Brenda Sandburg
Senior Editor
Latest From Brenda Sandburg
Payors Take Lead From FTC In Suing BI Over Its Orange Book Patent Listings For Inhalers
Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.
IRA Litigation: NJ Judge Looks For Own Path In Evaluating Medicare Price Negotiation Program
During oral argument in four cases challenging the IRA, Judge Zahid Quraishi suggested he may find that Medicare participation is voluntary but takings claim would still need to be considered. On question of whether the program is hurting innovation, Quraishi seemed skeptical.
Who's Who In The IRA Court Drama
Pink Sheet offers a graphical guide to the lawyers behind the briefs and at the podiums for the big showdown in Trenton.
Vanda Appeals FDA’s Denial Of Hetlioz Jet Lag Application As It Is Hit With CRL For Insomnia
Vanda CEO tells the Pink Sheet that the firm is going straight to appellate court to refute agency’s rejection of jet lag indication for Hetlioz. Similar battles may lie ahead over Vanda’s applications on Hetlioz for insomnia and tradipitant for gastroparesis.
Second Judge Rejects Constitutional Challenges To Medicare Price Negotiation Program
Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.
FDA Still Soliciting Applications For START Pilot As Deadline For Rare Disease Program Looms
Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.