, dubbed the Coalition for the Advancement of RWE through Randomized Controlled Trial Emulation (CARE) Initiative. Partners include industry giants, advocacy organizations, universities, and more.
Improving Treatment Adherence Through Digital Health
Half of people living with chronic illnesses do not take their medications in the way they are prescribed by their care provider, imperiling health outcomes. Several digital health technology (DHT) technology tools have been developed to help, but a lack of patient education complicates efforts. In a new PM Live article, Peter Schueler and Isaac Rodriguez-Chavez of ICON discuss ways to adapt DHT to help boost adherence and improve patient outcomes.
Lunit to Present Real-World Data of First AI in Breast Cancer Research
Lunit has extended its artificial intelligence (AI) efforts into the field of breast cancer, releasing real-world data (RWD) demonstrating promising results. Researchers used the AI to identify cancer from mammograms, beating a team of two radiologists in diagnostic accuracy. The data comes from a pool of nearly 56,000 patient mammograms. The research will be presented in several forms at the upcoming RSNA Annual Meeting.
Lumanity and HealthVerity Team Up to Improve Access to Real-World Data Resources
Lumanity has announced a new partnership with HealthVerity. As part of the partnership, the two companies will work together to advance research by combining the deep real-world data (RWD) and real-world evidence (RWE) offerings of Lumanity and HealthVerity’s IPGE platform, a massive interoperable RWD platform. IPGE contains RWD from claims data, pharmacy data, & lab data.
PBM Gets Ready for Congressional Investigations
The pharmacy benefit manager (PBM) industry is preparing for increased scrutiny from members of the US Congress. Politico recently spoke with JC Scott, CEO and President of the industry’s main lobbying group, the Pharmaceutical Care Management Association, about the industry’s plans going forward. A key sticking point at the moment is the drug pricing reform in the Democrat’s Inflation Reduction Act.
Achieving Better Health Outcomes with AI-Based Data Analytics – Interview with Richard Gliklich of OM1
Robert Gliklich, CEO and founder of OM1, recently sat down with Forbes to discuss how launched his company, which uses real-world data (RWD), big data analytics, and artificial intelligence (AI). Gliklich developed his interest in RWD and AI after his first major acquisition as a venture capitalist, noting that there was a wealth of data held by specialists that could be used to advance care for those with chronic conditions.
Podcast Q&A: Making HEOR More Accessible to Patients
This podcast segment features the Q&A from OPEN Health's October 13, 2022 webinar and features an expert panel, including Danielle [...]
Real-World Data Study Supports Use of Paxlovid for COVID-19 in High-Risk Patients
A newly-published real-world study in the Journal of the American College of Clinical Pharmacy finds new data supporting the use of Paxlovid in high-risk COVID-19 patients. The retrospective study followed patients administered the combination therapy at a single medical center, finding that the drug was well-tolerated and helped improve health outcomes for people at-risk for severe COVID-19.
Using Digital Twins to Accelerate Drug Development
Getting enough patients with the right characteristics for control arms in clinical trials is difficult and can be fraught with ethical concerns. A startup called Unlearn.ai hopes to address this issue using digital twins, simulated patients for control arms that are generated using real-world data (RWD) and artificial intelligence (AI).
Interview with Nasim Asfar, Chief Health Officer of Oracle Health
Chief Healthcare Executive has published a new interview with Nasim Asfar, Oracle Health’s Chief Health Officer. Asfar is spearheading efforts to target health disparities to support health equity efforts and how Oracle Health is using tech to do so. She starts by touching on the outsized importance of social determinants of health (SDoH).
FACILITATE Patient-Centered Framework Will Boost Repurposing of Clinical Trial Data
The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a project supported by a coalition of EU and Non-EU nations to help support the re-use of clinical trial data. This will allow increased access to existing pools of real-world evidence (RWE) that is often out of researchers’ reach. In addition, it will provide participants with access to their trial data.
Biden Executive Order to Lower Drug Prices May Have Outsized Impact
An executive order issued last month by the Biden Administration could have far-reaching consequences on drug pricing efforts, according to a new article in MedCity News. The order commands officials to explore value-based payment models. These methods may help reduce drug prices by tying payouts to patient health outcomes.
FDA Approves Hemophilia Gene Therapy with Highest Drug Price on Market
A newly approved gene therapy for Hemophilia B tops the charts as the most expensive therapy in the US. A round of the therapeutic, which provides substantial protection against bleeds with a single treatment, comes with a price of $3.5 million. The drugmaker CSL says that the steep price is justified.
