Core trends in 2023 FDA drug approvals: Oncology, neurology and hematology dominate

2023 was a big year for hematology, neurology and oncology, with the medical specialties seeing the most FDA approvals. In terms of sponsors, Pfizer had the most approvals with six total, followed by UCB and Chiesi, each with three apiece.

When looking at commercial prospects, AstraZeneca’s respiratory syncytial virus antibody Beyfortus could be the biggest blockbuster from the 2023 cohort with expected peak sales of $1.9 billion. Alzheimer’s drug Leqembi could also be a major success, making up for the tepid demand for Aduhelm, which won conditional approval in 2021. While Aduhelm’s sales have sputtered, Leqembi could see peak revenue of $4.8 billion according to analysts.

Oncology continues to be a hot specialty with the most competition among the newly approved drugs, as the FDA continues to green light new entrants in crowded target classes such as PD-1 inhibitors.

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Contract manufacturer Minnetronix Medical launches its first in-house product, MindsEye

Minnetronix Medical’s MindsEye expandable port [Photo courtesy of Minnetronix Medical]

Minnetronix Medical has launched MindsEye, making it the first medical device that the contract developer and manufacturer has conceived and commercialized.

St. Paul-based Minnetronix Medical’s MindsEye is the first expandable brain access port on the market. The FDA cleared the device under the 510(k) pathway in August 2020.

The minimally invasive device gives neurosurgeons deep brain access and visualization as they treat strokes, cancer and other conditions. The device features a flexible sheath made of cyclic olefin copolymer (COC) and an aluminum obturator. MindsEye won the Minnesota Technology Association’s TEKNE award for best medical technology and device in 2021.

“Its benefits to neurosurgeons — such as expandability, easier insertion and removal, and transparency that minimizes glare …

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A neurologist dishes on the migraine treatment landscape

Migraine image courtesy of Pixabay

Migraines are a prevalent condition, affecting about one billion people across the world. “In the U.S., about 13% of the population experiences migraine headaches regularly,” said Dr. Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago. 

In the following interview, Feoktistov shed light on the prevalence of the condition and shares his thoughts on the overall treatment landscape. A forthcoming article will touch on how migraine treatments have evolved over the past two decades, focusing on the impact of recently introduced therapies. 

Could you briefly summarize how you diagnose migraines? 

Feoktistov: Migraine headaches typically start in childhood or during adolescence and frequently continue throughout most of the patient’s life. We sometimes see outliers when people start experiencing headaches later …

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