Prohost Letter #424 Following the Stars Less Science and More Logic We reiterate that while a human star is born every once in a while on Earth, several stars born daily in research labs may be designated every other day by the FDA and other health regulatory agencies around the world. These agencies call these potential stars’ breakthrough drugs, but not all the molecules designated …

The U.S. Food and Drug Administration (FDA) has approved Paratek Pharmaceuticals’ (PRTK) product Seysara™ (sarecycline) for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Paratek has exclusively licensed U.S. development and commercialization rights of Seysara for acne to Allergan PLC, who has assigned such rights to Almirall SA. Paratek retains development and commercialization rights in the rest of the world. Seysara (sarecycline) …

Paratek Pharmaceuticals (PRTK) announced positive results from Phase 3 registration study comparing its once-daily, broad spectrum antibiotic, omadacycline, to linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The firm’s press release stated that its antibiotic drug met the FDA-specified primary efficacy endpoint of early clinical response. The study has also met the European Medicines Agency (EMA)-specified co-primary efficacy endpoints for …