Articles related to DEVICE/DRUG APPROVALS

CheckRare provides a list of the orphaned drugs that dominate the US pharmaceutical industry to start 2022. Orphan drugs are defined as those medications that remain commercially undeveloped because they’ve been deemed to have limited potential for profitability. However, nearly half of all novel medications approved by the FDA are orphan drugs.

At the outset of the pandemic, biotechnology company Novavax was one of the frontrunners to bring a vaccine against COVID-19 to market. But nearly two years later, Novavax’s vaccine has yet to appear. In a compelling article, the BMJ details the repeated delays and setbacks that have torpedoed Novavax’s once-promising vaccine candidate and rendered it unnecessary now that other vaccines from Pfizer, Moderna, and AstraZeneca flood the global marketplace.

For patients being prescribed isotretinoin, there used to be three risk categories: women of reproductive potential, women not of reproductive potential, and males. The new risk classifications are two: those who can become pregnant and those who cannot. This change was based on stakeholder feedback that gender-specific language can be a barrier to access for patients who do not identify with the previous gender-specific patient categories.

The additional approval expands immunization coverage to the most at-risk group for acquiring shingles – the immunocompromised. It also shortens the time to the second dose in the 2-dose Shingrix schedule.  Decision support based on the Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) phase III trial (JAMA).

Despite the pandemic interrupting trials and drug development in 2020, the US Food and Drug Administration (FDA) claims it is “full speed ahead” on the approval of novel cancer drug therapies. The authors of this Journal of the American Medical Association (JAMA) study wanted to verify these remarks, reviewing the FDA Hematology/Oncology Approvals website to ascertain all hematology/oncology drugs approved in 2020.

This new indication marks the second FDA approval for sacituzumab govitecan (Trodelvy, Immunomedics) and was based on the phase 2, single-arm TROPHY-U-01 main efficacy endpoints in objective response rate (ORR) and duration of response (DOR). With a relative 5-year survival rate of 5.5%, this is a significant advancement for patients with metastatic urothelial cancer (mUC), the most common type of bladder cancer.