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Business

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

Start up Miist Therapeutics raises $7 million in seed money, is developing inhaled therapies for smoking cessation and migraine

California-based startup Miist Therapeutics, which calls itself "a physics-based developer of inhaled medicines," announced that it has raised $7 million in seed funding and is developing 2 candidates: MST-01 for smoking cessation and MST-02 for the treatment of migraine. Investors included Refractor Capital, Entrepreneur First, and the California Innovation Fund. … [Read more...] about Start up Miist Therapeutics raises $7 million in seed money, is developing inhaled therapies for smoking cessation and migraine

InvisiShield says it is accelerating development of its intranasal antibodies against all influenza A&B, including H5N1 bird flu

InvisiShield Technologies said that it will speed up its H5N1 / Pan-influenza intranasal antibodies development program in response to recent outbreaks of H5N1 avian flu in mammals. The company says that it can move quickly into clinical development because it previously held successful pre-IND meetings with the FDA regarding its IS101 intranasal antibody fusion … [Read more...] about InvisiShield says it is accelerating development of its intranasal antibodies against all influenza A&B, including H5N1 bird flu

Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial

North Carolina-based Belhaven Biopharma announced that it has closed a funding round that raised $11 million for continued development of the company's Nasdepi intranasal dry powder epinephrine for the treatment of anaphylaxis. The company said that the funds will support the completion of clinical development and preparations for an NDA submission. Belhaven also … [Read more...] about Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial

Vast Therapeutics gets ~$2 million NIH grant for development of ALX1 inhalation solution for the treatment of P. aeruginosa lung infections

Vast Therapeutics announced that the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has awarded the company $1,988,594 to support a 2-year project titled "Nebulized ALX1 as a treatment for Pseudomonas aeruginosa infections in bronchiectasis patients." According to the company's web site, "ALX1 contains a water … [Read more...] about Vast Therapeutics gets ~$2 million NIH grant for development of ALX1 inhalation solution for the treatment of P. aeruginosa lung infections

Emergent BioSolutions acquires US and Canadian rights to Hikma’s Kloxxado naloxone nasal spray

Emergent BioSolutions announced that it has signed an agreement to acquire marketing rights to Hikma Pharmaceuticals’ Kloxxado naloxone nasal spray in the US and Canada. Kloxxado, which delivers an 8 mg dose, was approved by the FDA for the reversal of opioid overdose in September 2021. Emergent previously acquired Narcan nasal spray, which delivers a 4 mg dose of … [Read more...] about Emergent BioSolutions acquires US and Canadian rights to Hikma’s Kloxxado naloxone nasal spray

Rein Therapeutics announces name change, upcoming Phase 2 trial of LTI-03 DPI for IPF

A Texas-based company founded as Lung Therapeutics in 2013 and acquired by Aileron Therapeutics in 2023 announced that it has now changed its name to Rein Therapeutics. Lung Therapeutics spun off TFF Pharmaceuticals in 2018 to develop dry powders based on thin film freezing technology licensed from the University of Texas. Rein Therapeutics President and CEO … [Read more...] about Rein Therapeutics announces name change, upcoming Phase 2 trial of LTI-03 DPI for IPF

Leyden Labs raises $70 million for development of its intranasal vaccine platform

Intranasal vaccine developer Leyden Laboratories announced the closing of a $70 million funding round, with proceeds going to support development of prophylactic nasal sprays based on the company's "Mucosal Protection Platform." Leyden Labs, which initiated a Phase 1 trial of its lead candidate, PanFlu intranasal CR9114 anti-hemagglutinin stem human antibody, in … [Read more...] about Leyden Labs raises $70 million for development of its intranasal vaccine platform

Endo recalls epinephrine nasal solution after FDA determination that the product is misbranded

Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company's Adrenalin epinephrine for injection. As a result of the potential for confusion, Endo said, "FDA has determined the product to be misbranded … [Read more...] about Endo recalls epinephrine nasal solution after FDA determination that the product is misbranded

Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium

Aridis Pharmaceuticals said that "an undisclosed pharmaceutical company" has agreed to pay $6.5 million plus annual royalty payments for Aridis' AR-501 nebulized gallium for the treatment of chronic lung infections in patients with cystic fibrosis. Aridis said that it expects to receive 50% of the upfront payment by the end of the first quarter of 2025 and the other … [Read more...] about Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium

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