Denise Myshko

Newer treatments, including targeted and immunotherapies, have contributed to an increase in five-year survival rates for patients with some cancers.

New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.

The FDA ends the week with the approval of the Alzheimer’s medication lecanemab. Two other approvals include: Olpruva for urea cycle disorders and Wegovy for weight loss in teens. The agency has also accepted several applications, including Genentech’s second bispecific antibody, glofitamab, for blood cancer, UCB’s second application for generalized myasthenia gravis, and a therapy RSV prevention in infants. Two companies have submitted applications: Celltrion for a new formulation of infliximab and Orasis for blurry vision treatment.

An integrated approach helped Regence drive conversion to biosimilars with a 95% member utilization.

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.

In a busy week for FDA approvals, the agency cleared several first in class therapies: a treatment for HIV-1 and for follicular lymphoma. Other approvals include: Tymlos for osteoporosis in men; Vraylar for major depressive disorder; Cytalux to identify lung cancer during surgery. In COVID-19 news, the agency approved Actemra for hospitalized patients. The FDA has also accepted a sBLA for Padcev, Keytruda combo for urothelial cancer.

ICER analysts remain uncertain about using amyloid removal as a surrogate marker for clinical benefit in Alzheimer’s disease.

ICER analysts remain uncertain about using amyloid removal as a surrogate marker for clinical benefit in Alzheimer’s disease.

The monoclonal antibodies that treat patients with multiple sclerosis would have to be priced more than 50% lower to meet the common standards of cost-effectiveness, according to the Institute for Clinical and Economic Review.

The monoclonal antibodies that treat patients with multiple sclerosis would have to be priced more than 50% lower to meet the common standards of cost-effectiveness, according to the Institute for Clinical and Economic Review.

Smaller and midsize pharmacy benefit managers are taking on Optum Rx, CVS Caremark and Express Scripts. They say they have better technology and are more transparent about their pricing.

In COVID-19 news, the FDA granted fast track designation to COVID-19-flu vaccine combo. The FDA has approved the first gene therapy for bladder cancer, an 8th biosimilar referencing Humira, granted accelerated approval for KRAS-mutated lung cancer therapy, and approved Iyuzeh to reduce intraocular pressure. The agency also extended review of Lynparza/abiraterone combination for prostate cancer. In addition, two companies have submitted applications: Soligenix for a novel therapy for cutaneous T-cell lymphoma and AbbVie for Linzess in children and adolescents.

Prescryptive will offer a subscription-based program for employers that aims to provide a more predictable benefit for companies and their employees.

The Medicare Part D Senior Savings Model — a CMS effort to test $35 copays for insulin — led to lowered total costs for beneficiaries.

Moderna is developing an individualized cancer vaccine that uses mRNA technology to specifically target that person’s cancer.

This isn’t the first time pharmacy benefit managers (PBMs) have been ensnared in controversy. PBMs were first created in the 1960s to help insurance companies manage and administer claims for prescription drugs. Over time, they took on the roles of claims adjudication, rebate negotiation and benefit design.

Smaller and midsize pharmacy benefit managers are taking on Optum Rx, CVS Caremark and Express Scripts. They say they have better technology and are more transparent about their pricing.

Magellan Rx predicts oncology and high-cost rare disease treatments will continue to drive medical pharmacy spend in commercial, Medicaid and Medicare.

The acquisition provides Biocon Biologics with eight commercial biosimilars, and is part of Viatris’ efforts to pay down debt related to phase 1 research and the company’s acquisition of two ophthalmology businesses.

In COVID-19 news, the FDA has expanded the updated bivalent vaccines EUA to children. The FDA has requested athe removal of Pepaxto indication for multiple myeloma. Regulators have also accepted several applications for: Biogen’s Actemra biosimilar, Pfizer’s RSV vaccine, a resubmitted BLA for Fabry disease. Two companies — Janssen’s and Alnylam — have submitted new applications.

Oncopeptides disagrees with the FDA about Pepaxto and will make a decision about next steps by the end of the first quarter of 2023.

Health insurance premiums, especially in the ACA Marketplace, could increase if the federal government ends purchasing of COVID-19 vaccines and boosters.

Seven of the 10 top selling drugs with high price increases lack the clinical evidence to justify those increases.

Seven of the 10 top selling drugs with high price increases lack the clinical evidence to justify those increases.

The APOE gene is known for its association in Alzheimer’s disease. Investigators are beginning to understand its role in age-related macular degeneration and other eye diseases.

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.

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.

In an umbrella review — a review of reviews — investigators found that so far, studies of ocular biomarkers to diagnose Alzheimer’s disease had important limitations. Longitudinal studies that use artificial intelligence could perhaps identify ocular biomarkers, the researchers suggest.

This week, the FDA made two approvals, the first-ever microbiota product and a second indication for Brexafemme, and issued a CRL for a therapy for brain metastasis from neuroblastoma. The regulatory agency also granted priority review for a Duchenne gene therapy, and accepted three applications: for a cutaneous T-cell lymphoma therapy, for an antibiotic for drug-resistant infections and Evkeeza for children with rare high cholesterol. Additionally, Genentech has withdrawn Tecentriq’s indication for bladder cancer and Aldeyra has submitted an NDA for the novel dry eye therapy reproxalap.

In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.