FDA Opens Applications for PDUFA VII Real-World Evidence Programs
The US Food and Drug Administration (FDA) will start accepting applications for two programs that are part of the Prescription Drug User Fee Act (PDUFA VII). These programs are intended to help improve the use of real-world evidence (RWE) in approvals for new therapeutics. In addition, the program is set to promote novel clinical trial designs.
US HHS Secretary Becerra Says March-In Rights Not “Off the Table”
While pharma and biotech companies are still reeling from the passage of drug pricing reform in the US, their worries are still not over. Secretary Xavier Becerra of the Department of Health and Human Services (HHS) has mentioned that march-in rights are not “off the table.” The federal government has the power to take a drug’s patent and give it to other drugmakers in order to reduce the price for patients and payers, particularly those on the federal and state levels.
Researchers Put Forward New Healthcare Data Use Framework
A group of researchers from around the world have proposed a new framework for the use of healthcare data in research. The framework, published in several journals, guides researchers in several aspects of healthcare usage, such as transparency, quality assessment, and more. The team constructing the framework consisted of stakeholders from healthcare, government, research, and patient advocacy groups
EU Commission Approves Novavax COVID-19 Boosters
The EU Commission has approved the Novavax COVID-19 vaccine booster for adults 18 and above. The move comes only weeks after the European Medicine Agency (EMA) recommended the use of booster doses of the protein-based vaccine. The shot is currently authorized for the purpose in 3 APAC countries, Japan, New Zealand, and Japan.
Cityblock Health Raises $400 Million in Megaround
Cityblock Health has raised $400 million in its latest funding round. This brings the value of the startup to a whopping $5.7 billion. The company focuses on delivering care to patients in marginalized groups, aiming to provide care for 10 million patients by the end of the decade. Two key parts of the company’s strategy is integrating community support into care plans and connecting members with resources and specialized providers.
Incoming ISPOR President Talks HEOR
Jan Elias Hansen, PhD, will soon take the reins as the ISPOR President for 2022-2023. In this month’s Value & [...]
Inflation Reduction Act Maintains Expanded Health Insurance Subsidies
The Inflation Reduction Act, passed by the US Senate this Sunday, would preserve healthcare subsidies for 13 million people who purchase care through the marketplace. The bill, if passed by the House, would extend the subsidies through 2025. Originally, the subsidies only extended to the end of 2022.
Bristol Meyer Squibb Eyes More Major M&As
Last Wednesday, July 27th, Bristol Meyer Squibb’s CEO Giovanni Caforio signaled that the company has the resources to grow its holdings and it intends to do so. The company’s sales this Q2 were more than double the same period last year, giving the company more than enough funds to build off recent acquisitions.
Moderna Makes Deal with US Govt for Augmented COVID-19 Booster
Moderna has signed a contract worth up to $1.74 billion with the US government to provide an updated version of its mRNA vaccine. This version of the vaccine targets the BA.4/BA.5 Omicron strains that are currently dominant. The deal would get the US an initial 66 million doses, which could later include an additional 234 million.
Biosimilar Boom May be on the Horizon, Potentially Saving Patients Billions
Biosimilars, biologic generics, hold substantial promise in expanding access to lifesaving biologics, but growth has taken a while to ramp up. With 100 biosimilars currently in the pipeline, the industry may be set up for rapid growth in the next two years. With the potential influx of new biosimilars that are significantly cheaper than their reference drugs, patients could collectively save $100 billion in the next 5 years.
Delivering Real World Data-Driven Insights: An Executive Interview with Wendy Shusko and Jason Drenning
Delivering Real World Data-Driven Insights:An Executive Interview with Wendy Shusko and Jason Drenning Wendy Shusko, President and CEO and Jason [...]
ISPOR General Business Meeting to Take Place on May 26th
ISPOR will hold a virtual General Business Meeting on May 26th from 9:00 AM to 9:45 AM EDT. The session [...]
National AHIP Conference Provides Information on Drug Pricing and Health Policy Outlook
The national AHIP (America’s Health Insurance Plans) conference took place earlier this week. It provided important information regarding prescription drug [...]
NICE Talking to You: The Value of Early Scientific Advice
Starting in 2009, NICE became a pioneer among health technology assessment (HTA) agencies by offering the opportunity for early scientific [...]
Racial Biases Persist in Widely-used Analytics Software
According to a recent article published by Casey Ross of Stat News, infusion of bias into decisions about who should [...]
Educating the Next Leaders in Applied HEOR: Jefferson’s Unique Approach
Online education for the working professional is experiencing exponential growth. In the field of Health Economics and Outcomes Research (HEOR), [...]
The Influence of HEOR Data on Payer Formulary Coverage
A recent study presented by ISPOR demonstrated how HEOR data positively influenced changes to US payer formulary coverage. Investigators surveyed [...]
Cost-Sharing Waivers for COVID-19 Treatment Are Expiring
Cost-sharing waivers for COVID-19 treatment are due to expire in the upcoming months. Approximately 88% in individual and fully insured [...]
Payer Contact in a “Contactless” World: Achieving Early Engagement
The COVID-19 pandemic has prompted life sciences organizations to quickly pivot their payer strategic approach and tactical implementation. Engaging payers [...]
Kamala Harris Is No Friend to Pharma
Vice presidential nominee Kamala Harris is not exactly the centrist the media are making her out to be—especially when it [...]
Lilly + Prime Therapeutics Push the Envelope on Next Generation Value-based Agreements
Lilly has partnered with Prime Therapeutics to explore how value-based arrangements (VBA’s) can be used to improve patient outcomes while [...]
OM1 Insights: How We Use AI to Find Rare Disease Patients
"Correctly identifying a patient with a rare disease can be like looking for a needle in a haystack", according to [...]
Real-world Evidence Put to the Test: Medicare’s New Codes for Remdesivir
The Centers for Medicare & Medicaid Services (CMS) has created new ICD-10-PCS procedure reimbursement codes to facilitate the generation of [...]
COVID-19 Vaccine Pricing: Are the Manufacturers Signaling their Intent?
The Wall Street Journal is reporting that vaccine manufacturers are signaling the price for coronavirus vaccines, with prices ranging from [...]
Gilead Pricing of Remdesivir is “Immoral”, Says Pennsylvania’s Treasurer
Joe Torsella, Pennsylvania's elected treasurer, has come out swinging, calling Gilead Sciences "immoral" for their efforts to wring profit out [...]
