Denise Myshko

OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first PBM to make public its plans for the seven Humira biosimilars that could be introduced in 2023.

If approved, Xphozah will be the first phosphate absorption inhibitor for adults with chronic kidney disease who are on dialysis. An FDA decision is expected within 30 days.

OptumRx now requires prior authorization for 16 products, including 11 that are used to treat patients with diabetes.

The FDA approved several new therapies for cancers, including the combination of Imfinzi and Imjudo to treat lung cancer, Libtayo for second indication in lung cancer, and Adcetris for younger patients with Hodgkin lymphoma. In COVID-19 news, the agency issued an EUA for Kineret for hospitalized, but indicated bebtelovimab does not neutralize new omicron subvariants. The regulatory agency also accepted NDAs for a Parkinson’s disease therapy and for a therapy used for stem cell mobilization.

A 10-day implementation has given the team at Abarca Health the opportunity to challenge how they manage implementations in general.

Snezana Mahon, Pharm.D., Transcarent’s chief operating officer, discusses the company’s efforts to provide a seamless and interconnected pharmacy ecosystem.

The regulatory agency has added the risk of rare skin infections to the warnings and precautions section of the labeling for amoxicillin products.

The greatest reductions were seen in girls who were vaccinated when they were adolescents, with up to 73% reduction in cervical pre-cancerous lesions.

The FDA has approved a hepatitis B therapy for adolescents and an oral MEK inhibitor to treat blood cancers. The regulatory agency has granted priority review for an adult RSV vaccine but extended the review for a Pompe disease therapy. Additionally, CytoDyn has withdrawn its BLA for an HIV therapy.

Expanding pharmacist prescriber authority for HIV PrEP medications significantly increased PrEP use.

NIH researchers have created a 3D map of DNA within human retina cells and identified new gene variants that could be risk factors for age-related macular degeneration and glaucoma.

Wendy Barnes and Mark Campbell of RxBenefits discuss the company’s survey, which finds employers are curious about solutions to manage both specialty drug spend and the potential volatility that comes with employees who may be diagnosed with cancer and other high-dollar conditions.

A bioengineered corneal implant made with collagen from pig’s skin could be an alternative to human transplants for those with keratoconus, a rare condition that can lead to blurry vision and blindness.

Mikkael A. Sekeres, M.D., University of Miami Health System, discusses his latest book Drugs and the FDA and the use of accelerated approvals based on surrogate endpoints.

For patients with dry eyes, a cross-study comparison finds Tyrvaya may produce more natural tears than Xiidra.

A study of Oregon pharmacies finds there is significant disparities in reimbursement between the pharmacies, particularly in already disadvantaged communities.

The FDA approved two new novel cancer treatments: a bispecific antibody for multiple myeloma and a regimen of two drugs for liver cancer. The agency also granted priority review to two therapies. One is a novel therapy for C. difficile and the other is for a acute myeloid leukemia drug. The FDA has postponed an advisory committee meeting for an OTC birth control pill and accepted an NDA for new dry eye therapy. Additionally, Genmab submitted applications for a bispecific therapy for large B-cell lymphoma.

Renee Dua, M.D., chief strategy officer at Renee, discusses the digital health assistant and its subscription-based services for generic drugs.

One of the drivers of a lowered payer satisfaction is the public perception of PBMs, said Morgan Lee, Ph.D., of PSG.

In COVID-19 news, the FDA issued an EUA for Novavax booster. The agency has extended review time for new ALS therapy and accepted a supplemental NDA for Camzyos. Additionlly, the FDA granted six months pediatric exclusivity for Eylea.

Most of the brands that have been removed fall into the categories of hormonal therapies, pain and inflammatory conditions or skin conditions or high blood pressure/heart medications.

In COVID-19 news, the FDA has authorized updated boosters for younger children. The FDA also approved an at-home heart failure therapy, but issued a CRL for a Parkinson’s therapy. The agency has assigned PDUFDA dates for several BLA, including a hemophilia A gene therapy and Eylea for retinopathy in premature infants. Regulators have also announced an Adderall shortage. Additionally, a nonprofit company has begun the application process for OTC version of naloxone.

The Amgen Biosimilars Trend Report found that competition is lowering prices of biosimilars but the largest PBMs are inconsistent in their management of these products.

Regence implemented a preferred infliximab biosimilar strategy and was able to achieve more than 90% adoption.

If approved, valoctocogene roxaparvovec would be the first gene therapy in the U.S. for the treatment of severe hemophilia A. A PDUFA action date has been set for March 31, 2023.

In total, CVS Caremark has removed 26 products and added 31 products effective Jan. 1, 2023.

The submission is expected to be complete by the end of the year, and if approved, could be available in early 2024.

Ashley Jenne, managing director, strategy and business development at Evernorth, discusses the evolution of the PBM’s digital health formulary.

The FDA uses real-world data to show how Boostrix prevents infections in infants. The agency also approves a label expansion for Oxlumo, a new administration method for Trogarzo, and accepts an sBLA for Takhzyro. In COVID-19 news, Eiger won’t submit EUA for COVID-19 treatment. Additionally, an OIG reports finds many accelerated approvals have delayed confirmatory trials.

This is the first study to use an artificial intelligence algorithm to break down visual field loss in new-onset glaucoma cases among U.S.-based population groups.