The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.
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The production suspension will impact both the commercial and clinical trial supplies of Lutathera and Pluvicto in the United States and Canada.
Tracy Spencer, senior vice president at PSG, discusses what large, self-insured employers and plan sponsors want from their specialty drug benefit.
Centene is divesting both Magellan Rx and PANTHERx Rare and will exit the pharmacy benefit management space.
The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.
The FDA has made the labels consistent for combined hormonal contraceptives about the risk these products have to women who have or have had breast cancer.
UnitedHealthcare considers Aduhelm unproven and not medically necessary for treating Alzheimer’s disease.
The Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022; the PDUFA date is August 4, 2022.
Orphalan plans to launch Cuvrior in early 2023. It was approved to treat Wilson’s disease, which results in excess copper in the body.
The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.
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The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.
Lenvima is approved to treat thyroid cancer, renal cell carcinoma and in combination with Keytruda for metastatic kidney cancer.
Qelbree is the first new nonstimulant to be approved in 20 years.
The complete response letter identified the need for additional chemistry, manufacturing, and controls data related the drug product and manufacturing process.
The FDA’s Vaccines and Related Biological Products Advisory Committee has scheduled a meeting on June 7, 2022.
The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.
Moderna is also studying booster doses of the COVID-19 vaccine for all pediatric cohorts.
Javier Gonzalez, Pharm.D., Abarca’s chief growth and commercial officer, talks about Assura, the PBM’s net cost pricing solution, which provides more predictability to drug costs and guarantees an annual fixed cost.
Now called Camzyos, the therapy is first-in-class and treats the underlying cause of the disease. It is expected to be available next week.
Vivjoa is an oral therapy and the first for chronic yeast infections. It is expected to be available in the second quarter of 2022.
Ultomiris is the first approval for a long-acting C5 complement inhibitor for the treatment of generalized myasthenia gravis, a rare, chronic, autoimmune neuromuscular disease.
Pramod John, CEO, and Bhargav Raman, M.D., director, clinical product, at Vivio Health, discuss how their system can match patients to therapies based on data.
Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.
The FDA has set a Prescription Drug User Fee Act date for tremelimumab during the fourth quarter of 2022.
Higher than normal levels of nitrosamine have been detected. Long-term exposure to high amounts of nitrosamine can lead to cancer.
The FDA is seeking input from committee members about the phosphate lowering effect seen in trials for tenapanor, which now has the brand name of Xphozah.
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