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News
Emicizumab as a Potential Treatment Pathway for Select Hemophilia B Cases
11/22/2024
Lisa Kuhns, PhD, MD
New research highlights the potential of emicizumab, traditionally used to treat hemophilia A (HA), as a promising alternative therapy for certain hemophilia B (HB) genotypes.
New research highlights the potential of emicizumab, traditionally used to treat hemophilia A (HA), as a promising alternative therapy for certain hemophilia B (HB) genotypes.
New research highlights the...
11/22/2024
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News
Revolutionary Single-Dose Gene Therapy Offers New Hope for Adults with Hemophilia B
11/08/2024
Lisa Kuhns, PhD, MD
A groundbreaking gene therapy for hemophilia B has shown remarkable success in reducing bleeding episodes and improving the quality of life for adult patients, according to a recent international phase III clinical trial.
A groundbreaking gene therapy for hemophilia B has shown remarkable success in reducing bleeding episodes and improving the quality of life for adult patients, according to a recent international phase III clinical trial.
A groundbreaking gene therapy...
11/08/2024
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News
Advances in Factor IX Therapy Offer New Hope for Hemophilia B Treatment
10/23/2024
Lisa Kuhns, PhD, MD
New factor IX therapies promise improved treatment for hemophilia B.
New factor IX therapies promise improved treatment for hemophilia B.
New factor IX therapies promise...
10/23/2024
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News
New Guidance Addresses Management of Patients With Congenital Hemophilia
10/09/2024
Jolynn Tumolo
New guidelines from the International Society on Thrombosis and Haemostasis strongly recommend prophylactic treatment over episodic for patients with severe and moderately severe hemophilia A and B, with conditional recommendations for other...
New guidelines from the International Society on Thrombosis and Haemostasis strongly recommend prophylactic treatment over episodic for patients with severe and moderately severe hemophilia A and B, with conditional recommendations for other...
New guidelines from the...
10/09/2024
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News
New 4F-PCC Proves Effective in Rapid Reversal of Anticoagulation for Urgent Surgery, Clinical Trial Finds
09/10/2024
Lisa Kuhns, PhD, MD
An investigational 4-factor prothrombin complex concentrate (4F-PCC) is as effective and safe as an FDA-approved 4F-PCC for rapidly reversing vitamin K antagonist (VKA) anticoagulation in patients requiring urgent surgery, according to a...
An investigational 4-factor prothrombin complex concentrate (4F-PCC) is as effective and safe as an FDA-approved 4F-PCC for rapidly reversing vitamin K antagonist (VKA) anticoagulation in patients requiring urgent surgery, according to a...
An investigational 4-factor...
09/10/2024
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News
Fitusiran Prophylaxis Shows Promise for Protection Against Bleeding for Patients With Hemophilia A or B
06/05/2024
Grace Taylor, MS, MA
A phase 3 study evaluated the efficacy and safety of fitusiran in males with hemophilia A or B who were receiving bypassing agent (BPA)/clotting factor concentrate (CFC) prophylaxis.
A phase 3 study evaluated the efficacy and safety of fitusiran in males with hemophilia A or B who were receiving bypassing agent (BPA)/clotting factor concentrate (CFC) prophylaxis.
A phase 3 study evaluated the...
06/05/2024
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News
Study Finds No Treatment-Related Adverse Events in Boys Treated With Purified FIX Concentrate
05/09/2024
Jolynn Tumolo
Purified factor IX (FIX) concentrate was effective in treating and preventing bleeding episodes in real-world pediatric patients 6 years and younger with hemophilia B, according to a study published in the Journal of Blood Medicine.
Purified factor IX (FIX) concentrate was effective in treating and preventing bleeding episodes in real-world pediatric patients 6 years and younger with hemophilia B, according to a study published in the Journal of Blood Medicine.
Purified factor IX (FIX)...
05/09/2024
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News
Rebalancing Coagulation Pathways and Human Factor 9 Gene Knock-In Strategy Identified for Hemophilia B
04/25/2024

Grace Taylor

Grace Taylor
A study published in Molecular Therapy Nucleic Acids highlights a treatment strategy for treating hemophilia B by combining rebalancing coagulation pathways and human factor 9 (hF9) gene knock-in (KI) using a lipid nanoparticle and...
A study published in Molecular Therapy Nucleic Acids highlights a treatment strategy for treating hemophilia B by combining rebalancing coagulation pathways and human factor 9 (hF9) gene knock-in (KI) using a lipid nanoparticle and...
A study published in Molecular...
04/25/2024
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News
Antibody Test Determines Eligibility for Hemophilia Gene Therapy
12/11/2023
Jolynn Tumolo
The US Food and Drug Administration’s recent approval of the AAV5 DetectCDx test marked the agency’s first-ever approval of a companion diagnostic test for a gene therapy product.
