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.
By subject
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.
UnitedHealthcare Is Enlisting Doctors Against the Paperwork Behind 43% of Projected Medicaid Losses
CMS expects much of the coverage loss to come from process, not from failing the test. The insurer asked doctors to help.
China Ordered Rare Disease Clinics in Every Province by December and Left Payment Out
Every instruction raises the number of diagnosed patients. None addresses what they can be prescribed, or who pays.
India Got Three Different Access Mechanisms in Four Days
Three routes to patients in four days. In a market that pays out of pocket, not one announcement carries a price.
Japan Clears Five Products in a Day, Two With a Price Cut Attached
Five approvals, one calendar date, one November pricing round. The two expansions are the ones the system taxes.
The CHMP Refused Nothing in September and Five Applications Were Pulled Anyway
Twelve approvals and no refusals. Apitegromab was cleared in the US on 11 September and pulled in Europe by the 17th.