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Latest From Sue Sutter
Advisory committee recommends against approval of dry powder formulation for treating non-cystic fibrosis bronchiectasis due to inconsistent results in Phase III RESPIRE trials and concerns about long-term benefit and antibiotic resistance.
Advisory committee asked to opine on whether there is substantial evidence of efficacy even though Phase III studies missed on three of four primary efficacy measures; Bayer argues that totality of the evidence demonstrates a meaningful benefit in reducing exacerbations in a heterogeneous patient population with the rare disease.
Hepatitis B vaccine's favorable efficacy data relative to GSK's Engerix-B and neutral safety language mean that any partnership opportunity 'would need to be a highly attractive one to alter our current course,' Dynavax CEO Gray says.
Heplisav-B labeling notes myocardial infarction imbalance in one trial but also apparent absence of a causal relationship; sponsor will conduct a postmarketing safety cohort study involving 50,000 subjects, 10,000 more than initially planned.
In effort to speed competition and lower drug prices, US regulator will prioritize review of generic drug applications likely to be ready for approval on or shortly after the expiration of first-filer's exclusivity; experts say the move appears to formalize what once had been an informal Office of Generic Drugs policy.
If Pfizer doesn't get regulatory clarity that Phase IIb/III STRIVE study data could support broad indication in elective orthopedic surgeries, company says it would have to reassess resources needed to continue current development program, with study termination a possible outcome.