ROCHE ROCEPHIN IS FIRST SINGLE-DOSE OTITIS MEDIA ANTIBIOTIC following approval of Roche's supplemental NDA 50-585/S-046 by FDA on Dec. 23. The new indication for Rocephin (ceftriaxone) intramuscular injection covers acute otitis media due to Streptococcus pneumoniae and beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis. The 13 other antibiotics approved for otitis media are all orally administered and require a five- to 10-day dosing regimen, which can complicate compliance.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
