This is a new drug to combat MRSA and has been approved for use in Canada, Switzerland and the Ukraine, but still lacks the approval of the FDA and Europe who it appears are wanting additional information relative to clinical trials.
Stock prices might be a motivator here as well as the company stocks for Basilea have jumped around quite a bit, thus inquiring minds want to know. BD
A highly touted product in J&J’s pipeline, the antibiotic ceftobiprole, is turning into a headache for the U.S. company and its Swiss partner, Basilea.
Basilea is now taking J&J to arbitration over the delays in approval of the drug, which could be particularly lucrative because it treats complicated skin infections including ones caused by MRSA, the drug-resistant staph that has become a scourge.
The move comes as European regulators announced they would delay approval of the drug until they could inspect how J&J conducted the clinical trials and decide whether the company followed “good clinical practices.” The FDA in November delayed U.S. approval over the proper monitoring of trials at three sites.