Soleo Health will distribute Leqembi, the newly approved Alzheimer's therapy, to provider offices and infusion centers, as well as administer it across its own ambulatory infusions centers.
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New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.
Clarivate analysts have identified the treatments they forecast could deliver annual sales of more than $1 billion within five years. These include therapies for rare diseases, as well as HIV, Parkinson’s disease, Crohn’s disease, alopecia, and cancer.
Epinephrine (L-adrenaline) is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products.
The agency has assigned a Prescription Drug User Fee Act target action date of May 10, 2023, and plans to hold an advisory Committee
The supplemental BLA is based on data from a confirmatory phase 3 trial. The submission was made the same day Eisai/Biogen received accelerated approval.
Lecanemab, now with the brand name Leqembi, will launch with a wholesale acquisition cost of $26,500 a year.
Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.
Rozanolixizumab is a monoclonal antibody that addresses a different driver of generalized myasthenia gravis. An FDA decision is expected in the second quarter of 2023.
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
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Synergie Medication Collective, which launches this month, is focused on improving affordability and access to gene therapies, infusible cancer drugs and other medications administered in a clinical setting.
List prices of 450 medications have increased 5% overall at the beginning of 2023. More price hikes are expected.
CT-P13 SC is a subcutaneous formulation of Celltrion’s Inflectra, a biosimilar of Remicade. The BLA seeks approval to treat patients with inflammatory bowel disease.
Wegovy is a once-weekly prescription medication for obesity that has faced supply issues. Its manufacturer, Novo Nordisk, is increasing production capacity in 2023.
Hospira is calling one lot of vancomycin hydrochloride, an antibiotic to treat patients with serious infections caused by methicillin-resistant staphylococci.
If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.
An integrated approach helped Regence drive conversion to biosimilars with a 95% member utilization.
Olpruva is a new formulation of sodium phenylbutyrate to treat patients with urea cycle disorders, a genetic condition that causes ammonia to build up in the blood.
Among the best-read healthcare trend and PBM-related stories are ICER’s report on unsupported prices, fake drugs containing meth, an anti-tau drug that shows promise in Alzheimer’s, oncology docs say prior auth hurts patients, and satisfaction with PBMs declines.
Ublituximab, now with brand name Briumvi, is the first anti-CD20 monoclonal antibody approved for patients with multiple sclerosis that can be administered in a one-hour infusion twice-a-year.
Among the most-read product recall stories are those of amoxicillin, metformin, sodium bicarbonate Omnipod 5, and clopidogrel and atenolol.
Palovarotene is a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has requested additional information from clinical trials.
Among the most-read stories about PBMs include Transcarent and Prescryptive Health teaming up for employer pharmacy; Kroger Health ending agreement with Express Scripts; Mark Cuban Cost Plus Drugs teaming up with EmsanaRx and Vivio Health; and Abarca Health takes on a challenging implementation.
A decision by the FDA is expected by April 28, 2023, and, if approved, Harm Reduction Therapeutics will launch RiVive in early 2024.
Among the top safety stories this year are Genentech’s warning to Ocrevus label, FDA’s update to GnRH agonists, a study about JAK-inhibitor side effects, FDA’s warning about Prolia in kidney disease and safety issues related to the potential Alzheimer’s disease drug lecanemab.
Among the top-read FDA approval stories include the fast-acting Auvelity to treat major depressive disorder; an extended use for Mirena IUD; the first generic of Symbicort for asthma; Camzyos, a first-in-class treatment for obstructive hypertrophic cardiomyopathy; and Imbruvica’s expanded indication for children with chronic graft versus host disease.
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