The lots could contain trace amounts of sodium, silicon, chromium, aluminum, and cellulose, which could result in irritation or infection and has the potential to block blood vessels in the heart, lungs, or brain.
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The FDA has granted first approval for cartridges for use with Apokyn for Parkinson’s. Other approvals include: a generic of anticancer therapy Vidaza, the antibacterial Erythrocin, and the anti-epilepsy therapy Lamictal.
B. Braun is recalling five lots because of fluid leakage, which could expose patients to a bacterial or fungal infection.
This expands commercial coverage to 118 million lives and Medicare coverage to 7.1 million lives.
The company will distribute nalmefene for no profit, which is part of the company’s bankruptcy filing and settlement with states.
Supplemental applications have been submitted for the cancer therapies Nubeqa and Tibsovo, the gout treatment Krystexxa, and Oxlumo, which treats a rare disease.
Besremi is included as an option to treat the rare blood disorder polycythemia vera regardless of treatment history and for use in both low- and high-risk settings.
With a PDUFA date of Aug. 4, 2022, the FDA plans to hold an advisory committee meeting on resubmitted data for Nuplazid in patients with Alzheimer's disease who have psychosis.
Aadi Bioscience recently launched Fyarro, the first FDA-approved therapy to treat an ultra-rare sarcoma.
Generics are now available for the three therapies: Cystadane, Selzentry, and AmBisome.
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This is the first generic available for Revlimid in the United States.
The FDA cited issues related to the compatibility of lenacapavir and the vial used. The agency has not requested new clinical studies.
A total of 28 lots have been recalled because of a high rate of allergic reactions.
Over time, Egaten, an antiparasitic, can increase the QTc interval, resulting in a heart rhythm condition that can cause chaotic heartbeats.
Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.
Once approved, the insulins will be available to patients for no more than $30 per vial.
Vonjo is the first treatment first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
FDA approved Legend Biotech’s chimeric antigen receptor T-cell (CAR-T) treatment, Carvykti (ciltacabtagene autoleucel; cilta- cel), to treat relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy.
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
Agency says evidence points to Evusheld being more effective against omicron variants if doses are doubled.
The new indication for reducing the risk of cardiovascular death and hospitalization for heart failure is expected to boost Jardiance’s sales further. Revenue for the drug jumped 38% in 2021 to reach nearly $432 million globally.
This guidance discusses that individuals 12 years and older can receive the second dose of the Pfizer-BioNTech vaccine 3-8 weeks after the first. Additionally, the interval for those 18 years and older for Moderna is 4-8 weeks.
Sanofi and GSK today announce will try to get approval from the FDA and the European Medicines Agency (EMA) for their COVID-19 vaccine, entering a crowded market.
Pyrukynd, developed by Agios Pharmaceuticals, is a PK activator and the first in this drug class. The company is also awaiting approval by the European Medicines Agency, and a decision is expected by the end of 2022.
The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot.
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