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News

OINDP companies get together to create new event series

Led by inhaler device platform designer and supplier Merxin and by Nanopharm, a CRO specializing in inhaled and nasal drugs, a group of companies that offer products and services for OINDP development has come together to put on a new event series called Inspire Me. The first event will take place on June 4 and 5, 2019 in San Francisco, CA, USA, with the first day … [Read more...] about OINDP companies get together to create new event series

Akorn’s azelastine hydrochloride nasal spray approved by the FDA

The FDA has approved an ANDA for Akorn's generic azelastine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis in patients 5 years old and older and for vasomotor rhinitis in patients 12 and older, the company said. According to the FDA web site, ANDA #207610 was submitted by Hi-Tech Pharmacal, which was acquired by Akorn in 2014. There … [Read more...] about Akorn’s azelastine hydrochloride nasal spray approved by the FDA

Study finds as-needed budesonide/formoterol superior to as-needed albuterol (salbutamol) for reducing risk of severe exacerbations in mild asthma

A study published May 19, 2019 in the New England Journal of Medicine found that the Symbicort Turbuhaler budesonide/formoterol DPI demonstrated a greater than 50% reduction in the risk of asthma exacerbations in mild asthma patients compared to as-needed albuterol (salbutamol) alone. Compared to as-needed albuterol used in conjunction with maintenance budesonide, … [Read more...] about Study finds as-needed budesonide/formoterol superior to as-needed albuterol (salbutamol) for reducing risk of severe exacerbations in mild asthma

Respivant initiates Phase 2b study of RVT-1601 for IPF cough

Respivant Sciences has announced dosing of the first patient in the Phase 2b SCENIC trial of its RVT-1601 cromolyn sodium inhalation solution for the treatment of cough in idiopathic pulmonary fibrosis (IPF) patients. Respivant was spun off from Roivant in September 2018 specifically to develop RVT-1601. Roivant acquired the cromolyn sodium inhalation solution, … [Read more...] about Respivant initiates Phase 2b study of RVT-1601 for IPF cough

Nayzilam midazolam nasal spray approved by the FDA

UCB said that the FDA has approved an NDA for Nayzilam midazolam nasal spray (formerly USL261) for the treatment of seizure clusters in epilepsy patients aged and older. UCB acquired the nasal spray from former Upsher Smith subsidiary Proximagen in April 2018 and announced in August 2018 that the FDA had accepted the NDA. The midazolam nasal spray was granted … [Read more...] about Nayzilam midazolam nasal spray approved by the FDA

AMSL Diabetes to distribute Afrezza inhaled insulin in Australia

MannKind Corporation has announced that signed a marketing and distribution agreement with Australasian Medical & Scientific Ltd division AMSL Diabetes for commercialization of Afrezza inhaled insulin in Australia. AMSL Diabetes will take responsibility for getting Australian regulatory and reimbursement approval for Afrezza and for sales, marketing, and … [Read more...] about AMSL Diabetes to distribute Afrezza inhaled insulin in Australia

GSK’s Otrivin + Aptar Pharma’s Freepod nasal pump wins WorldStar Packaging Award

Aptar Pharma has announced that GSK's Otrivin xylometazoline nasal spray, which is delivered via Aptar's Freepod multidose nasal spray pump, won a 2019 WorldStar Packaging Award in the Medical & Pharma category. The WorldStar Packaging Awards, given by the World Packaging Organization, "are based on the judges' consensus that a pack is superior in its category and … [Read more...] about GSK’s Otrivin + Aptar Pharma’s Freepod nasal pump wins WorldStar Packaging Award

Lonza launches Capsugel Zephyr DPI capsules

Lonza has announced the launch of a new DPI capsule portfolio called Capsugel Zephyr "to meet the growing need for customized solutions for optimal pulmonary drug delivery." The new DPI capsules are customizable and can be made from a variety of "different polymers and compositions," with "product customization services to help address the specific needs of inhalation … [Read more...] about Lonza launches Capsugel Zephyr DPI capsules

RDD Europe 2019 addressed challenges to the status quo

Over 500 OINDP specialists attended RDD Europe 2019 in Estoril, Portugal, May 7-10, making the conference the biggest RDD Europe meeting ever, the organizers said. Carolyn Penot of Aptar Pharma, which co-organizes RDD Europe said, "We've had great feedback from all of the attendees about Estoril, that it's a great place to come for a meeting, and it's been our most … [Read more...] about RDD Europe 2019 addressed challenges to the status quo

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Robert Clarke steps down as Pulmatrix CEO

Robert Clarke is stepping down as CEO of DPI developer Pulmatrix and will be succeeded immediately by current Chief Business Officer Ted Raad, the company said. Clarke, who was appointed CEO in 2012, will stay on through August 14, 2019 as an advisor. Clarke said, "After fifteen years at Pulmatrix growing with the organization from Head of R&D to CSO and … [Read more...] about Robert Clarke steps down as Pulmatrix CEO

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  • June 17-June 18: Rescon Europe 2025, Paris, France
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