ReCode Therapeutics said that it has initiated a Phase 1 clinical trial of its RCT1100 nebulized mRNA-based therapeutic, which the company is developing for the treatment of primary ciliary dyskinesia (PCD) caused by certain genetic mutations. ReCode had announced positive preclinical results for RCT1100 for the treatment of PCD in August 2021. The Phase 1 single … [Read more...] about ReCode initiates Phase 1 trial of RCT1100 inhaled mRNA therapeutic
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Lonza Small Molecules adds powder characterization capabilities at Florida facility
The Lonza Small Molecules facility in Tampa, FL, USA has upgraded its powder analysis capabilities, the company said. In May 2022, Lonza announced that it was expanding its dry powder testing facilities in Tampa in order to increase its DPI development capacity. According to Lonza, the Tampa site recently added a Freeman Technologies FT4 universal powder flow … [Read more...] about Lonza Small Molecules adds powder characterization capabilities at Florida facility
Nemera and Nelson Labs announce expanded partnership
Device maker Nemera and Nelson Labs have announced the expansion of an existing partnership, with Nelson Labs performing microbiological and chemical analyses, extractables and leachables testing, and biocompatibility studies for Nemera customers. Nemera is an associate member of the International Pharmaceutical Aerosol Consortium on Regulation & Science … [Read more...] about Nemera and Nelson Labs announce expanded partnership
Bryn Pharma names Sandy Loreaux as CEO
Utuly intranasal epinephrine developer Bryn Pharma has named Sandy Loreaux as CEO, succeeding David Dworaczyk, who will remain with the company as head of R&D, regulatory, and production. Loreaux was most recently US President of Covis Pharma and previously held executive positions at Mallinckrodt, Valeant, and Sanofi-Aventis. Bryn recently announced results … [Read more...] about Bryn Pharma names Sandy Loreaux as CEO
Iliad publishes data from Phase 2b challenge study of BPZE1 intranasal pertussis vaccine
Iliad Biotechnologies announced that it has published data from a Phase 2b challenge study of its BPZE1 live-attenuated intranasal pertussis vaccine and said that the vaccine induced nasal mucosal and serum immune responses, with 90% of participants who received a single dose of BPZE1 protected from colonization following a challenge with attenuated B. pertussis at 3 … [Read more...] about Iliad publishes data from Phase 2b challenge study of BPZE1 intranasal pertussis vaccine
FDA approves Zavzpret zavegepant nasal spray for the treatment of migraine
The FDA has approved Pfizer's Zavzpret zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine. Pfizer said that it expects to launch Zavzpret in July 2023. The FDA accepted the NDA for the zavegepant (formerly "vazegepant") nasal spray submitted by Biohaven Pharmaceuticals in May 2022. Biohaven … [Read more...] about FDA approves Zavzpret zavegepant nasal spray for the treatment of migraine
FDA approves Amphastar’s naloxone nasal spray for the treatment of opioid overdose
The FDA has approved Amphastar Pharmaceuticals' NDA for 4 mg intranasal naloxone for the treatment of opioid overdose. According to the company, the nasal spray is delivered via a proprietary delivery device. A previous Amphastar NDA for a 2mg naloxone nasal spray received a CRL from the NDA in 2017, with the FDA asking for additional human factors and device … [Read more...] about FDA approves Amphastar’s naloxone nasal spray for the treatment of opioid overdose
Esteve Pharmaceuticals launches Inbrija levodopa DPI in Spain
According to Acorda Therapeutics, Esteve Pharmaceuticals has launched Acorda's Inbrija inhaled dry powder levodopa in Spain. Acorda announced the Spanish distribution deal with Esteve in July 2021. Inbrija DPI has been approved in Europe for the treatment of OFF periods in Parkinson’s disease since 2019. Acorda President and CEO Ron Cohen said, "Today’s … [Read more...] about Esteve Pharmaceuticals launches Inbrija levodopa DPI in Spain
AuraVax names Joseph Sullivan as CEO
AuraVax Therapeutics, which is developing intranasal antiviral technology licensed from Massachusetts General Hospital and the University of Houston, has named former Merck executive Joseph C. Sullivan as the company's first CEO. Sullivan was most recently Chief Commercial Officer at Nature's Toolbox and previously served in various roles at Merck in vaccines, … [Read more...] about AuraVax names Joseph Sullivan as CEO
NeOnc Technologies announces plans to develop NEO100 intranasal perillyl alcohol for pediatric brain tumors
NeOnc Technologies has announced plans to develop its NEO100 intranasal perillyl alcohol for the treatment of high-grade gliomas in children. In 2016, NeOnc initiated a Phase 1/2a trial of NEO100 in adults with glioblastoma multiforme; according to clinicaltrials.gov, that study is expected to be completed in 2024. In 2020,the company published Phase 1 data for 12 … [Read more...] about NeOnc Technologies announces plans to develop NEO100 intranasal perillyl alcohol for pediatric brain tumors