Progression Independent of Relapse Activity in Pediatric-Onset MS
Pediatric-onset multiple sclerosis (MS) patients showed progression independent of relapse activity (PIRA) even when they were relatively young, a prospective cohort study found. Confirmed PIRA events within 48 weeks of baseline occurred in 40.4% of pediatric-onset MS patients and were more frequent in older-onset groups, reported Maria Pia Amato, MD, of the University of Florence […]
Clinical Challenges: Determining When to Stop MS Therapy as Patients Age
Stopping multiple sclerosis (MS) treatment as patients age can be a fraught decision, but there are some signposts to help guide the way. This neurological disease of inflammatory damage to the brain most commonly starts in the second or third decade of life, and then by the fifth decade patients see declines in the frequency […]
Path to Multiple Sclerosis Cure on the Horizon
MILAN — A path to a cure for multiple sclerosis (MS) may be on the horizon, a top MS researcher suggested. The field faces a great opportunity to advance from suppressing the disease to curing it, said Stephen Hauser, MD, of the University of California San Francisco, in the keynote speech at the joint meeting […]
FDA Relents, Approves Novel Antidepressant After Many Rejections
After multiple prior rejections, gepirone hydrochloride extended-release (ER; Exxua) gained FDA approval for the treatment of major depressive disorder (MDD) in adults, drugmaker Fabre-Kramer Pharmaceuticals announced. Gepirone ER is the first approved antidepressant that selectively targets the serotonin 1A receptor, which regulates mood and emotion. The drug was approved based on data from two 8-week […]
CDC Details Multidrug-Resistant TB Outbreak in an Unlikely Spot
An outbreak of multidrug-resistant tuberculosis (TB) developed in Kansas in November 2021, and included multiple children who were born in the U.S. and became infected in the state, CDC researchers reported. The outbreak involved 13 people across four households in Kansas City and spanned 1 year. While a majority of the seven adults identified were […]
First Multiple Sclerosis Biosimilar Approved
The first biosimilar for multiple sclerosis (MS) was approved, the FDA announced late Thursday. Natalizumab-sztn (Tyruko) was approved as a biosimilar to natalizumab (Tysabri) injection to treat clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS, the agency said. Like its reference biologic, natalizumab-sztn (previously called PB006) also was approved to treat certain adult […]
Stem Cell Medical Tourism Leads to Meningitis in MS Patient
A woman with multiple sclerosis (MS) who had intrathecal injections of umbilical cord stem cells in Mexico ended up with a severe Mycobacterium abscessus infection that took weeks to identify and treat, according to a case study. In October 2022, the woman in her 30s traveled to Baja California, Mexico, and received two lumbar punctures […]
Another Online SARMs Retailer Gets a Warning From the FDA
The FDA issued a warning letter to an online retailer selling multiple selective androgen receptor modulators (SARMs) earlier this month, in an ongoing effort to curb their use in consumers, the agency said. This recent letter advised a California-based company, known as Warrior Labz SARMS, and its owner, Jeremy Brown, to stop actively marketing SARMs […]
Tainted ‘Male Enhancement’ Pills; Green Card Freeze Hits Nursing; Monkeypox Rebounds
Note that some links may require subscriptions. The FDA issued multiple new warnings over tainted sexual enhancement products that contain “potentially harmful hidden ingredients,” some of which are found in prescription drugs. Private equity-backed Envision Healthcare filed for bankruptcy, but a group of emergency room doctors plans to keep suing the controversial staffing firm anyway. […]
Anti-CD20 Agent Gains Approval for Multiple Sclerosis
Ublituximab (Briumvi), a monoclonal antibody targeting CD20, was approved for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, TG Therapeutics announced. The FDA’s decision was based on two identical phase III trials of people with relapsing MS, ULTIMATE I and ULTIMATE II. At 96 weeks, ublituximab […]