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
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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
Armata reports results from Phase 1b/2a trial of AP-PA02 inhaled phage therapy, announces initiation of Phase 2 trial of AP-PA02 for NCFB
Armata Pharmaceuticals announced that data from the Phase 1b/2a SWARM-P.a. SAD/MAD study of its AP-PA02 nebulized phage therapy in cystic fibrosis patients with chronic P. aeruginosa lung infections "confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure." The company had announced the completion of the … [Read more...] about Armata reports results from Phase 1b/2a trial of AP-PA02 inhaled phage therapy, announces initiation of Phase 2 trial of AP-PA02 for NCFB
FDA accepts Amneal’s ANDA for generic of Narcan naloxone nasal spray
According to Amneal Pharmaceuticals, the FDA has accepted the company's ANDA for a generic version of Narcan naloxone nasal spray, 4 mg, for the treatment of opioid overdose. Amneal generics Chief Commercial Officer Andy Boyer said, "Naloxone hydrochloride nasal spray is a critical tool in addressing the opioid public health emergency across the United States. We … [Read more...] about FDA accepts Amneal’s ANDA for generic of Narcan naloxone nasal spray
Akorn files for bankruptcy, closes all US facilities
Akorn Pharmaceuticals has filed for Chapter 7 bankruptcy and closed all US facilities, including its manufacturing plant in Decatur, IL. A Decatur newspaper, the Herald Review, published a video of Akorn President and CEO Douglas Boothe informing workers on a Zoom call that the company would lay off all employees without any severance pay or insurance coverage as of … [Read more...] about Akorn files for bankruptcy, closes all US facilities
Oragenics licenses intranasal mucosal adjuvant from Inspirevax for development of NT-CoV2-1 intranasal vaccine
Oragenics has announced a new license agreement with Inspirevax (formerly Biodextris) for use of Inspirevax's BDX301 intranasal mucosal adjuvant in Oragenic's NT-CoV2-1 intranasal COVID-19 vaccine candidate. The company said that the deal includes payments for the achievement of clinical, regulatory and commercial milestones, as well as tiered royalty payments. In … [Read more...] about Oragenics licenses intranasal mucosal adjuvant from Inspirevax for development of NT-CoV2-1 intranasal vaccine
Vistagen gets US patent for PH80 pherine nasal spray for the treatment of migraine
According to Vistagen, the US Patent and Trademark Office (USPTO) has granted US Patent 11,419,881 covering the company's PH80 pherine nasal spray for treatment of migraine until 2040. The company says that "PH80 is an investigational pherine nasal spray designed with a potential rapid-onset mechanism of action that is fundamentally differentiated from all currently … [Read more...] about Vistagen gets US patent for PH80 pherine nasal spray for the treatment of migraine