Category: pharma & healthcare

FDA Moves One Step Closer To Switching An Oral Contraceptive From Prescription-Only To Over-The-Counter Status

Today, the FDA moved one step closer to approving the first OTC birth control pill in the US. Perrigo had applied for a switch from prescription-only to OTC status for its once-daily oral contraceptive named Opill. FDA could reach a final decision on t…

RNA Gymnastics: How Does Hepatitis Delta Virus Replicate?

Hepatitis D is the most severe of all viral hepatitis infections, leading to quick onset of liver scarring and liver cancer. The pathogen that causes the disease, hepatitis D virus, is a virus like no other. What follows is an overview of its intricate…

As Ads For Sports Betting Proliferate In U.S., Europe Clamps Down Due To Potential Risk Of Compulsive Gambling

Ads for gambling blanket the airwaves and social media sites. While the U.S. advertising blitz is in full swing, many nations in Europe are moving to place strict limits on promotions or abolish betting ads altogether.

A New Understanding Of Osteoarthritis: Synovial Inflammation Inhibits Cartilage Repair (Part 1)

This is the first of two stories describing recent progress in understanding the cause and potential treatment for osteoarthritis.

Supreme Court’s Dobbs Decision Blocks Non-Pregnant Females From Critical Medication For Lupus, Rheumatoid Arthritis, Other Diseases

The Dobbs decision blocks non-pregnant female patients from receiving medications, like methotrexate, used to treat their autoimmune diseases. This could be just the beginning of government overreach for girls, women, and their families.

Donanemab’s Data Look Promising, But It Won’t Lead To An Imminent Change In Medicare’s Severe Restrictions On Coverage Of Alzheimer’s Disease Biologics

Until lecanemab and donanemab are granted regular FDA approval it’s very unlikely there will be a change in CMS’s current severely restrictive coverage policy. Once approved CMS will be inclined to relax coverage limits. This said, upon approval unfett…

Donanemab’s Data Look Promising, But It Won’t Lead To An Imminent Change In Medicare’s Severe Restrictions On Coverage Of Alzheimer’s Disease Biologics

Until lecanemab and donanemab are granted regular FDA approval it’s very unlikely there will be a change in CMS’s current severely restrictive coverage policy. Once approved CMS will be inclined to relax coverage limits. This said, upon approval unfett…

Dutch Researchers Suggest Women Consider Waiting A Bit After Stopping The Pill Before Getting Pregnant

In a study published last month, Dutch researchers suggest that use of birth control pills near the time of conception may increase certain pregnancy risks. Specifically, use of oral contraceptives is associated with a modest increase in risk of preecl…

Gene Therapies Are Still Hampered By Substantial Delays Between Approval And Launch

Gene therapies are still hampered by substantial delays between their date of approval and the time they launch. And it isn’t simply a matter of not having a payment or reimbursement system in place. Manufacturing and patient preparation delays figure …

ICER’s Positive Cost-Effectiveness Assessment Lends Support For New Sickle Cell Disease Gene Therapies

The important takeaway is that these gene therapies can be cost-effective and don’t break the bank. Too often the discussion of a therapeutic’s price is fixated on eye-popping numbers and not value. It’s laudable that ICER has redirected us to the disc…