FDA’s Surgical Robot Guidance Prefers Robotic Comparator Data, Which Mostly Means Measuring Challengers Against Intuitive
One test for every surgical robot, and by preferring robotic comparators it decides whose results set the score.
Regulatory
China Cleared Jaypirca in Frontline CLL on a Win Over Chemotherapy and Non-Inferiority to Ibrutinib
The label reaches frontline CLL, but against a modern BTK inhibitor the evidence so far is a response rate.
AbbVie’s Juvmo Won FDA Approval Three Days Before ICER Holds a Public Meeting on Its Value
AbbVie now has to name a price for Juvmo into a benchmark that ICER set before the drug was even approved.
Kodiak’s Zenkuda Put 54% of Wet AMD Patients on Six-Month Dosing, Four Years After an Extended-Dosing Miss
The molecule that failed on long intervals in 2022 now holds vision with most patients on six-month dosing.
Europe Approved Leriglitazone for Boys With cALD Two Years After the EMA Recommended Refusal
A drug the EMA refused two years ago is now approved, on a narrow label and under exceptional circumstances, with Europe first.
A Court Vacated the FDA’s Biologic Classification of MiMedx’s Wound Powder Because Similar Products Were Devices
The court did not rule on what AXIOFILL is. It ruled that FDA had not treated like wound care products alike.
The CHMP Refused Nothing in September and Five Applications Were Pulled Anyway
Twelve approvals and no refusals. Apitegromab was cleared in the US on 11 September and pulled in Europe by the 17th.
PDUFA VIII Keeps Every Review Clock and Hires Four Auditors
Industry renegotiated what it pays FDA without changing what it gets. The clocks held. What expanded is the apparatus for verifying the money buys reviewers.
One Missed, One Published the Arm That Failed, One Disclosed a Verb
Three Phase 3 toplines in one day, and the detail released runs inversely to the strength of the result. One company disclosed no number at all.
No Product Is Approved for Hernia Prevention. BD Is Spending Five Years to Change That.
BD is not testing a product against a competitor. It is testing whether an indication can be brought into existence, with no label, code or precedent.