Two GOP governors are talking about using COVID products in ways not authorized by the US government. But the different paths they are taking could lead to different enforcement approaches by the feds – as well as different political outcomes for the governors.
Gov. Larry Hogan, R-Md., said 20 January that his state was working on a study to see if nursing home residents and adults living in other congregate facilities needed an additional or fourth booster dose of COVID-19 vaccines and that he was willing to administer them without the US Food and Drug Administration or the Centers for Disease Control and Preventions endorsement.
“I think the federal government is talking about those things now, and we hope they will make a decision on...
Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines
Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.
