Latest From Brenda Sandburg
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
Biopharma Industry Sharply Divided Over Supreme Court Antibody Patent Brawl
Big biologic makers line up on opposite sides of dispute between Amgen and Sanofi over whether Amgen’s Repatha patents cover analogous antibodies with the same functional characteristics.
After Xtandi, Will Government Ever Seek March-In Rights Over Drug Pricing?
Market availability of Xtandi, not its cost, is the issue, NIH says in denying petition for government to invoke march-in rights to patents on the prostate cancer drug. But Biden administration makes two other same-day moves that could leave march-in advocates with some hope.
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.