A March 2021 agreement between the Frrench Ministry of Health and the French Pharmaceutical Companies Association has reduced barriers to access to orphan drugs for patients in France, according to an analysis by GlobalData. The agreement set a flat rate payment for orphan therapies that cost over […]
Interview with Tobias Polak: Gleaning Real-World Data from Expanded Access Programs
Tobias Polak, a PhD student at Erasmus University and Director of Real-World Data (RWD) myTomorrows, recently published a paper in the British Journal of Clinical Pharmacology entitled, “Expanded Access as a source of real-world data: An overview of FDA and EMA approvals.” Polak spoke with The […]
Real-World Data Study Shows that Biologics are Widely Used and Effective for Severe Asthma
A new real-world data (RWD) study published in the Annals of Allergy, Asthma & Immunology shows that biologics are both commonly used and very effective in the treatment of severe asthma. The results, taken from the ongoing CHRONICLE study, found that two-thirds of the nearly 2800 participants […]
US Attorney General Merrick Garland: States Can’t Ban Abortion Pill
Shortly after the US Supreme Court’s decision on Friday, June 24th, to reverse Roe V. Wade and allow states to end access to safe abortions, Attorney General Merrick Garland made an announcement that states cannot ban drugs used to induce abortions. Some speculate that pharma companies that produce […]
Biogen Ends Aduhelm Study Due to Medicare Restrictions
Biogen has ended its observational ICARE AD real-world data (RWD) trial for Aduhelm, another in a long series of setbacks for the drug. The move was caused in part by the Centers for Medicaid and Medicare Services’ (CMS) decision to only cover the drug for patients in clinical trials. The ICARE AD […]
Google Cloud Health Exec: Real-World Data May Supplant Use of Placebos in Clinical Trials
According to Shweta Maniar, Google Cloud’s director for healthcare and life sciences, real-world data (RWD) may speed up clinical trial and market access timelines for all forms of therapeutics. This advance is powered, Maniar argues, by the potential of RWD to empower decentralized clinical trials […]
How an NHS Trust Used Integrated Data Sets to Advance Better Population Health Outcomes
Lewisham and Greenwich NHS Trust, responsible for two hospitals and several community health centers, realized the need to address disparities in health outcomes and unmet community health needs in 2017. The Trust moved on this need by investing in a population health and care management program […]
US Supreme Court Won’t Hear UnitedHealth’s Medicare Advantage Lawsuit
UnitedHealth was handed a major setback Tuesday, June 21st, when the US Supreme Court declined to hear its lawsuit over the Medicare Advantage overpayment rule. The Centers for Medicare and Medicaid Services (CMS) established the overpayments rule in 2014, which mandates that MA plans must return […]
Politico Pulse: Addressing Monkeypox Antiviral Shortages
As monkeypox cases continue to spring up across the world, nations are seeking to stock up on the antiviral tecovirimat. The drug’s manufacturer Siga is currently in talks with the Biden administration regarding expanding their facilities to ramp up output. Tecovirimat is not currently approved for […]
BioNTech Starts Construction of Africa’s First mRNA Vaccine Manufacturing Plant
With the construction starting for BioNTech’s new plant in Kigali, Rwanda, Africa is finally getting its first mRNA vaccine manufacturing facility. Lower- and middle-income nations have not received enough COVID-19 vaccines since they’ve become available, especially nations in Africa. This new […]
Preventing Overdoses by Treating Opioid Use Disorder in Prisons
Compared to the general population, incarcerated people have a 40 times higher risk of death by opioid overdose shortly after their release. While treatment with medications for opioid use disorder (MOUD) has been shown to dramatically reduce these deaths, many prisons and jails withhold MOUDs as a […]
Health Affairs Policy Highlight: One-On-One with Admiral Rachel Levine
This Friday, June 24th, Health Affairs Editor-in-Chief Alan Weil will sit down with Admiral Rachel Levine, the US Department of Health and Human Services’ (HHS) Assistant Secretary for Health. Adm. Levine has overseen much of the department’s public health efforts since being appointed to the role […]
Enanta Sues Pfizer over Alleged Paxlovid Patent Infringement
Enanta Pharmaceuticals has filed a lawsuit against the pharma giant Pfizer over claims of patent infringement involving its COVID-19 treatment Paxlovid. The company claims Pfizer’s use of nirmatrelvir, a protease inhibor that makes up one half of Paxlovid, is in violation of several patents. Instead […]
FDA Will Present Draft Guidance on Real-World Evidence in Grand Rounds on June 22nd
The US Food and Drug Administration will unveil its highly anticipated draft guidance on real-world evidence this Friday, June 24th. The grand rounds session begins at 1:00 PM EST and will be presented by Dr. John Concato. According to Rethinking Clinical Trials, “Dr. Concato is the associate […]
RSS Course: Economic Evaluation of Cancer Drugs
Regulatory Scientific and Health Solutions is now offering a 1-day face-to-face course about health economics models for assessing cancer drugs. Attendees will learn how the models are made and applied, along with how their results are interpreted and acted upon by payer and health technology […]
Health Affairs Today: Using EHR to Boost Vaccination Rates in Unhoused or Incarcerated People in Minnesota
