News

Avanir gets Complete Response Letter for intranasal sumatriptan

According to Avanir Pharmaceuticals, it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for AVP-825 intranasal sumatriptan for the treatment of migraine. The company had recently warned that its NDA was unlikely to be approved by the PDUFA date due to FDA concerns about human factors issues. . . . Read more

Verona Pharma names David Ebsworth as Non-Executive Chairman of the Board of Directors

Respiratory drug developer Verona Pharma has named former Galenica CEO David Ebsworth as Non-Executive Chairman of the Board of Directors. Ebsworth succeeds Clive Page, who founded the company in 2006. The company’s lead product, RPL554, is an inhaled PDE3/PDE4 inhibitor being developed for the treatment of asthma, COPD, and cystic fibrosis. In September 2014, Verona . . . Read more

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