Via the very robust pharma blogosphere, reports that two much-anticipated new antibiotics will be remaining in the pipeline a while longer:
Fierce Biotech says that Pfizer has withdrawn its US and European applications for dalbavancin, a much-awaited new MRSA drug, and will conduct another Phase III trial.
Pharmalot reports (via Reuters) that the Food and Drug Administration has asked for additional trials for ceftobiprole, another much-anticipated new drug for MRSA, coming from Johnson & Johnson. Shearlings Got Plowed has more detail, speculates that a “new game face” is emerging at the FDA, and notes that J&J’s partner in ceftobiprole, Basilea, acknowledged that the FDA raises “issues of data integrity” regarding the current application. J&J’s press release is here.
Bad news on the new-drugs front
0 CommentsVia the very robust pharma blogosphere, reports that two much-anticipated new antibiotics will be remaining in the pipeline a while longer:
Fierce Biotech says that Pfizer has withdrawn its US and European applications for dalbavancin, a much-awaited new MRSA drug, and will conduct another Phase III trial.
Pharmalot reports (via Reuters) that the Food and Drug Administration has asked for additional trials for ceftobiprole, another much-anticipated new drug for MRSA, coming from Johnson & Johnson. Shearlings Got Plowed has more detail, speculates that a “new game face” is emerging at the FDA, and notes that J&J’s partner in ceftobiprole, Basilea, acknowledged that the FDA raises “issues of data integrity” regarding the current application. J&J’s press release is here.
So it’s back to vancomycin, again, for now.