Taipei-based inhaled drug developer Asia Scientific Global announced that it has completed a pre-IND meeting with the US FDA regarding its Beta 1 dry powder inhaler, a PDE-5 inhibitor that the company is developing for the treatment of erectile dysfunction. The company said that, "ASG will expedite the revision of clinical trial documents and execute additional test … [Read more...] about ASG says it held pre-IND meeting with FDA regarding Beta 1 PDE-5 inhibitor DPI for erectile dysfunction
News
Silo Pharma announces additional US patent related to SPC-15 intranasal ketamine
According to Silo Pharma, the US Patent and Trademark Office (USPTO) has indicated that it will issue a new patent on March 4, 2025 that will provide protection for Silo's SPC-15 intranasal ketamine. The company says that the expected patent number for the patent titled “Pharmacological Prophylactics Against Stress-Induced Affective Disorders in Females” is … [Read more...] about Silo Pharma announces additional US patent related to SPC-15 intranasal ketamine
Renaissance Lakewood to provide development services for Tiziana’s intranasal foralumab
Tiziana Life Sciences announced that it has contracted with CDMO Renaissance Lakewood for development services related to Tiziana's intranasal foralumab anti-CD3 monoclonal antibody. According to Tiziana, the project includes optimization of the formulation and development of "a comprehensive plan for the scale-up of foralumab in a nasal device." Tiziana is … [Read more...] about Renaissance Lakewood to provide development services for Tiziana’s intranasal foralumab
Boehringer Ingelheim announces initiation of Phase 1/2 trial of BI3720931 inhaled gene therapy for CF
A group comprised of Boehringer Ingelheim, IP Group, the UK Respiratory Gene Therapy Consortium, and CDMO OXB, has announced the initiation of the Phase 1/2 Lenticlair 1 study of BI 3720931, an inhaled lentiviral vector-based gene therapy in adult cystic fibrosis patients who cannot be treated with CFTR modulators. The trial is expected to be completed in 2027. … [Read more...] about Boehringer Ingelheim announces initiation of Phase 1/2 trial of BI3720931 inhaled gene therapy for CF
Zeteo Biomedical launches CygnusMR and Cygnus SDX dry powder nasal delivery devices
Texas-based Zeteo Biomedical has announced the launch of two new devices for intranasal delivery of dry powders: the CygnusMR multi-dose device and the CygnusSDX single dose disposable device. In 2022, the company announced the launch of its ZEOx1 OrionMRQ multi-dose nasal device for delivery of liquid drugs and vaccines. According to Zeteo, the new dry powder nasal … [Read more...] about Zeteo Biomedical launches CygnusMR and Cygnus SDX dry powder nasal delivery devices
Kyorin gets option to license Cyrano’s CYR-064 intranasal theophylline for the Japanese market
Kyorin Pharmaceutical is paying an undisclosed fee for the option to license Japanese development and marketing rights to Cyrano Therapeutics' CYR intranasal theophylline for the treatment of loss of smell, the companies said. A Phase 2 trial of the nasal spray in patients with post-viral hyposmia that was initiated in 2023 is still underway. According to the … [Read more...] about Kyorin gets option to license Cyrano’s CYR-064 intranasal theophylline for the Japanese market
Kexing Biopharm announces FDA approval of IND for GB05 human interferon α1b inhalation solution
According to Kexing Biopharm, the FDA has approved the company's IND for GB05 human interferon alpha-1b inhalation solution, which the company's subsidiary Shenzhen Kexing plans to advance into clinical development for the treatment of lung infections caused by respiratory syncytial virus in children. In April 2024, Kexing announced the initiation of a Phase 3 trial … [Read more...] about Kexing Biopharm announces FDA approval of IND for GB05 human interferon α1b inhalation solution
Ethris gets $5 million from CEPI for development of spray-dried RNA vaccines for nasal delivery
The Coalition for Epidemic Preparedness Innovations (CEPI) is providing $5 million to inhaled RNA developer Ethris for development of spray-dried RNA vaccines for nasal delivery. Ethris said that it plans to focus initially on a vaccine against influenza once a successful process is established. Within the past few months, CEPI also provided funding to an Abera … [Read more...] about Ethris gets $5 million from CEPI for development of spray-dried RNA vaccines for nasal delivery
AIM ImmunoTech announces planned trial of intranasal Ampligen in combination with FluMist against avian flu
AIM ImmunoTech has announced that it plans to move forward with a trial of intranasal Ampligen rintatolimod as an adjuvant to AstraZeneca's FluMist intranasal flu vaccine for the prevention of avian flu. The company said that it plans to run the trial as a follow-up to a 2012 trial of Ampligen in conjunction with FluMist that was conducted at the University of … [Read more...] about AIM ImmunoTech announces planned trial of intranasal Ampligen in combination with FluMist against avian flu
Flu Lab invests $5 million in ENA Respiratory to support development of INNA-051 intranasal dry powder immune enhancer
According to ENA Respiratory, California-based non-profit organization Flu Lab is providing a $5 million investment to support a Phase 2 proof of concept study of the company's INNA-051 intranasal dry powder TLR2/6 agonist for the treatment of viral respiratory infections. The Phase 2 study will take place in the US and evaluate the safety and efficacy of INNA-051 for … [Read more...] about Flu Lab invests $5 million in ENA Respiratory to support development of INNA-051 intranasal dry powder immune enhancer