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.
Topics
Novo Is Suing Lilly Over a Head-to-Head Trial Lilly Won, Arguing the Result Went Stale
Novo Nordisk filed a Lanham Act suit over Lilly’s Zepbound ads, arguing a genuine head-to-head result became misleading once a higher Wegovy dose launched.
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.
A Geneva BCI Company Records Its First Human Neural Data, and Europe Gets a Serious Entrant
ABILITY Neurotech recorded human neural data for the first time during tumour surgery in Munich, its first step toward a long-term implantable brain-computer interface.
The Only Non-Drug Pediatric ADHD Device Launches Its Second Generation Into a 1,500-Family Waitlist
The only FDA-cleared non-drug treatment for pediatric ADHD launched its second generation into a 1,500-family waitlist, with reimbursement still the open question.
JCR Gets Its Brain-Penetrating Hunter Therapy Out of Japan for the First Time, Through the UAE
IZCARGO, a therapy engineered to cross the blood-brain barrier, won its first marketing authorization outside Japan five years after launching there.
Crysvita Reaches One-Month-Old Infants in the EU, and Buys Two More Years of Orphan Exclusivity
The European Commission approved Crysvita for infants as young as one month with XLH, a decision that also buys Kyowa Kirin two more years of orphan exclusivity.
Spain rewrites its drug-pricing rulebook, and the price of a generic will now fall as it sells more
Spain’s new draft Medicines Law will cut the price of generics and biosimilars automatically as their market share grows, replacing a system where prices froze after one initial discount.
A Father’s Liver, One Incision: the First Single-Port Robotic Liver Transplant Lands in a Six-Year-Old
A six-year-old with a rare genetic liver disorder became the first patient to receive a liver transplant through a single robotic incision, donated by his father.