The labeling of Trikafta, which treats cystic fibrosis, has been updated to warn about the possibility of liver failure that could lead to the need for transplantation.
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Talicia treats H. pylori infection, a risk factor for stomach cancer; Twirla is a hormonal contraceptive.
Merck plans to seek emergency use authorization for molnupiravir as the first oral treatment for COVID-19.
Three products, including Pfizer’s smoking cessation product Chantix, have been removed because generics are now available.
AstraZeneca’s long-acting antibody combination has been shown to reduce the risk of developing symptomatic infection.
Data show that the vaccine was 94% effective against moderate infection and 100% effective against severe disease.
Tecartus is the first CAR T-cell therapy approved to treat adults with relapsed or refractory ALL.
The labeling for selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs) now must include information about sexual side effects in the warning and precautions and patient counseling sections.
Aetna, Cigna and UnitedHealthcare are enhancing their Medicare pharmacy benefits, including offering insulin for a copay of no more than $35 for a 30-day supply.
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Given together, bamlanivimab and etesevimab have an emergency use authorization from the FDA to both treat COVID-19 and prevent infection in those who have been exposed.
Livmarli is the first drug approved for Alagille syndrome.
Effective Oct. 1, 2021, Aetna has added several cancer drugs to its formulary and has updated exclusions and nonpreferred products.
Comprehensive medication management aided by AI clinical decision support can result in a large return on investment in a high-risk population. In this study, every dollar that was invested resulted in $12 in savings or cost avoidance.
Trudhesa was approved in September to treat migraine.
The company has also launched a website for patients affected by hereditary angioedema, a rare genetic disorder.
Half of the 14 oncology indications approved in the second quarter were accelerated approvals.
This is the seventh approval for Erbitux and the only anti-EGFR antibody approved for this indication.
The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.
The PDUFA target action date for the FDA decision is Jan. 30, 2022.
Data is being presented at the 10th Annual IDWeek Virtual Conference, September 29 to October 3.
AbbVie’s Qulipta is a once-daily oral to prevent migraines in adults.
The companies plan to request an emergency use authorization in a few weeks.
The companies are seeking accelerated approval based on the surrogate end point of beta amyloid reduction.
The flu program is the first in programs leveraging BioNTech’s mRNA technology for vaccines for other respiratory viruses, oncology, and genetic diseases.
Effective Jan. 1 2022, the move brings the price to 2008 levels.
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