Janssen Research & Development has published data from a Phase 2 study of its intranasal esketamine that demonstrate rapid improvement of symptoms in patients with treatment-resistant depression. The study was conducted from 2014-2015, and results were published in JAMA Psychiatry on December 27, 2017. The trial enrolled 126 patients diagnosed with major … [Read more...] about Janssen publishes results from Phase 2 trial of intranasal esketamine for depression
News
FDA workshop offers insights on OINDP development and BE assessment
By Lei Zhang, PhD, Deputy Director, Office of Research and Standards The FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs (OGD), Office of Research and Standards, Division of Therapeutic Performance has made great strides in new approaches that demonstrate therapeutic equivalence for locally-acting orally-inhaled and nasal drug products … [Read more...] about FDA workshop offers insights on OINDP development and BE assessment
Merxin’s MRX003 inhaler gets CE marking
Generic DPI device developer Merxin has announced that its MRX003 capsule based dry powder inhaler has received CE marking certification. The inhaler, which was launched in May 2017, is designed for generic tiotropium products submitted for approval under the 505(j) pathway. Merxin Co-Founder and Director Philippe Rogueda said in a LinkedIn post, "Merxin is … [Read more...] about Merxin’s MRX003 inhaler gets CE marking
Savara files IND for Molgradex study
Savara has submitted an investigational new drug application for Molgradex inhaled recombinant human GM-CSF for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) to the FDA, the company said. In May 2017, the company said that it planned to modify the Phase 2/3 IMPALA study of Molgradex for PAP in accordance with FDA advice in order to allow the … [Read more...] about Savara files IND for Molgradex study
Mylan citizen petition challenges the use of multiple-batch PK BE studies to support ANDAs for generic versions of Advair
A citizen petition filed by Mylan on December 5, 2017 asks the FDA not to approve any ANDA for a generic version of Advair Diskus that relies on data from multiple-batch PK bioequivalence studies "unless, after conducting an appropriately rigorous review under the established standards for establishing BE, generally, and for this product specifically, FDA concludes … [Read more...] about Mylan citizen petition challenges the use of multiple-batch PK BE studies to support ANDAs for generic versions of Advair
FDA okays removal of Boxed Warning from labels for ICS/LABA inhalers
The FDA said in a Drug Safety Communication that it has approved the removal of Boxed Warnings about asthma-related deaths from ICS/LABA combination inhalers. The inhalers affected by the change are Advair Diskus, Advair HFA, Breo Ellipta, AirDuo Respiclick, Dulera, and Symbicort. According to the agency, data from recent post-market requirement trials that … [Read more...] about FDA okays removal of Boxed Warning from labels for ICS/LABA inhalers
Huons reportedly licenses budesonide/salmeterol DPI from Laboratoires SMB
According to Korea Biomedical Review, Korean pharmaceutical company Huons has licensed Zephirus busesonide/salmeterol, a dry powder formulation delivered using the Axahaler capsule-based inhaler, from Belgian pharmaceutical company Laboratoires SMB. Korea Biomedical Review reported that Huons CEO Um Key-an commented, “Respiratory disease is a disease that greatly … [Read more...] about Huons reportedly licenses budesonide/salmeterol DPI from Laboratoires SMB
Iconovo signs development and licensing agreement with Intas Pharmaceuticals for DPI
Iconovo AB announced that it has signed an agreement with Intas Pharmaceuticals for development and licensing of a DPI for the treatment of asthma and COPD, including the dry powder formulation and a device based on Iconovo's ICOres reservoir inhaler. According to Iconovo, the deal is worth €2.8 million and includes royalties. In June 2017, Iconovo announced the … [Read more...] about Iconovo signs development and licensing agreement with Intas Pharmaceuticals for DPI
Neurodyn Cognition names Anthony Giovinazzo as Executive Chairman
Neurodyn Cognition (NCI), a Canadian company developing an intranasal therapy for Alzheimer's disease, has named Anthony Giovinazzo as a director and Executive Chairman. Giovinazzo was most recently President and CEO of Cynapsus Therapeutics, which was sold to Sunovion in 2016. NCI's Memogain is described as an intranasal formulation of a prodrug of galantamine, … [Read more...] about Neurodyn Cognition names Anthony Giovinazzo as Executive Chairman
DDL 2017 in review
DDL 2017 drew 750 delegates, a record number, to the Edinburgh International Conference Centre. Topics that received sustained attention over the course of the 3-day meeting included the use of modeling techniques, development of inhaled antibiotics for diseases such as tuberculosis, the lessons of e-cigarettes, and the use of acoustics for inhaler monitoring and … [Read more...] about DDL 2017 in review