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.
Regulatory
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.
FastWave’s Pivotal Trial Cannot Measure the Thing FastWave Is Selling
Everything FastWave sells is comparative. The word its chief executive used is clearance, and clearance means substantially equivalent.
Imvanex Now Covers European Two-Year-Olds. The Children Carrying the Burden Are in Africa.
A type II variation in Brussels does nothing directly for a child in Kinshasa. What it does is unlock the procurement channels that reach one.
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.
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.
PRIMA Can Be Sold in 30 Countries Tomorrow. Reimbursement Is the Real Timeline.
Science Corp’s retinal implant won a CE mark for sale across 30 European countries, after trial patients gained a mean 25.5 letters of visual acuity.
J&J Built Its Surgical Robot Into the Table, and Aimed It at the 92% of Surgery That Isn’t Robotic
The FDA granted De Novo authorization to OTTAVA, the first surgical robot with arms built into the operating table, cutting the footprint by up to half.
GSK Closed the Nuvalent Deal on 15 July. Seven Days Later, the FDA Approved the Drug.
GSK closed its Nuvalent acquisition on 15 July. The FDA approved Jideytro on 22 July, two months ahead of schedule, making it GSK’s first lung cancer drug.