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6 days ago | 
pharmacytimes.com | Luke Halpern
NewsArticleApril 18, 2025Author(s): Dupilumab (Dupixent) is now FDA-approved for CSU in patients 12+ unresponsive to H1 antihistamines. This approval marks the first new CSU treatment in over a decade, offering new management options. Kenneth Mendez emphasizes the significant impact of this approval on patients' quality of life and disease control.
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6 days ago | 
pharmacytimes.com | Luke Halpern
Lepodisiran (Eli Lilly), an investigational small interfering RNA (siRNA) therapy designed to reduce the production of lipoprotein(a) [Lp(a)], meaningfully reduced Lp(a) levels by an average of 93.9% over a 60-to-180-day period in adults with high Lp(a) levels following treatment at the highest tested dose of 400 mg, according to results from the phase 2 ALPACA (NCT05565742) trial that were presented at the American College of Cardiology 2025 Scientific Sessions.1-3 The ALPACA study, a...
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6 days ago | 
pharmacytimes.com | Luke Halpern |Alexandra Gerlach
Executive Order Advances Price Transparency EffortsAs part of the "Make America Healthy Again" movement, President Donald J. Trump signed an executive order (EO) to enforce stricter price transparency standards in the health care industry to help lower costs for Americans.
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1 week ago | 
pharmacytimes.com | Luke Halpern
Investigators of a randomized clinical trial (NCT02951234) that evaluated intravenous immunoglobulin (IVIG)-only treatment for patients with Kawasaki disease (KD) presenting with coronary artery lesions (CALs) found that the addition of high-dose aspirin did not play a meaningful role in managing CALs in this patient population.
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1 week ago | 
pharmacytimes.com | Luke Halpern
MIR 19 (siR-7-EM/KK-46), a small interfering RNA (siRNA) inhaled treatment targeting SARS-CoV-2—the virus that causes COVID-19—was found to meaningfully decrease the progression to moderate or severe disease in outpatients with mild COVID-19 while being well-tolerated, according to the results of an open-label, randomized, controlled multicenter phase 2b-3 clinical trial (NCT05783206) published in Allergy.1,2 Prior Research Into MIR 19 Finds Effectiveness As COVID-19 remains a dangerous...
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1 week ago | 
pharmacytimes.com | Luke Halpern
The FDA has granted orphan drug designation (ODD) to CK0801, an allogeneic T regulatory (Treg) cell therapy developed by Cellenkos Inc for the treatment of aplastic anemia.1 The ODD allows for expedited development of treatments for rare diseases;2 with an incidence of 1 to 2.3 per million in the US and a prevalence of 5000 patients, CK0801 is poised to transform treatment of patients with this hematologic condition.1 "Receiving ODD for CK0801 in aplastic anemia underscores the importance of...
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1 week ago | 
pharmacytimes.com | Luke Halpern
Little to no association is present between receiving pneumococcal conjugate vaccine 13 (PCV13) and severity of outcomes due to COVID-19 in older patients with COVID-19, according to the results of a case-control, observational study conducted by investigators and published in Vaccine: X.1Lower respiratory tract infections (LRTIs) are a common complication of infection with Streptococcus pneumoniae, which causes significant mortality across the world.
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1 week ago | 
neurologylive.com | Lauren B. Krupp |Isabella Ciccone |Luke Halpern
WATCH TIME: 3 minutes"We now have therapies that are highly effective, and since young people with MS relapse or have clinical attacks more frequently than older people with MS, it's very important to get those therapies on board quickly."Pediatric multiple sclerosis (MS) is a chronic autoimmune disorder affecting the central nervous system, with onset occurring before the age of 18 years.
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1 week ago | 
pharmacytimes.com | Luke Halpern
The FDA granted regulatory approval to efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo; argenx) prefilled syringe for self-injection for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and those with chronic inflammatory demyelinating polyneuropathy (CIDP), according to a news release from Halozyme Therapeutics.1 Prefilled efgartigimod alfa and hyaluronidase-qvfc was approved for use as a 20-to-30-second...
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1 week ago | 
pharmacytimes.com | Luke Halpern
Results from the phase 2b PURSUIT (NCT6173570) clinical trial studying AZD0780 (AstraZeneca) have indicated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care statin therapy compared with placebo, according to a news release from AstraZeneca and a study published in JACC Journals.1-3 AZD0780, an investigational once-daily oral PCSK9 inhibitor for patients not currently reaching their LDL-C lowering goal despite...
