FDA patience runs out for ProAmatine proof; Tauzin: PhRMA re-orientation ill advised;

> The FDA, wondering where the post-approval studies are that it required in 1996 as part of an accelerated approval, now proposes withdrawing that approval for ProAmatine (midodrine hydrochloride), used to treat a low blood pressure condition. Release

> Billy Tauzin advises new PhRMA leadership not to try turning back the "big ship" that he took "a long time turning." Item

> Mathi Senapathi has joined Radient as manufacturing director, responsible for the Onko-Sure in vitro diagnostic cancer test kits. Release

> Africa's Aspen Pharmacare will buy Australia's Sigma's pharmaceutical division, which manufactures generic and branded drugs. Article (sub. req.)

> EnWave is testing a multiple-vial prototype of its dehydration technology for standard industry serum vials containing vaccines, injectable drugs, analytical enzymes, diagnostic reagents, antibodies and other biological materials. Release


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.