Economists Suggest That Universal Coverage Is Already Possible for the US: What Obstacles Still Stand in the Way?
The current state of health insurance in the U.S. needs to be revised, even for insured Americans who face the [...]
BridgeBio’s Experimental Results Boosts Company Shares by 65%
BridgeBio Pharma Inc's experimental drug, acoramidis, for rare heart disease, has shown significant improvement in a late-stage study, boosting its [...]
FDA Approves AstraZeneca’s Beyfortus
The Food and Drug Administration has approved an AstraZeneca-developed monoclonal antibody, Beyfortus, in an effort to protect infants and young [...]
J&J Subsidiary Sues Doctors Over Talc-Cancer Research
Johnson & Johnson's subsidiary LTL Management has filed lawsuits against four doctors who have published studies suggesting links between J&J's [...]
Revolution in Women’s Health: First Over-The-Counter Contraceptive Coming to U.S. Shelves in 2024!
Perrigo's oral contraceptive, Opill, is now the first over-the-counter birth control pill in the United States. Opill has been around [...]
Sequoia Project and AHIMA Launch Health Data Usability Project
The Sequoia Project and the American Health Information Management Association (AHIMA) have partnered on the initiative "Data Usability Taking Root." [...]
BioGeneration Ventures Finalizes $167M Fund for Biotech Startups in Europe
What You Need To Know: Dutch venture capital firm BioGeneration Ventures (BGV) has secured €150 million ($167 million) for its [...]
Insights into the Global Real World Evidence Solutions Market 2023-2030
10 Things You Need to Know: The projection shows the market size growing from $16.3 billion in 2023 to $36.24 [...]
Unmasking Healthcare Costs: Beyond Transparency
What You Need to Know: Policymakers have shifted focus towards price transparency in healthcare to combat escalating costs; however, merely [...]
Is AI the Future of Pharma?
Here's What People Are Saying... ChatGPT is revolutionizing the pharmaceutical industry. Artificial intelligence and machine learning are expediting medication development, [...]
Price Break: Cigna Welcomes Trio of Discounted Biosimilars to Preferred Drug Roster
What You Need to Know: Cigna Group's unit, Express Scripts, is adding three biosimilar versions of AbbVie's arthritis treatment Humira [...]
Will the Medicare Price Negotiation Revamp Sufficiently Appease Pharma Companies?
The Centers for Medicare & Medicaid Services (CMS) amendments to its drug pricing negotiation program will unlikely deter past, current, [...]
Thermo Fisher to Acquire Data Firm CorEvitas for $912.5M
What You Need to Know: For $912.5 million, Thermo Fisher Scientific is set to acquire CorEvitas, a real-world data intelligence [...]
Accelerating the Rise of Value-Based Care
Enacting value-based care payment models has been a priority of payer and provider organizations in recent years, but the implementation has been uneven, with care centers serving underprivileged or vulnerable populations being left in the lurch. Helping close the gap is pivotal to reaching the US Centers for Medicare and Medicaid Services (CMS) goal of transitioning to value-based payment models for the majority of Medicaid and Medicare reimbursements.
Looking Back at the Orphan Drugs Act
In 1983, the US Congress passed the Orphan Drug Act (ODA) that offers financial incentives for developing drugs for rare diseases that have limited, if any, approved therapeutics. A new study published in the Orphanet Journal of Rare Diseases explores the impact that the ODA has had on the field of rare diseases over the past 40 years.
Examining the Five Biggest Players in Medicaid Managed Care
With over 70% of Medicaid beneficiaries being enrolled in plans from managed care organizations (MCOs), managed care has become a major player in the American health insurance industry. A new article by the Kaiser Family Foundation (KFF) takes a look at five of the largest MCOs and how they are influencing the managed care landscape.
ICER Faces Backlash for Proposed Changes to Value-Assessment Framework
The Institute for Clinical and Economic Review has received industry backlash over changes to its value-assessment process it proposed in June. The changes, if implemented, would lower the threshold ranges for cost-effectiveness down to $50,000 to $100,000 a year, a net drop of $50,000 at each end of the range. The outgoing ICER president Steve Pearson noted that these changes are not going to be immediately implemented and are still under consideration.
Biden Administration Rolls Back Limit on Short-Term Health Plans
The Biden administration and the US Department of Health and Human Services (HHS) have put forward a proposed rule that would set the limit for short-term health insurance to 4 months, reversing a Trump-era rule that gave them durations up to one year with the chance of renewal. Democrats derided these forms of insurance as “junk insurance,” noting that although they are cheap, they have poor coverage and are only meant to serve as a stop-gap measure.
Study Finds Many New Drug Indications Don’t Add Value
A newly published study in the BMJ finds that almost 60% of drugs receiving new indications from the US Food and Drug Administration (FDA) do not add high therapeutic value to patients. As a result, the researchers argue that patients and providers should be aware and that prices should be set accordingly.
Alzheimer’s Drug Leqembi Gets Full FDA Approval and Medicare Coverage
Eisai and Biogen’s Alzheimer’s treatment Leqembi (lecanemab) has received full approval by the US Food and Drug Administration (FDA). This marks the first full approval for an Alzheimer’s disease treatment in decades and clears the path to Medicare reimbursement, which previously required providers contribute data to a patient registry.
Expert Panel Agrees Recent Regulation has Advanced Real-World Data Applications
A panel of regulatory experts discussed how regulatory initiatives have advanced the use of real-world data (RWD) at this June’s Drug Information Association’s global meeting. The panelists, who came from the US Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), and Amgen, highlighted initiatives like the EMA’s Data Analysis and Real World Interrogation Network (DARWIN EU).
Using Real-World Evidence to Assess Hepatotoxicity of Biologics
A real-world evidence (RWE) study published in Nature Scientific Reports assessed the hepatotoxicity of several major biologics, such as adalimumab, trastuzumab, IF-Beta 1a, and insulin glargine. The study, which used real-world data (RWD) from over 2 million patients, found that many of these key biologics have some degree of hepatoxicity.
Major Hospitals Join Legal Battle Over High Generic Drug Prices
The Mayo Clinic, Mount Sinai, and around 150 other hospitals have joined other care centers in suing major drug manufacturers over inflated prices for generic medications. The lawsuit alleges that drugmakers like Pfizer, Sandoz, and Teva have illegally collaborated for over a decade to keep generic drug prices high.
Clinical Trial Diversity on the Decline
According to a recent IQVIA report, clinical trial diversity is on the downswing despite recent efforts to the contrary. The research specifically identified significant under-representation for Black and Hispanic patients. Industry action is needed, according to IQVIA, as clinical trial under-representation is systemic and negatively impacts people from marginalized racial and ethnic backgrounds.
Samsung and Pfizer Expand Collaboration to Accelerate Biosimilar Production
Samsung Biologics and Pfizer have announced they are expanding their current collaboration to ramp up production of biosimilars, bringing the agreement to a value of $897 million. The announcement comes as Pfizer and another branch of Samsung both prepare for US launches of their Humira biosimilars.
