Tony Hagen

Some study results tempered enthusiasm for one digital therapeutic but others are showing promising if early results.

Studies conducted in Taiwan and the United Kingdom have added to. the evidence that inherited genes play a prominent role in the development of treatment-resistant depression.

Spravato is a derivative of the anesthetic ketamine.

The FDA rejected an application to approve MDMA, also known as ecstasy, as a treatment for PTSD. Next up among the psychedelics vying for FDA approval: psilocybin for treatment resistant depression.

Biosimilars generally enter the market priced at roughly 50% of the amount of their reference drugs.

The market for biosimilars seems to be improving, partly because of provisions in the Bipartisan Budget Act of 2018 and the Inflation Reduction Act of 2022.

Pharmacy benefit managers (PBMs) are slowly coming around and putting biosimilars on their formularies. IQVIA estimates that the dearth of a Humira (adalimumab) biosimilars last year cost patients and employers cumulatively $6 billion.

An updated draft guidance says that promotional materials that suggest a biosimilar or reference product is superior “are likely to be false or misleading.” The agency has also warned against making comparisons between biosimilars and those with the interchangeable designation.

The authors of an article about relatively low biosimilar use by people with inflammatory bowel disease have suggestions for how to mitigage the nocebo effect.

Research published in JAMA Health Forum shows that biosimilar savings have not trickled down to out-of-pocket savings for patients.

Ten biosimilars to Humira are now on the market, but AbbVie’s Skyrizi and Rinvoq are soaking up revenues as Humira’s sales fall off.

But Amgen and Sandoz are in a patent fight over the launching of Sandoz's biosimilars to the bone-building drugs.

The market for Humira biosimilars may be shrinking as AbbVie works to boost prescriptions for its next-generation anti-inflammatories, Skyrizi (risankizumab) and Rinvoq (upadacitinib).

There is no vaccine against the hepatitis C virus. A subscription-like payment model may help overcome some of the cost issues posed by direct-acting antivirals.

Acceptance is greater in oncology than in other specialties.

Two possibly curative gene therapies for the disease, which disproportionately affects Black people, are under consideration by the FDA.

The National Bleeding Disorders Foundation (NBDF) has joined a petition demanding that Payer Matrix stop representing itself as a patient advocacy organization.

Despite positive safety and quality of life results for FEIBA, the emergency of Hemlibra created difficulties for the FEIBA study and resulted in it being halted.

Joe Pugliese, president and CEO of the patient advocacy group Hemophilia Alliance, discusses recent announcements by manufacturers of two ultra-expensive gene therapies for hemophilia that they will offer payers partial or full reimbursement if patients fail on their therapies.

BioMarin Pharmaceutical and CSL Behring are offering valu\ed-based contracts for their hemophilia gene therapies.

The British cost-effectiveness agency said the evidence from a pivotal clinical trial wasn't strong enough to clarify Hemgenix's effectiveness relative to other therapies or satisfy concerns about its long-term durability.

University of Pittsburgh’s Margaret Ragni, M.D., M.P.H., discussed fitusiran, the investigational small interfering RNA (siRNA) therapeutic, with Managed Healthcare Executive and also some of the possible limitations of gene therapy for hemophilia.

A yearlong study of the newly approved half-life extender showed no evidence of factor VIII inhibitors.

Emissions from healthcare facilities contribute to climate change, and climate change, in turn, is presenting new challenges for healthcare.

Promising results were reported in The Lancet and The Lancet Haematology.

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.