The companies plan to request an emergency use authorization in a few weeks.
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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.
Prices paid by Veterans Affairs were the lowest and were 50% to 60% below list prices.
The FDA assigned a Prescription Drug User Fee Act goal date of May 28, 2022.
Repatha is now available for children 10 and older to lower low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia.
The diabetes therapy is being recalled because of a lack of potency.
Amgen’s Biosimilar Trend Report finds that biosimilars have been introduced at a price that is generally 15% to 37% lower than the reference product.
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Shifting cancer patients to the physician setting for administration of cancer therapies could save insurers $1.28 billion.
Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations.
This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.
Keytruda plus chemotherapy reduces the risk of death by 27% in patients with triple-negative breast cancer.
People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster.
Dr. Reddy’s has also launched a generic of Librax. Recent generic approvals include clindamycin phosphate foam and sodium acetate.
Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.
Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.
The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.
In trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.
Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.
Effective October 1, 2021, CMS will reimburse for the infusion product when dispensed in the outpatient setting.
The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.
The vaccines advisory committee voted late on Friday, September 17, 2021, to provide emergency authorization of Pfizer’s COVID-19 vaccine as a booster for those over the age of 65, as well as for those at high risk of developing severe disease.
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