July 6 Quick Takes: Ocugen eyes BLA following Phase III COVID vaccine readout; plus SCOTUS, Provention, British Patient Capital and more

The COVAXIN COVID-19 vaccine from Ocugen Inc. was 77.8% effective against symptomatic disease and 93.4% effective against severe infection in a Phase III study in India, building the case for approval of a new vaccine modality by FDA. The study, conducted by Ocugen’s partner Bharat Biotech, enrolled 25,798 participants, and the vaccine was 65.2% effective against the delta and beta variants of the virus in the same study. Last month, Ocugen said it would pursue a BLA to FDA for the whole inactivated virus vaccine.

The U.S. Supreme Court has agreed to consider a suit brought by hospitals against HHS challenging Medicare’s 2018 decision to adjust payment rates for Medicare Part B drugs purchased by hospitals. Under the 2018 decision, CMS reimburses 340B hospitals the average sales price (ASP) minus 22.5%, rather than the ASP plus 6% reimbursement rate provided to non-340B hospitals. The reimbursement cut is intended to reflect 340B hospitals’ acquisition costs and prevent them from profiting from the spread between acquisition cost and the traditional Part B reimbursement formula. The case will be heard in the term that starts in October. ...