FDA Approves Nipocalimab for Adult and Pediatric Myasthenia Gravis
The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive, Johnson & Johnson announced Wednesday. Nipocalimab is designed to block the immunoglobulin G (IgG) binding site on the neonatal Fc receptor (FcRn) to reduce […]
Side Benefit of Botulinum Toxin A? Reduced IOP in Hemifacial Spasm
Injection with botulinum toxin A (BTX-A) for hemifacial spasm (HFS) may have an additional benefit: decreasing unilateral eyelid spasms and intraocular pressure (IOP), according to a small Brazilian study. Mean IOP was 11 ± 3.42 mm Hg before treatment in the affected eye and 9 ± 2.98 mm Hg in the contralateral eye (P=0.012). Post-BTX-A […]
Subcutaneous Ocrelizumab Not Inferior to IV Infusion
MILAN — An investigational 10-minute subcutaneous injection of ocrelizumab (Ocrevus) was non-inferior to the established IV infusion formulation of the drug in multiple sclerosis (MS), the phase III OCARINA II trial showed. During the first 12 weeks of treatment, blood levels of ocrelizumab — measured as the area under the serum concentration time curve (AUC) […]
FDA OKs Another Injectable for Rare Kidney Disorder
Nedosiran (Rivfloza), a once-monthly RNA interference (RNAi) injection, gained FDA approval for certain patients with primary hyperoxaluria type 1 (PH1), drugmaker Novo Nordisk announced Monday. The lactate dehydrogenase A-directed small interfering RNA is indicated to lower urinary oxalate levels in patients ages 9 years and older with relatively preserved kidney function, defined as an eGFR […]
Ukraine’s Mobile Medical Teams Duck Rockets
VIENNA — After 20 years of battling an epidemic of HIV and hepatitis fueled by injection drug use, Tetiana Deshko, PhD, woke up February 24, 2022, to a whole new challenge as director of the Kyiv-based Alliance for Public Health, Ukraine — providing services to a country torn apart by invading Russian forces and bombers. […]
FDA Approves First Treatment for Geographic Atrophy Secondary to AMD
The FDA approved pegcetacoplan injection (Syfovre) as the first treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a statement from Apellis Pharmaceuticals. Primary support for the approval came from the randomized, sham-controlled DERBY and OAKS trials, which showed a 22% overall reduction in growth of GA with pegcetacoplan over 24 […]
Intratumoral Combo Shrinks Melanomas Refractory to Anti-PD-1
Intratumoral injection of an investigational agent, BO-112, combined with pembrolizumab (Keytruda) demonstrated promising efficacy in certain patients with advanced melanoma refractory to anti-PD-1-based therapy, according to results from a single-arm phase II trial. Ten of 40 evaluable patients responded to treatment — six partial and four complete responses — meeting the study’s primary endpoint of […]
New type of earthquake discovered
A Canadian-German research team have documented a new type of earthquake in an injection environment in British Columbia, Canada. Unlike conventional earthquakes of the same magnitude, they are slower and last longer. The events are a new type of induced earthquake that have been triggered by hydraulic fracturing, a method used in western Canada for […]
FDA Warns on Needle-Free Injection Devices for Facial Fillers
The FDA issued a safety alert on Friday warning against the use of needle-free injection devices for lip or facial fillers — such as hyaluron pens for injecting hyaluronic acid — as these devices are unapproved and have been linked with serious injuries. Patients “may not be aware of the serious adverse events that have […]
Clearing the Hurdles to Safe Injection Facilities
Rhode Island authorized the first ever safe injection facilities (SIFs) or “harm reduction centers” in the U.S. last week, but many states still face an uphill battle to opening their own sites. The bill calls for launching a two-year pilot program which would permit harm reduction centers or SIFs to serve as a community resource, […]