Hailie inhaler monitoring system maker Adherium has announced the appointment of Tara Creaven-Capasso as VP of Quality, Regulatory and Clinical Affairs. Creaven-Capasso has been a long-time regulatory affairs consultant; earlier in her career, she also held QA positions at several companies, including Xoma and Medtronic. Adherium received 510(k) clearance for its next … [Read more...] about Adherium names Tara Creaven-Capasso as VP of Quality, Regulatory and Clinical Affairs
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Gerresheimer to manufacture ICOone DPI for Phase 3 trials of ISR’s intranasal COVID-19 vaccine
Gerresheimer has announced that it will manufacture supplies of Iconovo's IcoOne dry powder inhaler for Phase 3 trials of ISR's intranasal COVID-19 vaccine and has started the design process for molding and manufacturing the device. In March 2021, Iconovo announced that it would develop an inhaled vaccine for ISR, and in July 2021, Icovono said that it was developing … [Read more...] about Gerresheimer to manufacture ICOone DPI for Phase 3 trials of ISR’s intranasal COVID-19 vaccine
Upperton Pharma Solutions announces plans to build new facility
CDMO Upperton Pharma Solutions, which recently launched a new nasal delivery development platform, has announced that it will invest £15 million in a new 50,000 sq ft facility in Nottingham, UK that will include new laboratory space and 10 times more GMP manufacturing space than the company has currently. The new facility will also have the ability to handle highly … [Read more...] about Upperton Pharma Solutions announces plans to build new facility
FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD
United Therapeutics has announced the FDA's approval of its NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil Technosphere from MannKind Corporation in September 2018 and submitted the NDA for Tyvaso DPI in … [Read more...] about FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD
Blue Lake’s intranasal RSV vaccine gets Fast Track designation
According to CyanVac subsidiary Blue Lake Biotechnology, the FDA has granted Fast Track designation for the company's BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) in children under 2 and adults over 60. The vaccine is based on an attenuated strain of canine parainfluenza virus (PIV5). In March 2022, Blue Lake announced that the FDA had … [Read more...] about Blue Lake’s intranasal RSV vaccine gets Fast Track designation
Lonza announces expansion of DPI testing capacity
CDMO Lonza has announced that it is adding dry powder inhaler testing capabilities at its facility in Tampa, FL, USA for increased DPI development capacity. Lonza, which established a Center of Excellence for DPI particle engineering and formulation in Bend, OR, USA in 2020, said that the new laboratories in the Florida location will include capabilities for handling … [Read more...] about Lonza announces expansion of DPI testing capacity
FDA accepts Biohaven’s NDA for intranasal zavegepant for the treatment of migraine
According to Biohaven Pharmaceuticals, the FDA has accepted the company's NDA for its zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine and has set a PDUFA goal date in the first quarter of 2023. In December 2019, Biohaven announced positive results from a Phase 2/3 pivotal trial of the nasal … [Read more...] about FDA accepts Biohaven’s NDA for intranasal zavegepant for the treatment of migraine
RDD 2022 returned with the latest in OINDP technology
Approximately 400 OINDP experts gathered in Orlando, FL, USA May 1-May 5 for the first in-person Respiratory Drug Delivery meeting since 2019, with another 75 attending virtually. RDD Online's Richard Dalby welcomed delegates from 28 countries to the meeting in a full ballroom at the Omni Championsgate. Throughout the meeting, delegates expressed how happy they were … [Read more...] about RDD 2022 returned with the latest in OINDP technology
SoftOx reports positive Phase 1 results for its hypochlorous acid inhalation solution
SoftOx Solutions has announced that a Phase 1 study of its SoftOx inhalation solution (SIS) demonstrated that nebulized SIS was well tolerated with no serious adverse effects observed and no adverse effects related to pulmonary function. The study enrolled 57 healthy volunteers who got either SIS or placebo delivered via jet nebulizer 4 times per day for 5 days, with … [Read more...] about SoftOx reports positive Phase 1 results for its hypochlorous acid inhalation solution
Moderna highlights partnership with Vertex on inhaled mRNA therapy for CF
According to Moderna Therapeutics, the company used its annual "Science and Technology Day" to highlight its work on lipid nanoparticle (LNP) mRNA formulations, and CEO Stéphane Bancel made special note of the company's advances in pulmonary delivery, including a partnership with Vertex on development of an inhaled mRNA formulation that could give CF patients the … [Read more...] about Moderna highlights partnership with Vertex on inhaled mRNA therapy for CF