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
News
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
Bryn Pharma says study demonstrated that its Utuly intranasal epinephrine “provides an enhanced PK profile” compared to autoinjector
Bryn Pharma has presented data from a bioavailability study of its Utuly epinephrine nasal spray demonstrating that 13.2 mg dose of Utuly absorbed as fast and produced higher and longer-lasting epinephrine plasma levels than a 0.3 mg autoinjector. Compared to a 0.5 mg dose of epinephrine delivered via manual syringe, Utuly absorbed faster and reached comparable or … [Read more...] about Bryn Pharma says study demonstrated that its Utuly intranasal epinephrine “provides an enhanced PK profile” compared to autoinjector
Aerami expands development of AER-901 inhaled imatinib to include PH-ILD
Aerami Therapeutics announced that it will develop its AER-901 nebulized imatinib for pulmonary hypertension associated with interstitial lung disease (PH-ILD) in addition to pulmonary arterial hypertension (PAH). The FDA granted orphan drug designation to AER-901 for the PAH indication in August 2021, and the company says that it recently completed a Phase 1 trial of … [Read more...] about Aerami expands development of AER-901 inhaled imatinib to include PH-ILD
ARS Pharmaceuticals reacquires European rights to ARS-1 intranasal epinephrine from Recordati
According to ARS Pharmaceuticals, Recordati has returned the European marketing rights to ARS-1 epinephrine nasal spray (Neffy) in return for an unspecified amount up front plus future milestone payments connected to European approval and launch and royalties on sales in the EU, UK and other countries covered by the original deal. In September 2020, Recordati … [Read more...] about ARS Pharmaceuticals reacquires European rights to ARS-1 intranasal epinephrine from Recordati
Impel announces “streamlining plan,” halts development of INP105 intranasal olanzapine
Impel Pharmaceuticals announced that it will cut 16% of its workforce and halt development of INP105 intranasal olanzapine for the treatment of agitation in autism spectrum disorder. The company also said that its Chief Medical Officer, Stephen Shrewsbury, will be leaving Impel at the end of March. According to the company, the move will allow the company to … [Read more...] about Impel announces “streamlining plan,” halts development of INP105 intranasal olanzapine