Latest From Brenda Sandburg
Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA
If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.
Paxlovid Gets FDA Panel Backing For Full Approval; Combating Rebound Misperception Urged
Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.
Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval
Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.
Biogen And Millennium May Be Ensnared In Tentacles Of Genentech’s Expired Cabilly Patent
Genentech claims Biogen and Millennium owe royalties on sales of Tysabri and Entyvio that were stockpiled when the Cabilly patent expired. Hospira faced similar litigation over its erythropoietin biosimilar and had to pay Amgen $70m in damages.
FDA Panel Agrees GSK’s RSV Vaccine Is Effective But Wants More Data Before Approval
Advisory committee votes 10-2 that data are adequate to support safety of the vaccine in adults 60 and older, voicing concern about small potential safety signals after co-administration with influenza shot. Several members question rush to market with just one season of data.
FDA’s CDER Is Fostering Use Of Artificial Intelligence In Drug Development
Center for Drug Evaluation and Research plans to issue a request for information this year to engage stakeholders on issues related to AI and machine learning. It received 175 AI/ML submissions in 2022, up from 14 in 2020.