Pfizer Thelin development (correction)
Pfizer has commenced enrollment of patients in a Phase III study for Thelin (sitaxsentan) to support a U.S. filing for the treatment of pulmonary arterial hypertension. The "Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil" (SR-PAAS) is expected to be completed by June 2010. An article in "The Pink Sheet" inaccurately stated that Pfizer was likely to abandon a Thelin NDA (1"The Pink Sheet" Jan. 5, 2009, p. 8)
You may also be interested in...
Perceptions that FDA is more conservative in its approval standards than its European regulatory counterpart are misguided and largely overblown, Office of New Drugs Director John Jenkins said
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.