Guidance for VAWD® Accreditation

Citing a need for more Chemistry Manufacturing and Controls information, Abeona intends to address the requirements quickly.

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA).

Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters.

Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio.

Data displayed rapid and sustained B-cell depletion, with 97.2% of study patients with relapsing and primary progressive multiple sclerosis experiencing no relapses.

Data from the Phase III APPLAUSE-IgAN study showed a 38.3% reduction in proteinuria in patients treated with Fabhalta for IgA nephropathy compared to placebo.