The US Food and Drug Administration’s recent approval of the AAV5 DetectCDx test marked the agency’s first-ever approval of a companion diagnostic test for a gene therapy product.
The US Food and Drug...
12/11/2023
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News
Patient Education on AAV Vectors for Hemophilia Essential to Prevent ‘Buyer’s Remorse’
11/10/2023
Jolynn Tumolo
Having long served as the model disorders for the development of gene therapy, hemophilia A (HA) and hemophilia B (HB) are currently benefitting from the role with the emergence of adeno-associated viral (AAV) vectors, according to a review...
Having long served as the model disorders for the development of gene therapy, hemophilia A (HA) and hemophilia B (HB) are currently benefitting from the role with the emergence of adeno-associated viral (AAV) vectors, according to a review...
Having long served as the model...
11/10/2023
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Behind the Bill

Behind the Bill
The Medicare Paradox: How Tariffs Could Undermine IRA Drug Pricing Reforms
04/23/2025
Katie Hayes, MJ
The Trump administration's recent announcement of national security investigations into pharmaceutical imports has set up a potential collision course with one of the most significant health care reforms in recent years. While the White...
The Trump administration's recent announcement of national security investigations into pharmaceutical imports has set up a potential collision course with one of the most significant health care reforms in recent years. While the White...
The Trump administration's...
04/23/2025
First Report Managed Care
Behind the Bill
The Bitter Pill, Now in Motion: Pharma Tariffs Move from Rhetoric to Reality
04/16/2025
Katie Hayes, MJ
Last week, I flagged the growing risk that tariffs could upend affordability in the generics market. This week, the Trump administration made it official: it’s launching national security investigations under Section 232 of the Trade...
Last week, I flagged the growing risk that tariffs could upend affordability in the generics market. This week, the Trump administration made it official: it’s launching national security investigations under Section 232 of the Trade...
Last week, I flagged the growing...
04/16/2025
First Report Managed Care
Behind the Bill
The Bitter Pill: How Tariffs Could Make Generics Less Affordable
04/09/2025
Katie Hayes, MJ
As President Donald Trump’s administration introduces a series of tariffs aimed at rebalancing trade and boosting US manufacturing, one sector in particular is watching closely: pharmaceuticals. While drugs themselves may not be directly...
As President Donald Trump’s administration introduces a series of tariffs aimed at rebalancing trade and boosting US manufacturing, one sector in particular is watching closely: pharmaceuticals. While drugs themselves may not be directly...
As President Donald Trump’s...
04/09/2025
First Report Managed Care
Behind the Bill
SCOTUS Takes on the Nondelegation Doctrine: Surprising Reactions and What They Mean for Agency Power
04/02/2025
Katie Hayes, MJ
The Supreme Court recently heard arguments in Federal Communication Commission (FCC) v Consumers’ Research, a case that I covered in February and one that could dramatically reshape federal agency authority through the nondelegation...
The Supreme Court recently heard arguments in Federal Communication Commission (FCC) v Consumers’ Research, a case that I covered in February and one that could dramatically reshape federal agency authority through the nondelegation...
The Supreme Court recently heard...
04/02/2025
First Report Managed Care
Behind the Bill
Dr Oz’s Prescription for Making Medicaid “Viable at Every Level”
03/26/2025
Katie Hayes, MJ
On Tuesday, March 25, 2025, the Senate Finance Committee voted to advance Dr Mehmet Oz in his confirmation as the next head of the Centers for Medicare and Medicaid Services (CMS).1 The full Senate vote is expected “soon” (whatever that...
On Tuesday, March 25, 2025, the Senate Finance Committee voted to advance Dr Mehmet Oz in his confirmation as the next head of the Centers for Medicare and Medicaid Services (CMS).1 The full Senate vote is expected “soon” (whatever that...
On Tuesday, March 25, 2025, the...
03/26/2025
First Report Managed Care
Behind the Bill
The $880 Billion Question Continues: Dr Oz's Confirmation and the Future of Medicaid
03/19/2025
Katie Hayes, MJ
Last week, I explored the $880 billion question facing Congress—whether lawmakers could achieve their budget goals without cutting Medicaid. This week, that question took center stage as Dr Mehmet Oz, President Trump's nominee to lead the...
Last week, I explored the $880 billion question facing Congress—whether lawmakers could achieve their budget goals without cutting Medicaid. This week, that question took center stage as Dr Mehmet Oz, President Trump's nominee to lead the...
Last week, I explored the $880...
03/19/2025
First Report Managed Care
Behind the Bill
The $880 Billion Question: Can Congress Cut Spending Without Touching Medicaid?
