Ramsey Baghdadi
Latest From Ramsey Baghdadi
The Gene Therapy Wave Is Here
The long-talked about wave of gene therapy approvals is beginning to reveal itself.
Will The Excise Tax Torpedo The IRA Drug Price Negotiation Program?
A case involving a tax that was an “exceedingly heavy burden” and played into the Supreme Court’s original ruling on the ACA could reemerge once the IRA challenge reaches the high court.
Using A Natural History Study As An External Control In Rare Diseases: Ipsen Offers An Example
Although the advisory committee was uncomfortable with the external control, US FDA was reassuring over the approach – which eventually secured a ‘yes’ vote from the panel on palovarotene for FOP.
Artificial Intelligence Legislative Activity To Start In Fall; Sen. Schumer Lays Out Principles, Process
As US FDA offers initial issues for industry consideration, Senate majority leader outlines framework and process of a bipartisan effort to construct the ‘first of its kind’ legislation to regulate AI.
Patient-Focused Drug Negotiation? CMS Revised Guidance Says Listening Sessions To Begin This Fall
Patient input meeting will be an added element to the Medicare Drug Price Negotiation Program.
The Greatest FDA Advisory Committees Of All Time Part IV: Neurology Lays Claim To The Crown
We look back at another of the greatest FDA advisory committees of the last 20 years. This time: the nearly 12-hour meeting in 2016 on Sarepta’s eteplirsen for Duchenne muscular dystrophy.