Tony Hagen

Many companies are pursuing interchangeable status.

Hemophilia A is seen as a male-only disease, but this study shows the extent to which female carriers also suffer from bleeding and joint problems related to reduced levels of clotting factors VIII.

The researchers concluded that delayed prophylaxis start with intermediate dose intensity of factor VIII prevents bleeds, but at a cost of more joint damaged and reduced health-related quality of life.

FDA has announced evidence-based changes that will allow more individuals to donate blood without increasing the risk of HIV infection.

Bowing to political and public pressure, insulin makers have slashed their prices. So far, insulin biosimilars haven’t had much of an effect on prices.

How long the gene therapies for hemophilia will keep factor levels high is unclear, said the authors of a review in the Annual Review of Medicine. Patients also need to be counseled that they can receive only one adeno-associated viral (AAV) vector in their lifetime.

Nonexclusive licensing of discoveries made at academic institutions would work to lower prices, say the writers of a recent opinion piece published in the New England Journal of Medicine. CMS price negotiation under the Inflation Reduction Act will not have any immediate effect on gene therapy prices and may never have.

CSL Behring's Hemgenix may have some competition. At least three gene therapies for hemophilia B are in development.

STAQ Pharma has stepped in to supply desmopressin nasal spray for people with hemophilia A or Type 1 von Willebrand disease. The company is also producing albuterol for children’s hospitals.

STAQ, a 503B outsourcing facility, started making desmopressin nasal spray after Ferring Pharmaceuticals suspended production nearly three years ago.

Hemgenix for hemophilia B is priced to cost $3.5 million per treatment. Roctavian for hemophilia A may be approved by the FDA in July and is likely to be priced to cost between $2 million and $3 million per treatment.

The patient groups say the insurer is cutting off access to important medications. The Tennessee Blues plans say many of the drugs that it excluded from coverage have zero utilization.

Patient groups say the insurer is cutting off access to important medications. The Tennessee Blues plan say many of the drugs that it excluded from coverage have zero utilization.

Pharmacy benefit managers say they exclude high-cost drugs and have alternatives on their formularies. Critics say exclusions narrow patient options and may put effective medication financially out of reach.

It took less than a year to develop the first COVID-19 vaccine, but an epidemic preparation group has said even more speed could be added and proposed setting 100 days as a goal for the development of future vaccines,

Some research has shown an association between flooding, which is becoming more common with climate change, and Clostridioides difficile infections.

As many as 10 Humira biosimilars may be on the U.S. market before 2023 is over. AbbVie has taken several steps to protect its revenues, including the launches of Skyrizi and Rinvoq.

Pradaxa (dabigatran) and Coumadin (warfarin) came out even in this randomized study. The Brazilian researchers who conducted the study said one explanation for the result is that use of Coumadin was exceptionally well managed because the patients were enrolled a study.

Korean study shows that depression, insomnia and anxiety add to the risk of atrial fibrillation among those with diabetes, according to a Korean study. Those mental health condition may affect the autonomic nervous system that regulates the heart. Bipolar disorder and schizophrenia did not increase the risk.

Animal, human and epidemiologic studies point to an association between alcohol consumption and atrial fibrillation. The association is especially strong with binge drinking.

Investigators also said right atrial enlargement was associated with greater left ventricular mass and volume, higher systolic pulmonary atrial pressure and more significant tricuspid regurgitation.

Researchers compared radiofrequency ablation, cryoballoon ablation and the thoracoscopic maze procedure. After adjustments for age and left atrium diameter, they found no prognostic differences among the treatment strategies for atrial fibrillation.

Past studies have linked epicardial fat to a variety of other heart problems, including diastolic dysfunction, atrial inflammation and atrial systolic function disorders.

The question of whether it is safe to switch among biosimilars, not just between biosimilars and the reference product, is coming more pertinent as the number of biosimilars on the market increases.

A phase 3 trial sponsored by the biosimilar maker shows that its candidate, temporarily named MYL-1601D, has the same immunogenicity, efficacy and safety levels as NovoLog, Novo Nordisk’s brand-name insulin aspart. Novolog and its authorized generic currently have the U.S. insulin aspart market to themselves.

Lack of an adherence may have been a factor. The Democratic Senate candidate stopped taking the medications he was prescribed after being diagnosed with atrial fibrillation in 2017.

In mouse and other studies, University of South Florida researchers traced the effects of cigarette smoke on cardiac acetylcholine-activated inward rectifier potassium current, known as the heart’s 'pacemaker.'

U.S. Preventive Services Task Force hasn't endorsed screening for atrial fibrillation. Findings from these two studies might factor into a reconsideration.

Samsung Bioepis executive Tom Newcomer’s touts the 10-year-old biosimilar company’s achievements as it gets ready to launch its Humira biosimilar, Hadlima.