Replimune Won Accelerated Approval on 91 Evaluable Patients and a 24% Response Rate
CBER took a 24% response in 91 evaluable patients, one day after the same committee voted nine to three against Capricor. Measurement, not size.
United States
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.
Tau does its damage inside mitochondria, independent of tangles and microtubules. The field’s imaging toolkit was built to see neither.
Tau does its damage inside mitochondria, independent of tangles and microtubules. The field’s imaging toolkit was built to see neither.
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.
The FDA Approved Orzeyful and Handed the Approval Date to the DEA
FDA’s letter says the approval date is whenever the DEA publishes scheduling. Takeda holds a first-in-class approval it cannot sell yet.
Argenx’s $2.2 Billion Bought a Phase 1b With Ten Patients on Placebo
FB102’s entire human efficacy dataset in vitiligo is 42 patients, ten of them on placebo. argenx paid $2.2 billion in cash, with no milestones.
Lilly’s Volume Rose 60%, Its Realized Prices Fell 13%, and the Top of Its EPS Range Came Down
QuickAccess read/Cardio-Metabolic/Peptide Lilly’s Volume Rose 60%, Its Realized Prices Fell 13%, and the Top of Its EPS Range Came Down Athithi Verma· 6 August 2026· 3 min read· Synopulse Eli Lilly reported Q2 2026 revenue of $23.0 billion, up 48%, driven by a 60% increase in volume and partially offset by a 13% decrease in … Read more
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.
Pathos Put 6% Down on a Phase III ADC, and Alphamab Kept the Market It Can Actually Reach
Fresenius describes an end to end biopharma business. Dr. Reddy’s developed, made and filed this rituximab. Fresenius is only the channel.
Dr. Reddy’s Developed, Made and Filed the Rituximab. Fresenius Only Sells It.
Fresenius describes an end to end biopharma business. Dr. Reddy’s developed, made and filed this rituximab. Fresenius is only the channel.