Inhaled cannabinoid developer Senzer said that it believes the company is the first to receive ISO 13485:2016 certification for design and development of a pharmaceutical-grade cannabinoid delivery device. Senzer's Systemic inhaled Delivery Device (SiDD) platform recently won two design awards, a 2018 Good Design Award and an iF Design Award. The company is … [Read more...] about Senzer gets ISO 13485:2016 certification
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ARS Pharmaceuticals’ intranasal epinephrine gets Fast Track designation
ARS Pharmaceuticals said that the FDA has granted Fast Track designation to its ARS-1 intranasal epinephrine, which is in development for the treatment of anaphylaxis. In December 2018, the company announced that it had raised $20 million for clinical development of ARS-1. ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “The FDA’s decision to … [Read more...] about ARS Pharmaceuticals’ intranasal epinephrine gets Fast Track designation
Impel NeuroPharma appoints Jennifer L. Berman as VP of Marketing
Intranasal drug developer Impel NeuroPharma has announced the appointment of Jennifer L. Berman VP of Marketing. Berman was most recently Worldwide Brand Director at Novartis Pharmaceuticals. In December 2018, Impel announced that it had raised $67.5 million in a Series D financing round for continued development of intranasal products based on its Precision … [Read more...] about Impel NeuroPharma appoints Jennifer L. Berman as VP of Marketing
OtiTopic gets patents for inhaled aspirin for the treatment of myocardial infarction
The US Patent and Trademark Office (USPTO) has granted OtiTopic, Inc. two patents covering its Asprihale (OTI-0726) inhaled aspirin formulation, which OtiTopic is developing as a rescue treatment for suspected myocardial infarction (MI), the company announced. According to OtiTopic, the Asprihale DPI is also covered by utility patents from the US, Japan, and … [Read more...] about OtiTopic gets patents for inhaled aspirin for the treatment of myocardial infarction
Aradigm files for bankruptcy, plans to sell all assets
Inhaled liposomal ciprofloxacin developer Aradigm Corporation announced that it has filed for bankruptcy under Chapter 11 of the US Bankruptcy Code and plans to sell all of its assets. The company said that "Aradigm remains confident in the efficacy, safety and quality of Apulmiq (US)/Linhaliq (EMA). We are committed to continue working toward the approval of … [Read more...] about Aradigm files for bankruptcy, plans to sell all assets
Glenmark inhaled RORγt inhibitor to be developed by US spin-off
Glenmark Pharmaceuticals has announced that it plans to spin off a US-based company for development of innovative drugs, including GRC 39815, a retinoid-related orphan receptor gamma t (RORγt) inhibitor in pre-clinical development as a potential inhaled treatment for COPD. The new US-based company is expected to employ over 400 people, and all employees, assets, … [Read more...] about Glenmark inhaled RORγt inhibitor to be developed by US spin-off
VistaGen gets notice of allowance for patent covering PH10 nasal spray for the treatment of depression
The US Patent and Trademark Office (USPTO) has provided VistaGen a notice of allowance regarding a patent covering the use of its PH10 nasal spray for the treatment of depression, the company said. VistaGen announced that it had licensed PH10, a neurosteroid nasal spray, from Pherin Pharmaceuticals in October 2018. PH10 is currently in Phase 2 development for the … [Read more...] about VistaGen gets notice of allowance for patent covering PH10 nasal spray for the treatment of depression
FDA advisory committee recommends approval of Janssen’s intranasal esketamine
The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee met on February 12, 2019 to consider Janssen's NDA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults and voted in favor of approval. On the question, "Has the Applicant provided substantial evidence … [Read more...] about FDA advisory committee recommends approval of Janssen’s intranasal esketamine
GSK, Mylan launch generic versions of Advair Diskus in US
Both GSK and Mylan have announced the availability of generic versions of GSK's Advair Diskus fluticasone propionate/salmeterol DPI in the US. GSK made a statement regarding its authorized generic on February 8, 2019, and Mylan has responded by announcing the US launch of the Wixela Inhub fluticasone propionate/salmeterol DPI, which was recently approved by … [Read more...] about GSK, Mylan launch generic versions of Advair Diskus in US
Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus
FluGen has announced that preliminary data from a Phase 2 trial show that its intranasal M2SR manufactured with a strain of influenza that was used in vaccines during the 2008-2010 influenza seasons protected against a live H3N2 influenza virus from the 2014-15 flu season. Demonstrating protection against the highly mismatched virus is a "major step toward … [Read more...] about Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus