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.
Athithi Verma
The MHRA Authorised Two Obesity Drugs in Two Days. Neither Is on the NHS.
Two MHRA authorisations in two days. One drug is too common to fund, the other too rare to prioritise. Neither is on the NHS.
CMS Opened a Same-Day Coverage Lane for Devices and Closed the Payment Route Underneath It
CMS Opened a Same-Day Coverage Lane for Devices and Closed the Payment Route Underneath It
Washington Narrowed the Childhood Schedule, and the Insurer Backstop Quietly Stopped Being One
Washington Narrowed the Childhood Schedule, and the Insurer Backstop Quietly Stopped Being One
OrphanPulse Wk 32: Tarsus Paid $450M Upfront for a Readout in 2029
Tarsus committed $450 million at signing for a Stargardt asset whose pivotal trial reads out in 2029, while a competitor is already filing.
NeuroPulse Wk 32: Takeda Fixed the Cause, and Cannot Ship It Yet
FDA approved the first medicine treating narcolepsy type 1 as a disease rather than a symptom set. Takeda cannot sell it for up to ninety days.
The Year’s Two Largest Conjugate Deals Were Not ADCs, and Not Cancer Drugs
Buyers stopped paying for conjugate drugs and started paying for conjugate chemistry. The year’s two biggest cheques bought neither an ADC nor a cancer drug.
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
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.
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