RiboX’s China Trial Data Bought It an Accelerated Dose Titration and a Subcutaneous Route
RiboX filed its Chinese investigator-initiated data with the IND. FDA granted faster escalation and a subcutaneous route on the strength of it.
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Scholar Rock Filed With Two Fill-Finish Sites. One Just Failed, and the Date Held.
Catalent Indiana failed its FDA inspection. Scholar Rock had named a second fill-finish site in the same BLA, so the PDUFA date did not move.
Sphere-9 Can Ablate VT in Europe While Its US Pivotal Is Still Enrolling
Medtronic can sell Sphere-9 into ventricular tachycardia in Europe while the trial meant to prove it works in the US is only now enrolling.
Reckitt’s Real Innovation at Mucinex Is the NDA, Not the Twelve Hours
Almost every OTC cold remedy is sold under the monograph system, which confers no protection at all. Reckitt spent a decade filing its way out.
The EPO Revoked BMS’s 480mg Opdivo Patent Because the Trial Behind It Dosed by Weight
BMS claimed a 480mg flat dose. The only clinical example in its filed application dosed by weight. The EPO revoked the patent on added matter.
A Private Device Company Just Put Its Pivotal Trial Head to Head Against the Market Leader
VDyne treated the first patient in a pivotal trial randomising its tricuspid valve replacement head to head against Edwards’ commercially available EVOQUE.
Agilent Has Built an Annuity on Merck’s Clinical Programme, One Indication at a Time
Agilent won its eighth CE-marked companion diagnostic indication for a single PD-L1 assay, each one riding on a label expansion Merck paid to generate.
China Approved the World’s First Once-Daily Oral Factor B Inhibitor, and a US Small-Cap Licensed It a Month Early
China approved Haisco’s ciprocopan for PNH, the world’s first once-daily oral complement Factor B inhibitor, a month after a US small-cap licensed ex-China rights.
One Robot, Three Ways In: Momentis Clears Multiport a Day After J&J Shrank the Footprint
Momentis won FDA clearance for multiport surgery, making Anovo the first robotic platform cleared for natural orifice, single-port and multiport approaches.
A Company Called StrokeDx Just Cleared a Device That Is Not Cleared to Detect Stroke
NeuraNova, formerly StrokeDx, won FDA clearance for a bedside device measuring cerebral fluid asymmetry, cleared as an adjunct rather than a diagnostic.