TauRx’s oral anti-tau therapy HMTM has shown in a phase 3 trial that it can stabilize cognitive decline in patients with Alzheimer’s disease.
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Cigna and Express Scripts have not yet made a decision about which of the Humira biosimilars will be included but they will evaluate all products in the coming months.
A Prescription Drug User Fee Act action date for pegunigalsidase alfa is set for May 9, 2023.
If approved, clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus.
In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.
SUL-DUR is a targeted antibiotic designed to treat serious drug-resistant infections. The target PDUFA date is May 29, 2023, and the FDA plans to hold an advisory committee meeting to discuss this application.
Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.
I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.
Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.
Rebyota is the first fecal microbiota product to prevent recurrence of C. diff infection, a serious and potentially life-threatening disease.
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Doctors surveyed by the Association for Clinical Oncology said payer prior authorization can cause disease progression and loss of life.
Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.
If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.
A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.
If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.
If approved, SRP-9001 (delandistrogene moxeparvovec) would be the first gene therapy for Duchenne. The FDA action date is May 29, 2023.
An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.
The reference to “maximum fair price” in the act bodes poorly for manufacturers and suggests more of a take-it-or-leave-it situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price.
Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It is administered by intravenous infusion once daily for 14 consecutive days.
An FDA decision on Takeda’s dengue vaccine TAK-003 is expected within six months.
Adderall pills containing methamphetamine and oxycodone pills containing fentanyl have been among the fake pills the DEA and investigators have confiscated.
Hemgenix is the first one-time gene therapy treatment for adults with hemophilia B. It will have a list price of $3.5 million.
An FDA review has found that Prolia can result in low calcium levels in the blood in patients with advanced kidney disease and can lead to hospitalization and death.
A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.
The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.
If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.
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