In a research letter published in JAMA Health Forum, researchers say most of the cost figures for Aduhelm have left out the additional MRI scans and other services that will be required because the drug is associated with the development of amyloid-related imaging abnormalities (ARIAs).
Problems with N-nitrosodimethylamine (NDMA)-contaminated metformin were identified by the FDA in 2020. Viona Pharmaceuticals announced in earlier this month that it was recalling 23 lots of the popular diabetes medication.
Leo Pharma's Adbry (tralokinumab-ldrm) is the second, FDA-approved biologic for atopic dermatitis. Dupixent (dupilumab) was the first.
CMS has proposed covering the anti-amyloid treatment only if the person taking it is enrolled in a clinical trial.
Smaller doses are recommended for people with moderate renal impairment and the treatment should not be taken by people with serious kidney disease. There are also drug interactions to be aware of because Paxlovid is an inhibitor of CYP3A.
Lecanemab and donanemab, monoclonal antibodies for Alzheimer’s, are on the list of drugs in late-stage development that Clarivate analysts will have annual sales of a $1 billion or more in the next five years.
Leqvio (inclisiran) is the first small interfering RNA therapy approved to lower LDL cholesterol in certain adults at risk for life-threatening cardiovascular events.
But Paxlovid and molnupiravir will be available only at certain Walmart and Sam’s Club locations.
A review of real-world data from Israel didn't show any increase risk of myocardities or pericarditis.
ICER's analysis is slated to include two as-yet unapproved monoclonal antibody treatments, donanemab and lecanemab, as well as Aduhelm (aducanumab).
The FDA has approved Amgen and AstraZeneca’s Tezspire (tezepelumab-akko) for severe asthma. But the drug may have limited uptake in the near term, according to one analyst.
News about counterfeit versions of Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) and Descovy (emtricitabine, tenofovir alafemamide) and the pause in the REMS program for clozapine were among the best read articles of 2021.
Our best read stories about formularies include news about 2022 formularies from CVS Caremark and Express Scripts.
News about interchangeable Semglee (insulin glargine-yfgn) was among the most read in 2021.
Apotex's importation of Chantix (varenicline) and Express Scripts' formulary exclusions were among the best read articles this year that didn't concern COVID-19.
The FDA's warning about Xeljanz (tofacitinib) and other JAK inhiitors and the extension of its review of Janssen's CAR T therapy for multiple myeloma were among the best read articles about the agency in 2021.
The attention-getting articles about COVID-19 included news about Pfizer's booster and the FDA's rejection Zyesami (aviptadil) for treatment of COVID-19-related respiratory failure.
The approval of the generic version of smoking-cessation drug Chantix (varenicline) garnered a lot of attention as did the OKs of Besremi (ropeginterferon alfa-2b-njft), a treatment for polycythemia vera, and Trudhesa (dihydroergotamine mesylate), a nasal spray for acute treatment of migraines.
Reporting of PRO in oncology clinical trials increased after standards from ISOQOL and others were published in 2013.
This is the Areva's second importation of bupivacaine this year.
The FDA has set a Prescription Drug User Fee Act goal date of Sept. 28, 2022.
During the period 2015 to 2020, if a proposed policy that increases Medicaid rebates for drugs with accelerated approvals had been enacted, up to $5.2 billion could have been saved.
Dr. Reddy’s launches generics of Diovan and venlafaxine ER, Apotex launches generic atropine sulfate solution, and Teva launches generic of Epiduo Forte.
Because of a COVID-19 related shortage, facilities may not have immediate access to Actemra, which is required as part of the REMS programs for CAR T-cell therapies.
