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

Suggested Articles

South Korea’s Celltrion, which has a massive biologics site in Songdo, has decided it is time to build some operations in China.

WuXi Biologics is taking control of a Bayer plant in Germany and agreed it could serve as a backup facility for supply of hemophilia drug Kovaltry.

A Chinese OTC drugmaker gets the distinction of ringing in the new year as the first company to be slapped with an FDA warning letter.