Roche Claims Best-in-Class Potential for Sefaxersen Without Disclosing How Much It Cut Proteinuria
Sefaxersen hits the same target as Novartis’s Fabhalta. Roche withheld the one number that would show which drug does more.
Athithi Verma
A Court Vacated the FDA’s Biologic Classification of MiMedx’s Wound Powder Because Similar Products Were Devices
The court did not rule on what AXIOFILL is. It ruled that FDA had not treated like wound care products alike.
Plaintiffs Say CMS’ Frailty Rule Raises Projected Medicaid Losses From 6.4 Million to 8.2 Million a Year
Congress named who is medically frail. CMS’s rule decides who can prove it, and the new lawsuit is about that gap.
CMS Cancelled Coverage for 760,000 People and Froze New Brokers for 2027 Over Unauthorized Enrollments
CMS frames this as fraud recovery. Its release says much less about the 760,000 people whose marketplace coverage ends.
Medicare’s Preliminary Lab Rates Cut Genomic Sequencing 23% and Proprietary Tests Just 2.4%
The average cut is 16%. The tests carrying the newest science take the deepest cuts, and proprietary ones barely move.
Boehringer’s $1 Billion Cancer Deal Will Pay to Put Envisagenics’ ALS Drug Into the Clinic
Boehringer is buying options on cancer targets. Envisagenics plans to spend the money taking an ALS drug into the clinic.
Beacon Succeeded in XLRP Where Biogen and J&J Failed, on an Endpoint Neither of Them Used
QuickCI read/Ophthalmology/Cell & Gene Tx Beacon Succeeded in XLRP Where Biogen and J&J Failed, on an Endpoint Neither of Them Used Athithi Verma· 22 September 2026· 2 min read· Synopulse Beacon Therapeutics said on 21 September 2026 that laru-zova met the FDA-endorsed primary endpoint of VISTA, a 12-month randomised trial in 85 males aged 12 … Read more
Brazil Approved AstraZeneca’s Camizestrant 17 Days After the FDA, Whose Own Advisers Had Voted Against It
Every major regulator has now said yes to a strategy the FDA’s advisers doubted. The constraint is a blood test.
Novartis’s $900 Million BoomRay Licence Names No Target, No Isotope and No Upfront
Without an upfront, a target or an isotope, BoomRay’s $900 million headline is a ceiling rather than a valuation.
Caplyta Doubled the Mania Response Rate, and Only Dry Mouth and Nausea Cleared J&J’s Side Effect Bar
The efficacy is the headline. The competitive case sits in the side effect line, and it points at AbbVie’s Vraylar.