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
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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
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
Jazz Paid $820 Million Upfront for a Phase 1b/2a Because the FDA Pathway Came With It
QuickDeal read/Rare Diseases/Small Molecule Jazz Paid $820 Million Upfront for a Phase 1b/2a Because the FDA Pathway Came With It Athithi Verma· 11 August 2026· 3 min read· Synopulse Jazz Pharmaceuticals will acquire privately held Actio Biosciences for $820 million upfront plus up to $500 million in approval and sales milestones, a maximum of $1.32 … Read more
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.
NICE Backed Acalabrutinib and Venetoclax Without Obinutuzumab, and the Omission Is the Decision
AMPLIFY tested acalabrutinib and venetoclax with and without obinutuzumab. NICE recommended the doublet, which is a decision about infusions.
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.