03/12/2025
Katie Hayes, MJ
I’d like to step away from administrative law for a moment to provide a quick update on Medicaid. With news coming from all sides, what does the future of Medicaid actually look like? The House of Representatives narrowly passed a budget...
I’d like to step away from administrative law for a moment to provide a quick update on Medicaid. With news coming from all sides, what does the future of Medicaid actually look like? The House of Representatives narrowly passed a budget...
I’d like to step away from...
03/12/2025
First Report Managed Care
Behind the Bill
RFK Jr’s Public Comment Ban: The Silent Shift in Health Care Rulemaking
03/05/2025
Katie Hayes, MJ
The erosion of administrative law continues, and with it, the dismantling of decades-long precedent. In June, the Supreme Court overturned a 40-year-old doctrine that allowed federal agencies to interpret their own ambiguous statutes. Later...
The erosion of administrative law continues, and with it, the dismantling of decades-long precedent. In June, the Supreme Court overturned a 40-year-old doctrine that allowed federal agencies to interpret their own ambiguous statutes. Later...
The erosion of administrative...
03/05/2025
First Report Managed Care
Behind the Bill
Prevention Over Pills? The First 2 Weeks of Health Care’s New Direction
02/26/2025
Katie Hayes, MJ
The dust has barely settled from Robert F Kennedy Jr’s confirmation as Secretary of Health and Human Services (HHS), but the changes are already coming fast and furious—a key theme of the Trump Administration’s actions within the last several...
The dust has barely settled from Robert F Kennedy Jr’s confirmation as Secretary of Health and Human Services (HHS), but the changes are already coming fast and furious—a key theme of the Trump Administration’s actions within the last several...
The dust has barely settled from...
02/26/2025
First Report Managed Care
Behind the Bill
The Nondelegation Doctrine: The Next Constitutional Showdown (Part 2)
02/19/2025
Katie Hayes, MJ
Last week, I explored the potential revival of the nondelegation doctrine through Federal Communication Commission v Consumers’ Research. Today, I want to examine what this could mean for health care regulation by considering the parallels...
Last week, I explored the potential revival of the nondelegation doctrine through Federal Communication Commission v Consumers’ Research. Today, I want to examine what this could mean for health care regulation by considering the parallels...
Last week, I explored the...
02/19/2025
First Report Managed Care

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News
Low Postoperative Bleeding Rates in Patients at Hemophilia Treatment Center
05/19/2023
Jolynn Tumolo
“We demonstrated that with comprehensive care and preoperative planning, persons with bleeding disorders can undergo elective major surgeries with risks of major bleeding complications similar to those of the general, nonbleeding disorder...
“We demonstrated that with comprehensive care and preoperative planning, persons with bleeding disorders can undergo elective major surgeries with risks of major bleeding complications similar to those of the general, nonbleeding disorder...
“We demonstrated that with...
05/19/2023
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News
Therapy Improves Type 2 Asthma Outcomes Regardless of Allergic Status
06/09/2023
Jolynn Tumolo
Researchers found that long-term treatment with dupilumab improved outcomes in patients with moderate-to-severe GINA-based type 2 asthma, regardless of allergic status.
Researchers found that long-term treatment with dupilumab improved outcomes in patients with moderate-to-severe GINA-based type 2 asthma, regardless of allergic status.
Researchers found that long-term...
06/09/2023
First Report Managed Care
News
Dupilumab Reduces COPD Exacerbations in Patients With Type 2 Inflammation
07/07/2023
Jolynn Tumolo
“In some patients with COPD, type 2 inflammation may increase exacerbation risk and may be indicated by elevated blood eosinophil counts,” said researchers. 
“In some patients with COPD, type 2 inflammation may increase exacerbation risk and may be indicated by elevated blood eosinophil counts,” said researchers. 
“In some patients with COPD,...
07/07/2023
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News
Exploring the Cost-Effectiveness of Acalabrutinib Regimens for Treatment-Naive CLL
07/31/2023
Julie Gould
Acalabrutinib monotherapy may be a cost-effective treatment option for Medicare patients with treatment-naïve chronic lymphocytic leukemia, according to recent findings.
Acalabrutinib monotherapy may be a cost-effective treatment option for Medicare patients with treatment-naïve chronic lymphocytic leukemia, according to recent findings.
Acalabrutinib monotherapy may be...
07/31/2023
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News
Timing and Cost of New Vaccines Vary by Virus and Health Insurance Status
08/25/2023
Julie Appleby
Vaccine season includes influenza, COVID-19, and the newly approved vaccines for RSV, prompting questions about who should receive which vaccine and when, as well as concerns about the cost of obtaining them.
Vaccine season includes influenza, COVID-19, and the newly approved vaccines for RSV, prompting questions about who should receive which vaccine and when, as well as concerns about the cost of obtaining them.
Vaccine season includes...
08/25/2023
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