News

QIDP designation for two Bayer inhaled antibiotics

According to Bayer, its Amikacin Inhale inhalation solution and its ciprofloxacin DPI have both been granted qualified infectious disease product (QIDP) designation by the FDA. Both products are currently in Phase 3 development. Bayer HealthCare Pharmaceuticals VP and Head Dario Mirski commented, “We welcome the QIDP designation for Ciprofloxacin DPI and Amikacin Inhale, as we . . . Read more

Positive Phase 1 results for Milestone’s intranasal calcium channel antagonist

Milestone Pharmaceuticals has announced that a Phase 1 clinical trial of an intranasal formulation of its MSP-2017 calcium channel antagonist for possible treatment of paroxysmal supraventricular tachycardia (PSVT) showed that the drug has a rapid onset, along with other promising PK properties, and was well tolerated at doses up to 140 mg. The company said . . . Read more

Endo acquires rights to Trimel’s intranasal testosterone

Endo International has acquired exclusive US and Mexican rights to Trimel BioPharma’s Natesto testosterone nasal gel, which was approved by the the FDA in May 2014 as a replacement treatment for men with low levels of endogenous testosterone. Endo is paying $25 million up front plus potential milestone payments. In addition, Endo will manufacture and . . . Read more