Evaluation of the effect of rozanolixizumab on pregnancy outcomes and pre- and postnatal development in cynomolgus monkeys.

Rozanolixizumab, a humanised immunoglobulin (Ig) G4 monoclonal antibody that selectively inhibits binding of IgG to the neonatal Fc receptor (FcRn), was evaluated in an embryo-foetal enhanced pre- and postnatal development (ePPND) study. Pregnant female cynomolgus monkeys (19 per group) received subcutaneous rozanolixizumab 50 mg/kg or 150 mg/kg or vehicle every 3 days from gestation day 20 until delivery. The proportion of pregnancy losses was 15.

Blood analytes of clinically normal and diseased neonatal and weaned farmed white-tailed deer () fawns.

Recent research focused on farmed deer has exposed many knowledge gaps regarding health assessment protocols for white-tailed deer (WTD). The objectives of this study were to establish de novo blood analyte reference intervals for farmed WTD fawns at birth (1-2 days of age;  = 84) and again at weaning (76-125 days of age;  = 28), to compare data at birth and at weaning to understand how these analytes are affected by the intrinsic factors age and sex in clinically normal WTD fawns, and to compare between clinically normal and sick WTD weanlings (respiratory disease  = 12; orbivirus-infected  = 6). Reference intervals were established for WTD fawns at birth and weaning.

The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.

Assessment of reversibility from nonclinical toxicity findings in animals with potential adverse clinical impact is required during pharmaceutical development, but there is flexibility around how and when this is performed and if recovery animals are necessary. For monoclonal antibodies (mAbs) and in accordance with ICH S6(R1) if inclusion of recovery animals is warranted, this need only occur in one study. Data on study designs for first-in-human (FIH)-enabling and later-development toxicity studies were shared from a recent collaboration between the NC3Rs, EPAA, Netherlands Medicines Evaluation Board (MEB) and 14 pharmaceutical companies.

Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.

To support registration of monoclonal antibodies (mAbs) for chronic indications, 6-month toxicity studies have historically been conducted. Experience with mAb development has shown a relatively benign and well-understood safety profile for this class, with most toxicity findings anticipated based on pharmacology. We evaluated whether a 6-month toxicity study is necessary to assess the long-term safety of mAbs.

Prospective trial of different antimicrobial treatment durations for presumptive canine urinary tract infections.

Background: Avoidance of unnecessary antimicrobial administration is a key tenet of antimicrobial stewardship; knowing the optimal duration of therapy obviates over-treatment. However, little research has been performed to establish course lengths for common canine infections. In clinical practice, antimicrobial therapy is frequently prescribed in dogs presenting lower urinary tract signs (haematuria, pollakiuria and dysuria/stranguria).