ITM’s Complete Response Letter Names No Clinical Concern. It Names a Third-Party Facility.
COMPETE hit its endpoint and is published in The Lancet. The FDA did not touch any of it. What stopped the approval is a facility ITM does not own.
CI read
DuPont Spun Chemours Off in 2015. Eleven Years On, Both Are Named in the Same Order.
QuickCI read/Legal & Policy/Medtech DuPont Spun Chemours Off in 2015. Eleven Years On, Both Are Named in the Same Order. Athithi Verma· 11 August 2026· 3 min read· Synopulse Chief Judge Renée Marie Bumb of the US District Court for New Jersey approved settlements worth more than $2.5 billion on 7 August 2026, resolving claims … Read more
Corline’s Whole Pulsed Field Upside Depends on One Customer’s Regulatory Calendar
QuickCI read/Cardio-Metabolic/Medtech Corline’s Whole Pulsed Field Upside Depends on One Customer’s Regulatory Calendar Athithi Verma· 11 August 2026· 3 min read· Synopulse Corline Biomedical disclosed, under EU market abuse rules and at 08:32 on 10 August 2026, that Health Canada has granted a Medical Device Licence for Kardium’s Globe Pulsed Field System, opening the Canadian … Read more
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.
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.