Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

Boston Scientific’s S-ICD subcutaneous implantable cardioverter defibrillator performed well in the EFFORTLESS registry, with clinical event rates and inappropriate shock rates similar to those reported for conventional ICDs in a real-world context.

A percutaneous intravascular cardioverter-defibrillator matched a conventional ICD in a randomized comparison of defibrillation thresholds. The authors of the study believe the PICD could reduce many of the complications associated with conventional defibrillators.

U.K. biotech Circassia has the first potential cat allergy vaccine to reach advanced clinical studies in Europe and the U.S., funded by a large round of VC financing completed in 2011. Its allergen-free technology could revolutionize the treatment of allergies.