Compared to the rest of the population, vaccination rates are much lower amongst Minnesotans who are unhoused or in the penitentiary system. To help close the gap, a team of researchers developed a set of tools to guide and compare interventions enacted to reduce health disparities. The work, […]
14 Million May Lose Health Insurance When Public Health Emergency Ends
The Families First Coronavirus Response Act of 2020 helped provide coverage to millions who lost their employer-provided health insurance during the pandemic. However, with the end of the public health emergency looming over the horizon, those citizens are set to lose the coverage provided by the […]
American Medical Association Launches Initiative to Advance Health Equity
People from marginalized groups often face systemic bias that worsens their health outcomes. To combat this problem, the American Medical Association has announced a new initiative to bring equitable, quality patient-centered care to people of all backgrounds. The initiative comes will provide a […]
Labcorp Teams Up with HealthVerity in Real World Data Collaboration
The life sciences giant Labcorp has announced a new partnership with HealthVerity, a leader in real-world data (RWD). Labcorp will leverage HealthVerity’s Identity, Privacy, Governance, and Exchange (IPGE) platform to enhance their drug development and clinical trial offerings. This platform is the […]
Carbon Bioscience Partners with the Cystic Fibrosis Foundation to Develop New Viral Vector-Based Therapy
Although adeno-associated virus (AAV) gene therapies have represented a large swath of the gene therapeutic landscape for years, they have been weighed down by various limitations and adverse effects. The biotech Carbon Biosciences, led by seeks to disrupt the field of cystic fibrosis gene therapies […]
Bringing Data-Enabled Healthcare to Asian-Pacific Nations
Asia-Pacific (APAC) is the most population-dense region of the world with an increasingly growing aged populace. However, substantial disparities to healthcare access exist, setting the stage for an upcoming healthcare crisis. In an article published by the World Economic Forum, Ahmed Elhusseiny […]
FTC puts PBMs and Pharma “On Notice” over Insulin Prices
The US Federal Trade Commission (FTC) has issued a new policy statement saying it will actively target pharmacy benefit managers (PBMs) and drugmakers in its efforts to lower the cost of insulin. The agency noted that it would increase its vigilance to stop actions that “block patients’ access to […]
OM1 Webinar – July 19th: Using Real-World Data to Explore and Demonstrate Comparative Effectiveness
Real-world data (RWD) can empower clinical trials and regulatory decisionmaking, but knowing which data to use and how best to implement it is tricky. In an upcoming webinar on July 19th, Jessica Paulus, SciD, Senior Director of Research/Epidemiology, will discuss the opportunities and issues […]
Webinar – July 26th: Optimize Your Value Story Through Integrated Evidence Generation – From Bench to Patient
Getting new, innovative treatments to patients requires an increasingly comprehensive set of evidence demonstrating their efficacy and value-effectiveness. Doing so efficiently requires an integrated evidence generation approach that relies on real-world evidence (RWE) and insights […]
ISPOR Europe 2022: Call for Abstracts – Deadline: 30 June
This November, health economics and outcomes research (HEOR) professionals from across Europe will gather at ISPOR Europe 2022 to share their latest findings, collaborate with colleagues, attend workshops led by HEOR experts and more. ISPOR is seeking research and case study abstract submissions for […]
EFPIA-EURORDIS Publishes Joint Statement on Patient Access to Rare Disease Medicines
The European Federation of Pharmaceutical Industries and a Associations has issued a joint statement with EURODIS Rare Diseases Europe on access to treatment for people with rare diseases. In the statement, the organizations put forward their shared goal to reduce disparities in access to treatments […]
Clovis Withdraws Approval Applications for Ovarian Cancer Drug Rubraca
Clovis Oncology has announced it will withdraw its FDA approval application for Rubraca, its third-line BRCA-mutated ovarian cancer drug. The company is also withdrawing its application for approval by the European Medicines Agency. The move comes after overall survival data found that a subset of […]
Real-World Data Study Finds Clear Differences Between Rheumatoid Arthritis Drug Classes
A new paper published in the Annals of Rheumatic Diseases found significant differences in the three main classes of rheumatoid arthritis drugs. The study used real-world data (RWD) from a European registry dataset of almost 32,000 rounds of treatment given to RA patients, showing that abatacept had […]
Lumanity Acquires Endpoint Outcomes, Creating a Unique and Comprehensive Health Economics and Outcomes Research Offering
Lumanity Acquires Endpoint Outcomes, Creating a Unique and Comprehensive Health Economics and Outcomes Research Offering Lumanity Acquires Endpoint Outcomes, Creating a Unique and Comprehensive Health Economics and Outcomes Research Offering World-class outcomes research capability teamed with […]
Healthcare stocks offer defence against inflation
Andy Acker, Janus Henderson Investors In the current scenario of 40 year-high inflation and rising interest rates, there is a reasonable chance of a recession in the next 12 to 18 months, said Andrew Acker, portfolio manager of JHI’s Global Life Sciences Fund. To defend against this macroeconomic […]
